Single payer system within 7 years

I especially love when you believe stats from places like Cuba.

never brought up Cuba...

I was doing an apples to apples comparison of the G-7 nations. and we fall behind every last one of them in key health metrics.

A) Where are NEW drugs going to be developed?
Cost to Develop New Pharmaceutical Drug Now Exceeds $2.5B
A benchmark report estimates that the cost of bringing a drug to market has more than doubled in the past 10 years
CSDD’s finding, a bellwether figure in the drug industry, is based on an average out-of-pocket cost of $1.4 billion and an estimate of $1.2 billion in returns that investors forego on that money during the 10-plus years a drug candidate spends in development. The center’s analysis drew from information provided by 10 pharmaceutical companies on 106 randomly selected drugs first tested in humans between 1995 and 2007.

The study concludes that another $312 million is spent on postapproval development—studies to test new indications, formulations, and dosage strengths—for a life-cycle cost of $2.9 billion,
Cost to Develop New Pharmaceutical Drug Now Exceeds $2.5B

B) So what country in this world has developed more Drugs then the USA???
Obama Care Will End Drug Advances and Europe's Free Ride (Unless China Steps in)
Ninety five percent of the new drugs coming on the market are developed for sale in the United States. They are paid for by American consumers, while other countries, such as Canada, Germany and France, free ride at our expense. The United States is the last major country that allows the market to set prices high enough to compensate pharmaceutical companies for their R&D investments. Obama Care will increasingly control pharmaceutical prices as costs rise and federal and state funds fall short. Major pharmaceutical advances will stop (How well will government labs work?), and the rest of the world will lose along with Americans.
Obama Care Will End Drug Advances and Europe's Free Ride (Unless China Steps in)

C)What is the success rate of a drug???
report released today by the biotech industry’s national trade group finds less than one of every 10 drugs that enter clinical trials is ultimately approved by the Food and Drug Administration.
The report is sponsored by the Biotechnology Innovation Organization, or BIO. Its reported success rate, of 9.6 percent, is less than the success rate cited in a widely cited 2014 study by Tufts University’s Center for the Study of Drug Development, which set the rate of success at 11.8 percent, or one in eight.
http://www.amplion.com/inthenews/report-suggests-drug-approval-rate-now-just-1-in-1
So you think that drugs developed in the US should cost Americans more than in any other country? :rolleyes:

So you think that drugs developed in the US should cost Americans more than in any other country?

How do you stop other countries from stealing our new drug intellectual property? Spell it out.
 
I especially love when you believe stats from places like Cuba.

never brought up Cuba...

I was doing an apples to apples comparison of the G-7 nations. and we fall behind every last one of them in key health metrics.

A) Where are NEW drugs going to be developed?
Cost to Develop New Pharmaceutical Drug Now Exceeds $2.5B
A benchmark report estimates that the cost of bringing a drug to market has more than doubled in the past 10 years
CSDD’s finding, a bellwether figure in the drug industry, is based on an average out-of-pocket cost of $1.4 billion and an estimate of $1.2 billion in returns that investors forego on that money during the 10-plus years a drug candidate spends in development. The center’s analysis drew from information provided by 10 pharmaceutical companies on 106 randomly selected drugs first tested in humans between 1995 and 2007.

The study concludes that another $312 million is spent on postapproval development—studies to test new indications, formulations, and dosage strengths—for a life-cycle cost of $2.9 billion,
Cost to Develop New Pharmaceutical Drug Now Exceeds $2.5B

B) So what country in this world has developed more Drugs then the USA???
Obama Care Will End Drug Advances and Europe's Free Ride (Unless China Steps in)
Ninety five percent of the new drugs coming on the market are developed for sale in the United States. They are paid for by American consumers, while other countries, such as Canada, Germany and France, free ride at our expense. The United States is the last major country that allows the market to set prices high enough to compensate pharmaceutical companies for their R&D investments. Obama Care will increasingly control pharmaceutical prices as costs rise and federal and state funds fall short. Major pharmaceutical advances will stop (How well will government labs work?), and the rest of the world will lose along with Americans.
Obama Care Will End Drug Advances and Europe's Free Ride (Unless China Steps in)

C)What is the success rate of a drug???
report released today by the biotech industry’s national trade group finds less than one of every 10 drugs that enter clinical trials is ultimately approved by the Food and Drug Administration.
The report is sponsored by the Biotechnology Innovation Organization, or BIO. Its reported success rate, of 9.6 percent, is less than the success rate cited in a widely cited 2014 study by Tufts University’s Center for the Study of Drug Development, which set the rate of success at 11.8 percent, or one in eight.
http://www.amplion.com/inthenews/report-suggests-drug-approval-rate-now-just-1-in-1
So you think that drugs developed in the US should cost Americans more than in any other country? :rolleyes:

So you think that drugs developed in the US should cost Americans more than in any other country?

How do you stop other countries from stealing our new drug intellectual property? Spell it out.

I don't think automobiles should cost more in America than any other country and we all NEED our cars!
I don't think auto insurance should cost more in America than any other country!
GEEZ what dumb ass comment.
Now as far as your 2nd point.
Can't you do any research on your own? Do you depend on everyone to supply you with information? Don't you have access to Google??

Under FDA’s Globalization Initiative, the agency addresses the challenge of making sure imported drugs, as well as other products, are as safe and effective as products made in the United States. For example, the agency enters into arrangements with foreign counterpart regulatory authorities to share information about products, which improves FDA’s ability to protect U.S. consumers from unsafe drugs manufactured outside the United States. FDA has also posted staff in certain overseas regions (including China, India, Europe, and Latin America) to expand oversight of imported medical products.

FDA does not oversee the manufacturing of drugs that are imported illegally into the United States, such as those that consumers purchase from Canada or other sources on the Internet, and their quality cannot be assured by FDA.
How does FDA oversee domestic and foreign drug manufacturing?
 
On Fox News, Charles Krauthammer predicts America will have single-payer health care within 7 years

The recent passage of a tweak on Obamacare by the GOP is viewed with disdain by pretty much everyone, just like when the Dims passed Obamacare and were rounded up and thrown out of office.

According to some, however, this will only lead to a single payer in a very short time.

The GOP acted like a bunch of Dims yesterday as they tweaked, not repealed, Obamacare. They were not even very sure what was in the bill, Nancy Pelosi style. They did not even wait for a CBO analysis of what exactly they were voting for. Then they all went to the White House to celebrate like a bunch of retards. Of course, the main objective in Washington is simply to "get things done" that work 100%, 100% of the time for 100% of the population. This is nothing short of a socialist mentality. And since socialism is nothing but a never ending quest for the unattainable, the drum beat will continue for a single payer system

what recent passage of a tweak on Obamacare? the "GOP" hasn't passed anything. the House GOP did.

you still need a senate vote.... and that looks less and less plausible...

don't insult Democrats by saying your wackjob failures in the GOP acted like Dems. the problem with the GOP is that you don't know how to govern and hate this country and its government. that doesn't make you very popular with normal people.
 
I especially love when you believe stats from places like Cuba.

never brought up Cuba...

I was doing an apples to apples comparison of the G-7 nations. and we fall behind every last one of them in key health metrics.

A) Where are NEW drugs going to be developed?
Cost to Develop New Pharmaceutical Drug Now Exceeds $2.5B
A benchmark report estimates that the cost of bringing a drug to market has more than doubled in the past 10 years
CSDD’s finding, a bellwether figure in the drug industry, is based on an average out-of-pocket cost of $1.4 billion and an estimate of $1.2 billion in returns that investors forego on that money during the 10-plus years a drug candidate spends in development. The center’s analysis drew from information provided by 10 pharmaceutical companies on 106 randomly selected drugs first tested in humans between 1995 and 2007.

The study concludes that another $312 million is spent on postapproval development—studies to test new indications, formulations, and dosage strengths—for a life-cycle cost of $2.9 billion,
Cost to Develop New Pharmaceutical Drug Now Exceeds $2.5B

B) So what country in this world has developed more Drugs then the USA???
Obama Care Will End Drug Advances and Europe's Free Ride (Unless China Steps in)
Ninety five percent of the new drugs coming on the market are developed for sale in the United States. They are paid for by American consumers, while other countries, such as Canada, Germany and France, free ride at our expense. The United States is the last major country that allows the market to set prices high enough to compensate pharmaceutical companies for their R&D investments. Obama Care will increasingly control pharmaceutical prices as costs rise and federal and state funds fall short. Major pharmaceutical advances will stop (How well will government labs work?), and the rest of the world will lose along with Americans.
Obama Care Will End Drug Advances and Europe's Free Ride (Unless China Steps in)

C)What is the success rate of a drug???
report released today by the biotech industry’s national trade group finds less than one of every 10 drugs that enter clinical trials is ultimately approved by the Food and Drug Administration.
The report is sponsored by the Biotechnology Innovation Organization, or BIO. Its reported success rate, of 9.6 percent, is less than the success rate cited in a widely cited 2014 study by Tufts University’s Center for the Study of Drug Development, which set the rate of success at 11.8 percent, or one in eight.
http://www.amplion.com/inthenews/report-suggests-drug-approval-rate-now-just-1-in-1
So you think that drugs developed in the US should cost Americans more than in any other country? :rolleyes:

So you think that drugs developed in the US should cost Americans more than in any other country?

How do you stop other countries from stealing our new drug intellectual property? Spell it out.

yeah, it's a pity dubya made that deal with big Pharma.... we should be able to use our bargaining power to lower the price of prescription drugs.

or do you want to pretend it wasn't dubya who made that deal?
 
REMINDER: Dems had a super majority to pass single payer in 2010. they...didn't.

You don't go from 10% of the population not having any insurance to single payer in one step. What the Dems dID was take a giant step towards single payer, and that path will continue. Single payer is inevitable at this point, IMO.
 
I especially love when you believe stats from places like Cuba.

never brought up Cuba...

I was doing an apples to apples comparison of the G-7 nations. and we fall behind every last one of them in key health metrics.

A) Where are NEW drugs going to be developed?
Cost to Develop New Pharmaceutical Drug Now Exceeds $2.5B
A benchmark report estimates that the cost of bringing a drug to market has more than doubled in the past 10 years
CSDD’s finding, a bellwether figure in the drug industry, is based on an average out-of-pocket cost of $1.4 billion and an estimate of $1.2 billion in returns that investors forego on that money during the 10-plus years a drug candidate spends in development. The center’s analysis drew from information provided by 10 pharmaceutical companies on 106 randomly selected drugs first tested in humans between 1995 and 2007.

The study concludes that another $312 million is spent on postapproval development—studies to test new indications, formulations, and dosage strengths—for a life-cycle cost of $2.9 billion,
Cost to Develop New Pharmaceutical Drug Now Exceeds $2.5B

B) So what country in this world has developed more Drugs then the USA???
Obama Care Will End Drug Advances and Europe's Free Ride (Unless China Steps in)
Ninety five percent of the new drugs coming on the market are developed for sale in the United States. They are paid for by American consumers, while other countries, such as Canada, Germany and France, free ride at our expense. The United States is the last major country that allows the market to set prices high enough to compensate pharmaceutical companies for their R&D investments. Obama Care will increasingly control pharmaceutical prices as costs rise and federal and state funds fall short. Major pharmaceutical advances will stop (How well will government labs work?), and the rest of the world will lose along with Americans.
Obama Care Will End Drug Advances and Europe's Free Ride (Unless China Steps in)

C)What is the success rate of a drug???
report released today by the biotech industry’s national trade group finds less than one of every 10 drugs that enter clinical trials is ultimately approved by the Food and Drug Administration.
The report is sponsored by the Biotechnology Innovation Organization, or BIO. Its reported success rate, of 9.6 percent, is less than the success rate cited in a widely cited 2014 study by Tufts University’s Center for the Study of Drug Development, which set the rate of success at 11.8 percent, or one in eight.
http://www.amplion.com/inthenews/report-suggests-drug-approval-rate-now-just-1-in-1
So you think that drugs developed in the US should cost Americans more than in any other country? :rolleyes:

So you think that drugs developed in the US should cost Americans more than in any other country?

How do you stop other countries from stealing our new drug intellectual property? Spell it out.

yeah, it's a pity dubya made that deal with big Pharma.... we should be able to use our bargaining power to lower the price of prescription drugs.

or do you want to pretend it wasn't dubya who made that deal?

No! We need to lessen the Rx drugs impact on cost by using less Rx drugs. People don't take responsibility for their own health. They want a pill to fix high cholesterol, weight, sleep, high blood pressure and the list go on. Rather than change their diet and life style which is more effective and cost less. It just takes the patient taken on ownership for their health.
 
REMINDER: Dems had a super majority to pass single payer in 2010. they...didn't.

You don't go from 10% of the population not having any insurance to single payer in one step. What the Dems dID was take a giant step towards single payer, and that path will continue. Single payer is inevitable at this point, IMO.

I agree...my sister works in medicine and the doctors she works with all support single payer. Krauthammer predicts it in seven years and he may be right....I only hope they do it the right way
 
never brought up Cuba...

I was doing an apples to apples comparison of the G-7 nations. and we fall behind every last one of them in key health metrics.

A) Where are NEW drugs going to be developed?
Cost to Develop New Pharmaceutical Drug Now Exceeds $2.5B
A benchmark report estimates that the cost of bringing a drug to market has more than doubled in the past 10 years
CSDD’s finding, a bellwether figure in the drug industry, is based on an average out-of-pocket cost of $1.4 billion and an estimate of $1.2 billion in returns that investors forego on that money during the 10-plus years a drug candidate spends in development. The center’s analysis drew from information provided by 10 pharmaceutical companies on 106 randomly selected drugs first tested in humans between 1995 and 2007.

The study concludes that another $312 million is spent on postapproval development—studies to test new indications, formulations, and dosage strengths—for a life-cycle cost of $2.9 billion,
Cost to Develop New Pharmaceutical Drug Now Exceeds $2.5B

B) So what country in this world has developed more Drugs then the USA???
Obama Care Will End Drug Advances and Europe's Free Ride (Unless China Steps in)
Ninety five percent of the new drugs coming on the market are developed for sale in the United States. They are paid for by American consumers, while other countries, such as Canada, Germany and France, free ride at our expense. The United States is the last major country that allows the market to set prices high enough to compensate pharmaceutical companies for their R&D investments. Obama Care will increasingly control pharmaceutical prices as costs rise and federal and state funds fall short. Major pharmaceutical advances will stop (How well will government labs work?), and the rest of the world will lose along with Americans.
Obama Care Will End Drug Advances and Europe's Free Ride (Unless China Steps in)

C)What is the success rate of a drug???
report released today by the biotech industry’s national trade group finds less than one of every 10 drugs that enter clinical trials is ultimately approved by the Food and Drug Administration.
The report is sponsored by the Biotechnology Innovation Organization, or BIO. Its reported success rate, of 9.6 percent, is less than the success rate cited in a widely cited 2014 study by Tufts University’s Center for the Study of Drug Development, which set the rate of success at 11.8 percent, or one in eight.
http://www.amplion.com/inthenews/report-suggests-drug-approval-rate-now-just-1-in-1
So you think that drugs developed in the US should cost Americans more than in any other country? :rolleyes:

So you think that drugs developed in the US should cost Americans more than in any other country?

How do you stop other countries from stealing our new drug intellectual property? Spell it out.

yeah, it's a pity dubya made that deal with big Pharma.... we should be able to use our bargaining power to lower the price of prescription drugs.

or do you want to pretend it wasn't dubya who made that deal?

No! We need to lessen the Rx drugs impact on cost by using less Rx drugs. People don't take responsibility for their own health. They want a pill to fix high cholesterol, weight, sleep, high blood pressure and the list go on. Rather than change their diet and life style which is more effective and cost less. It just takes the patient taken on ownership for their health.

No we use our bargaining power to negotiate lower prices. We shouldn't pay more for the same meds here than they do elsewhere

You so understand that's the issue, right?

The rest of your rant is silly and pointless.
 
REMINDER: Dems had a super majority to pass single payer in 2010. they...didn't.

You don't go from 10% of the population not having any insurance to single payer in one step. What the Dems dID was take a giant step towards single payer, and that path will continue. Single payer is inevitable at this point, IMO.
As simple as making Medicare available for everyone .. no problem.
 
Way to go ! I totally agree this guy was a dick. And like most ignorant people what YOU do is you take the EXCEPTION and make it the rule!
ALL drug companies are evil dicks like this guy.

No, he's just more blatant about it. Oh, and I'm not a millennial...

Pfizer (PFE, -0.18%) reports that it donated more than $3 billion in medicines last year, in addition to cash. The pharmaceutical company declined to share details on its biggest cash donations in 2015. But it said that recent grantees include the International Trachoma Initiative, which seeks to eliminate the eye infection that can cause blindness, and Gavi, the Vaccine Alliance, which increases access to immunizations. Pfizer provides employees with the chance to spend up to six months embedding with international aid groups. To date, more than 300 people have participated.

Hey, the local pusher has a policy like that. it's called "Here, Kid, the first one is free!"
 
So you think that drugs developed in the US should cost Americans more than in any other country?

How do you stop other countries from stealing our new drug intellectual property? Spell it out.

We don't.

Here's the thing. When Jonas Salk invented the Polio vaccine, he published the formula and made it available to anyone who wanted to produce it to get it onto the market faster.

A drug shouldn't cost any more than it's cost to produce. Period. The drug companies don't operate like that.

drugcosts.gif
 
So you think that drugs developed in the US should cost Americans more than in any other country?

How do you stop other countries from stealing our new drug intellectual property? Spell it out.

We don't.

Here's the thing. When Jonas Salk invented the Polio vaccine, he published the formula and made it available to anyone who wanted to produce it to get it onto the market faster.

A drug shouldn't cost any more than it's cost to produce. Period. The drug companies don't operate like that.

drugcosts.gif

And your source? Of course you don't put a link to it because you and your ilk are dishonest also I guess you and the above researcher just don't know how to shop around
Screen Shot 2017-07-24 at 7.43.14 AM.png

Prices and Coupons for Valium


On March 26, 1953, American medical researcher Dr. Jonas Salk announces on a national radio show that he has successfully tested a vaccine against poliomyelitis, the virus that causes the crippling disease of polio.

And what he did would NO LONGER be possible!!!

Significant Dates in U.S. Food and Drug Law History
1953
Federal Security Agency
becomes the Department of Health, Education, and Welfare (HEW).
Factory Inspection Amendment clarifies previous law and requires FDA to give manufacturers written reports of conditions observed during inspections and analyses of factory samples.

1954
Miller Pesticide Amendment
spells out procedures for setting safety limits for pesticide residues on raw agricultural commodities.
First large-scale radiological examination of food carried out by FDA when it received reports that tuna suspected of being radioactive was being imported from Japan following atomic blasts in the Pacific. FDA begins monitoring around the clock to meet the emergency.
1955
HEW Secretary Oveta Culp Hobby
appoints a committee of 14 citizens to study the adequacy of FDA's facilities and programs. The committee recommends a substantial expansion of FDA staff and facilities, a new headquarters building, and more use of educational and informational programs.
The Division of Biologics Control became an independent entity within the National Institutes of Health, after polio vaccine thought to have been inactivated is associated with about 260 cases of polio.
1958
Food Additives Amendment
enacted, requiring manufacturers of new food additives to establish safety. The Delaney proviso prohibits the approval of any food additive shown to induce cancer in humans or animals.
FDA publishes in the Federal Register the first list of substances generally recognized as safe (GRAS). The list contains nearly 200 substances.
1959
U.S. cranberry crop
recalled three weeks before Thanksgiving for FDA tests to check for aminotriazole, a weedkiller found to cause cancer in laboratory animals. Cleared berries were allowed a label stating that they had been tested and had passed FDA inspection, the only such endorsement ever allowed by FDA on a food product.
1960
Color Additive Amendment
enacted, requiring manufacturers to establish the safety of color additives in foods, drugs and cosmetics. The Delaney proviso prohibits the approval of any color additive shown to induce cancer in humans or animals.
Federal Hazardous Substances Labeling Act, enforced by FDA, requires prominent label warnings on hazardous household chemical products.
1962
Thalidomide
, a new sleeping pill, is found to have caused birth defects in thousands of babies born in western Europe. News reports on the role of Dr. Frances Kelsey, FDA medical officer, in keeping the drug off the U.S. market, arouse public support for stronger drug regulation.
Kefauver-Harris Drug Amendments passed to ensure drug efficacy and greater drug safety. For the first time, drug manufacturers are required to prove to FDA the effectiveness of their products before marketing them. The new law also exempts from the Delaney proviso animal drugs and animal feed additives shown to induce cancer but which leave no detectable levels of residue in the human food supply.
Consumer Bill of Rights is proclaimed by President John F. Kennedy in a message to Congress. Included are the right to safety, the right to be informed, the right to choose, and the right to be heard.
1965
Drug Abuse Control Amendments
are enacted to deal with problems caused by abuse of depressants, stimulants and hallucinogens.
1966
FDA contracts with the National Academy of Sciences/National Research Council to evaluate the effectiveness of 4,000 drugs approved on the basis of safety alone between 1938 and 1962.
Child Protection Act enlarges the scope of the Federal Hazardous Substances Labeling Act to ban hazardous toys and other articles so hazardous that adequate label warnings could not be written.
Fair Packaging and Labeling Act requires all consumer products in interstate commerce to be honestly and informatively labeled, with FDA enforcing provisions on foods, drugs, cosmetics, and medical devices.
1968
FDA Bureau of Drug Abuse Control
and Treasury Department Bureau of Narcotics are transferred to the Department of Justice to form the Bureau of Narcotics and Dangerous Drugs (BNDD), consolidating efforts to police traffic in abused drugs.
Reorganization of federal health programs places FDA in the Public Health Service.
FDA forms the Drug Efficacy Study Implementation (DESI) to implement recommendations of the National Academy of Sciences investigation of effectiveness of drugs first marketed between 1938 and 1962.
Animal Drug Amendments place all regulation of new animal drugs under one section of the Food, Drug, and Cosmetic Act-Section 512-making approval of animal drugs and medicated feeds more efficient.
1969
FDA begins administering Sanitation Programs for milk, shellfish, food service, and interstate travel facilities, and for preventing poisoning and accidents. These responsibilities were transferred from other units of the Public Health Service.
The White House Conference on Food, Nutrition, and Health recommends systematic review of GRAS substances in light of FDA's ban of the artificial sweetener cyclamate. President Nixon orders FDA to review its GRAS list.
1970
In Upjohn v. Finch the Court of Appeals upholds enforcement of the 1962 drug effectiveness amendments by ruling that commercial success alone does not constitute substantial evidence of drug safety and efficacy.

FDA requires the first patient package insert: oral contraceptives must contain information for the patient about specific risks and benefits.
The Comprehensive Drug Abuse Prevention and Control Act replaces previous laws and categorizes drugs based on abuse and addiction potential compared to their therapeutic value.
Environmental Protection Agency established; takes over FDA program for setting pesticide tolerances.
1971
PHS Bureau of Radiological Health
transferred to FDA. Its mission: protection against unnecessary human exposure to radiation from electronic products in the home, industry, and the healing arts
National Center for Toxicological Research is established in the biological facilities of the Pine Bluff Arsenal in Arkansas. Its mission is to examine biological effects of chemicals in the environment, extrapolating data from experimental animals to human health.
Artificial sweetener saccharin, included in FDA's original GRAS list, is removed from the list pending new scientific study.
1972
Over-the-Counter Drug Review
begun to enhance the safety, effectiveness and appropriate labeling of drugs sold without prescription.
Regulation of Biologics--including serums, vaccines, and blood products--is transferred from NIH to FDA.
1973
The U.S. Supreme Court
upholds the 1962 drug effectiveness law and endorses FDA action to control entire classes of products by regulations rather than to rely only on time-consuming litigation.
Low-acid food processing regulations issued, after botulism outbreaks from canned foods, to ensure that low-acid packaged foods have adequate heat treatment and are not hazardous.
Consumer Product Safety Commission created by Congress; takes over programs pioneered by FDA under 1927 Caustic Poison Act, 1960 Federal Hazardous Substances Labeling Act, 1966 Child Protection Act, and PHS accident prevention activities for safety of toys, home appliances, etc.
1976
Medical Device Amendments
passed to ensure safety and effectiveness of medical devices, including diagnostic products. The amendments require manufacturers to register with FDA and follow quality control procedures. Some products must have pre-market approval by FDA; others must meet performance standards before marketing.
Vitamins and Minerals Amendments ("Proxmire Amendments") stop FDA from establishing standards limiting potency of vitamins and minerals in food supplements or regulating them as drugs based solely on potency.
1977
Saccharin Study and Labeling Act
passed by Congress to stop FDA from banning the chemical sweetener but requiring a label warning that it has been found to cause cancer in laboratory animals.
Introduction of the Bioresearch Monitoring Program as an agency-wide initiative ensures the quality and integrity of data submitted to FDA and provides for the protection of human subjects in clinical trials by focusing on preclinical studies on animals, clinical investigations, and the work of institutional review boards.
1979
In the hours following the Three Mile Island nuclear emergency of March 28, 1979, FDA contracted with firms in Missouri, Michigan, and New Jersey to prepare and package enough doses of potassium iodide to protect those threatened with thyroid cancer if exposed to radiation. Nearly one quarter of a million bottles-enough for every household in the area-were delivered to Harrisburg, Pennsylvania within 72 hours.
1980
Infant Formula Act
establishes special FDA controls to ensure necessary nutritional content and safety
1981
FDA and the Department of Health and Human Services revise regulations for human subject protections, based on the 1979 Belmont Report, which had been issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The revised rules provide for wider representation on institutional review boards and they detail elements of what constitutes informed consent, among other provisions.

1982
Tamper-resistant Packing Regulations
issued by FDA to prevent poisonings such as deaths from cyanide placed in Tylenol capsules. The Federal Anti-Tampering Act passed in 1983 makes it a crime to tamper with packaged consumer products.
FDA publishes first Red Book (successor to 1949 "black book"), officially known as Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food.
1983
Orphan Drug Act
passed, enabling FDA to promote research and marketing of drugs needed for treating rare diseases.
1984
Fines Enhancement Laws
of 1984 and 1987 amend the U.S. Code to greatly increase penalties for all federal offenses. The maximum fine for individuals is now $100,000 for each offense and $250,000 if the violation is a felony or causes death. For corporations, the amounts are doubled.
Drug Price Competition and Patent Term Restoration Act expedites the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of brand-name drugs without repeating the research done to prove them safe and effective. At the same time, the brand-name companies can apply for up to five years additional patent protection for the new medicines they developed to make up for time lost while their products were going through FDA's approval process.
1985
AIDS test for blood
approved by FDA in its first major action to protect patients from infected donors.
1986
Childhood Vaccine Act
requires patient information on vaccines, gives FDA authority to recall biologics, and authorizes civil penalties.
1987
Investigational drug regulations revised
to expand access to experimental drugs for patients with serious diseases with no alternative therapies.
1988
Food and Drug Administration Act
of 1988 officially establishes FDA as an agency of the Department of Health and Human Services with a Commissioner of Food and Drugs appointed by the President with the advice and consent of the Senate, and broadly spells out the responsibilities of the Secretary and the Commissioner for research, enforcement, education, and information.

The Prescription Drug Marketing Act bans the diversion of prescription drugs from legitimate commercial channels. Congress finds that the resale of such drugs leads to the distribution of mislabeled, adulterated, subpotent, and counterfeit drugs to the public. The new law requires drug wholesalers to be licensed by the states; restricts reimportation from other countries; and bans sale, trade or purchase of drug samples, and traffic or counterfeiting of redeemable drug coupons.

Generic Animal Drug and Patent Term Restoration Act
extends to veterinary products benefits given to human drugs under the 1984 Drug Price Competition and Patent Term Restoration Act. Companies can produce and sell generic versions of animal drugs approved after October 1962 without duplicating research done to prove them safe and effective. The act also authorizes extension of animal drug patents.
1989
FDA issues a nationwide recall of all over-the-counter dietary supplements containing 100 milligrams or more of L-Tryptophan, due to a clear link between the consumption of L-tryptophan tablets and its association with a U.S. outbreak of Eosinophilia Myalgia Syndrome (EMS), characterized by fatigue, shortness of breath, and other symptoms. By 1990 the Centers for Disease Control and Prevention confirm over 1,500 cases of EMS, including 38 deaths, and FDA prohibits the importation of l-tryptophan.
1990
Responding to increasing illicit traffic, Congress passes the Anabolic Steroid Act of 1990, which identifies anabolic steroids as a class of drugs and specifies over two dozen items as controlled substances. In addition, a four-part definition of this class is established to permit new, black market compounds to be assigned to this category, and thus subject to regulation as controlled substances.
Nutrition Labeling and Education Act requires all packaged foods to bear nutrition labeling and all health claims for foods to be consistent with terms defined by the Secretary of Health and Human Services. The law preempts state requirements about food standards, nutrition labeling, and health claims and, for the first time, authorizes some health claims for foods. The food ingredient panel, serving sizes, and terms such as "low fat" and "light" are standardized.
Safe Medical Devices Act is passed, requiring nursing homes, hospitals, and other facilities that use medical devices to report to FDA incidents that suggest that a medical device probably caused or contributed to the death, serious illness, or serious injury of a patient. Manufacturers are required to conduct post-market surveillance on permanently implanted devices whose failure might cause serious harm or death, and to establish methods for tracing and locating patients depending on such devices. The act authorizes FDA to order device product recalls and other actions.
1991
Regulations published to Accelerate the Review of Drugs for life-threatening diseases.
The policy for protection of human subjects in research, promulgated in 1981 by FDA and the Department of Health and Human Services, is adopted by more than a dozen federal entities involved in human subject research and becomes known as the Common Rule. This rule issues requirements for researchers who obtain and document informed consent, secures special protection for children, women, and prisoners, elaborates on required procedures for institutional review boards, and ensures that research institutions comply with the regulations.
1992
Generic Drug Enforcement Act
imposes debarment and other penalties for illegal acts involving abbreviated drug applications.

Prescription Drug User Fee Act
requires drug and biologics manufacturers to pay fees for product applications and supplements, and other services. The act also requires FDA to use these funds to hire more reviewers to assess applications.
Mammography Quality Standards Act requires all mammography facilities in the United States to be accredited and federally certified as meeting quality standards effective Oct. 1, 1994. After initial certification, facilities must pass annual inspections by federal or state inspectors.
Nutrition facts, basic per-serving nutritional information, are required on foods under the Nutrition Labeling and Education Act of 1990. Based on the latest public health recommendations, FDA and the Food Safety and Inspection Service of the Department of Agriculture recreate the food label to list the most important nutrients in an easy-to-follow format.

1993
A consolidation of several adverse reaction reporting systems is launched as MedWatch, designed for voluntary reporting of problems associated with medical products to be filed with FDA by health professionals.
Revising a policy from 1977 that excluded women of childbearing potential from early drug studies, FDA issues guidelines calling for improved assessments of medication responses as a function of gender. Companies are encouraged to include patients of both sexes in their investigations of drugs and to analyze any gender-specific phenomena.
1994
Dietary Supplement Health and Education Act
establishes specific labeling requirements, provides a regulatory framework, and authorizes FDA to promulgate good manufacturing practice regulations for dietary supplements. This act defines "dietary supplements" and "dietary ingredients" and classifies them as food. The act also establishes a commission to recommend how to regulate claims.
FDA announces it could consider regulating nicotine in cigarettes as a drug, in response to a Citizen's Petition by the Coalition on Smoking OR Health.
Uruguay Round Agreements Act extends the patent terms of U.S. drugs from 17 to 20 years.
Animal Medicinal Drug Use Clarification Act allows veterinarians to prescribe extra-label use of veterinary drugs for animals under specific circumstances. In addition, the legislation allows licensed veterinarians to prescribe human drugs for use in animals under certain conditions.
1995

FDA declares cigarettes to be "drug delivery devices." Restrictions are proposed on marketing and sales to reduce smoking by young people.

A series of proposed reforms to reduce regulatory burden on pharmaceutical manufacturers is announced, including an expansion of allowable promotional material on approved uses of drugs that firms can distribute to health professionals, streamlining certain elements in the documentation of investigational drug studies, and a reduction in both environmental impact filings and pre-approval requirements in tablet manufacture.
1996
Federal Tea Tasters Repeal Act
repeals the Tea Importation Act of 1897 to eliminate the Board of Tea Experts and user fees for FDA's testing of all imported tea. Tea itself is still regulated by FDA.
Saccharin Notice Repeal Act repeals the saccharin notice requirements.
Animal Drug Availability Act adds flexibility to animal drug approval process, providing for flexible labeling and more direct communication between drug sponsors and FDA.
Food Quality Protection Act amends the Food, Drug, and Cosmetic Act, eliminating application of the Delaney proviso to pesticides.
1997
Food and Drug Administration Modernization Act
reauthorizes the Prescription Drug User Fee Act of 1992 and mandates the most wide-ranging reforms in agency practices since 1938. Provisions include measures to accelerate review of devices, regulate advertising of unapproved uses of approved drugs and devices, and regulate health claims for foods.
1998
FDA promulgates the Pediatric Rule, a regulation that requires manufacturers of selected new and extant drug and biological products to conduct studies to assess their safety and efficacy in children
Mammography Quality Standards Reauthorization Act continues 1992 Act until 2002.
First phase to consolidate FDA laboratories nationwide from 19 facilities to 9 by 2014 includes dedication of the first of five new regional laboratories.

1999
ClinicalTrials.gov
is founded to provide the public with updated information on enrollment in federally and privately supported clinical research, thereby expanding patient access to studies of promising therapies.
A final rule mandates that all over-the-counter drug labels must contain data in a standardized format. These drug facts are designed to provide the patient with easy-to-find information, analogous to the nutrition facts label for foods.
2000
The U. S. Supreme Court, upholding an earlier decision in Food and Drug Administration v. Brown & Williamson Tobacco Corp. et al., ruled 5-4 that FDA does not have authority to regulate tobacco as a drug. Within weeks of this ruling, FDA revokes its final rule, issued in 1996, that restricted the sale and distribution of cigarettes and smokeless tobacco products to children and adolescents, and that determined that cigarettes and smokeless tobacco products are combination products consisting of a drug (nicotine) and device components intended to deliver nicotine to the body.
Federal agencies are required to issue guidelines to maximize the quality, objectivity, utility, and integrity of the information they generate, and to provide a mechanism whereby those affected can secure correction of information that does not meet these guidelines, under the Data Quality Act.
Publication of a rule on dietary supplements defines the type of statement that can be labeled regarding the effect of supplements on the structure or function of the body.
2002
The Best Pharmaceuticals for Children Act
improves safety and efficacy of patented and off-patent medicines for children. It continues the exclusivity provisions for pediatric drugs as mandated under the Food and Drug Administration Modernization Act of 1997, in which market exclusivity of a drug is extended by six months, and in exchange the manufacturer carries out studies of the effects of drugs when taken by children. The provisions both clarify aspects of the exclusivity period and amend procedures for generic drug approval in cases when pediatric guidelines are added to the labeling.
In the wake of the events of September 11, 2001, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 is designed to improve the country's ability to prevent and respond to public health emergencies, and provisions include a requirement that FDA issue regulations to enhance controls over imported and domestically produced commodities it regulates.
Under the Medical Device User Fee and Modernization Act, fees are assessed sponsors of medical device applications for evaluation, provisions are established for device establishment inspections by accredited third-parties, and new requirements emerge for reprocessed single-use devices.
The Office of Combination Products is formed within the Office of the Commissioner, as mandated under the Medical Device User Fee and Modernization Act, to oversee review of products that fall into multiple jurisdictions within FDA.
An effort to enhance and update the regulation of manufacturing processes and end-product quality of animal and human drugs and biological medicines is announced, the current good manufacturing practice (cGMP) initiative. The goals of the initiative are to focus on the greatest risks to public health in manufacturing procedures, to ensure that process and product quality standards do not impede innovation, and to apply a consistent approach to these issues across FDA.
2003
The Medicare Prescription Drug Improvement and Modernization Act requires, among other elements, that a study be made of how current and emerging technologies can be utilized to make essential information about prescription drugs available to the blind and visually impaired.
To help consumers choose heart-healthy foods, the Department of Health and Human Services announces that FDA will require food labels to include trans fat content, the first substantive change to the nutrition facts panel on foods since the label was changed in 1993.
An obesity working group is established by the Commissioner of Food and Drugs, charged to develop an action plan to deal with the nation's obesity epidemic from the perspective of FDA. In March 2004 the group releases "Calories Count: Report of the Obesity Working Group," which addresses issues connected to the food label, obesity therapeutics, research needs, the role of education, and other topics.
The National Academy of Sciences releases "Scientific Criteria to Ensure Safe Food," a report commissioned by FDA and the Department of Agriculture, which buttresses the value of the Hazard Analysis and Critical Control Point (HACCP) approach to food safety already in place at FDA and invokes the need for continued efforts to make food safety a vital part of our overall public health mission.
The Animal Drug User Fee Act permits FDA to collect subsidies for the review of certain animal drug applications from sponsors, analogous to laws passed for the evaluation of other products FDA regulates, ensuring the safety and effectiveness of drugs for animals and the safety of animals used as foodstuffs.
FDA is given clear authority under the Pediatric Research Equity Act to require that sponsors conduct clinical research into pediatric applications for new drugs and biological products.
2004
Project BioShield Act of 2004
authorizes FDA to expedite its review procedures to enable rapid distribution of treatments as countermeasures to chemical, biological, and nuclear agents that may be used in a terrorist attack against the U. S., among other provisions.
Passage of the Food Allergy Labeling and Consumer Protection Act requires the labeling of any food that contains a protein derived from any one of the following foods that, as a group, account for the vast majority of food allergies: peanuts, soybeans, cow's milk, eggs, fish, crustacean shellfish, tree nuts, and wheat.
A ban on over-the-counter steroid precursors, increased penalties for making, selling, or possessing illegal steroids precursors, and funds for preventive education to children are features of the Anabolic Steroid Control Act of 2004.
FDA publishes "Innovation or Stagnation? -- Challenge and Opportunity on the Critical Path to New Medical Products," which examines the critical path needed to bring therapeutic products to fruition, and how FDA can collaborate in the process, from laboratory to production to end use, to make medical breakthroughs available to those in need as quickly as possible.
Based on recent results from controlled clinical studies indicating that Cox-2 selective agents may be connected to an elevated risk of serious cardiovascular events, including heart attack and stroke, FDA issues a public health advisory urging health professionals to limit the use of these drugs.
To provide for the treatment of animal species other than cattle, horses, swine, chickens, turkeys, dogs, and cats, as well as other species that may be added at a later time, the Minor Use and Minor Species Animal Health Act is passed to encourage the development of treatments for species that would otherwise attract little interest in the development of veterinary therapies.
Deeming such products to present an unreasonable risk of harm, FDA bans dietary supplements containing ephedrine alkaloids based on an increasing number of adverse events linked to these products and the known pharmacology of these alkaloids.
2005
Formation of the Drug Safety Board is announced, consisting of FDA staff and representatives from the National Institutes of Health and the Veterans Administration. The Board will advise the Director, Center for Drug Evaluation and Research, FDA, on drug safety issues and work with the agency in communicating safety information to health professionals and patients.

2009
President Obama signs the Family Smoking Prevention and Tobacco Control Act into law. The Tobacco Control Act gives FDA authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health.

FDA Center for Tobacco Products established.
FDA announced a ban on cigarettes with flavors characterizing fruit, candy, or clove.
2011
FDA Food Safety and Modernization Act (FSMA).
FSMA provides FDA with new enforcement authorities related to food safety standards, gives FDA tools to hold imported foods to the same standards as domestic foods, and directs FDA to build an integrated national food safety system in partnership with state and local authorities.
2012
Food and Drug Administration Safety and Innovation Act (FDASIA).
Expands FDA authorities to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biological products; promotes innovation to speed patient access to safe and effective products; increases stakeholder involvement in FDA processes, and enhances the safety of the drug supply chain.
Medical Device User Fee and Modernization Act (MDUFMA III). As part of FDASIA, reauthorizes user fees from industry to fund reviews of medical devices in exchange for FDA to meet certain performance goals.

In 2012, an outbreak of fungal meningitis linked to a contaminated compounded drug product resulted in the loss of 64 lives and caused more than 751 illnesses. In response, Congress enacted the 2013 Drug Quality and Security Act (DQSA) that insures greater regulatory oversight of facilities creating compounded drugs.
2013
Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA).
Establishes and reauthorizes certain programs under the Public Health Service Act and the Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response.

Drug Quality and Security Act. Following an outbreak in 2012 of an epidemic of fungal meningitis linked to a compounded steroid, Congress enacted the Drug Quality Safety and Security Act (DQSA). Among other provisions it outlines steps for an electronic and interoperable system to identify and trace certain prescription drugs throughout the U.S.
 
Last edited:
REMINDER: Dems had a super majority to pass single payer in 2010. they...didn't.

You don't go from 10% of the population not having any insurance to single payer in one step. What the Dems dID was take a giant step towards single payer, and that path will continue. Single payer is inevitable at this point, IMO.
And 18 million Under 34 making over $50,000 didn't want their employers' insurance because they were able to save money using health savings account and paying the few medical expenses out of that! Yet they were counted as part of the "46 million" as well as 10 million illegals and 14 million that never knew they were eligible for Medicaid!
These are the facts!
never46millionrev2.png
 
REMINDER: Dems had a super majority to pass single payer in 2010. they...didn't.

You don't go from 10% of the population not having any insurance to single payer in one step. What the Dems dID was take a giant step towards single payer, and that path will continue. Single payer is inevitable at this point, IMO.

I agree...my sister works in medicine and the doctors she works with all support single payer. Krauthammer predicts it in seven years and he may be right....I only hope they do it the right way


There is no "right" way to do it on a Federal level. Check out how well the VA system works and explain why anybody would be confident our federal government is going to know how to run a national single payer system. There are ways to do it, but our government won't do it the right way, I guarantee it. It will harm the poor and lower class more than the people who can afford to pay for their healthcare.
 
I especially love when you believe stats from places like Cuba.

never brought up Cuba...

I was doing an apples to apples comparison of the G-7 nations. and we fall behind every last one of them in key health metrics.

A) Where are NEW drugs going to be developed?
Cost to Develop New Pharmaceutical Drug Now Exceeds $2.5B
A benchmark report estimates that the cost of bringing a drug to market has more than doubled in the past 10 years
CSDD’s finding, a bellwether figure in the drug industry, is based on an average out-of-pocket cost of $1.4 billion and an estimate of $1.2 billion in returns that investors forego on that money during the 10-plus years a drug candidate spends in development. The center’s analysis drew from information provided by 10 pharmaceutical companies on 106 randomly selected drugs first tested in humans between 1995 and 2007.

The study concludes that another $312 million is spent on postapproval development—studies to test new indications, formulations, and dosage strengths—for a life-cycle cost of $2.9 billion,
Cost to Develop New Pharmaceutical Drug Now Exceeds $2.5B

B) So what country in this world has developed more Drugs then the USA???
Obama Care Will End Drug Advances and Europe's Free Ride (Unless China Steps in)
Ninety five percent of the new drugs coming on the market are developed for sale in the United States. They are paid for by American consumers, while other countries, such as Canada, Germany and France, free ride at our expense. The United States is the last major country that allows the market to set prices high enough to compensate pharmaceutical companies for their R&D investments. Obama Care will increasingly control pharmaceutical prices as costs rise and federal and state funds fall short. Major pharmaceutical advances will stop (How well will government labs work?), and the rest of the world will lose along with Americans.
Obama Care Will End Drug Advances and Europe's Free Ride (Unless China Steps in)

C)What is the success rate of a drug???
report released today by the biotech industry’s national trade group finds less than one of every 10 drugs that enter clinical trials is ultimately approved by the Food and Drug Administration.
The report is sponsored by the Biotechnology Innovation Organization, or BIO. Its reported success rate, of 9.6 percent, is less than the success rate cited in a widely cited 2014 study by Tufts University’s Center for the Study of Drug Development, which set the rate of success at 11.8 percent, or one in eight.
http://www.amplion.com/inthenews/report-suggests-drug-approval-rate-now-just-1-in-1
So you think that drugs developed in the US should cost Americans more than in any other country? :rolleyes:

So you think that drugs developed in the US should cost Americans more than in any other country?

How do you stop other countries from stealing our new drug intellectual property? Spell it out.

yeah, it's a pity dubya made that deal with big Pharma.... we should be able to use our bargaining power to lower the price of prescription drugs.

or do you want to pretend it wasn't dubya who made that deal?

yeah, it's a pity dubya made that deal with big Pharma

Tell me more.......
 
A) Where are NEW drugs going to be developed?
Cost to Develop New Pharmaceutical Drug Now Exceeds $2.5B
A benchmark report estimates that the cost of bringing a drug to market has more than doubled in the past 10 years
CSDD’s finding, a bellwether figure in the drug industry, is based on an average out-of-pocket cost of $1.4 billion and an estimate of $1.2 billion in returns that investors forego on that money during the 10-plus years a drug candidate spends in development. The center’s analysis drew from information provided by 10 pharmaceutical companies on 106 randomly selected drugs first tested in humans between 1995 and 2007.

The study concludes that another $312 million is spent on postapproval development—studies to test new indications, formulations, and dosage strengths—for a life-cycle cost of $2.9 billion,
Cost to Develop New Pharmaceutical Drug Now Exceeds $2.5B

B) So what country in this world has developed more Drugs then the USA???
Obama Care Will End Drug Advances and Europe's Free Ride (Unless China Steps in)
Ninety five percent of the new drugs coming on the market are developed for sale in the United States. They are paid for by American consumers, while other countries, such as Canada, Germany and France, free ride at our expense. The United States is the last major country that allows the market to set prices high enough to compensate pharmaceutical companies for their R&D investments. Obama Care will increasingly control pharmaceutical prices as costs rise and federal and state funds fall short. Major pharmaceutical advances will stop (How well will government labs work?), and the rest of the world will lose along with Americans.
Obama Care Will End Drug Advances and Europe's Free Ride (Unless China Steps in)

C)What is the success rate of a drug???
report released today by the biotech industry’s national trade group finds less than one of every 10 drugs that enter clinical trials is ultimately approved by the Food and Drug Administration.
The report is sponsored by the Biotechnology Innovation Organization, or BIO. Its reported success rate, of 9.6 percent, is less than the success rate cited in a widely cited 2014 study by Tufts University’s Center for the Study of Drug Development, which set the rate of success at 11.8 percent, or one in eight.
http://www.amplion.com/inthenews/report-suggests-drug-approval-rate-now-just-1-in-1
So you think that drugs developed in the US should cost Americans more than in any other country? :rolleyes:

So you think that drugs developed in the US should cost Americans more than in any other country?

How do you stop other countries from stealing our new drug intellectual property? Spell it out.

yeah, it's a pity dubya made that deal with big Pharma.... we should be able to use our bargaining power to lower the price of prescription drugs.

or do you want to pretend it wasn't dubya who made that deal?

No! We need to lessen the Rx drugs impact on cost by using less Rx drugs. People don't take responsibility for their own health. They want a pill to fix high cholesterol, weight, sleep, high blood pressure and the list go on. Rather than change their diet and life style which is more effective and cost less. It just takes the patient taken on ownership for their health.

No we use our bargaining power to negotiate lower prices. We shouldn't pay more for the same meds here than they do elsewhere

You so understand that's the issue, right?

The rest of your rant is silly and pointless.

We shouldn't pay more for the same meds here than they do elsewhere

How do you stop other countries from stealing our new drug intellectual property?
 
So you think that drugs developed in the US should cost Americans more than in any other country?

How do you stop other countries from stealing our new drug intellectual property? Spell it out.

We don't.

Here's the thing. When Jonas Salk invented the Polio vaccine, he published the formula and made it available to anyone who wanted to produce it to get it onto the market faster.
A drug shouldn't cost any more than it's cost to produce. Period. The drug companies don't operate like that.

drugcosts.gif

We don't.

Exactly. So why are you whining?

A drug shouldn't cost any more than it's cost to produce.

Currently, a new drug that gains approval in the US costs $2.6 billion.
 
On Fox News, Charles Krauthammer predicts America will have single-payer health care within 7 years

The recent passage of a tweak on Obamacare by the GOP is viewed with disdain by pretty much everyone, just like when the Dims passed Obamacare and were rounded up and thrown out of office.

According to some, however, this will only lead to a single payer in a very short time.

The GOP acted like a bunch of Dims yesterday as they tweaked, not repealed, Obamacare. They were not even very sure what was in the bill, Nancy Pelosi style. They did not even wait for a CBO analysis of what exactly they were voting for. Then they all went to the White House to celebrate like a bunch of retards. Of course, the main objective in Washington is simply to "get things done" that work 100%, 100% of the time for 100% of the population. This is nothing short of a socialist mentality. And since socialism is nothing but a never ending quest for the unattainable, the drum beat will continue for a single payer system

Did he mentioned that our government will be bankrupt in 7 years also?
 

Forum List

Back
Top