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[Hugo]

From www.fdareview.com/reform

Drop the Proof-of-Efficacy Requirement

Prior to 1962, the FDA screened drugs only for safety. NDAs did not have to demonstrate efficacy. As we have seen, the pre-1962 years were a time of great pharmaceutical advance. Also, we know from the current practice of off-label prescriptions that a panoply of nongovernmental institutions research, mediate, and certify efficacy of drugs, quite apart from FDA efficacy evaluation. Hence, there is strong evidence that private enterprise and tort law takes care of efficacy and that the costs, delays, and drug loss from FDA efficacy requirements are unredeemed. A splendid reform, therefore, would be to drop the proof-of-efficacy requirements in drug approval and return to the pre-1962 principle of requiring only proof of safety. That simple reform would greatly expand the range of drugs developed (in particular for rare diseases), increase the speed with which they get to market, and significantly reduce costs and drug prices.

An excellent website I recommend everyone investigate. This amendment was responsible for depriving heart patients life saving medications in the 60's and AIDS patients from life saving medications in the 80's. Nor were aspirin companies allowed to advertise the potential life savings benefits of aspirin in preventing heart attacks until well after it was commonly accepted in the medical community.

While we can only estimate the number of deaths due to medicines never developed due to the Kefauver Amendment and the number of deaths prevented from the prevention of ineffective drugs, due to the Kefauver Amendment, analysis of pre-Kefauver Amendment drug development and deaths due to ineffective, or unsafe, medications in the same era overwhelmingly indicates that there is a huge net loss of lives due to this amendment.

[Jaime]

<div><table width='50%' cellpadding='0' cellspacing='0' style='border: 1px solid black' align='center'><tr><td class='maintitle'> Topic closed...</td></tr><tr><td id='QUOTE'>Reason: Question to debate too vague or missing.<br /><br />Recommended action: If you started this topic, please contact the staff member who closed it by clicking the PM button below this post with a clear question to debate.<br /><br />Helpful links:<br />- Starting New Topics<br />- Survival Guide<br />- The Rules<br />- Staff Directory</td></tr><tr><td class='darkrow1'><div align='center'>Note: This is an automated response.</div></td></tr></table></div>

[Jaime]

REOPENED.

TOPIC TO DEBATE:
Should the Kefauver Amendment be repealed?

[DaffyGrl]

Should the Kefauver Amendment be repealed?

No, I don't believe so. Drug companies are too greedy by half, and allowing them freer rein is a frightening thought. That is not to say that change doesn't need to happen-it most certainly does.

Many pharmaceuticals took advantage of a trusting public to sell largely ineffective and sometimes dangerous substances. The unregulated use of antibiotics in throat lozenges and syrups resulted in bacteria becoming resistant to useful drugs and provoked sometimes-fatal allergic reactions.

Calls that proof of efficacy be legally required received an inhospitable reception in the pro-business climate of the Eisenhower administration. In 4 years of Senate hearings (1959-62), Tennessee Senator Estes Kefauver waged a lonely battle trying to expose drug industry stock manipulation, advertising fraud, collusion with the FDA and deception of the public.

The current turf-conscious, restrictive attitude of the FDA is the bureaucratic descendant of the originally well-founded FDA distrust of unscrupulous drug companies which conducted hurried, badly designed trials and rushed shabby data to the FDA to gain New Drug Application (NDA) approval before rival companies could develop similar products. ActUp

(emphasis mine)
This statement, from the thread originator's referenced website bothers me:

The number of victims of Elixir Sulfanilamide tragedy and of all other drug tragedies prior to 1962 is very small compared to the death toll of the post-1962 FDA. FDA Review

I have a problem with this statement. The Elixir deaths occurred in 1937, when the population was much, much smaller. I have no doubts that if drug companies were given unrestricted license to release drugs to the market without testing their effectiveness, we would see another Thalidomide-type tragedy with several more times the deaths attributed to the "Elixer."

I think, rather than repealing the Amendment and returning to the days when greedy drug companies rushed new drugs to market without researching whether or not they did what the company claimed (and did it without extremely harmful side effects); the process of getting a drug to market should be streamlined. The FDA has become a ponderous, bloated bureaucracy. Instead of dismantling Kefauver, effort should be directed in making the FDA process more efficient and productive. According to the same website, when Kefauver was initially enacted, it took an average of 30 months to get a drug to market with the new restrictions; now it’s 8 YEARS. That could change, and should.

Over time there has been a clear tendency for FDA regulations and requirements to expand and multiply. In 1980, the typical drug underwent thirty clinical trials involving about fifteen hundred patients. By the mid-1990s, the typical drug had to undergo more than sixty clinical trials involving nearly five thousand patients. FDA Review