Potentially Incompatible Goals at F.D.A. – New York Times

The New York Times has an article on the FDA’s competing needs of safety and speed in drug approval.

Potentially Incompatible Goals at F.D.A. – New York Times

Safety and speed are the yin and yang of drug regulation. Patients want immediate access to breakthrough medicines but also want to believe the drugs are safe.

These goals can be incompatible. Race a drug to market and much is likely to remain unknown when patients take it. Test a drug thoroughly to assess all possible risks and its release may be delayed by years.

A series of drug-safety scandals has led many on Capitol Hill to question whether the Food and Drug Administration has failed to strike the right balance between speed and safety. A clear sign of this imbalance, these critics say, is the increasing number of F.D.A. drug-safety officers who say they have been punished or ignored after uncovering dangers of popular medicines.

Safety and speed may be mutually incompatible. The biggest culprit is the Prescription Drug User Fees Act (PDUFA) which stipulated that in exchange for fees paid by pharma to the FDA for speedy approval, pharma would get a say in how that money was used. They used this say to cut down on post approval monitoring, weaken post approval data analysis and generally hide unfavorable results.

Do patients always benefit from speed? Again, you have to make distinctions between acute life threatening conditions and chronic, life management conditions. A delay in the approval of a cancer drug may result in the immediate death of the people affected with the cancer. But, a serious safety issue overlooked in this hasty approval would not hurt a healthy person. Yes, it would affect the cancer patient, but they would accept that risk. Something like Vioxx, or Avandia, on the other hand is a drug potentially consumed by millions of people to treat chronic conditions that can be managed in other ways. Since safety issues affecting these drugs could adversely affect otherwise healthy people, the approval process needs to be much more deliberate, involving more patients, and has to include lengthy post-approval monitoring, adverse event reporting, the availability of all data for meta-analysis, etc.

So why does this not happen? Because pharma makes much more money on that blockbuster “lifestyle” drugs taken by millions of otherwise healthy people. The pool of healthy people is much bigger than the pool of cancer victims. It is in their best interest to get a speedy approval.

The answer I guess is to make a clear distinction between these two different types of drugs and have completely different standards, somehow, I don’t think that will happen.

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