Drug Truths

A site devoted to teaching about drug discovery and development.

Why Doesn’t the FDA Get More Respect?

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It is surprising that a recent commentary in the September 21st issue of the Journal of the American Medical Association entitled “The FDA – A Misunderstood Agency” seems to have received little attention.  Written by Dr. Joshua Sharfstein, the current Secretary of the Maryland Department of Health and Mental Hygiene and the former FDA Principal Deputy Commissioner, the article presents both an explanation and defense of the FDA’s policies and procedures.  I wish Dr. Sharfstein went further in his comments.

The FDA, while not perfect, is often criticized unfairly.  Here are three typical examples.  Invariably, after a new drug is on the market for a few years, the FDA will announce that this new medicine has some new safety issue that hadn’t been seen previously.  This issue is not unusual.  When a new drug is approved, it generally has been tested in perhaps 10,000 patients for a year.  Once it is on the market, if it is a chronically used drug, it may get used by millions of people over the period of a few years.  As it is more broadly used, more information is gathered on the drug and the FDA will react to this.  Unfortunately, when this occurs, there will be members of Congress (Sen. Grassley comes to mind) who will hold a press conference and rail against the FDA for its lax attitude in approving new drugs.  There are ALWAYS risk-benefit issues with any medicine, old or new.  Some politicians don’t seem to get this.  The FDA does.

Interestingly, there are those who criticize the FDA for being too slow in approving new drugs.  This can occur in diseases where this is no adequate treatment for life-threatening diseases.  In these cases, there are patient advocacy groups who want certain medicines approved as quickly as possible.  Their view is that, if there is a drug in trials that can save the lives of themselves or their loved ones, the FDA has no right to prevent patients from getting this medicine.  In these cases, the FDA generally has significant questions about whether the drug indeed is effective and will not approve it without hard data showing that the drug works.  It should be noted that the FDA has a good track record of reacting with alacrity to health crises, as evidenced by their actions in approving AIDS drugs in the early days of that epidemic.

But what I find most exasperating is the criticism that the FDA is beholden to the pharmaceutical industry because of the Prescription Drug User Fee Act (PDUFA).  Back in the 1990s, there was a “drug lag” – drugs were getting approved in Europe years ahead of their approval in the US.  Congress was outraged and demanded an explanation.  The FDA correctly said that the organization was grossly understaffed and that new resources were need to deal with the backlog of drugs awaiting approval.  Rather than allot the FDA more funds, Congress enacted PDUFA which essentially was a charge to the pharmaceutical companies on the filing of their New Drug Application (NDA).  In 2011, this fee is $1,542,000 for each NDA.  Critics say that, because the FDA is dependent on these user fees to support their division, FDA staffers feel beholden to pharmaceutical companies and, as a result, try to do all they can to help these companies. This view is ludicrous.

To a certain extent, the FDA is in a no win position.  It has to judge what medicines the US population should or shouldn’t take.  This is rarely a black or white decision.  As was stated above, all medicines have side-effects.  The question the FDA must answer is what is the risk-benefit of each new drug–this is always a judgment call.  The FDA tries to work closely with all of those dependent on its actions – patients, physicians, companies and government officials.  The FDA is not infallible, but it gets it right most of the time.  It’s time to respect this.


Written by johnlamattina

September 29, 2011 at 1:08 pm

Posted in Uncategorized

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