Taking back the FDA

[Guest guest]

IT'S TIME to take the Food and Drug Administration back from the drug

companies.

Before a prescription drug can be sold, the manufacturer must conduct

clinical trials to prove to the FDA that the drug is safe and effective.

Without that, doctors have no way of knowing how good or bad a drug is. Just

trying it out would be not only risky, but unreliable, since individual

experience can be misleading. The scrutiny that this agency exists to

provide is vital to our health.

 

But in 1992, Congress put the fox in the chicken coop. It passed the

Prescription Drug User Fee Act, which authorizes drug companies to pay " user

fees " to the FDA for each brand-name drug considered for approval. Nearly

all of the money generated by these fees has been earmarked to speed up the

approval process.

 

In effect, the user fee act put the FDA on the payroll of the industry it

regulates. Last year, the fees came to about $300 million, which the

companies recoup many times over by getting their drugs to market faster.

 

But while it's a small investment for drug companies, it's a lot of money

for the agency, and it has drastically changed the way it operates --

creating a disproportionate emphasis on approving brand-name drugs in a

hurry. Consequently, the part of the agency that reviews new drugs gets more

than half its money from user fees, and it has grown rapidly. Meanwhile, the

parts that monitor safety, ensure manufacturing standards, and check ads for

accuracy have languished or even shrunk.

 

Most tellingly, the office that approves generic drugs is so small that

approval time for generics is twice as long as for brand-name drugs. There

is now a backlog of more than 800 generics. That delay is worth billions of

dollars to the drug companies whose high prices depend on not having generic

competition.

 

As part of the emphasis on speed, the FDA often approves brand-name drugs on

the basis of less evidence than in the past. In these cases, approval may be

contingent on companies conducting further safety studies after the drugs

are on the market. But the companies usually don't honor that commitment. Of

the roughly 1,200 such studies outstanding -- some for years -- over 70

percent haven't been started.

 

The FDA is strangely silent about this inexcusable dereliction. When

questioned, it weakly protests that it doesn't have the authority to compel

the research. In fact, it has enormous leverage, since it can withdraw drugs

from the market.

 

The FDA also refuses to release unfavorable research results in its

possession without the sponsoring company's permission. Here again, it

contends not to have the authority to do so, but providing evidence of

side-effects or negative results would seem to be an integral part of its

job. It's no wonder that serious safety concerns about drugs such as Vioxx,

Paxil, and Zyprexa have emerged very late in the day -- years after they

were in widespread use.

 

The agency's coziness with industry is underscored by the composition of its

18 advisory committees -- outside experts who help evaluate drugs.

 

Incredibly, many of these advisers work as consultants for drug companies.

Although they are supposed to recuse themselves if there is a direct

conflict of interest, the FDA regularly grants exemptions from that

requirement. Of the six members of the advisory committee that in 1999

recommended approving Vioxx -- the arthritis drug pulled from the market in

2004 because it caused heart attacks -- four had received waivers from the

conflict-of-interest rule.

 

The FDA now behaves as though the pharmaceutical industry is its user, not

the public. Fortunately, the user fee law is subject to renewal every five

years, and this is one of those years.

 

Congress should let the law die this time around and substitute its own

support -- which ought to be increased. Other reforms recently proposed,

such as administratively separating drug approval from safety surveillance,

will not mean much as long as this law is in effect.

 

At $300 million to $400 million a year, the equivalent of about a day in

Iraq, Congress can easily afford to buy this vital agency back for the

public, and it should.

*Dr. Marcia Angell, a senior lecturer at Harvard Medical School, is a guest

columnist. *

 

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