Charting a New Course at the FDA

On March 14, President Obama nominated
Margaret Hamburg to become commissioner of the FDA and appointed Joshua
Sharfstein, a longtime critic of the pharmaceutical industry, as her
principal deputy. Sharfstein, who does not need Senate approval, took
over the agency as acting commissioner last week, pending Hamburg's
confirmation. His appointment gives real hope that the FDA will stop
kowtowing to the big drug companies. For too long the agency has
behaved as though its job is to speed brand-name drugs to market, not
to ensure that they are safe and effective. But while new leadership is
crucial, more needs to be done.

First, Congress should repeal the Prescription Drug User Fee Act.
This 1992 law, renewable every five years, authorizes drug companies to
pay "user fees" to the FDA for every drug the agency considers for
approval. That puts the FDA on the payroll of the industry it
regulates, and makes it more likely that drugs will be reviewed
favorably - a bargain for drug companies. Drug companies should not be
considered "users" of the FDA; the public is the user, and it alone
should support the agency.

Second, consultants for drug companies should no longer be permitted to serve on FDA advisory panels.
These panels consist of outside experts who advise the FDA on whether
drugs should be approved, and their recommendations are nearly always
followed. But many panel members double as paid consultants for drug
companies. Although they are supposed to recuse themselves from
decisions in which they have a large, direct financial interest, that
requirement is often waived. There is no reason to tolerate any
conflicts of interest in such key positions.

Third, the agency should see that the post-marketing studies it mandates are actually carried out. Some
drugs are approved on condition that further studies are done after
they are on the market, mainly to make sure there are no serious
side-effects that did not show up in the pre-marketing clinical trials.
Drug companies agree to these studies, but then renege on their
commitments. More than 1,000 such studies haven't been started, thus
exposing the public indefinitely to drugs of uncertain safety.

Fourth, the FDA should review generic drugs as fast as brand-name drugs.
A key to lowering drug prices is to get generic drugs to market quickly
after their brand-name counterparts lose their exclusive marketing
rights. Drug companies want to delay the appearance of generic drugs as
long as possible, and the FDA helps by taking roughly twice as long to
approve them as to approve brand-name drugs.

Congress should give the FDA the authority to require drug companies to
compare new drugs with existing drugs of the same type.
newly approved drugs are trivial variations of top-selling drugs on the
market. Called "me-too" drugs, they are especially profitable, because
they usually target ill-defined medical conditions - huge markets that
are easily expanded. For example, there are now five drugs of the SSRI
type (that is, with the same mechanism of action) to treat depression.
Me-too drugs are approved if clinical trials show they are better than
placebos, but they don't have to be compared with another drug of the
same type. We simply don't know whether a new me-too drug is better or
worse than the others, although they are always marketed as though they
have some advantage.

Sixth, the FDA should stop approving me-too drugs on the basis of surrogate endpoints.
A surrogate endpoint is a measurement that is thought to be related to
a clinical outcome. For example, cholesterol level is a surrogate
endpoint for heart attacks or strokes. But surrogate endpoints do not
always have the expected predictive value. It makes sense to rely on
them in clinical trials of drugs to treat serious conditions for which
there are no existing treatments of the same type, because such trials
are faster, even if sometimes misleading. But for me-too drugs, there
is no rush and the FDA should insist on clinical endpoints.

Finally, the FDA should prohibit direct-to-consumer advertising for three years after drugs are approved. Every
newly approved drug has been tested only under controlled conditions in
relatively small numbers of patients. Once drugs come into widespread
use, unanticipated risks may become apparent. In recent years, a record
number of drugs have had to be withdrawn from the market because they
turned out to be dangerous. If new drugs are heavily advertised, people
may be unnecessarily exposed to risks.

is time to restore the FDA to its purpose, which is to protect the
public from unsafe food, drugs, and devices, not to accommodate the
industries it regulates. The change in leadership is reason for

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