FDA Looks to Streamline Drug Panel Practices

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FDA Looks to Streamline Drug Panel Practices

By JENNIFER CORBETT DOOREN

May 5, 2006 12:21 p.m.

WASHINGTON -- The Food and Drug Administration is

beginning what is expected to be a yearlong review of

the standard operations of the outside medical experts

who advise the agency on drug approval and safety

issues.

There are currently 16 panels housed under the FDA's

Center for Drug Evaluation and Research. Other FDA

centers such as the device center also have advisory

panels, but the current effort to improve and

standardize panel processes is expected to initially

involve the drug committees.

While each of the panels must adhere to certain

guidelines -- especially on financial disclosures of

panel members -- and broadly act in a similar manner,

some practices, such as how the panels discuss or vote

on certain questions, differ among the panels. The set

of questions the panels discuss or vote on affect

whether the FDA will approve or reject proposed drugs.

While the FDA isn't required to abide by its panels'

advice, the agency typically does so. The panels often

recommend whether they think a particular drug should

be approved, and if so, under what conditions. Panels

might recommend restricting the drug to certain

patients or urge the FDA to require a drug company to

keep studying the drug after it is on the market.

Most panels have roughly a dozen members and include

doctors who treat patients, academic researchers and

experts from other government agencies such as the

National Institutes of Health. There is also a

nonvoting industry and a patient representative. The

FDA can also add people on a one-time basis for

certain meetings. Panel members serve for about two

years.

The level of involvement varies for FDA officials,

including the division heads of the part of the drug

center that is reviewing a particular drug. Some of

the division heads can be vocal about the FDA's views

on a particular drug and take an active role during

panel meetings. Other division heads tend to stay

relatively quiet during the meetings. The divisions

include oncology, which reviews cancer drugs, and

endocrinology, which would review diabetes drugs.

Gottlieb, the FDA's deputy commissioner for

medical and scientific affairs, said in an interview

that the " advisory panels are a fundamental, integral "

part of the way the FDA conducts its work. While he

believes the process works well, he said certain

changes can be made to improve the consistency and

predictability of how the panels, and more broadly the

FDA, operate.

Debbie , the director of the FDA's drug

center's office of executive programs, which oversees

the advisory panels and FDA staff, said he has heard

from her own staff and even some drug companies that

certain panels run better than others. The idea is to

take the best practices of each panel and see if they

can be applied to all of them. Some drug companies

have also complained about inconsistencies in how each

panel operates.

Typical panel meetings are daylong affairs. The

company seeking approval makes a presentation about

their drug followed by a presentation by FDA staff.

Then the panel spends several hours discussing and

sometimes voting on certain questions that have been

drafted by the agency. Many of the questions focus on

particular safety issues that are seen in clinical

studies of the particular drug as well as whether the

drug works better than existing therapies. There is

also time scheduled for an open public hearing. Most

panels vote on at least one consideration -- the

so-called approval question -- in order to give the

FDA and the company a clear view of what the panel

thinks about a particular product.

While most of the panels advise the agency on whether

to approve or reject certain drugs, one focuses on

drug safety issues and another on scientific issues

that come up during the drug development and

manufacturing process.

Write to Corbett Dooren at

jennifer.corbett-dooren@...