NEWS - GAO: FDA falls down on drug oversight

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GAO: FDA falls down on drug oversight

Agency needs to improve scrutiny of products after approval

By L. Watts, MarketWatch

Last Update: 6:35 PM ET Apr 24, 2006

WASHINGTON (MarketWatch) -- The Food and Drug Administration is doing an

inadequate job of monitoring the safety of drugs after they're approved for

the market, congressional investigators said in a study released Monday.

" FDA lacks clear and effective processes for making decisions about, and

providing management oversight of, post-market safety issues. The process

has been limited by a lack of clarity about how decisions are made and about

organization roles, insufficient oversight by management, and data

constraints, " the Government Accountability Office said, in its report.

The report recommended that the FDA be given the authority to require

drug-makers to conduct studies on products already approved for the market.

The investigation was requested by Senate Finance Committee

Grassley, R-Iowa, and House Energy and Commerce Committee Chairman Joe

Barton, R-Texas. It was prompted by complaints that FDA was slow to require

potentially dangerous drugs, including Merck's Vioxx, to be pulled from the

market.

Merck Co. (MRK34.37, -0.37, -1.1%) yanked Vioxx from the market in 2004

after a clinical study showed that patients who took the drug for 18 months

or longer ran a higher risk of suffering a heart attack or stroke. Vioxx, an

anti-inflammatory agent, was used primarily to treat arthritis and injuries.

Grassley released the study at a Capitol Hill news conference, where he

blasted the FDA for failing to address long-standing complaints.

" We get press releases listing accomplishments rather than a meaningful

revamping of the way things work inside the FDA. My staff investigators

continue to hear from FDA employees who believe in their agency and ... want

to do the right things, but experience intimidation, suppression and

reassignments when they raise concerns about the integrity of the FDA's

work, " Grassley said.

In a response included with the GAO report, the FDA's Center for Drug

Evaluation and Research said the report was " well done " and found that the

" conclusions reached are reasonable and consistent with actions we already

have underway or planned. "

Grassley, whose panel oversees the federal Medicare and Medicaid programs,

urged passage of legislation that would give FDA scientists authority to

conduct an independent, post-market review of drugs. He also called for

action on a separate bill that would establish a mandatory clinical-trials

registry.

Neither piece of legislation has moved out of the Senate Health, Education,

Labor and Pensions Committee, which has direct oversight jurisdiction for

FDA.

" This report is extremely helpful in evaluating the procedures used by the

FDA to keep tabs on drugs once they are approved and allowed on the market.

It is critical that we maintain public confidence in the FDA's ability to

protect the public health, " said Senate Health, Education, Labor and

Pensions Committee Chairman Mike Enzi, R-Wyo.

Enzi said that he plans to soon introduce " comprehensive drug legislation "

with Sen. Kennedy of Massachusetts, the committee's senior Democrat.

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Not an MD

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org