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FDA on shaky ground

Pressure is mounting on US regulator, the Food and Drug Administration, to revamp its drug safety procedures.

Pressure is mounting on US regulator the Food and Drug Administration to revamp its drug safety procedures after senators questioned its handling of Vioxx, Merck's painkiller that was pulled from the market last September.

With senators due to vote on whether acting FDA commissioner, Lester Crawford, should assume a full-time role as head of the troubled agency, all eyes will be on the FDA as it makes two key decisions in the coming weeks.

As well as coming to a final decision on the status of the COX-2 class of anti-inflammatory drugs (including Vioxx), the FDA also has to rule on whether to allow Barr Pharmaceuticals to sell emergency contraceptive RU-486 over-the-counter.

Speaking at a confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions, Crawford said he would ìdo everything in my power to stem the tide and do the right thingî.

He also promised to change FDA disclosure procedures: ìThe FDA is reviewing ways to make our current process for providing disclosures more transparent and readily available to the public.î

Opinion is currently split on how much responsibility the FDA should take for perceived shortfalls in drug monitoring as well as Crawford's future role. While Republican senators have backed his nomination, Democrats are undecided whether to vote him in next month.

ìDisturbing allegations have been raised that the FDA has prevented open scientific discussion of important drug-safety issues, has disregarded science that conflicts with ideology, and has retaliated against whistleblowers,î said Democrat senator Edward Kennedy.

However, Republican senators have defended Crawford, saying that he has a difficult balancing act - waiting too long to approve a drug can put lives at risk, in the same way as acting too quickly.

US pharma industry association the Pharmaceutical Research and Manufacturers of America (PhRMA) said it would support Crawford's nomination.

ìDr Crawford knows the agency and he knows it well,î said PhRMA spokesman Jeff Trewitt. ìHe responds to crises quickly and with quiet efficiency.î

Since the Vioxx withdrawal, the Bush administration has announced the creation of a new oversight board within the FDA to manage safety issues, to be staffed by FDA employees and medical experts from other government agencies. However, health experts are calling for a separate, independent body to fulfil this function.

Meanwhile, European regulator EMEA has revised its internal code of conduct, drawing particular attention to ensuring employees declare any direct or indirect interests in the pharma industry.

30th September 2008

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