Healthy Skepticism Library item: 14561

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Publication type: news

Taylor L.
US White House “weakened safety rules to protect drugmakers”
PharmaTimes 2008 Nov 3
http://www.pharmatimes.com/WorldNews/article.aspx?id=14658&src=EWorldNews

Full text:

The Bush Administration introduced new drug labelling regulations which would shield pharmaceutical companies from lawsuits brought at state level, despite senior Food and Drug Administration (FDA) officials’ strong concerns that this would harm consumer safety, says a US Congressional report.

The report, published by the House Committee on Oversight and Government Reform, says that, in the past, the FDA has viewed provide lawsuits brought by people injured by drugs as providing “an additional layer of protection against unsafe drugs.” However, in 2006 and 2008 the agency rewrote the rules to “restrict” manufacturers’ ability to disclose new safety risks without prior agency approval and advocated in favour of federal law pre-empting product liability cases brought under state laws.

Internal agency documents obtained by the Committee show that these new “changes being effected” (CBE) rules were introduced over the strong objections of senor FDA officials, who repeatedly warned that the central justifications for them were factually false, and warned that they would harm patients by significantly delaying the addition of important safety information to drug labels.

The officials included the director of the FDA’s Office of New Drugs, John Jenkins, who warned that it was “a gross overstatement of reality” that drugmakers would disclose all the safety risks associated with new medicines, while Jane Axelrad, FDA associate director for policy said that “we usually find ourselves dealing with situations where [drug] sponsors want to minimize the risk information.”

“We know that many current approved drug labels are out of date and in many cases contain incorrect information,” Dr Jenkins wrote, adding: “it is unwise to suggest that FDA-approved labeling is always up-to-date and always contains a full and complete listing of all pertinent risk information.”

The internal documents also show that “the White House played a significant role in drafting the industry-friendly rules,” according to a report by CongressDaily.

“FDA has an obligation to ensure the safety and effectiveness of drugs. In this case, however, the internal documents indicate that the Bush administration weakened important drug safety regulations to shield manufacturers from liability. That is a serious abuse of the agency’s public health authorities,” the Congressional report concludes.

Its publication comes just ahead of the case of Wyeth versus Levine, to be heard by the Supreme Court on November 3, which is expected to be most important US legal event for the drug industry in 2008.

The case concerns a $6.8 million award granted by a jury in Vermont to Diana Levine, who developed gangrene and lost a hand and forearm after inadvertently being injected in an artery with Wyeth’s antinausea drug Phenergan (promethazine). Phenergan’s labelling warned of the risk of gangrene if the drug was injected into an artery, but Ms Levine claimed that the labelling was unsafe.

Wyeth’s case is that the FDA had determined Phenergan to be safe and effective and mandated the warnings which should appear on its labeling, and it is urging the Court to rule that federal law pre-empts product liability cases brought under state laws which challenge the adequacy of FDA-approved label warnings.

The firm is being supported by a government’s amicus curiae (friend of the court) brief, and another, filed jointly by the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Industry Organization (BIO), which points out that “state law cannot require what federal law prohibits.”

Commenting on the Congressional report, PhRMA senior vice president Ken Johnson said the CBE rule “represents good policy and protects patients.” He added that the industry’s support for rule is “ consistent with five former FDA chief counsels, who maintained in a bipartisan letter: ‘If every state judge and jury could fashion their own labeling requirements for drugs and medical devices, there would be regulatory chaos for these two industries that are so vital to public health, and FDA’s ability to advance the public health by allocating scarce space in product labeling to the most important information would be seriously eroded’.”

However, Brian Wolfman, director of the litigation group at consumer advocacy organization Public Citizen, claimed the report “is proof that the Bush administration has pulled out the stops to shield drug companies from liability for dangerous drugs while leaving patients out in the cold.”

“Top FDA officials who deal with drug safety on a day-to-day basis do not believe that lawsuits undermine consumer safety, but their views were overridden by political appointees who lacked any empirical support for their views,” he said.