January 15, 2006
Via the paid-subscription Wall Street Journal, exactly the kind of thoughtful policy decision
America big pharma expects from the FDA:
The Food and Drug Administration is preparing to declare that federally approved medication labels pre- empt state law, a move that could strengthen pharmaceutical makers’ defenses against lawsuits claiming injury by the companies’ products.
The policy could help companies argue they weren’t required to warn consumers about a potential risk when the FDA had determined that the safety issue didn’t warrant inclusion on a medicine’s label. The new policy, which would address state liability statutes, has been written into a broad new drug-labeling rule that is likely to be issued shortly, according to people with knowledge of the matter, though the rule has been repeatedly delayed.
Product-liability suits have become a huge problem for drug makers. In one of the more high-profile cases lately, Merck & Co. faces dozens of lawsuits across the country over its withdrawn painkiller Vioxx. Merck pulled that hugely popular drug from the market in 2004 following a study that linked the drug to an increased risk of heart attacks and strokes in patients taking it for 18 months or longer.
… Plaintiffs’ lawyers, however, oppose the policy. “If the proposed changes were to be enacted, drug-product safety in the U.S. would suffer a major setback at a time when the conduct of pharmaceutical companies and the FDA have been called into question,” said Thomas R. Kline, a plaintiffs’ attorney with Kline & Specter and a key player in Vioxx litigation.
Inclusion of the new FDA policy in the long-awaited drug-labeling rule has sparked disagreements between FDA career officials and Bush administration appointees, according to people with knowledge of the matter. Some FDA career staffers have argued internally that it isn’t relevant to the rule’s focus on drug-labeling reform, and may draw controversy to an important regulatory improvement that isn’t itself politically divisive.
As the Journal points out, the Bush administration has pressed other federal agencies to make similar moves to help shield businesses from legal action—often undermining state regulatory authority in the process:
The National Highway Traffic Safety Administration last August proposed a new rule on car-roof strength that would grant legal protection to car makers that adhere to the safety standard. The U.S. Office of the Comptroller of the Currency issued a sweeping regulation in early 2004 that said federal banking laws take precedence over a number of state consumer-protection statutes when applied to national banks. The agency challenged an investigation of potentially discriminatory lending practices by New York Attorney General Elliot Spitzer, arguing that his probe impinged on federal enforcement turf.
The National Conference of State Legislatures describes the FDA’s initiative as a “thinly-veiled attempt… to confer upon itself authority it does not have by statute.” More bluntly, the NCSL calls it an “abuse of agency process.”
In other words, business as usual in Bushland.
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