The US Food and Drug Administration is reportedly set to announce a proposed rule which would protect the pharmaceutical industry from liability litigation, by declaring that federally-approved drug labels pre-empt US state laws.
This would mean that, if faced with lawsuits relating to side-effects or adverse reactions which surface after a product has been approved by the FDA, a manufacturer could claim that it was not required to warn consumers about such issues if the agency had decided, during the approval process, that they did not warrant inclusion on the product’s labelling.
Therefore, a drug would only have to be “as good or as bad as its label declares at any given time,” says the report, by Steve DiJoseph, published on Newsinferno, which quotes a number of “informed sources,” including the Wall Street Journal, as the basis for claiming the agency’s intentions.
In an ideal world, a proposal such as that reportedly being readied at the FDA could be regarded as an incentive to drugmakers to boost their R&D initiatives, as it would free them from the problems and expense of liability lawsuits, says the article; however, it adds, the FDA’s lack of independence and its staffing and funding problems mean that this would not be the case.
The agency has put itself in a position riddled with conflict by accepting “huge” sums of money from the pharmaceutical industry, which is now estimated to provide more than 50% of funding the agency’s Office of New Drugs, and this is now expected to fast-track new drugs to market. However, no such funding is provided to the agency’s Office of Drug Safety for post-approval monitoring of adverse reactions and side effects, says Mr DiJoseph.
Specifically, he claims that, under the proposed rule, there would be no way to ensure full disclosure of data on a new drug during its approval process, and no incentive for companies to provide it. Nor would it address the “serious” problem of off-label prescribing, which he says is often improperly encouraged by manufacturers. A drug could be rushed through the fast-track approval process with inadequate testing and limited warnings, remain on the market long enough to do catastrophic harm to the public and be withdrawn before any label changes – which would in any case be immaterial because the company would be insulated by the approval of the original, inadequate label, he says.
This development, which would effectively mark the end of the FDA as a credible public watchdog, would also impose the type of tort reform which the Bush Administration is currently seeking to implement across all health care-related industries, says the report. It also warns of the dangers of allowing administrative agencies such as the FDA to usurp the lawmaking powers of Congress by simply promulgating rules rather than legislatively-enacted statutes.
Similar allegations were levelled at the Administration just before Christmas, when the Senate approved, as part of the fiscal 2006 Department of Defense Conference Report, legislation giving limited liability protections for makers of vaccines which would be used to tackle health emergencies and pandemics.
These reforms were welcomed as “sensible and measured” by Senate Majority Leader Bill Frist, but were attacked by consumer and patient groups. For example, the National Autism Association claimed they were part of plans, spearheaded by Sen Frist and “years in the making,” to give drugmakers sweeping liability protections.
Previous attempts had included the “notorious 2002 Eli Lilly rider, covertly slipped into the Homeland Security Act under cover of darkness,” said the NAA, whose president, Wendy Fournier, added: “such drastic changes to public health and our judicial system should have been open for public debate, not slipped in surreptitiously to unrelated, must-pass legislation.”
