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Pemoline ban

The FDA, under pressure from Ralph Nader's Public Citizen, has required pemoline to be withdrawn from the market on the grounds that there are less risky ways of treating ADHD. This doesn't help Teresa Nielsen Hayden, who found the drug (often marketed as Cylert) to be the only adequate treatment for her narcolepsy, and is looking at the "end of [her] functional working life" (via Taylor). Since a black-box warning had been added in 1999, there had been one case of liver failure, though the rarity doesn't stop one plaintiffs' firm from trotting out the standard trope against Abbott for ever selling the drug in the first place: "We believe that drug companies who place profit above people must be held accountable for their negligence and the damage they cause to innocent victim´┐Żs [sic] lives." Kline & Specter also advertises for Cylert patients. Trial lawyers often work hand in hand with Public Citizen to promote work-creating measures for the plaintiffs' bar, but you won't see this documented in books on political movements' "war on science."

As I've noted elsewhere, the FDA already errs on the side of false negatives when it comes to drug approval—which makes the additional layer of risk of civil liability through tort a dangerous over-deterrent to pharmaceutical innovation.

Update: Note also the distorting effect of civil litigation on the FDA process. A pharma manufacturer faced with the lobbying campaign of a Public Citizen is limited these days in how hard it can fight back against unfair characterizations of its drugs. If the manufacturer lobbies the FDA in the opposite direction, it risks being second-guessed at a future trial: witness the lambasting Merck is taking for arguing with the FDA over Vioxx labeling. If the manufacturer says one thing that is later shown wrong after more data comes in, it is accused of "lying." Plaintiffs' attorneys and their surrogates are under no such constraints, and this pushes the FDA anti-approval bias even further in the wrong direction.



Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.