Pharmaceutical law has long provided that once a drug is approved a physician can prescribe it for any purpose, including uses far afield from that for which it was approved.
However, the manufacturer is forbidden to promote the drug for any off-label purposes, and the Food and Drug Administration, which has never liked what it views as a gap in the perfection of its regulatory control, gives broad meaning to “promotion,” including activities best classified as “providing information.” Penalties are severe: “over the last three years, Pfizer was hit with an eye-popping $2.3 billion settlement; Eli Lilly paid $1.4 billion; Novartis paid $422 million; Allergan paid $600 million; Elan paid $204 million; and GlaxoSmithKline has set aside $3.4 billion for its settlement.”
In The FDA’s War on Drugs, two Hoover Institution researchers bemoan the FDA’s aggressive and escalating war against off-label uses of approved pharmaceuticals, pointing out a number of benefits from off-label uses, and concluding:
Multiple arms of the federal government are actively fostering off-label usage. But if a drug company encourages off-label usage in some trifling or inadvertent way, the government damns that company for greedily putting profits above public health, it slams a stiff fine on the company, and it even pressures the company to fire its CEO, even though he has never been charged with or convicted of any crime. The prohibition on off-label promotion is nothing more than a prohibition on the communication of legally and medically legitimate uses of pharmaceuticals. How can doctors make the right therapy choices without the right information? Real Americans are suffering real, and sometimes catastrophic, harms as a result of the FDA’s single-minded policy on off-label promotion.
A point worth adding is that the FDA philosophy is cross-wise of the current emphasis in the tech world on collaboration and open innovation. As the new cliché has it, “wherever you are, most of the smart people are somewhere else,” so innovation is best spurred by enlarging the pool of people with access to information and freedom to decide for themselves to act on it. In the medical context, once a drug is proven safe, as is required for approval in the first place, we should want doctors to exercise their ingenuity in finding new uses, based on their own experiences. Far from penalizing the manufacturers for participating in such expansions, they should be encouraged to be information hubs, and provide them with incentives to nurture the trend.
As the late John Calfee wrote last year, many breakthrough treatments come from new uses of old drugs. There is something downright scary about the agency thinking that can produce so completely perverse a regulatory policy.
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