When a doctor writes a prescription it is normally for a drug's approved, or "on-label," use. But doctors are also free to prescribe the drug for any illness they think it will effectively treat. In fact, some 56% of all cancer patients get at least one "off-label" prescription. But the Food and Drug Administration has resolutely barred drug companies from providing physicians with peer-reviewed, scientific research literature on precisely these kinds of treatment regimens. Which means that some patients who might benefit don't get them.
Last week, a federal judge struck down this nanny-state regulation on First Amendment grounds. District Judge Royce Lamberth declared that while the Food and Drug Administration could properly block drug companies from distributing their own marketing materials to physicians if they tout non-FDA approved uses, it was an infringement of their commercial speech rights to prevent them from handing out medical textbooks and the like that describe uses for a drug discovered after its initial approval.
The judge's opinion rejected FDA arguments that data in peer-reviewed articles were "inherently misleading" if provided by drug companies. Judge Lamberth concluded that "in asserting that any and all claims about the safety, effectiveness, contraindications, side effects, and the like regarding prescription drugs are presumptively untruthful or misleading until FDA has had the opportunity to evaluate them, FDA exaggerates its overall place in the universe."
Scientific and academic speech have always been entitled to the highest level of First Amendment protection. The FDA tried an end-run around that reality by declaring that drug company distribution of scientific research was merely an exercise of commercial speech, and therefore not entitled to full constitutional protection. But Judge Lamberth noted that even in commercial speech cases the courts have "repeatedly rejected governmental attempts to equate less information with better decision making." Our own view is that the FDA personnel are institutionally antithetical to the very idea of for-profit drug development. The agency's mindset would be more appropriate for drug development in, say, Cuba.
Needless to say, the FDA is expected to appeal or perhaps even seek a stay of Judge Lamberth's ruling. It long ago decided to push beyond its power to approve the safety and efficacy of drugs and micromanage the practice of medicine. At a Congressional hearing, former FDA Commissioner David Kessler once indicated that his agency might even have to protect users of soap if manufacturers of the product ever touted its "off-label" usefulness in self-examinations for breast cancer.
That kind of paternalistic thinking led to the formulation of the FDA gag rules on off-label medical research. The FDA and Naderite consumer groups were concerned that distributing such materials could give overworked physicians misleading information that overstated the benefits of some drugs while minimizing their risks. In addressing such concerns, Judge Lamberth dryly observed that physicians "are certainly capable of critically evaluating journal articles or textbook reprints." He pointed out that the FDA can still require that any textbooks and scientific articles originate with independent publishers and that doctors in seminars be told that some drug uses hadn't been approved by the agency.
We live in the Information Age. The FDA lives in the Age of Regulation. Clearly incapable of adjusting to the flow of scientific information across the industry in any sort of timely fashion, the agency defaulted to a tradition of hypersafe, hyperslow approval of new drugs and subsequent, additional uses for these drugs. It is now clear that such practice constitutes a gag order on this country's fundamental belief in the benefits of information, and is impermissible.
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