We noted a week ago Saturday, and analyzed on Thursday, the lawsuit that Allergan recently filed challenging the FDA's regulations that forbid drug manufacturers from providing truthful information about off-label uses of drugs.
We also mentioned that we were disappointed to learn about the Allergan case by reading about it in The New York Times, rather than learning about it from our usual source -- our readers, who typically report to us just moments after a complaint is filed or an issue decided.
Shame worked wonders! We received an avalanche of e-mails from readers telling us about news on the FDA - First Amendment front.
We're using this post to sort through that stuff.
First, several tobacco companies have indeed filed a complaint in federal court in Kentucky challenging the FDA's authority to restrict certain communications relating to the sale of tobacco products. But that's not a drug or device case, so we're setting it aside.
Second, some readers speculated that there may be an interesting First Amendment appeal arising out of Scott Harkonen's conviction in a criminal case alleging that Harkonen made illegal statements about the efficacy of Intermune's drug Actimmune.
We're not waiting with bated breath for that one. Although Harkonen was convicted of wire fraud, he was acquitted of having misbranded a product in violation of the Food, Drug, and Cosmetic Act. It's thus uncertain whether that appeal will raise issues about the FDA's ability to restrict speech.
Third, you alerted us to "three" cases filed by the Alliance for Natural Health US against the Secretary of Health and Human Services (Kathleen Sebelius), the FDA, and others challenging the regulation of certain health claims made by manufacturers of dietary supplements.
There's news on that front -- although it doesn't really involve "three" cases. One of the Alliance-Sebelius cases challenges an FDA regulation that deems violation of the GMP record-keeping regulations to constitute "adulteration" of a product without any evidence of a glitch in the actual manufacturing process or any evidence of a risk to public health. That's an interesting case, but we're not calling it a First Amendment issue.
The remaining two Alliance-Sebelius cases are worth noting (even if they involve only dietary supplements, rather than prescription drugs, which are this blog's sweet spot).
In Alliance for Natural Health US v. Sebelius, No. 1:09-cv-01470 (D.D.C. filed Aug. 4, 2009) (complaint here), a non-profit outfit that protects the rights of practitioners of alternative medicine, two scientists who design dietary supplements, and an association formed to advocate "that federal government agencies not block consumer access to accurate representations concerning the science on the role of nutrients" joined forces as plaintiffs.
Their complaint recites that the Nutrition Labeling and Education Act of 1990 provided a "safe harbor" for certain claims made by dietary supplement manufacturers about their products. The Act required the FDA to create rules for approving those health claims. The FDA then promulgated 21 C.F.R. Secs. 101.14 and 101.70 to set up a system to evaluate claims.
According to plaintiffs, those regulations required "near conclusive proof before any claim would be authorized by the agency." Complaint at para. 13. In 1999, the D.C. Circuit struck down the "FDA's policy of censoring all claims it did not approve" through the established regulatory process. Id. at para. 14. The court "required FDA to use claim qualification in lieu of outright suppression as a less speech restrictive means to eliminate potential misleadingness." Id.
In April 2008, the plaintiffs filed a petition with the FDA seeking approval of certain "health claims involving the relationship between selenium and the reduction of risk of cancer." Id. at para. 19. Among other things, the plaintiffs wanted to be able to say that "selenium may reduce the risk of certain cancers," "selenium may reduce the risk of prostate cancer," and "selenium may reduce the risk of colon and digestive tract cancers." Id. In June 2009, the FDA issued an order completely banning the use of four of the five health claims, and requiring that many qualifications be included if a company chose to make the fifth claim. Id. at 20.
The spat is about the quantity and quality of evidence needed for a dietary supplement manufacturers to make a health claim. The manufacturer had cited in its petition to the FDA "over 150 peer-reviewed publications supporting the risk reduction relationship between selenium and cancer." Id. at para 25. But the FDA "dismissed all but a very small number of the studies as irrelevant, unreliable, unsupported, or inapplicable for a myriad of reasons." Id. "[I]n its final analysis the FDA gave credence to only 20 publications out of 233." Id.
The complaint pleads that the ban of four health claims, and required qualification of the fifth, violates the First Amendment. The case was assigned to Judge Ellen S. Huvelle. From our review of the docket, it looks as though cross-motions for summary judgment will be fully briefed by January 15, 2010, and we can expect an opinion thereafter.
The second case, Alliance for Natural Health US v. Sebelius, No. 1;09-cv-01546-RJL (D.D.C. Aug. 14, 2009) (complaint here), recites a similar regulatory history and then objects to the FDA's ban of four, and restrictions imposed on two, health claims relating to the ingestion of Vitamins C and E on the risk of cancer. That case was assigned to Judge Richard J. Leon, and no briefing schedule appears yet to have been set.
We'll stand by our assessment that the Allergan case will be most interesting to readers of this blog. First, it involves drugs, which are our true passion. [Every time we write that, it sounds funny.] Second, the Allergan case challenges big chunks of the FDA's regulatory scheme, while the Alliance-Sebelius cases are much narrower -- they seek only advance judicial approval for a company to make certain specific statements.
But we'll nonetheless gently monitor the progress of the dietary supplement cases.
And keep those cards and letters -- egad! A cliche rendered obsolete by the passage of time!
Keep those e-mails coming in.
If we don't hear from our readers, then this blogging game won't be worth the candle.