Cross-posted at WLF’s Forbes.com contributor page
The Food and Drug Administration (FDA) has long had “commitment issues” in its relationship with the First Amendment. It possesses statutory authority to prevent the sale and distribution of drugs whose intended use and labeling are not FDA-approved, but in doing so it routinely treads on manufacturers’ speech. Federal courts have held repeatedly that the First Amendment severely restricts FDA’s regulation of truthful speech about approved drugs. The agency has responded with assurances that it will comply fully with those court decisions. Recent actions make clear, however, that FDA shows little or no respect for those rulings and apparently believes it is not bound by the First Amendment.
The latest example of FDA’s defiance took the form of a Warning Letter issued by FDA’s Office of Prescription Drug Promotion (OPDP) on November 8, 2013 to Aegerion Pharmaceuticals. OPDP’s letter objected to an appearance by Aegerion’s CEO on a CNBC talk show directed to the financial community. During the course of his interview, the CEO suggested that Juxtapid, a drug manufactured by Aegerion, was safe and effective for several off-label uses that are closely related to its approved uses. For example, the CEO could reasonably have been understood to say that the drug, when taken by itself, was effective in reducing a patient’s “bad” cholesterol levels, even though FDA has approved Juxtapid as a treatment for reducing “bad” cholesterol only as an “adjunct” to a “low-fat diet and other lipid lowering treatments.” The Warning Letter did not contend that the CEO’s statement regarding efficacy was false, but it nonetheless charged that the statement was illegal because it rendered Juxtapid “misbranded.” The letter demanded that Aegerion “immediately cease misbranding Juxtapid” and to issue “corrective messages” to rectify the situation.
So how did OPDP reach the remarkable conclusion that truthful statements made on a television talk show aimed at the financial community can render an otherwise lawful drug “misbranded?” OPDP noted that a “misbranded” drug is defined to include a drug that lacks adequate directions for all intended uses. It is safe to assume that a drug’s approved labeling does not include adequate directions for uses that have not been approved by FDA. So if a manufacturer distributes a drug with the objectively verifiable intent that it be sold for an off-label use, the drug can be deemed “misbranded.” So far so good. Continue reading