Nov. 11, 2013 – The FDA Office of Prescription Drug Promotion’s (OPDP’s) recent enforcement actions – four Untitled Letters and two Warning Letters issues since July 1 – include a Nov. 8 Warning Letter to Aegerion Pharmaceuticals Inc. that cites the company not for advertising or promoting its JUXTAPID capsules to physicians or consumers, but for statements its CEO made during broadcast interviews on CNBC’s “Fast Money” program, which aired June 5 and Oct. 31.
The Warning Letter alleges that the statements Aegerion CEO Marc Beer made on the television show “provide evidence that Juxtapid is intended for new uses, for which it lacks approval and for which its labeling does not provide adequate directions for use.”
“For OPDP to send a Warning Letter based on a cable business show interview is an aggressive action,” according to Coalition for Healthcare Communication Executive Director John Kamp. “Clearly, the statements were not directed to doctors or patients, raising a serious question about what made them false or misleading,” he said. “Nonetheless, it is clear guidance that public relations counsel must warn company officials to be very precise and careful about what they say to the press.”
Specifically, OPDP alleges that statements made during the Fast Money program interviews “misleadingly suggest that Juxtapid is safe and effective for use in decreasing the occurrence of cardiovascular events including heart attacks and strokes, and increasing the lifespan of patients with [homozygous familial hypercholesterolemia (HoFH)], and thus will have an effect on cardiovascular morbidity and mortality as well as overall mortality. However, Juxtapid is approved only as an adjunct to a low-fat diet and other lipid lowering treatments to reduce specific lipids … in patients with HoFH.”
The Warning Letter also notes that Juxtapid’s labeling limits its use as an adjunct to other therapies and not as a monotherapy, and that it is not approved to reduce the occurrence of cardiovascular events in HoFH patients or to increase their lifespans. Further, OPDP states that the presentation of information “fails to communicate any of the risks associated with these new intended uses or its approved use,” even though the Juxtapid PI includes a Boxed Warning “regarding potential liver toxicity and the product is subject to an associated REMS.”
Kamp contends that because the statements were not made in promotional materials, but in response to interview questions, OPDP’s enforcement action might be out of line. “Given the obvious First Amendment question here, it would be very useful to get guidance from the courts on whether or not the FDA appropriately can engage in this sort of enforcement,” Kamp said.
The other Warning Letter issued during this period was sent July 25 to Acorda Therapeutics Inc. for a consumer print ad for AMPYRA Extended Release Tablets, which are indicated to improve walking in patients with multiple sclerosis (MS). OPDP contends that the print ad for Ampyra is false or misleading because it omits risk information associated with the product’s use. The Warning Letter to Acorda follows a June 21, 2012, Untitled Letter to the company for overstatement of efficacy in an Ampyra video segment.
OPDP asserts that the print ad “entirely omits any risk information, including contraindications, warnings and precautions, and the most frequently reported adverse events for Ampyra,” and states that even though the ad included a disclaimer stating that the ad is not medical advice and that readers should talk to their doctors, “this does not mitigate” the omission of risk in the ad. “These violations are concerning from a public health perspective because they suggest that Ampyra is safer than has been demonstrated,” the letter states.
The four Untitled Letters issued by OPDP from July to the present cite firms for unsubstantiated claims in professional direct mail, overstatement of efficacy/unsubstantiated claims/unsubstantiated superiority claims/minimization of risk in patient brochures/omission and minimization of risk in Web site materials, and minimization of risk/overstatement of efficacy/omission of material facts in a professional sales aid.
Although none of the above enforcement actions resulted from complaints submitted to the agency under its “Bad Ad” program, it is worth noting that the agency is stepping up its efforts to spread the word about that program among health professionals. In late October, the FDA announced the launch of an e-Learning course on evaluating drug promotion, which is designed “to increase awareness among practicing HCPs of misleading drug advertising and promotion while providing continuing educational credit,” according to a letter to “current and future healthcare professionals” from Commissioner of Food and Drugs Margaret Hamburg, M.D. The CME course, which contains seven modules (one of which covers the Bad Ad program), also includes educational case studies that are based on real examples – Web pages, a journal ad, a television ad and a television segment – that have been addressed by the agency in past enforcement actions. The agency reported in a 2011-2012 Year End Report that several Untitled Letters and one Warning Letter resulted from Bad Ad complaints.