Once again, a congressional lawmaker is introducing legislation that would end the tax break that drug makers can take for advertising medicines to consumers.
Called the End Taxpayer Subsidies for Drug Ads Act, the bill reflects concerns that drug makers are spending too much to market high-priced medicines at a time of growing anger over the cost of prescription drugs, according to U.S. Sen. Claire McCaskill (D- Mo.), who introduced the bill. She noted that only the U.S. and New Zealand allow consumer advertising of pharmaceuticals.
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It’s worth noting that the claim of “off label promotion” by the authors of the JGIM is based on the misperception that anything outside of the approved indication (rather than the entire PI) is off-label. This is not so. For example, the labeling for the GLP-1 receptor agonist dapagliflozin (Farxiga) includes statistically significant weight-loss outcomes in nine separate controlled studies of Farxiga in combination with other antidiabetics and as monotherapy. While Farxiga cannot promote itself as indicated for weight loss (and the authors quote language which makes it clear that they do not) they are entirely free, within FDA regulations, to mention this beneficial side effect in communications both to consumers and to healthcare professionals. Academics, such as the authors of this paper, should recognize that medical credentialization, by itself, does not fully qualify them to understand or analyze the nuances of regulatory law.
Bruce, we appreciate the comment, even if it was intended to be snide and a bit rude. To be honest, interpreting these statements is not straightforward and puts anyone in a bit of a grey zone. Under FDA regulations for direct-to-consumer promotion, companies can’t recommend or even suggest a “use” that is not in the approved labeling. The narrow interpretation is that “use” means “indication,” so companies can only talk about FDA-approved indications to consumers. You seem to be suggesting that it’s okay to talk about a “side effect” of weight loss that’s in the labeling. But given the fact that regulations for direct-to-consumer promotion are much more restrictive than promotion to health professionals, we believed the former interpretation to be a more accurate representation of the regulations. In the end, only whether the FDA takes an action to limit claims of benefit that are observed in a trial “as a side effect” can clarify this point, as you can imagine this would be quite a slippery slope to start down. Best, Joe Ross
Dr. Ross — I have worked in pharmaceutical regulatory affairs for the last 35 years, and I can assure you that, as a matter of settled law, anything in the approved labeling can be used in promotion. AstraZeneca (and the other GLP-1 manufacturers) have been scrupulous in specifying that their antidiabetic products are not indicated for use as weight loss drugs, which explicitly immunizes them against claims that they are marketing for an off-label “intended use” . Having made that disclaimer, they are free to make the claims that they do about weight loss, for which they all have substantial evidence (defined by FDA as ≥ 2 “adequate, well-controlled studies”) included in their approved labeling (the totality of which is, by definition, on-label). Furthermore, both professional and consumer promotion are evaluated under the same set of regulations; there are not separate, “more restrictive” regulations for DTC promotion. Finally, all DTC TV commercials are pre-submitted to FDA for advisory comments, obviating any suggestion that off-label claims somehow slipped by an overburdened FDA staff. I have great respect for the methodologic rigor that your team brought to the JGIM study, but do feel that you would have benefited by including someone experienced in FDA regulatory affairs in reviewing the final manuscript.