Recently, the Food and Drug Administration (FDA) released a series of warnings to 14 pharmaceutical companies. According to the FDA's website under the Center for Drug Evaluation and Research (CDER), in cooperation with the Division of Drug Marketing, Advertising, and Communications (DDMAC), the Agency sent warning letters to 14 drugmakers regarding "misleading" direct-to-consumer (DTC) internet advertisements.
The exact language used in many of these letters states that, “the sponsored links (of the drug maker) on the internet are misleading, because they make representations and/or suggestions about the efficacy of (the specific drug or device), but fail to communicate any risk information associated with the use of this product.” Read a letter from FDA to Merck & Co., Inc.
Moreover, the FDA states that “promotional materials, other than reminder pieces, which include the name of the drug product but do not include indications or other representations or suggestions relative to the drug product, are required to disclose risk and other information about the drug.”
Furthermore, the FDA classifies materials as misleading if they “fail to reveal facts that are material in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials.”
One FDA expert outlined that these were violations of the Fair Balance Principle in the FDA and that risks were not easily seen on these particular advertisements.
In light of these statements, DDMAC asked each of the drug makers to immediately cease the dissemination of violative promotional materials for the specified drug product, and to submit a written response on or before April 9, 2009.
As of today’s date, FDA has sent letters to over twenty companies including Merck & Co., Roche Holding AG, Bayer AG, Johnson & Johnson, Forest Laboratories Inc., Eli Lilly & Co., Boehringer Ingelheim GmbH, Genentech Inc., GlaxoSmithKline Plc and Novartis AG, and individual doctors. A full list of the companies and their drug products can be found here.
It is likely, that the decision to send these letters was a political one. When 20 companies get hit for the same violation (“1 click policy – the balanced drug information was one click away”), it means that the regulation must have been misinterpreted for a very long time. It is doubtful that the legal departments which must approve all advertising at all these companies would have let this by, unless there was some level of ambiguity in the rules.
When situations like this have happened before at the Agency, they would gather all the parties together and give them a stern verbal warning, to discontinue this practice then send out a clarification to the rules.
Companies need to take these warning letters very seriously; various State Attorneys General are already pursuing litigation over this direct-to-consumer advertising practice using warning letters as a basis for investigations.
With many states, collaborating on collective action against drug companies for violations in drug advertising practices, this serves as a good example of the FDA doing its job in regulating the industry; perhaps Congress will take notice and become less critical of the Agency.
Eye on FDA: A Conversation Around the Legal Questions About the FDA's 14 Untitled Letters on Paid Search Ads