Last year, Congress considered limits on direct to consumer (DTC) prescription drug advertising (about which we wrote here), but this effort stalled. A recent letter from two Congressional leaders of the Energy and Commerce Committee suggest that Congress is looking at these issues once again. This advertising has become important to television networks, and to drug manufacturers anxious to distribute information about their latest products to consumers. Congress held a hearing in May to consider issues about this advertising. One concern was whether ads could be misleading when they featured celebrities (a particular concern was when Robert Jarvic, the inventor of the artificial heart who is not an medical doctor, was seen in a drug commercial, which some felt implied that he was giving medical advice). Other concerns include the potential for advertising to build up large demands for new drugs, quickly exposing these drugs to large populations, when a slower roll out would give the companies and the medical community more time to discover any unanticipated side effects. An article about these concerns is available to Wall Street Journal subscribers, here. The Congressional letters, which can be accessed here, address both of these issues.
The letter, from Congressmen Dingell and Stupak, both from Michigan, ask several drug companies and the Pharmaceutical Research and Manufacturers of America (the trade association for Pharmaceutical companies), if they were planning to update their guidelines on direct to consumer advertising to address the issue of celebrity advertising. Also, the letter asked if the companies and the association would back a voluntary two year moratorium on advertising for new drugs, presumably while new guidelines are worked out. FDA guidelines already require a statement on the major risks of the drug and information on where consumers can learn more about the risks of the drug (suggesting a combination of 4 datapoints in each ad – a toll-free telephone number, a website, a recent print publication – all dealing in more detail with side effects and cautions – and a recommendation to "ask your doctor" about the effects of the drug). The Congressional Research Service of the FDA has prepared a good history of regulations in this area and a summary of the issues. Watch upcoming Congressional actions to see if even more disclosures will be necessary.