By Mary Gabb ([email protected])

In a previous issue of HOC , we outlined some of the commonly expressed pros and cons of direct-to-consumer advertising (DTCA), which is currently allowed only in the United States (US) and New Zealand but under consideration for Europe .

On May 5, 2008, three executives, from Pfizer, Schering-Plough/Merck and Company, and Johnson & Johnson, appeared before the US Congress Subcommittee on Oversight and Investigation, to answer questions regarding three specific “potentially misleading and deceptive tactics” used in DTCA for Pfizer’s Lipitor, J&J’s Procrit, and Vytorin, which is sold by Merck and Schering-Plough. The congressional subcommittee asked whether the three companies would be willing to commit to six guidelines:

  • Follow the American Medical Association’s guidelines regarding the use of actors and health professionals in DTCA.
  • Not market products in DTCA until a valid outcomes study of the product is completed.
  • Place a 2-year DTCA moratorium on new prescription drug products, as recommended by the Institute of Medicine .
  • Not market off-label uses for prescription products in DTCA.
  • Add the FDA toll-free MedWatch phone number in all DTCA.
  • Include “black box” warnings in DTCA for products that contain such warnings.

All three companies agreed to only two of the six guidelines (following AMA guidelines on use of physicians in DTCA and placing a 6-month moratorium on DTCA for new products). Some of the companies also agreed to specific guidelines, or more often, agreed to work with FDA guidance or seek advice from the FDA on the proposed guidelines. The trade association for the pharmaceutical industry, the Pharmaceutical Research and Manufacturers of America (PhRMA), also participated in the congressional hearing. In 2005, PhRMA had developed its own guiding principles on DTCA.

DTCA are reviewed by the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC). The reviews are for the most part voluntary, except for specific categories of drugs, such as cancer drugs, where the risk-to-benefit ratio may be weighted on the risk side. In the latter cases, the advertisement must be submitted ahead of time – but the pharmaceutical manufacturer does not have to heed the DDMAC advice nor even wait for the comments before it releases the ad.

Nonetheless, PhRMA maintains that DTCA is one of the most highly regulated forms of advertisement in the US . To date in 2008, the FDA DDMAC has issued 5 warning letters outlining regulation violations in promotional advertisements.

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The changing face of DTCA

The New England Journal of Medicine reports on a new form of DTCA of which we may be seeing more – for medical devices. (NEJM 2008;358:21). The article also describes the differences in DTCA requirements based on format – television ad, web site, and patient-education brochure. For example, the FDA requires that only “major risk information” be disclosed in broadcast DTCA, but these ads must direct viewers to other sources of information on associated risks.

Print advertisements, by contrast, must include all information about associated risks (ie, major side effects, contraindications, and precautions contained in the FDA’s label). As an example, a television ad for a drug-eluting coronary stent listed 4 potential adverse events related to use of stents in general, but none associated with the product. The web site listed 10 device-related adverse events, and 5 that were product-specific. The patient education brochure listed 31 device-related adverse events, and 13 product-specific adverse events. So, patients must do their homework, depending on the type of DTCA they see. A spokesperson from the FDA said that all ads – for devices and drugs – are required to not be false or misleading and to present information that is in accord with product label