DTC Prescription Drug Advertising Update
Merck Agrees to FDA Preclearance in Settlement over Vioxx
As part of a $58 million settlement reached with the Attorneys General of thirty states in regard to its promotion and marketing of Vioxx, Merck has agreed to substantial restrictions on its DTC advertising. In the settlement, it has agreed to submit all ads for new drugs to the FDA for preclearance. It has also agreed to follow any FDA recommendations for a delay in airing television ads for pain relief drugs.
Just last year, Congress, as part of drug safety legislation, considered mandatory FDA preclearance and a two- or three-year moratorium on drug ads. These provisions, which raised significant constitutional issues, were later removed in favor of granting the FDA enhanced civil monetary penalties for false and misleading ads and allowing drug companies to voluntarily submit ads for review. The FDA is still working on implementing these new powers.
Energy and Commerce Committee Sends Letters on Ad Practices to Drug Companies
As a follow up to the May 8, 2008 Oversight and Investigations Subcommittee hearing on DTC ads for Vioxx, Lipitor, and Procrit, the Chairman of the House Energy and Commerce Committee, John Dingell (D-MI), and the Chairman of the Oversight and Investigation Subcommittee, Bart Stupak (D-MI), have sent letters to the CEOs of four drug companies and the Pharmaceutical Research and Manufacturers of America (PhRMA) requesting information on drug marketing practices.
Specifically, the letters ask the companies if they will:
Follow the American Medical Association's guidelines regarding the use of actors and health professionals in DTC advertisements.
- Not market products in DTC advertisements until a valid outcomes study of the product is completed and the results are released.
- Place a two-year DTC advertisement moratorium on new prescription drug products, as recommended by the Institute of Medicine.
- Not market off-label uses for prescription products in DTC advertisements.
- Add the FDA's toll-free MedWatch phone number to all DTC ads.
- Add a "black box" warning to ads if they are required to add a black box warning to labels.
The letters also indicate that a second hearing, at which the CEOs will be asked to testify, will be held.
If you have any questions, please contact Dan Jaffe in ANA's Washington office at 202-296-2359 or at email@example.com.