Medicare Compliance & Reimbursement

Critics question appropriateness of PhRMA making DTC ad guidelines.

The trade association that represents most of the country's leading drug makers unveiled a document it says will act as a compass for companies advertising products to consumers. But critics made it immediately clear that they'd sooner leave a fox in charge of a sheep herd than let the pharmaceutical industry police itself.

On August 2, the Pharmaceutical Research and Manufacturers of America released "PhRMA Guiding Principles Direct to Consumer Advertisements About Prescription Medicines," a list of 15 "guiding principles" that PhRMA wants its drug making clients to adopt in order to keep their direct-to-consumer advertising in line with Food and Drug Administration regulations.

"DTC advertising of such important and powerful products as prescription drugs should be responsibly designed to achieve these goals, and to encourage the appropriate use of these products," according to the PhRMA report.

PhRMA CEO Billy Tauzin stressed that these guidelines were voluntary, but 23 companies have already committed to following them. According to Tauzin, Bristol-Myers Squibb, GlaxoSmithKilne, Eli Lily and Co., Johnson & Johnson and Bayer Healthcare AG are among the companies that have already agreed to follow the rules.

These guidelines "are a significant step in the right direction," said Peter R. Dolan, CEO of Bristol-Myers Squibb and chairman-elect at PhRMA.

According to the guidelines, drug makers' DTC advertising should always:
  clearly explain whether a product is a prescription drug.
  start after health care providers are properly educated about the new product.
  be updated immediately if "information indicates a serious, previously unknown safety risk."
    include any non-pharmaceutical treatments available for the advertised condition, such as change in diet. The document also reports PhRMA plans to set up a telephone hot line and monitoring office to address complaints about DTC prescription drug ads.

"Patients need accurate and timely information, and should be encouraged to discuss diseases and treatment options with physicians. These principles will help us reach that goal," said Tauzin.
 
Those opposed to a pharmaceutical trade association leading DTC advertising governance lined up immediately to offer their takes on the announcement. Leading the way was Sen. Chuck Grassley (R-IA), who released a statement the same day PhRMA made its guidelines public.

This announcement "doesn't deliver a single guarantee for consumers," Grassley said in a statement. "The FDA needs to stop dragging its feet and start exercising its authority to closely monitor the marketing of pharmaceuticals.

"It doesn't make sense to rely on drug companies to police themselves."

Grassley has been a leading critic of DTC ads for years. In April, he co-sponsored of a bill that would, among other things, set up a new drug safety office within the FDA and require drug makers to submit ads to the FDA for approval.