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1/6/2003

Report Criticizes FDA's Oversight of DTC Ads

Donna Young

FDA has been slow to enforce federal regulations concerning direct-to-consumer (DTC) ads for prescription drug products, according to a recent report released by the General Accounting Office (GAO), the investigative arm of Congress.

Even after FDA has issued repeated regulatory letters warning companies to stop, some pharmaceutical firms have continued to mislead consumers in broadcast and print advertising, GAO investigators said.

Part of the problem, they reported, can be blamed on a policy change by the Bush administration in January 2002 that requires FDA’s Office of the Chief Counsel to review letters informing drug companies about violations before the letters may be sent—a process that can take several weeks.

The new review process, investigators found, "has adversely affected FDA’s ability to issue regulatory letters in a timely manner."

Most television advertisements for prescription drug products air for one to two months. But some regulatory letters, GAO found, were not sent until 78 days after FDA had identified an advertisement as violating regulations—long after some advertisements had completed their broadcast cycle.

In 1997, FDA issued a draft guidance document that allows pharmaceutical companies to use television and radio commercials to promote specific drug products and provide less detailed information about possible adverse effects and other precautions than is required of print advertisements. The agency finalized its rule on DTC ads in 1999.

Under the regulation, drug companies must submit all pharmaceutical advertisements to FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC).

DDMAC reviewed 248 broadcast advertisements in 2001, investigators said. The division does not document the number of print advertisements it reviews.

Between 1997 and 2001, the pharmaceutical industry’s spending on direct-to-consumer advertising increased by 145%, while research and development spending increased by 59%, the General Accounting Office (GAO) determined. In 2001, pharmaceutical companies spent $2.7 billion on advertising aimed at consumers.

GAO also noted that 80% of drug companies’ promotional spending is directed toward physicians, not consumers.

Of the 39 DDMAC employees dedicated to oversight of promotional advertisements, 7 of those staff members are responsible for reviewing DTC ads. Two of those positions remain unfilled, investigators found.

Since 1997, FDA has issued at least 88 regulatory letters to drug companies, including 14 to GlaxoSmithKline, 6 to Schering Corporation, and 5 to Merck & Co. Inc., about their misleading advertisment practices.

Most regulatory letters, known as "untitled" letters, are for less serious violations. "Warning" letters often cite multiple, serious violations, according to GAO.

Acting through the Department of Justice, FDA can initiate court action to seize drug products for which advertisements are false or misleading, investigators said. FDA may ask a court to stop an advertisement and request the company to run a corrective campaign. In addition, the Justice Department can impose criminal penalties on a firm for deceptive advertising.

Half of the regulatory letters issued by FDA in 2001 cited advertisements that made misleading claims about a drug’s efficacy, GAO found.

For example, FDA’s August 2001 regulatory letter to Connectics Corp. noted that advertisements for Luxiq cream, a dermatological product containing betamethasone valerate and used to treat psoriasis, overstated the product’s efficacy. The ads claimed that the product was highly effective for three out of four patients, even though the clinical study cited in the labeling had found that the cream improved various symptoms for 41%–67% of patients, or no more than two in three.

In another misstatement of the product’s efficacy, the advertisement claimed that Luxiq improved symptoms within days, even though the study’s results were for patients who used the cream for four weeks.

In the past four years, investigators said, FDA has issued four regulatory letters to Pfizer for misleading broadcast and print advertisements about its cholesterol-lowering product Lipitor.

The advertisements, FDA said, falsely implied that Lipitor, containing atorvastatin, reduced heart disease and is safer than competing products.

Advertising directed to consumers seems to increase prescription drug use and spending, investigators concluded.

The GAO team indicated that about 8.5 million consumers have both requested and received from their physicians a prescription for a particular drug product after viewing an advertisement. In 1999 and 2000, the number of prescriptions dispensed for the most heavily advertised drugs rose by 25% but increased only 4% for drugs that were not heavily advertised, according to the report.

GAO based its report on interviews with FDA officials, pharmaceutical industry records, and studies from various health care advocacy groups, including the Kaiser Family Foundation and the National Institute for Health Care Management Foundation.