A Bush administration change in agency rules has "sharply reduced" the U.S. Food and Drug Administration's ability to regulate advertising for prescription drugs, a government report has found.
The report by the General Accounting Office, the investigative arm of Congress, detailed limitations of the FDA's oversight of direct-to-consumer advertising by drug companies, which has tripled since drug promotion rules were loosened in 1997.
The FDA is responsible for seeing that the ads are fair and accurate.
From 1997 to 2002, the FDA sent 88 letters to companies citing inaccurate advertising claims about a drug's safety or efficacy, the report found, and companies stopped running the misleading ads in all cases.
But a Bush administration procedure instituted in January requires the FDA's legal office to review all letters before they are sent for "legal sufficiency and consistency with agency policy." Evaluating a letter now takes up to 78 days.
Janet Rehnquist, inspector general at the U.S. Department of Health & Human Resources, defended the more extensive review but said the agency would work to review letters within 15 days.
"The FDA cannot afford to be considered a paper tiger," Rehnquist wrote in response to the report. "When FDA takes a position, companies must believe that FDA can and will back it up."
The report found that many pharmaceutical companies have run misleading ads for a particular drug again and again. Others did not submit new ads to the FDA in a timely manner for review.
Drug manufacturer Pfizer, for instance, was issued four letters during the past four years about broadcast and print advertisements for its cholesterol-lowering drug Lipitor. The agency said the ads gave the false impression that Lipitor can reduce heart disease and falsely claimed that Lipitor is safer than competing drugs.
The report said the agency cited GlaxoSmithKline Plc four times between 1999 and 2000 over various ads for the company's Flonase allergy drug.
The FDA is also constrained by staffing shortages, the report said. The office, responsible for evaluating all direct-to-consumer drug advertising, currently employs just five people, with two slots vacant.
The report answered a long-standing concern by Democratic critics that the industry spends more on advertising than on research. Spending on research and development was 10 times more than on drug advertising in 2001. It is estimated that companies spent $30.3 billion on research and $19.1 billion on all promotional activities, which includes $2.7 billion in direct-to-consumer advertising.
Combined Wire Services, Newsday.com
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