Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Harold Engstrom who wrote (7418)	12/4/2002 9:25:59 PM
From: John Metcalf	Read Replies (1) \| Respond to of 52153

I know that you're already riled, Harold. I apologize in advancing for interrupting a wood-shedding with news of a GAO report on FDA's role in policing drug advertising. FWIW, there have been many times I've thought the FDA had strayed far afield in going after ads. Every time I sit through the endless recitations of cautionary statements in a drug-ad, I wonder how much the company is spending at FDA's direction to make the recitation! And then, the company is criticized for what it spends on ads, after govt requirements have increased the costs. As a taxpayer, can I follow your lead and unsubscribe from FDA's free service of requiring repetition of low-incidence adverse reaction data? FDA Has Limitations in Policing Drug Ads By JANELLE CARTER 12/04/2002 17:03:12 EST WASHINGTON (AP) - It takes federal regulators so long to approve a letter aimed at stopping misleading drug advertisements that often the ad campaign is over before the drug company receives the letter, a report said Wednesday. The report by the General Accounting Office, the investigative arm of Congress, detailed some limitations of the Food and Drug Administration's oversight of direct-to-consumer advertising by drug companies, which has tripled since the FDA loosened drug promotion rules in 1997. Many drug companies promote their products to consumers through ads in magazines and broadcasts on radio and television. The industry spent $2.7 billion on consumer advertising in 2001, the report said. The FDA is responsible for seeing that the ads are fair and accurate, but the report found a number of problems in getting misleading advertisements removed. For instance, many pharmaceutical companies have run misleading advertisements for a particular drug again and again. Others did not submit new ads to the FDA in a timely manner for review. Under government regulations, drug companies must submit all ads to the FDA once they are disseminated to the public. Drug manufacturer Pfizer, for instance, was issued four letters over the last 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. One improvement that could be made is for the agency to expedite the review of regulatory letters sent to a drug company about an advertising violation, the report said. Since January, the Department of Health and Human Services, which oversees FDA, has said that no violation letter can be issued until FDA's Office of Chief Counsel reviewed them. The agency has said the additional review was needed to ensure "legal sufficiency and consistency with agency policy." But the report said it now often takes weeks for a letter to get approved. Most advertisements run for just a short time. In a response, Janet Rehnquist, HHS's inspector general, 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. "When FDA takes a position, companies must believe that FDA can and will back it up by going to court if necessary." In a related matter, 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. Rick Smith, senior vice president for policy and research for the Pharmaceutical Research and Manufacturers of America, said the findings proved that "The mythology that's gone up about how pharmaceutical companies are spending money is wrong." ___ The report can be found at gao.gov