Jennifer Warner
Dec. 4, 2002 — A new government report shows misleading drug advertisements persist due to delays in the U.S. Food and Drug Administration (FDA) review process and repeated violations by some pharmaceutical companies.
According to the report released today by the U.S. General Accounting Office (GAO), spending on direct-to-consumer (DTC) advertising of prescription medicines has tripled in recent years, and prescription drug spending is the fastest growing component of healthcare spending.
Under current government regulations, pharmaceutical companies are required to submit all drug ads to the FDA when they are first released to the public through print or broadcast media. If the FDA finds the advertisement to be misleading or otherwise fails to fairly represent both the benefits and risks of the advertised drug, it may issue a regulatory letter requesting that the company either withdraw or revise the ad or a warning letter for more serious violations.
The FDA issued 88 regulatory letters and 4 warning letters between August 1997 and August 2002 for DTC advertisements that violated its standards. FDA officials told GAO researchers that companies that received these letters have invariably ceased dissemination of the misleading advertisement.
But the report found that receiving a letter from the FDA isn't always enough to deter pharmaceutical companies from continuing to make misleading claims about their products.
In fact, between 1997 and 2002 the report says the "FDA has issued repeated regulatory letters to several pharmaceutical companies, including 14 to GlaxoSmithKline, 6 to Schering Corporation and 5 to Merck & Co." Some companies have received multiple letters for new ads with misleading claims about the same drug.
"For example," the report states, "FDA issued four separate regulatory letters, one of which was a warning letter, to stop misleading advertisements for the allergy drug Flonase marketed by Glaxo Wellcome in 1999 and 2000." The letters cited a lack of balance, unsubstantiated claims about efficacy, and failure to provide risk information about major side effects.
The FDA also issued four regulatory letters to Pfizer within the last four years for making misleading claims in its DTC ads for the cholesterol-lowering drug Lipitor. The agency said the ads gave the false impression that the drug can reduce heart disease and is safer than competing products.
In addition, researchers found that a recent change in the review process has significantly increased the time between the identification of a misleading advertisement by the FDA and the subsequent letter to the company, "with the result that some regulatory letters may not be issued until after the advertising campaign has run its course."
The change, implemented in January 2002 by the Bush administration, requires lawyers at the Department of Health and Human Services (HHS) to review those letters before they can be issued.
HHS has said it intends to speed up this process and reduce the number of days that letters are under review.
Bruce Kuhlik, general counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA), an industry trade group, says he agrees with the GAO's finding that the review process needs to move more quickly.
But Kuhlik says DTC drug ads are already subject to the most stringent regulatory oversight compared with other types of advertising, and the report doesn't question the rigor or comprehensiveness of the review process.
"Out of the hundreds and hundreds of DTC ads under review, the FDA has only issued a small number of letters and only 4 of the more serious warning letters," says Kuhlik. "And companies have uniformly complied in response to those letters.
Although critics have charged that pharmaceutical companies now spend more on advertising than research and development of new drugs, the report found that pharmaceutical companies spent $30.3 billion on research and development and $19.1 billion on all promotional activities, which includes $2.7 billion on DTC advertising in 2001.
But the amount that pharmaceutical companies spend on DTC ads is rising quickly compared with resources devoted to research and development. From 1997 to 2001, DTC spending grew by 145%, while research and development spending increased by only 59%, according to the report.
Researchers also found that the bulk of the rise in prescription drug spending is due to more people using the medications, not necessarily price increases. Prescription drug use has grown at an average rate of 6% a year since 1992 thanks to an aging U.S. population, new and more effective medications, and increased insurance coverage for medications.
However, the number of prescriptions filled for the most heavily advertised drugs is growing much faster than those for nonadvertised drugs. Between 1999 and 2000, the number of prescriptions dispensed for the most heavily advertised drugs grew by 25% compared with an increase of only 4% for drugs that were not heavily advertised.
Reviewed by Gary D. Vogin, MD
Medscape Medical News
http://www.medscape.com/viewarticle/445686?mpid=7001
Misleading Drug Ads Persist
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