Pharmaceutical Industry

Fewer Citations Issued to Drug Companies for Misleading Ads

The Federal Drug Administration (FDA) is not only issuing fewer warning letters to drug companies for false and misleading ads, but is taking longer to do so, according to a new report put out by the Government Accountability Office (GAO), the investigational division of Congress.

The report indicates that between the period of 1997 through 2001 and the period of 2002 through 2005, the number of warning letters to drug companies fell by almost half. Also, during the earlier period it took an average of two weeks for the FDA to issue a letter compared with an average of four months to do the same for violations in the latter period.

A lack of effective means to screen, review and track the more than 10,000 ads and Web sites that are constantly increasing in number is a major factor hindering the FDA's review process, concluded the report.

The Health and Human Services Department (HHS), the parent agency of the FDA, responded that because they employ only six reviewers to police the entire industry, they focus on ads with the greatest potential impact on public health. HHS also stated that companies take their letters more seriously because they are both lengthy and legally-based.

Coalition for Healthcare Communications Executive Director John Kamp characterized the report’s criticism as silly.

DDMAC (Division of Drug Marketing, Advertising and Communications) has issued virtually no DTC warning letters since 2005 largely because of adherence to PhRMA’s self regulatory principles. Let’s praise the achievement, not damn it, Kamp said. We need to shorten the regulatory review times, but it is also time for FDA to reform the advertising review process to ensure that it is objective, predictable and social science based.