Changes Ahead
by Marilyn Grady
January 2008
The Food and Drug Administration Amendments Act of 2007 increases FDA funding, raising questions about the future of how the agency regulates drug marketing.
As one of only two countries in the world that permit direct-to-consumer (DTC) pharmaceutical advertising—New Zealand being the other—the U.S. government is in a precarious position with regard to policing the activity. The recently passed Food and Drug Administration Amendments Act (FDAAA) contained additional funding for the agency to enhance its review of DTC, although the overall effect of the additional resources will be unclear for some time.
Under the updated law, the U.S. Food and Drug Administration (FDA) will have an expanded timeline to review DTC advertisements, receive more funding to hire reviewers and also have expanded authority to cite misleading ads and levy fines.
New Timeline
According to an article in the Aug. 16, 2007 issue of the New England Journal of Medicine (NEJM), the FDA’s ability to enforce DTC advertising in a timely manner has weakened in recent years. Between 1999 and 2004, the percentage of broadcast advertisement that underwent FDA review before airing declined from 64 percent to 32 percent, the article states. In addition, a Government Accountability Office report found that many FDA warning letters are sent out to pharmaceutical companies long after the advertising campaign has run its course.
A new section under the FDAAA might address this delay, however. Under the new law, the FDA can require submission of DTC advertising for review no less than 45 days before dissemination of the advertisement.
New Drug Disclosure
In September 2006, the Institute of Medicine (IOM) released a report titled, The Future of Drug Safety: Promoting and Protecting the Health of the Public. Among other areas of concern, the IOM stated that DTC advertising needs additional regulations. One of the suggested regulations requires drug makers to include the age of a drug in DTC advertising if the drug is less than two years old. In addition, the advertising should note that evidence for a new drug’s risks and benefits are less developed than those of older drugs and suggest that patients consult a physician.
The FDAAA has made some strides toward meeting the IOM recommendations, however strict rules are not yet in place. The law states, “In conducting a review of a television advertisement under this section, the Secretary may require the advertisement to include, for a period not to exceed two years from the date of the approval of the drug … a specific disclosure of such date of approval if the Secretary determines that the advertisement would otherwise be false or misleading.”
More Sources of Revenue
According to a September 2007 FDA press release, the amendments authorize a new program for the collection of user fees to support FDA review of television advertisements directed at consumers. Karen Mahoney, a consumer affairs specialist for the FDA and spokesperson for the FDA’s Division of Drug Marketing, Advertising and Communication (DDMAC), says with the additional resources, the FDA will be able to provide faster reviews, which will be more predictable in terms of timeframes. The performance metrics are 45 days for initial ads and 30 days for resubmission. “Companies have conveyed that this predictability in timeframes and the shorter timeframe for comments is important to them and should encourage them to submit more of their ads for review.”
Whether or not these additional resources will lead to better and more effective reviews remains to be seen. According to the NEJM article, the FDA’s reviewing staff has remained relatively stable, whereas the use of DTC advertising has grown substantially. “In 2002, three FDA staff members were dedicated to reviewing direct-to-consumer advertisements,” the article states. “In 2004, four staffers were reviewing such advertisements, even though spending on this form of advertising (and probably the volume of ads to review) had increased by 45 percent, from US$2.9 billion to US$4.2 billion.”
Moratorium
Due to the potential problems with new drugs, as well as concerns about marketing new drugs through DTC advertising, many groups would like to see a moratorium on DTC advertising immediately after a new drug is released.
For example, in its September 2006 report, the IOM suggests that all new drugs carry a special label for two years after FDA approval. In addition, drugs carrying the label should be prohibited from DTC advertising. However, the report also acknowledged the potential legal issues involved in such a ban.
The report also says that 17 of the top 20 most advertised pharmaceutical products began DTC advertising within one year after FDA approval. Plavix, the blockbuster drug developed by Bristol-Myers Squibb and Sanofi, was one of the three drugs in the top 20 that delayed DTC advertising. The FDA approved Plavix in 1997, but advertising didn’t begin until 2001.
According to the NEJM article, the Pharmaceutical Research and Manufacturers of America has recommended that manufacturers delay DTC campaigns for new drugs until after health professionals have been sufficiently educated, although no details have been provided on how long a period was deemed necessary.
Bristol-Myers Squibb is one of a handful of manufacturers that has announced a voluntary moratorium on DTC advertising for drugs in the first year after FDA approval, the NEJM article states.
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