Consumer Reporting of Adverse Events to FDA

by Susan F. Wood, PhD 

The FDA Amendments Act (FDAAA) of 2007 includes a small section addressing direct to consumer (DTC) advertising.  The bill doesn't limit advertising to consumers, nor does it give FDA authority to put a moratorium on advertising while more data on safety or effectiveness is collected during the first months or years that a product is on the market.  A moratorium was recommended by the IOM in it's drug safety report in 2006, but was not adopted by Congress - perhaps due to arguments about first amendment rights, but perhaps due to objections by both the pharmaceutical industry and the advertising industry.

What was included is a small section requiring that all print DTC ads carry "the following statment printed in conspicuous text:  'You are encouraged to report negative side effects of prescription drugs to the FDA.  Visit, or call 1-800-FDA-1088' "

This is a good idea and it would be better if all DTC ads, including TV and web ads were required to provide this information as well.  But what was included in the law regarding TV ads is - A Study.  If such a study concludes that it is appropriate for TV ads to include information about Medwatch, then the FDA is to issued regulations to that effect.

The Consumers Union (producers of Consumer Reports) and the drug safety advocacy group WoodyMatters - named after the husband of founder Kim Witczak - has called for FDA to speed up the study and to require this information on all DTC advertising.  They have submitted a citizens petition to FDA and collected over 56,000 signatures of consumers around the nation calling for this information.

They also conducted a poll about prescription drug advertising and found some interesting, if not surprising, results.  One finding is that although the vast majority (81%) of people have seen prescription drug advertising (and 98% of these saw the ad on TV) only 7% identified FDA as the place that they would report a serious adverse event.  Most (79%) identified their doctor, which is good, but they did not identify FDA as an additional place to report serious events.

When asked, 45% said they were aware that they could report to the FDA, leaving a majority in the dark about this possibility.  This is a real problem given that 16% (and 22% of those over 55) reported having experienced a serious side effect from a prescription medication.

The public is a real resource for information, recognizing that it may not be complete or as accurate as a report from a health professional.  But it is one way of gathering signal data that can be of use to the FDA and ultimately helping the agency fulfill its mission for the benefit of the public.  Providing information about safety reporting to the FDA through DTC advertising also is a way of informing patients and families about the risks and benefits of prescription (and non-prescription) drugs.  Increasing the health literacy of the public is a good thing.  As long as we have DTC advertising, this is one step that can help improve communication to the public and to benefit by hearing directly back from them.

Both Rep. Jan Schakowsky (who inserted this provision into FDAAA) and Rep. Rosa DeLauro, chair of the House Agriculture, FDA Appropriations subcommittee, strongly advocate for FDA requiring this information be in TV ads.

FDA is planning a workshop or meeting in May on this subject - a part of the study required by the FDAAA.  Concerns about how to handle an influx of data, and what will be the quality and utility of it will no doubt be raised.  These are real questions and will require the FDA to have both the infrastructure and scientific resources to handle the information.  But it shouldn't stop FDA from requiring that all DTC ads, TV included, provide information to the public on how to report adverse events.

Susan F. Wood, PhD is Research Professor at George Washington University School of Public Health and Health Services, where she is part of the Project on Scientific Knowledge and Public Policy (SKAPP).  She also served as Director of the FDA Office of Womenâs Health from 2000-2005

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