Prescription Drug Television Ads Should Be Required To Include Toll-Free Number, Web Site For Consumers To Report Serious Side Effects To FDA

Main Category: Pharma Industry / Biotech Industry
Also Included In: IT / Internet / E-mail;  Public Health;  Regulatory Affairs / Drug Approvals
Article Date: 04 Apr 2008 - 11:00 PDT

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Reps. Rosa DeLauro (D-Conn.) and Jan Schakowsky (D-Ill.) on Wednesday asked FDA to mandate that all prescription drug television advertisements include information for consumers to report serious side effects to the agency, the Los Angeles Times reports.

DeLauro and Schakowsky cited a recent Consumers Union survey that found 16% of respondents had experienced an adverse prescription drug side effect serious enough for them to seek treatment from a physician, but just 35% of respondents were aware that serious side effects could be reported to FDA. In addition, 7% of respondents named FDA as a place where they would report a serious side effect.

FDA monitors adverse events related to prescription and over-the-counter drugs through its MedWatch program. However, FDA officials said that they estimate only about one in 10 adverse events are reported to MedWatch (DuBose, Los Angeles Times, 4/3).

Last summer, Schakowsky co-sponsored an early version of legislation that required all print drug ads to contain reporting information, CQ HealthBeat reports. The measure passed in September 2007 and contained a provision that FDA conduct a study to see if it would be feasible for TV ads to contain similar information (Cooley, CQ HealthBeat, 4/2). The measure required the study to be completed by the end of March. FDA spokesperson Rita Chappelle said the study is still in progress (Los Angeles Times, 4/3). DeLauro has introduced legislation that would prohibit direct-to-consumer ads for new drugs during their first three years on the market to give time for adverse events to be reported before heavy marketing begins. DeLauro noted that spending on prescription drug ads increased from $650 million in 2001 to $1.1 billion in 2005 (CQ HealthBeat, 4/2).

Consumers Union has sent FDA a petition with more than 55,000 signatures requesting the agency require that a toll-free number and a Web site address to be included in TV ads to make it easier for people to report side effects. Chappelle said the agency has received the petition and is reviewing it (Los Angeles Times, 4/3).

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DeLauro said FDA "is failing to serve its most vital supervisory responsibility," adding, "The more we know about serious drug side effects, the more we can do."

Schakowsky said, "We're working with and pushing the FDA" to require reporting information, adding, "The interest and signatures from consumers certainly help" (Los Angeles Times, 4/3).

A spokesperson for the Pharmaceutical Research and Manufacturers of America said that the trade group would not take a position on the petition until FDA completes the feasibility study (CQ HealthBeat, 4/2).

The survey is available online (.pdf).

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