Healthy Skepticism Library item: 13412

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Blum J.
Drug Ads on TV Should Include U.S. FDA Phone Number, Group Says
Bloomberg News 2008 Apr 2
http://www.bloomberg.com/apps/news?pid=20601202&sid=ab0D1IfId8BU&refer=healthcare

Full text:

Consumers Union is pressing U.S. regulators to require that television commercials for medicines include a toll-free number to report harmful side effects.

The group, the publisher of Consumer Reports magazine, said today it collected about 56,000 signatures on a petition calling for the Food and Drug Administration to require the inclusion of the agency’s phone number. Consumers Union also released results from a telephone poll it conducted showing that only 35 percent of respondents knew they could report side effects to the FDA.

Legislation signed in September by President George W. Bush requires the FDA’s phone number to be listed in print ads for drugs. The measure called on the Health and Human Services Department, the FDA’s parent agency, to study by the end of March whether to include the number in TV commercials as well. A study hasn’t been completed.

``You can’t turn on a TV today without seeing a drug ad, but those ads never mention that consumers should be reporting serious drug side effects to the FDA,’‘ said Liz Foley, a campaign coordinator with Yonkers, New York-based Consumers Union, in a statement today.

The FDA is reviewing a request from the consumer advocacy group, filed in December, to require the phone number in television commercials, said agency spokeswoman Rita Chappelle, in an interview. The required study is under way, she said.

Voluntary Reporting

The FDA says it relies on voluntary reporting of drug side effects by health-care providers and consumers. The FDA tracks the reports as a way of monitoring drug safety. Spikes in reports of injuries or deaths can lead to new warnings or other regulatory action.

The agency says side effects are under-reported. The legislation approved last year calls on the FDA to use databases, such as those maintained by insurance companies, to detect side effects suffered after medications come on the market.

The Pharmaceutical Research and Manufacturers of America, a Washington-based trade group, is waiting for the study before taking a position on including the phone number, said Jeff Trewhitt, a spokesman, in an interview.

Consumer Union’s telephone survey found that one in six of those who had taken a prescription drug experienced serious side effects, such as those that are life-threatening or require a visit to a doctor.

Of those polled, 87 percent said TV ads should include information about reporting side effects, according to Consumers Union.

The poll found that 81 percent of respondents had seen or heard advertising for prescription drugs in the previous 30 days. Of those, 98 percent saw ads on television.

Consumers Union said the survey, of 1,013 randomly selected adults, was conducted from Feb. 14 to Feb. 17. The sampling error is plus or minus 3.1 percentage points, according to the group.