FDA To Study Whether TV DTC Drug Ads Should Include Phone Number For Adverse Event Reporting
Currently Print Drug Ads Are Required To Show Information So That Patients Can Report Serious Side Effects To FDA MedWatch Program
(Posted by Tom Lamb at DrugInjuryWatch.com)
A November 25, 2008 Associated Press (AP) article, "FDA to study phone number to report side effects", let us know about an issue that the FDA will be considering, soon: Whether television drug advertisements should urge patients to report serious side effects to the FDA's MedWatch program.
From the November 25 AP newspaper article:
On Tuesday the agency laid out plans for a large-scale study to assess whether adding instructions about reporting side effects would overwhelm viewers who are already being bombarded by medical information.
Pharmaceutical "ads are already quite dense when compared with ads for other products," the agency states in documents posted online. "The risk information should not be compromised by the addition of the toll-free statement."...
For its study, the FDA will show ads for a fictitious blood-pressure drug to 1,600 consumers, who would then be interviewed to see how much of the information they understood. Specifically, researchers will assess how the placement, time and wording of the statements affects comprehension.
Regulators did not say when they would launch the study, but the FDA said it would accept comments on the proposal for the next two months.
Federal legislation already requires drug companies to include contact information for the FDA's adverse event reporting program, MedWatch, on print advertisement items. That same legislation, which passed in September 2007, ordered the FDA to report to Congress by late March 2008 whether that MedWatch contact information should also be mandatory for TV "direct-to-consumer" (DTC) drug ads. The FDA, however, requested and received more time to study whether or not these TV drug ads should show a toll-free number for MedWatch.
According to the November 25 AP article, in the U.S. drug companies "spent roughly $3.5 billion on commercials last year".
Do you think showing a toll-free number for FDA's MedWatch program on TV drug ads is a good or bad idea in terms of drug safety, i.e., possible earlier detection of unsafe drugs?
Let us know your opinion on this issue by submitting a Comment, below.
P.S. Here is the FDA's Notice, as it appears in the November 26, 2008 Federal Register:
[Docket No. FDA–2008–N–0595]
72058 Federal Register / Vol. 73, No. 229
(12/12/08)
