IMPORTANT: If you’re interested in signing onto the attached petition, please contact Consumers Union directly (Bill Vaughan at email@example.com or Susan Herold at firstname.lastname@example.org)
December 31, 2007
Divison of Dockets Management
Food and Drug Administration
Department of Health and Human Services
5630 Fishers Lane, Room 1061
Rockville, Maryland 20852
Consumers Union, the independent, non-profit publisher of Consumer Reports
submits this petition pursuant to 4(d) pf the Administrative Procedure Act, 5 USC 553(e), 21 CFR 10.25 & 10.30, and PL 110-85, section 906.
Section 906 of the FDA Amendments Act of 2007 provides that the
Secretary of Health and Human Services shall conduct a study to determine if the [following] statement [“You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088”] required with respect to published direct-to-consumer advertisements is appropriate for inclusion in…television advertisements.
Consumers Union (CU) requests the Food and Drug Administration require that all television advertisements for prescription drugs and over the counter drugs include a toll-free number and a website address for the public to report side effects to the agency. All television advertisements for prescription drugs should include the following, “You are encouraged to report adverse effects of prescription drug medication. Log onto www.fda.gov/Medwatch or call 1-800-FDA-1088.”
The FDAAA (P.L. 110-85) requires all print advertisements to include this statement, but this should be expanded to include TV advertisements.
Statement of Grounds
All too often, drug advertisements fail to present the benefits and risks of using prescription drugs in an accurate and balanced way. It is often the newest drugs that are the most heavily advertised, and it is these drugs whose side effects we know the least about. Two-thirds of all drug withdrawals occur within the first three years of release and it estimated that only half of all label changes occur in the first seven years that a drug is on the market. The recent action by the FDA on the use of over-the-counter cold remedies on young children is a clear example of why the public should be encouraged to report adverse events from not just prescription drugs but from over the counter products, even those long considered safe. Therefore, it is important to have information on TV advertisements where consumers can report side effects.
Currently, it is estimated that adverse drug event reporting system catches only a small fraction of all adverse incidents of drugs. Adverse drug reactions are responsible for as many as 700,000 emergency room visits annually. Including a toll-free number and a website to report side effects will increase the information the FDA has on drug risks and would also increase awareness to consumers.
And television drug ads run far more frequently than print ads. Consumers are repeatedly faced with TV ads, with their pictorial power, compared to what is generally a one time scan in the print media. Including this number and website in TV ads would reach far more Americans than through print ads.
The FDA has stated about MedWatch:
“The MedWatch program has four goals:
To clarify what should and should not be reported to FDA.
To increase awareness of serious reactions caused by drugs or medical devices.
To make the reporting process easy.
To give the health community regular feedback about product safety issues.
While participation in MedWatch is voluntary, FDA encourages anyone aware of a serious adverse reaction, including consumers, to make a MedWatch report.”
Including a toll-free number and a website to report side effects would certainly help the FDA achieve the above goals and it would help encourage many more consumers to report adverse reactions with medications.
Increased reporting and use of MedWatch would help in the earlier detection and better analysis of problems. All television ads should contain information on how patients should report unusual side effects to the FDA.
We believe that pursuant to section 21 CFR 25.30(a), this petition is excluded from the requirement for an environmental impact statement.
The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.
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 Matthew F. Hollon, MD., “Direct-to-Consumer Advertising: A Haphazard Approach to Health Promotion,” JAMA, April 27, 2005. Vol. 293, No. 16, p. 2032.
 Institute of Medicine, “The Future of Drug Safety, 2006, p.53
 Daniel S. Budnitz, MD., “National Surveillance of Emergency Department Visits for Outpatient Adverse Drug Events,” JAMA, October 18,2006. Vol. 296, No. 15 p.1863
 John Henkel., “Medwatch: FDA’s Heads Up on Medical Product Safety,” FDA Consumer Magazine, November-December 1998.