Healthy Skepticism Library item: 14804

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

Perrone M.
FDA to study phone number to report side effects
The Associated Press 2008 Nov 25
http://www.google.com/hostednews/ap/article/ALeqM5j3-F1p4HIlUjQ1OHdqpvoISZNphAD94M48801

Full text:

The Food and Drug Administration plans to interview more than 1,500 consumers to decide whether television drug advertisements should urge patients to report side effects.
The regulatory agency is considering requiring TV promotions to carry a toll-free number where patients can report serious problems with their medication. However, some critics argue the toll-free number could distract viewers from other important safety information about the drugs.
Print advertisements already include contact information for the FDA, as required by a law passed last September. The legislation ordered the FDA to report to Congress by late March whether that information should also be mandatory for TV ads.
But the agency requested more time to complete its work and is expected to soon begin a formal study of the question – well over a year after the drug safety legislation was signed into law.
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.”
Drug promotions are already required to list a drug’s benefits and risks.
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.
The Pharmaceutical Research and Manufacturers of America has not yet taken a stance on the issue. However, the group – which represents Merck & Co. Inc., Pfizer Inc., Wyeth and other drugmakers – supported adding the language about side effects to print ads.
TV promotions have become a cornerstone of the pharmaceutical business since regulators opened the floodgate a decade ago. Companies spent roughly $3.5 billion on commercials last year.
But some lawmakers and consumer advocates say the advertisements can encourage over-prescribing of medications before all their side effects are known. By encouraging patients to report negative reactions to FDA, they hope regulators will be able to catch drug safety problems sooner.
By the time the FDA completes its study of the toll-free number, policymakers in the now Democrat-dominated Washington may have already moved ahead with even stricter regulations.
Rep. Rosa DeLauro, D-Conn., introduced a bill this spring that would ban consumer-directed advertisements during the three years after a new drug’s launch. The proposal is aimed at limiting the use of new drugs until they have been demonstrated safe.
The legislation would also require drugmakers to mount public awareness campaigns about the risks of certain types of drugs. DeLauro is expected to reintroduce the measure next year.
“The FDA has important drug oversight responsibilities, and the push to promote new drugs and devices should not get in the way,” DeLauro said, upon releasing the bill.