Senate Explores Restrictions On Direct-To-Consumer Device Ads
Full article reprinted from "The Gray Sheet" - September 22, 2008
Find out how the Senate Special Committee on Aging Chairman Herb Kohl, D-Wis., is considering legislation to restrict direct-to-consumer advertising of medical devices.
Full article reprinted from "The Gray Sheet" - September 22, 2008
Senate Special Committee on Aging Chairman Herb Kohl, D-Wis., is considering legislation to restrict direct-to-consumer advertising of medical devices.
A Senate aide told "The Gray Sheet" that the committee is closely monitoring negotiations between the House Energy and Commerce Committee and the pharmaceutical industry on drug DTC advertising. Kohl may use the results of those negotiations as a model either for Senate legislation on DTC device advertising to be introduced in the next Congress, or for a voluntary agreement between the device industry and FDA on review of device ads.
"We need to be sure that people who are considering getting medical devices get as much information as they need from the right sources, so that they can make the proper decision," Kohl said at a Sept. 17 Aging Committee hearing on DTC device advertising. He said he has no immediate plans to introduce a bill on the subject, but added, "This is not to say that we won't."
Possible restrictions on device ads mentioned by Kohl and Sen. Ken Salazar, D-Colo., at the hearing include an 18-24 month ban on DTC ads for new devices and requirements for more risk and safety information in the ads.
A Senate bill might require firms to submit ads to CDRH for review before publication or broadcast. Pre-review of device advertising would require more resources at FDA, Kohl acknowledged.
FDA has voluntarily reviewed pharmaceutical DTC ads for years, and last year was given authority through the FDA Amendments Act to require an agency pre-review of broadcast drug ads. The act also allows FDA to fine sponsors for violative ads.
In addition, an FY 2008 appropriations bill increased federal money available to fund the FDA drug advertising reviews.
Cypher Stent Ad Heightens Doctors' Concerns
While most device television ads seem to focus on cosmetic implants and hip and knee replacements, Johnson & Johnson/Cordis launched a TV ad campaign for its Cypher sirolimus-eluting stent on Thanksgiving Day ("1The Gray Sheet" Dec. 17, 2007, p. 5). The ad, which Kohl's aide said was reviewed and OK'd after edits by CDRH before its release, was replayed at the Senate hearing.
William E. Boden, M.D., chief of cardiology at Buffalo General Hospital, criticized the Cypher ad, testifying that it "crossed the line," because the decision to use a stent requires "a very sophisticated medical understanding" that few members of the lay public could gain through a DTC ad campaign.
Ami Gadhia of the Consumers Union argued that TV ads for implantable devices such as stents and joint replacements should include warnings about potential risks, such as hospital-acquired infections.
Responding to a question from Sen. Kohl on whether FDA should pre-review device ads as frequently as it reviews drug ads, CDRH Director Dan Schultz said such reviews are important, but noted the device center's finite resources.
"We have a number of other priorities, including import safety, product surveillance, good manufacturing, and making sure we have a review process that gets good life-saving devices to the marketplace in a reasonable time frame," Schultz said.
"The question is not whether I have the resources. The question is, where do I put [DTC ad oversight] in terms of priorities?"
AdvaMed: Ads Are "Powerful Educational Tool"
Steve Ubl, president of the device trade association AdvaMed, testified that DTC advertising can be helpful to patients by "providing a powerful educational tool that allows patients to learn of new technologies and treatment options in a timely fashion."
Ubl said AdvaMed's executive board is currently reviewing a series of principles for the group's members to follow in DTC advertising. The principles will emphasize the importance of forthright, consumer-friendly language in the ads.
While Congress gave FDA more authority to regulate pharmaceutical DTC advertising in the FDA Amendments Act, lawmakers did not call for a moratorium on consumer-directed drug ads, as some Democrats have advocated. For example, in October 2007, Rep. Rosa DeLauro, D-Conn., said she might introduce a bill to ban DTC advertising for orthopedic implants for three years post-FDA approval ("2The Gray Sheet" Oct. 8, 2007, p. 9).
Clark Rector of the American Advertising Federation and James Davidson of the law firm Polsinelli Shalton Flanigan Suelthaus, who both attended the hearing but did not testify, said that any legislation that attempted to place a moratorium on DTC ads would violate the free speech clause of the Constitution.
In June, under grilling by the House Energy and Commerce Committee and the House Oversight and Government Reform Committee, pharmaceutical companies Pfizer, Merck, Johnson & Johnson and Schering-Plough stressed that they abide by American Medical Association guidelines that discourage having actors portray physicians in drug broadcast ads and recommend including all appropriate warnings about drug risks.
The drug companies say they usually wait six months after product approval before launching new DTC ad campaigns, but they rejected AMA's recommendation that they refrain from advertising their products until all outcomes research is completed.
DTC Ad Guidances Are Priority For FDA
After the hearing, CDRH's Schultz told "The Gray Sheet" that FDA plans to finalize an agency-wide DTC guidance soon that would cover both drugs and devices. A draft guidance on device DTC advertising was issued by FDA in January 2004 ("3The Gray Sheet" Feb. 9, 2004, p. 6).
In a related matter, Rep. Henry Waxman, D-Calif., on June 17 released an internal FDA e-mail dated June 15, 2007, between former FDA Chief Counsel Sheldon Bradshaw and Bradshaw's special assistant Scott Danzis indicating that a final FDA guidance on "Consumer-Directed Broadcast Advertising of Restricted Devices" is one of FDA's priority projects. Another agency priority listed was: "Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements."
- Sue Darcey
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