FDA Readies Report On DTC, Says Physician Survey Supports Current Policy

FDA expects to publish a report on its 1997 direct-to-consumer broadcast advertising policy this spring.

The report will incorporate three surveys conducted by the agency on the impacts of direct-to-consumer advertising on the physicians-patient relationship. The report will also include outside data, such as surveys conducted by other organizations.

The report is unlikely to recommend any substantial changes to the 1997 policy.

FDA released the data from its most recent DTC advertising survey, which included 500 physicians, on Jan. 13. The data "confirm FDA's current understanding about DTC advertising," the agency declared.

"Ads can and do help increase patient awareness about the availability of effective treatments for their health concerns," FDA said. "But FDA's DTC policies must help prevent potential misperceptions about benefits and risks of the advertised treatment," the agency added.

In addition to the physician survey, FDA will include in its report results from two consumer surveys conducted in 1999 and 2002. The findings FDA highlighted from those surveys included the perception by consumers that ads are not affecting the doctor-patient relationship.

The physician survey appears to bear out that finding. According to data presented by Division of Drug Marketing, Advertising & Communications analyst Kathryn Aikin, PhD, at the Strategic Research Institute's Pharmaceutical Marketing Global Summit Jan. 13 in Philadelphia, few physicians describe the impact of DTC advertising on their patients as very positive (3%) or very negative (5%).

Most describe DTC as having affected their practice either somewhat positively (37%), somewhat negatively (27%), or not at all (28%).

Overall, physicians felt that ads "prompted thoughtful discussions," the agency said, although "they also felt they had to provide additional information to patients beyond what the patients retained from the DTC advertising."

However, the survey did find that "many physicians felt some pressure to prescribe something when patients mentioned DTC ads," FDA said, particularly when patients request a specific brand.

Twenty-nine percent of physicians asked generally for a prescription felt "a little" pressured to prescribe a drug while 14% felt "somewhat" pressured and 2% felt "very" pressured. However, when asked for a particular brand, 32% felt "a little" pressured, 22% felt "somewhat" pressured, and 9% felt "very" pressured (¹ "see graphic).

One apparent difference between the physician survey and the earlier consumer survey is that patients report receiving a prescription for a specific drug more frequently than doctors report prescribing them.

FDA's physician survey found that, of those physicians who were asked to prescribe a specific brand, 57% wrote a script for it. The 2002 consumer survey found that 69% of patients who asked their doctors about a brand received a script (² , p. 20).

The 2002 FDA consumer survey findings also differ sharply from those of a National Consumers League survey, which found that 42% of patients received a prescription for a drug in the ad that they saw.

The NCL survey asked its question in a slightly different way, which may explain the difference.

FDA's continued support for the 1997 broadcast ad policy illustrates the wisdom of the approach taken by industry towards the issue at that time. Although FDA was under pressure from Congress and industry, the policy change was ultimately made at the agency level, rather than in response to legislation or a court order.

Five years later, FDA is now one of the most effective advocates of the current approach to DTC.

The upcoming report will likely serve as a touchstone for renewed Congressional debate over the topic.

"There's no lack of voices out there criticizing direct-to-consumer advertising," Pfizer's Senior Director-Federal Relations Dolly Judge noted during the SRI conference.

"As you know it takes on many forms. The increasing price of drugs is one...that somehow the price of the drugs reflects the cost of the advertising. Inappropriate prescribing" is another, she added.

Judge named three Republicans in leadership positions as likely candidates to keep debate over DTC advertising alive: incoming Senate Health Committee Chairman Judd Gregg (R-N.H.), House Ways & Means Committee Chairman Bill Thomas (R-Calif.), and Centers for Medicare & Medicaid Services Administrator Tom Scully.

Gregg, Scully, and Thomas "are critical of direct-to-consumer advertising" so the issue "is probably not going away," Judge said.

Gregg joined former Health Committee Chairman Edward Kennedy (D-Mass.) in pressing Commissioner McClellan on DTC issues during the confirmation process (³ (Also see "FDA Labeling Standards Top Kennedy’s Agenda For Commissioner Nominee" - Pink Sheet, 14 Oct, 2002.), p. 4).

Thomas has considered a proposal to increase co-pays under a Medicare Rx plan for drugs that have DTC advertising (⁴ (Also see "DTC Restrictions Under Consideration For House Medicare Rx Bill" - Pink Sheet, 6 Aug, 2001.), p.26).

The proposal was not supported by House Energy and Commerce Chairman Billy Tauzin (R-La.) (⁵ (Also see "GAO Will Study Impact Of DTC Advertising Under House Medicare Rx Bill" - Pink Sheet, 24 Jun, 2002.), p. 19).

Pfizer's Judge cited a recent General Accounting Office report on DTC advertising as another possible cause for more stringent regulation. "You may see tougher enforcement coming out of the agency based on the findings of the GAO report," she said.

Judge called the report a "mixed bag" for industry. She noted that while it did "clearly state once and for all" that industry spends more money on research and development than advertising, it was also "fairly critical" of FDA and suggested that "enforcement isn't...as strong as it could be."

Expedited handling of DTC ad letters was requested in the GAO report. FDA's Office of Chief Counsel subsequently added two lawyers to review draft regulatory letters from the agency's ad division. One lawyer had been performing the duty since review by the chief counsel's office was established in February (⁶ (Also see "DTC Ad Letter Review Cited By GAO; Chief Counsel’s Office Adds Two To Task" - Pink Sheet, 9 Dec, 2002.), p. 3).

Judge said that concerns about DTC from both Congress and FDA will likely focus on "communicating risk of pharmaceuticals" and urged industry to be "ultra-compliant."

The Pfizer exec also advised industry to "know the facts" about the cost of drug development and to "help people recognize the good our industry does and the value we bring to the health care system."

During an appearance on National Public Radio's "The Diane Rehm Show" Jan. 15, Commissioner McClellan took an even-handed approach when asked about the value of DTC advertising.

"The positive is that there are clear evidence that people do pay attention to what's in the ad and that many people come in to see their physician about a health problem that wasn't being treated," he said.

However, McClellan continued, "physicians have expressed concerns about patients getting misleading information from the ads, not getting a full appreciation of the risks, and that's why FDA has to be vigilant."

The commissioner indicated that one possible area to receive more stringent oversight could be repeated offenses. "If we see a recurrent pattern of behavior though, which is what concerns me, I think we ought to take further action."