That was a prevailing theme yesterday, the first day of the 2006 DTC National Conference, the sixth annual gathering of influential decision-makers from the pharmaceutical industry.
Bob Ehrlich, CEO of DTC Perspectives magazine, the host of the conference, sounded the warning call in his opening remarks.
While saying that he was generally pleased with the way the industry progressed in 2005, particularly with a self-examination that resulted in the Pharmaceutical Research and Manufacturers of America advertising guidelines, Mr. Ehrlich said he can envision several scenarios that would put DTC advertising at risk in the future.
"Despite talk of First Amendment rights, [DTC] can be legislated away," said Mr. Ehrlich, the former VP-consumer marketing for Parke-Davis, responsible for the launch of Lipitor. "I can see the Food and Drug Administration attacked by a Democratic Congress for not doing enough, and making changes," he added.
He mentioned several other problems that could put DTC at risk, including the PhRMA guidelines not being followed and another Vioxx-type withdrawal from the market. "That," Mr. Ehrlich said, "would accelerate the process and really put some traction behind [opponents of DTC] this time."
But the biggest danger to DTC would be legislative.
Jim Davidson, president-government relations firm Davidson & Co., echoed Mr. Ehrlich's thoughts with a presentation that was media- and government-centric. Mr. Davidson was incredulous that several major print outlets have called for an end to DTC, or at least a moratorium on ads, when "two-thirds to three-quarters of their revenue is dependent on advertising."
He also took Advertising Age to task for a 2005 editorial that called for a moratorium on consumer advertising of new prescription drugs and restrictions on marketing as "a pro-consumer move."
"I didn't see where they said anything about the restriction of information to consumers," he said.
Mr. Davidson said the 109th Congress has already focused a great deal of attention on DTC, and is likely to do more in the fall. Where Mr. Ehrlich said he could see problems if a Democratic Congress is elected, Mr. Davidson said it could happen as soon as the next session. He mentioned the negotiations involving the Prescription Drug User Fee Act IV, also known as PDUFA. Pharma companies pay a fee to the Food and Drug Administration to put a drug through the regulatory process. In turn, the FDA guarantees a drug maker what is known as a "date certain"-approval or denial of the drug by a pre-determined date.
Clinical trial fee rates
According to the Department of Health and Human Services, the fee rates are as high as $767,400 for an application for clinical trial. In 2004, PDUFA brought in $259 million for the FDA, or almost half the agency's budget for drug approvals.
"There's no doubt in these hearings this fall, you'll hear DTC regulations raised again," Mr. Davidson said.