Consumer drug marketers huddled in Washington for the start of the DTC National Conference yesterday, unsure of the future but certain they faced a more active FDA and an uphill battle with regulators and policymakers.
“The ad fight is not over,” warned Jim Davidson of Polsinelli Shughart and the Advertising Coalition, noting that Rep. Henry Waxman (D-CA) continues to call an advertising moratorium a “top priority” on the argument that the risks of new drugs can't be fully known upon launch. The industry won a major victory in 2007 when the FDA Amendments Act was stripped of restrictions on advertising, but advocates of a crackdown are more powerful today. On the upside, said Davidson, Congress just gave FDA new powers to regulate advertising, and the industry would have allies among publishers and broadcasters already reeling from a deep advertising recession were Congress to threaten consumer drug ads.
Michael McCaughan, senior editor of Elsevier's RPM Report, said DTC foes he talks to aren't eager for another bite at a DTC ban, fearing that pharmas have an airtight First Amendment case. There's plenty of other ways they can clamp down on pharmaceutical promotion, noted McCaughan, such as fining companies for non-compliance or mandating safety disclosures. And drug companies are just beginning to recognize the far-reaching effects of the FDA Amendments Act, which McCaughan said compares to the 1962 Kefauver Amendments in scope and ambition.
“No longer is a drug approved or not,” said McCaughan. “Now it's about what kind of approval a drug will get. They've created a form of regulatory-driven personalized medicine.”
The good news, such as it is: “DTC is not popular, but there's a glimmer of hope if you can demonstrate a public health benefit,” said McCaughan.
Healthcare reform is “a moment of truth and opportunity” for the drug industry, said Bill Novelli, co-founder of PR powerhouse Porter Novelli and chairman-emeritus of AARP.
“We cannot fix our economy without fixing healthcare,” said Novelli, citing fast-rising and “unsustainable” healthcare costs driving Americans into bankruptcy and “sapping our competitive strength.” Nonetheless, reform is far from a sure thing, he said.
“It has an air of inevitability,” said Novelli, reminded of the momentum behind President Clinton's failed 1994 effort, “but we've seen this before.”
Novelli called on pharmas to cooperate with comparative effectiveness studies and said FDA should be empowered to approve ads for prescription drugs.