Marketers weigh DTC policy pitfalls

Share this article:
Consumer drug marketers huddled in Washington for the start of the DTC National Conference in mid-April, 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 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, noted McCaughan, such as fines or mandating safety disclosures. And pharmas 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.”

Healthcare reform is “a moment of truth and opportunity” for the drug industry, said Bill Novelli, chairman-emeritus of AARP. Novelli called on pharmas to cooperate with comparative effectiveness studies and said FDA should be empowered to approve ads for prescription drugs.
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Features

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Is your marketing strategy stuck in 2005?

Is your marketing strategy stuck in 2005?

It is not enough to just have a killer black book or Rolodex. The market needs agile, swift marketing

Is guidance stifling social media?

Recent FDA draft guidance was meant to help companies create FDA-compliant tweets and handle third-party misinformation on the web. What other obstacles lie in the path of effective social media use?

FDA social media guides draw flak

FDA social media guides draw flak

Two FDA guidance documents on how health product manufacturers may participate in social media have drawn criticism from industry and consumer groups.