Drug Industry Dismayed by FDA Delay on Digital Marketing Guidelines

Three-Month Pushback Frustrates Industry Digging into Social Media and Internet Advertising

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NEW YORK (AdAge.com) -- The Food and Drug Administration just dropped a lump of coal in the pharmaceutical industry's stocking. The FDA has delayed its much-anticipated regulatory guidance for digital pharma marketing until the first quarter of 2011, further frustrating an industry eager to broaden its scope of internet and social-media marketing.

The agency released a statement Tuesday night to the EyeonFDA blog that read: "The Division of Drug Marketing, Advertising and Communications (DDMAC) has been researching draft-guidance topics on the following issues related to internet/social-media promotion of FDA-regulated medical products: Responding to unsolicited requests; fulfilling regulatory requirements when using tools associated with space limitations; fulfilling post-marketing submission requirements; online communications for which manufacturers, packers or distributors are accountable; use of links on the internet; correcting misinformation."

It continued: "Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed. The public will be notified officially when any guidance is issued via Federal Register announcements."

The FDA was expected to announce online guidelines by the end of this year after holding two-day public hearings in November of 2009. Delaying that potentially for three more months -- and guaranteeing draft guidance on only one of those topics -- is not sitting well. "It's infuriating," said one health-care-centric ad agency president. "On one hand, you want FDA to get it right. On the other hand, the (public hearings) were last November. They've had more than a year to get it right. It's bullshit."

But Paul Machado, CEO and founder of New Jersey-based Health Innovation Partners, said the delay is not such a bad thing. "If you think about it from the FDA's perspective and the challenges they're dealing with regarding health-care reform, why come out with a position? There's not a need right now. Why bother?"

Mr. Machado added that the industry will "continue to meander through the forest and see what happens, be conservative, see what others do and slowly create a position for themselves. Even if they do come out with guidance, it will take companies a long time to react to it. The reality is, you can only do so much anyway. "

At the November 2009 hearings, more than 60 people spoke, including representatives from Google, drug-makers and ad agencies. A month later the FDA published its Guidance Agenda for 2010, and the "Guidance on the Internet and Social Media" was listed -- meaning, at some point this year, the FDA expected to issue those guidelines.

One of the first inklings that it was going to be delayed came earlier this month when the FDA issued its Guidance Agenda for 2011 and "Guidance on the Internet and Social Media" was again listed.

Asked in an email why the agency would delay its online guidance, former FDA associate commissioner Peter Pitts replied: "Lack of knowledge. Lack of urgency. First Amendment angst."

Ironically, as the pharmaceutical industry itself begs for online/social-media guidance in order to pursue marketing in the new media, the first documented enforcement letter stemming from the FDA's new "Bad Ad" program was online-related.

The Dec. 3 letter from the Division of Drug Marketing, Advertising and Communications (DDMAC) to Hill Dermaceuticals claimed the company's web pages for its Derma-Smoothe product "are false or misleading because they omit and minimize the risks associated with the use of Derma-Smoothe Body Oil, overstate its efficacy, present unsubstantiated superiority claims, broaden and inadequately communicate the indication, and present unsubstantiated claims for the drug product. Thus, the webpages misbrand the drug in violation of the Federal Food, Drug and Cosmetic Act."

The "Bad Ad Program," instituted in May, urges the medical community to report ads and sales pitches that violate FDA rules. Ostensibly, the program was designed primarily to catch what the FDA can't see -- the behind-office-doors pitches from pharmaceutical sales reps to physicians. But the broad definition of the program allows doctors and medical professionals to report false or misleading ads to the FDA, and to do so anonymously.

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