Life Science Compliance Update

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July 09, 2013

FDA: Delay of Online and Social Media Guidance Creates Confusion

It has been quite a while since we have written about social media and the Food and Drug Administration (FDA)—mostly because the issue has been pretty quiet at the agency. The last major event regarding the topic occurred this past summer, when Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) which contains a provision mandating that FDA issue final social media guidance no later than July 2014.

Several recent developments regarding FDA and its Office of Prescription Drug Promotion (OPDP) have taken place over the last few weeks. For example, in late May of this year, OPDP held a webinar that discussed the office's latest batch of enforcement letters, as summarized by the Coalition for Healthcare Communication (CHC).

According to the CHC post, OPDP "continues to cite industry for overstating efficacy, minimizing or omitting risk and making unsubstantiated claims, according to six untitled letters issued by OPDP from November 2012 through the end of March 2013." OPDP regulatory counsel staff members "discussed specific problems it found with various promotional claims, and responded to questions about online promotional guidance and the agency's approach to enforcing misbranding violations in the wake of the recent U.S. v. Caronia decision."

An OPDP enforcement letter to Alcon Research Ltd. regarding PATADAY™ stated that promotional materials for the drug touted "zero itch" associated with its use. OPDP states that such claims overstate efficacy "because they suggest that all patients who use Pataday will experience 'zero-itch' and be symptom-free." The letter also states that the company made unsubstantiated superiority claims about zero itch.

"The study cited for the zero-itch claim was a post hoc study and was not considered substantial evidence;" said OPDP Regulatory Counsel Cynthia Ng. "Substantial evidence is generally demonstrated through two adequate and well-controlled trials." She clarified that a study "does not necessarily need to be published to support efficacy claims, but the data need to be readily accessible if OPDP requests it."

CHC reported that "in response to a listener question regarding the promotion of investigational uses of a drug on a Website and in a podcast," OPDP Regulatory Counsel Julie Chronis stated that companies "can discuss investigational uses for their drugs, but they have to do it in an appropriate manner."

She noted that Salix Pharmaceuticals Inc. and Napo Pharmaceuticals were cited by OPDP in an enforcement letter for discussing investigational uses for the drug CROFELEMER tablets in part because they indicated that the drug was safe and/or effective for children as young as three months, which it states has not yet been proven. Other enforcement letters issued during this period alleged the following violations:

  • Omission of material fact;
  • Omission and minimization of risk;
  • Unsubstantiated superiority claims;
  • Unsubstantiated efficacy claims;
  • Overstatement of efficacy; and
  • Inadequate communication of indication.

In the absence of long-awaited OPDP guidance regarding online promotion, one Webinar attendee asked whether OPDP would be issuing guidance on how companies can properly promote their drugs using social media, such as Facebook and Twitter.

"We publicly announced that we would be publishing several Internet guidances, one of which [on unsolicited requests] has already been issued," OPDP Regulatory Counsel Robyn Tyler said. "So that these guidances don't quickly become obsolete because of the ever-changing technology, the guidances won't be just for a specific medium like Facebook or Twitter." She did not address the million-dollar question regarding when additional guidance on electronic media promotion could be expected.

Interestingly around the same time of the Webinar, FDA released a consumer alert that interviewed OPDP's Director Tom Abrams, asking about social media and several other topics regarding direct-to-consumer (DTC) promotion. Abrams remarked that social media "certainly" has complicated his job. He noted that "[t]he Internet and social media have increased the volume and extent of materials and speeded the delivery of those materials. Websites can have hundreds of pages and can change daily."

Importantly, Abrams clarified that although OPDP closely monitors "what companies say, we generally do not have authority over statements made by independent organizations or persons—what we call third parties—unless they are acting on behalf of a company." In addition to this comment, Abrams explained that OPDP has taken action against several companies for misleading promotional materials disseminated by companies using social media platforms such as YouTube and Facebook.

For instance, OPDP sent a warning letter to a company that developed and posted a video testimonial promoting its drug on YouTube. The testimonial featured a well-known TV celebrity. The warning letter noted, among other things, that the promotional testimonial violated the regulations by overstating the benefits of the drug product and not mentioning the serious risks of using the product. The company removed the ad and complied with OPDP's request to create a plan of action to disseminate truthful information to audiences exposed to the promotion.

Moving back to the OPDP webinar, the panel was asked whether OPDP would change its enforcement approach toward drug misbranding in light of the recent U.S. Court of Appeals for the Second Circuit decision in U.S. v. Caronia. "That's a good question. No significant changes with be made to the enforcement process in light of the Caronia decision," Tyler responded.

"This is based on the determination by the court that the promotion of a drug for an unapproved use is an intended one and that a drug that lacks adequate directions for its intended use is misbranded. Additionally, because the court also acknowledged that the First Amendment does not preclude an enforcement action based on unapproved uses that are false or misleading, OPDP will continue to enforce the misbranding provisions of the Food, Drug & Cosmetic Act."

When asked whether OPDP could provide some tips to companies to help them avoid getting an enforcement letter, Tyler advised industry to:

  • Review OPDP guidance documents;
  • Look to posted enforcement letters for how OPDP has treated similar situations/claims in the past; and
  • Utilize the advisory comment process.

"Companies have the resources that they need to best insulate themselves from receiving an OPDP enforcement letter," Tyler asserted.

OPDP Activities

Abrams explained that the U.S. allows DTC advertising because it is protected as commercial speech under the First Amendment. However, FDA is charged by law "to make sure advertising and other promotional materials are accurate and balanced, and provide helpful information to consumers about medical conditions and drugs to treat them."

He explained that with respect to television (TV) commercials, drug companies are required to submit to OPDP all advertisements and other promotional materials at the time they make them public. Some companies submit materials to us for advisory comments before they make them public.

OPDP receives anywhere from 6,000-8,000 pieces of advertising and promotional submissions each month. The materials are assigned to one of its 32 reviewers, who specialize in specific drug categories, such as asthma medicines or cardiac (heart) treatments. Many reviewers are health care professionals with diverse backgrounds in academia, industry, hospitals and pharmacies. They use a risk-based approach that allows them to prioritize their work to quickly identify promotional materials with the most potential for negative impact on public health.

The first step for a review who finds something potentially false or misleading, Abrams explained, is to review the promotion and take action if needed. Most often OPDP issues enforcement letters (like those discussed above), which ask that companies stop the misleading promotion. FDA can take additional actions if the misleading promotion is not discontinued, including legal actions through the Justice Department.

Abrams explained that an ad is "false or misleading" if it "states that the drug is more effective or has fewer or less severe side effects than has been demonstrated, we'd consider that false or misleading. Same thing if the ad claims, without solid evidence, that the product is safer or more effective than a competitor's drug, or if it misrepresents the product's risks." OPDP also pays "careful attention to balance, making sure the risks are displayed prominently so that they can be read, heard and understood easily."

The OPDP director also encouraged consumers and healthcare professionals to use FDA's Bad Ad web page to learn about how to identify "bad ads" and report them to OPDP.


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