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Sept. 17 --Pharmaceutical companies should establish a corporate social media policy, attorney John Manthei, with Latham & Watkins LLP in Washington, said Sept. 17.
Speaking during a session on drug product compliance at the Food and Drug Law Institute's Advertising & Promotion Conference, Manthei said the Food and Drug Administration is “incredibly” advanced at using social media, but it hasn't yet said how it will regulate others when it comes to social media.
Manthei said the FDA is required by the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) to issue specific guidance on social media by July 9, 2014. However, he said FDA's message in warning letters has been that “current standards apply” when it comes to social media.
Social media is “interactive and the formats are constantly evolving,” Manthei said.
Manthei said companies should establish a “clear corporate social media policy and provide adequate training to employees.”
Additionally, Manthei said that companies should ensure that their internal and promotional labeling review program is “attuned to developing issues in the media space.”
Manthei said both the FDA and the Securities and Exchange Commission regulate public statements by firms and the statements must be “truthful and nonmisleading.”
The SEC “may scrutinize disclosures about FDA-related events to prevent stock price manipulation,” Manthei said. “The FDA is unlikely to object to a disclosure that is required under the securities law.”
Manthei said companies should implement internal review procedures to ensure public statements are “accurate, complete and not misleading”
Additionally, Manthei said that when drafting public statements subject to the SEC's and the FDA's scrutiny, the statements should:
• be complete and accurate in characterizing clinical trial results;
• not omit or mischaracterize relevant communications from the FDA; and
• not “get out in front” of the FDA by implying or stating that a development product is safe and effective for an indication that is still investigational.
Attorney Julie K. Tibbets, of Alston & Bird LLP in Washington, said that from October 2012 to September 2013, the FDA Center for Drug Evaluation and Research's Office of Prescription Drug Promotion (OPDP) issued one warning letter and 18 “untitled” letters (the latter cite violations that don't meet the threshold of regulatory significance for an FDA warning letter).
“Compared to prior years, this a downward trend in letters, especially in warning letters,” Tibbets said. In the 19 letters, OPDP said it had issues with the following topics:
• risk information presentations (three letters);
• data from flawed study designs unable to provide substantial evidence for a claim about a drug (11 letters);
• investigational product promotion (three letters);
• press/news release about a product (three letters); and
• composite date (one letter).
Tibbets said there are few instances where OPDP issued letters that do not mention risk and data presentations.
“Focus your legal and regulatory resources on risk and data presentations” in advertisements and don't overlook investigational product materials and websites, Tibbets said.
Tibbets also said companies should:
• partner with marketing team members to ensure risk presentations get equal time and attention in promotional materials during the drafting stage (including labeling);
• lean on medical reviewers to understand study designs and the limitations for supporting data;
• not overlook investigational product materials and websites;
• ensure product-related press releases undergo multidisciplinary review; and
• inventory claims supported by composite score data for overstatement of efficacy.
Tibbets said companies also should “keep an eye out” for the FDA's direct-to-consumer advertising composite score study results “to inform future benefit presentations of score-based claims.”
In August, the FDA announced that the Office of Management and Budget approved a study on communicating composite scores in DTC advertising (11 PLIR 1015, 8/16/13). Pharmaceutical companies must demonstrate to the FDA the efficacy of their drugs, the agency said. Drug efficacy is sometimes measured by a single endpoint, such as high blood pressure. It often is measured by multiple endpoints that sometimes are combined into an overall score called a composite score, the agency said.
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