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
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
Manthei also said that “if you plan to allow third-party
content on company-hosted media, ensure [that] you maintain control to maintain
to alert users that content will be reviewed and may be deleted.
Additionally, Manthei said that companies should ensure that their internal
and promotional labeling review program is “attuned to developing issues in the
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:
complete and accurate in characterizing clinical trial results;
omit or mischaracterize relevant communications from the FDA; and
“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:
information presentations (three letters);
from flawed study designs unable to provide substantial evidence for a claim
about a drug (11 letters);
product promotion (three letters);
release about a product (three letters); and
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:
with marketing team members to ensure risk presentations get equal time and
attention in promotional materials during the drafting stage (including
on medical reviewers to understand study designs and the limitations for
overlook investigational product materials and websites;
product-related press releases undergo multidisciplinary review; and
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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