FDA Plays Catch Up in the Digital Age

by JD Supra Perspectives

Life sciences is one of the most heavily regulated industries in the country. In particular, labeling and advertising for prescription drugs are significantly limited by the Food, Drug and Cosmetic Act as well as FDA regulations. All product labeling and advertising must be accurate, complete, not misleading and balanced with information related to both benefits and risks.

As pharmaceutical manufacturers increasingly turn to social media to exchange information, laws and regulations that are decades old struggle to keep pace. These requirements were written not only before social media but before the Internet was even invented.

It is arguably impossible to provide adequate benefit and risk information in the 140 characters allotted for a Tweet. How to handle “Likes” and “Retweets” has become a regular conversation between in-house compliance lawyers and their outside counsel.

In a long awaited effort to keep up with digital media, the FDA released a draft guidance regarding the “Regulatory Requirements for Post-marketing Submissions of Interactive Promotional Material.” Other guidances due out later in 2014 include (1) character and space limitations and presenting risk and benefit information, (2) correcting independent-third party misinformation, and (3) use of links.

The comments to this first guidance, which became available mid-April, show the stress points between the life sciences industry and the FDA. Some of the largest pharmaceutical manufacturers provided comments in addition to several industry trade organizations. There are two common themes throughout the comments.

First, many call the guidance “ambiguous” and “overboard” because the FDA’s power to regulate is limited to “labeling” and “advertising.” The comments argue that all communications via social media do not fall into these two categories as defined by law and therefore should not be subject to FDA regulations. This criticism directly challenges the FDA’s authority to regulate some exchanges on social media—such an open challenge to FDA authority is not common.

As technology forces industry to rethink its business, lawmakers must rethink the laws accordingly...

The second theme relates to the “control and influence” standard set forth in the guidance. Essentially, the draft guidance calls for regulatory submission to the FDA for any content over which the manufacturer has control or influence, “even if…limited in scope.” Industry comments suggest that this standard deviates from the Food, Drug and Cosmetic Act and previous FDA positions.

The draft guidance and comment period foreshadow the challenges to come as regulators and industry clash in trying to keep up with innovation. As technology forces industry to rethink its business, lawmakers must rethink the laws accordingly.


[Part of our JD Supra Perspectives series in which we asked our contributors, experts in their fields, to write about examples in which technological innovation has outpaced the law.

Scott S. Liebman is a partner at Loeb & Loeb LLP, where he heads the FDA Regulatory and Compliance Practice. He can be reached at sliebman@loeb.com or on Twitter @ScottLiebman.]

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