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21st Century Cures discussion draft includes textbook/reprint language, communication fixes

Written by: | JKamp@wileyrein.com | Dated: Wednesday, April 15th, 2015

By John Kamp

New legislation to spur medical innovation through new authorities for FDA and NIH is creating a lot of buzz in the Washington medical community, most of it very good. Indeed, even with outgoing FDA Commissioner Margaret Hamburg’s March 30 note of caution that regulatory innovation requires increased staff and other resources, the passage of some regulation during this session of Congress appears possible.

John Kamp

John Kamp

Clearly the House is ahead of the Senate in this effort. A House 393-page discussion draft of the legislation designed to accelerate the 21st Century Cures initiative – released in late January – has yet be replaced with a more definitive draft for a major Energy and Commerce Committee vote. Meanwhile, the Senate HELP Committee is working on a much more limited set of provisions.

Nevertheless, you should not overlook the three significant communication proposals in the nearly 400 page House draft. They include provisions that would exclude medical textbooks and journal reprints from Sunshine Act reporting, allow manufacturers to communicate off-label scientific and medical developments with stakeholders, and clarify the regulation of social media communication.

These three highlight the draft for communication professionals, but there is much to like for industry and patients in this far-reaching piece of legislation led by Representatives Fred Upton (R-MI) and Diana DeGette (D-CO). The most specific communication provision includes language introduced by Reps. Michael C. Burgess (R-TX) and Peter DeFazio (D-OR) that would make clear that peer-reviewed journals, journal reprints, journal supplements, and medical textbooks are excluded from being reported as transfers of value under the Sunshine Act. The language in the discussion draft would amend the original Sunshine legislation by stipulating that a reporting exclusion would apply to a transfer of value of these items “to a covered recipient who is a physician if the thing of value is intended solely for purposes of providing continuing medical education to the physician.”

Senators John Barasso (R-WY) and Robert Menendez (D-NJ) are planning to introduce a companion bill in the Senate soon, confirming Congressional interest in advancing the Sunshine Act exception for reprints and reference texts.

The most controversial communication provision of the House discussion draft addresses the off-label communication controversies playing out in First Amendment battles in the courts and currently the topic of much anticipated new guidance at FDA.

“FDA’s current rules and policies governing what drug and device developers may say about their own products were designed decades ago,” a document summary issued by the Energy and Commerce committee states. The draft legislation includes only placeholder language, “because the committee is working on a proposal that would clarify and rationalize these rules of the road so that scientific and medical developments can be shared … in order to optimize patient care,” states the document summary.

Almost lost in the huge draft bill is the provision entitled “Modernizing the Regulation of Social Media.” Proposed by Congressman Billy Long (R-MO), it is designed to “provide more certainty regarding the regulations of communications on social media by FDA.” The draft language calls on the FDA to review and revise regulation and guidance that applies to disseminating information about medical products on the Internet, including social media platforms.

The key provision is a call for the agency to “treat hyperlinked information … as if the information appeared in introductory information.” This language is significant for Twitter users, because firms could use hyperlinks to include the risk information required by the FDA while being able to limit Tweets to 140 characters. The FDA’s current draft guidance on this limited-character platform does not allow hyperlinks and states that drugs with complex risk profiles may not be suitable for such platforms. In effect, this provision would end the current FDA policy that one click away is just too far away, and instead create a much more digital friendly rule for the Internet.

Stay tuned as these provisions and the larger 21st Century Cures initiative move forward – or not – in this session of Congress. If this legislation is going to happen before the next presidential election and the next session of Congress, Congressman Upton must move his version no later than this summer. Otherwise, politics and political posturing on other matters will squeeze out the potential for passage.

John Kamp is the executive director of the Coalition for Healthcare Communication.

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