May 21, 2015 – In a unanimous (51-0) vote today, the House Energy and Commerce Committee approved the 21st Century Cures Act, which includes three closely followed provisions on off-label communication and Sunshine reporting. The bill, which stretches over 300 pages, also includes a broad array of amendments related to the National Institute of Health (NIH) and the Food and Drug Administration (FDA).
“Today’s action is great testimony that Congress can move forward on a bipartisan basis to advance the public health,” said Coalition for Healthcare Communication Executive Director John Kamp.
The provisions in the 21st Century Cures legislation that are especially important to medical marketers include: (1) exemption of CME, reprints and reference texts from reporting under the Sunshine Act; (2) expanded authority for biopharmaceutical companies to provide economic information to payers; and (3) direction to the FDA to provide further guidance on off-label marketing.
“The Coalition has been working with [Pharmaceutical Research and Manufacturers of American (PhRMA)] and other industry allies on all of these provisions for the past year, and is immensely pleases that they are moving ahead this far in this session of Congress,” Kamp stated.
In addition to amending Section 114 of the Food and Drug Modernization Act of 1997 (FDAMA 114) to clarify and expand how and to whom companies can communicate with payers on economic issues, the legislation would set a deadline for FDA to update its policies on company-sponsored communication on off-label uses of drugs. The FDA missed its self-imposed deadline of December 2014 for issuing such guidance, and recently announced a hearing on the topic sometime this summer. Inclusion of the issue in the House bill is a strong signal to the FDA that there is a bipartisan consensus in support for an updated policy.
The new legislative text is straightforward: “Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue draft guidance on facilitating the dissemination of responsible, truthful, and non-misleading scientific and medical information not included in the label of drugs.”
The legislation could be up for a full House vote early this summer. A similar bill is expected to be introduced in the Senate as early as this summer with possible votes later this year. Assuming passage of the 21st Century Cures Act later this year or early next year, the FDA would be required to issue guidance sometime in 2017. Meanwhile, threats of court action on off-label promotion continue, including the new law suit filed by Amarin seeking court action on its desire to distribute off-label information to professionals on its Vascepa drug.