Over on the Health Industry Washington Watch blog, Reed Smith attorneys Katie Pawlitz and Jeremy Alexander highlight the proposed changes to the Sunshine Act contained within H.R. 6, the “21st Century Cures Act,” which (as previously reported on Life Sciences Legal Update) was approved by the House Energy and Commerce Committee last Thursday, May 21, by a unanimous vote of 51-0. The Sunshine Act is just one of several interesting topics in life sciences and health care addressed by the 21st Century Cures Act.
Another interesting provision in the bill pertains to the concept of “off-label promotion.” As Jim Beck and the Drug and Device Law blog have discussed on a number of occasions (including here), the FDA has not set clear guidelines about off-label promotion, even though truthful off-label promotion should be protected under the First Amendment. The present version of the 21st Century Cures Act specifies that, within 18 months of its enactment, the Secretary of Health and Human Services “shall issue draft guidance on facilitating the responsible dissemination of truthful and non-misleading scientific and medical information not included in the approved labeling of drugs and devices.” It will be interesting to see what happens with this part of the bill and, if it passes, what draft guidance the FDA will develop. Stay tuned.