21st Century Cures bill advances to House floor
Lawmakers in the House Energy and Commerce Committee voted 51-0 to pass a bill that would expand the information that drugmakers are allowed to share with payers and other entities.
The sweeping 21st Century Cures Act seeks to make a number of changes to the regulations as well as the development and approval process for drugs and medical devices. The initiative was spearheaded by Chairman Fred Upton (R-Mich.) and Rep. Diana DeGette (D-Colo.).
There are two notable provisions in the legislation that relate to medical marketing. One seeks to allow pharma companies to share scientific and medical information with payers, formulary committees or “similar entities” beyond what is included on the label of FDA-approved products. This is currently called off-label marketing and instances of off-label promotion of drugs has led to dozens of government investigations and hundreds of millions of dollars in settlements paid by manufacturers.
The definition of healthcare economic information includes clinical data, inputs and comparative-effectiveness research and “presumably [enables] the sharing of information not precisely tied to randomized clinical trials,” according to the Coalition for Healthcare Communication.
“The new language clearly would enable communication both of more information and to expanded audiences,” John Kamp, the coalition's executive director, said in a statement issued today, following the vote.
In addition, the Department of Health and Human Services would be required to issue draft guidance on pharma communications relating to off-label uses of their products within 18 months of the bill's being signed into law.
The legal debate about what information drug and device manufacturers are legally allowed to share with third parties, including physicians and insurers, hit a pivot point this year.
Earlier this month drugmaker Amarin sued the FDA, saying the First Amendment protects its right to discuss off-label uses of its fish oil pill Vascepa with physicians.
The FDA has also said it plans to issue draft guidance in the next few months about manufacturer communications of unapproved uses of FDA-approved products. “A number of stakeholders have raised issues about the agency's policies regarding manufacturer communications with physicians as well as with other entities,” an FDA spokesman said in an e-mail last week.
Another marketing provision in the bill would override current reporting requirements for continuing medical education. The requirements are based on the Centers for Medicare and Medicaid Services' interpretation of the Physician Payment Sunshine Act, a provision of the Affordable Care Act that requires extensive reporting of financial relationships between industry and healthcare providers in an effort to increase transparency. The CMS last year reversed an earlier interpretation to require reporting of some third-party payments made to physicians for CME activities.
Reporting requirements for medical journal reprints and medical texts would also be exempt under the 21st Century Cures Act.
The House is expected to vote on the bill this summer. Sens. John Barrasso (R-Wyo.) and Robert Menendez (D-NJ) will likely introduce a companion bill over the next few weeks although sources have said the Senate version may not be voted on until the end of the year.