May 18, 2015 – Major medical legislation, including closely followed provisions on off-label communication and Sunshine reporting, survived a House Energy and Commerce Committee vote last week, is set for a full committee vote this week, and could be up for a full House vote early this summer. The 21st Century Cures Act, championed by House Commerce Committee Chair Fred Upton (R-Texas) and Rep. Diana DeGette (D-Colo.), contains wide-ranging provisions to speed medical innovation through research, funding and drug approval provisions overseen by the National Institutes for Health (NIH) and the Food and Drug Administration (FDA).
Three provisions in the 21st Century Cures legislation are especially important to medical marketers: (1) exemption of 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 to professionals. A provision in an earlier draft enabling “one click away” access to contraindication information in Internet drug ads will be reintroduced soon by Rep. Billy Long (R-Mo.) as a stand-alone bill.
The newest section of the bill, entitled “Facilitating Dissemination of Health Care Economic Information,” would expand Section 114 of the Food and Drug Modernization Act of 1997 (FDAMA 114) that regulates to the promotion of health economic information by drug companies to formulary committees. Reflecting long-standing requests by industry, the bill would provide needed clarity and flexibility for companies to communicate with a full range of payers on economic issues.
The existing limits of FDAMA 114 are far from clear, but the new language would enable communication of more information to expanded audiences. The new draft amends the clause requiring that a promotional claim “directly relates” to the FDA-approved indications to “relates,” presumably enabling the sharing of information not precisely tied to randomized clinical trials. Information beyond randomized clinical trial information would require a disclosure of such. In addition, communication would no longer be limited to formulary committee members, but also would include “payers,” “formulary committees” and “similar entities.”
Currently, FDAMA 114 calls for health care economic information to be provided to a formulary committee or other similar entity only if the healthcare economic information “is based on competent and reliable scientific evidence.”