House Bill on Sharing Certain Information about Investigational Products Moves Forward

Jan. 22, 2018 – The House Energy and Commerce Subcommittee on Health held a markup Jan. 17 that advances H.R. 2026 (http://bit.ly/2G4cRM1), the “Pharmaceutical Information Exchange Act,” which will clarify how drug and medical device companies can share health care economic or scientific information about investigational drugs or devices with payers and formulary committees.

“By allowing drug manufacturers to communicate with insurance companies, the Pharmaceutical Information Exchange Act will help insurers prepare for the cost of new prescription drugs in advance so that they can cover them immediately, ensuring the treatments are easier for patients to obtain following FDA approval,” according to a statement from bill sponsor Rep. Brett Guthrie (R-Ky.), who also explained that currently, delays occur when payers must await approval before reviewing their policies.

Although a Jan. 16 letter from Public Citizen to the House committee leadership strongly urged opposition to the bill, stating that it would “further erode the restrictions on the promotion of drugs for unapproved (off-label) uses,” the Biotechnology Innovation Organization (BIO) commented in a Jan. 17 letter to Guthrie that the legislation “would provide biopharmaceutical manufacturers with additional clarity and certainty in the exchange of health care economic and other scientific information” about investigational products, and “builds on the important progress made in 21st Century CURES.”

“While it is a long time coming, the passage of this bill would vastly improve the quality of conversations drug and device companies have before approval. It’s a shame Public Citizen opposes the ability of sponsors to share truthful information, leading to Democratic opposition,” said Coalition for Healthcare Communication Executive Director John Kamp.

BIO asserted that “as value-based health care and contracting become more and more prevalent, so does the need to ensure stakeholders are able to share timely, scientifically-based information with one another before a product comes to market.”

“Good public health policy demands quality conversations among sponsors and payers before approval,” Kamp asserted. “Let’s hope that Congress or the FDA takes this and the next steps soon, i.e., enabling rigorous information sharing of label and off-label information about drugs in development with medical professionals.”

The bill stipulates that such information shall not be considered false or misleading if it is based on “competent and reliable scientific evidence and relates to an investigational new drug or investigational use of an approved drug.” Scientific information, the bill states, includes “clinical and pre-clinical data and results relating to an unapproved drug therapy, or drug indication, or other condition or use being investigated or developed.”

H.R. 2026 now must be approved by the full House Energy and Commerce Committee before advancing to a vote on the House floor.