WASHINGTON, Jan. 17, 2018 /PRNewswire-USNewswire/ -- The Academy of Managed Care Pharmacy (AMCP) applauds the U.S. House Energy and Commerce Committee's Subcommittee on Health for its approval today of H.R. 2026, the "Pharmaceutical Information Exchange (PIE) Act of 2017." The bill now goes to the full Energy and Commerce Committee for consideration.
H.R. 2026, sponsored by Rep. Brett Guthrie (R-KY2), would allow manufacturers to proactively share certain clinical and economic information with decision makers on emerging therapies in advance of Food and Drug Administration approval, an area currently restricted by federal law and FDA regulation.
"The Academy is very pleased with today's approval of H.R. 2026," said AMCP CEO Susan A. Cantrell, RPh, CAE. "We thank bill sponsor Rep. Brett Guthrie (R-KY2) for his leadership on this important issue. The thrust of the PIE Act is to give health plans the economic and scientific information they need to make coverage determinations more quickly on medications in the pipeline — so that upon FDA approval patients can get access to innovative therapies sooner. For patients waiting for breakthrough medicines, every minute counts."
Cantrell also notes the bill contains requirements that communications be "truthful, nonmisleading, and based on competent and reliable scientific evidence." This, along with safeguards that communications take place only between sophisticated parties such as health plans and formulary committees, ensures that such exchanges will be responsible, she added.
"The PIE Act will allow AMCP's 8,000 members — who manage pharmacy benefits for more than 270 million Americans — to more accurately forecast and make coverage decisions sooner on these emerging products. AMCP is proud to have led on this issue on behalf of our members," Cantrell said.
AMCP in fall 2017 led a multi-stakeholder effort to develop recommendations on allowing pre-approval information exchange. H.R. 2026 closely aligns with these recommendations. For more information on AMCP's recommendations allowing pre-approval information exchange, read "Enabling the Exchange of Clinical and Economic Information Pre-FDA Approval."
The Academy of Managed Care Pharmacy (AMCP) is the nation's leading professional association dedicated to increasing patient access to affordable medicines, improving health outcomes and ensuring the wise use of health care dollars. Through evidence- and value-based strategies and practices, the Academy's 8,000 pharmacists, physicians, nurses and other practitioners manage medication therapies for the 270 million Americans served by health plans, pharmacy benefit management firms, emerging care models and government. www.amcp.org.
SOURCE Academy of Managed Care Pharmacy