Le Lézard
Classified in: Health
Subjects: NPT, EXE, FDA, AVO

AMCP-Supported Bill to Create Safe Harbor for Pre-FDA-Approval Product Communications is Examined in House Subcommittee on Health Hearing

WASHINGTON, July 12, 2017 /PRNewswire-USNewswire/ -- The U.S. House Energy and Commerce Committee's Subcommittee on Health held a hearing today on the "Pharmaceutical Information Exchange (PIE) Act of 2017" (H.R. 2026). The bill, sponsored by Rep. Brett Guthrie (R-KY), 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.

Academy of Managed Care Pharmacy. (PRNewsFoto/Academy of Managed Care Pharmacy)

AMCP last fall led a multi-stakeholder effort to develop recommendations on allowing pre-approval information exchange. H.R. 2026 closely aligns with these recommendations. AMCP CEO Susan A. Cantrell, RPh, CAE, issued the following statement on the hearing:

"The Academy of Managed Care Pharmacy strongly supports H.R. 2026 as it represents significant progress in the move toward value-based health care. We are delighted that the Energy & Commerce Subcommittee on Health is holding this important hearing today.

"As the health care system moves toward payments based on value, rather than volume, access to more and better information becomes crucial for health care decision makers.

"H.R. 2026 would enable the proactive dissemination of pre-FDA-approval information, with appropriate safeguards. This would allow health plans and other population health decision makers to more accurately forecast and prepare for emerging products. By allowing payers to make better coverage decisions sooner, patients can get access to breakthrough therapies sooner".

Long-time AMCP member Katherine Wolf Khachatourian, PharmD, MBA, Vice President of Pharmacy Services, Strategy and Delegation Oversight at Qualchoice Health Plan Services, Inc., testified in support of H.R. 2026. Her comments included:

"The limitations on information we are able to obtain, results in a hindrance to patient access to novel and emerging therapies. It limits our ability to accurately forecast, plan and budget for anticipated expenditures, and it precludes our ability to contract on value rather than volume. This is the reason I am here before you today ? to demonstrate the need for legislative framework, which will provide the key to unlock additional information needed for us to make more informed benefit decisions for better patient access to treatments."

The Subcommittee on Health's July 12 hearing was titled "Examining Medical Product Manufacturer Communications." For more information on AMCP's recommendations allowing pre-approval information exchange, read "Enabling the Exchange of Clinical and Economic Information Pre-FDA Approval."

About AMCP
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

These press releases may also interest you

at 19:30
Arena Pharmaceuticals, Inc. today announced that Amit D. Munshi, the Company's President and Chief Executive Officer, will present a corporate update at the 17th Annual Needham Healthcare Conference on Tuesday, March 27 at 3:00 p.m. EDT.  The...

at 19:08
The Honourable Ginette Petitpas Taylor, Federal Minister of Health, will be announcing federal measures to increase access to opioid treatment. Government of Canada officials will also hold a media technical briefing (teleconference only) following...

at 17:33
? LDIC Inc. (the "Manager"), the manager of Healthcare Special Opportunities Fund (the "Fund"), a closed-end investment fund, today announces the quarterly distribution of CDN$0.0535 per Class A unit and US$0.0553 per Class U unit. The distribution...

at 17:26
Home Care Assistance Cincinnati, a leading provider of in-home care for seniors, is proud to offer the first senior care solution with an emphasis on balance and longevity. The industry's most experienced and vetted caregivers undergo extensive...

at 17:19
Leaders from three of Ontario's largest unions are meeting Monday and Tuesday (March 26 and March 27, 2018) in Toronto to work together to move stalled provincial negotiations with Ontario's hospitals. Collectively the...

at 16:53
Canadian owned scientific integrator and developer, Quorum Technologies Inc. ("Quorum"), is pleased to announce the recent acquisition of the highly respected Volocity software application from PerkinElmer Health Sciences, Inc.  Volocity software has...

News published on 12 july 2017 at 16:27 and distributed by: