April 05, 2019
On Wednesday April 3, 2019, after reaching bipartisan consensus, the U.S. House Energy and Commerce Committee passed the following 6 bills to boost generics:
- H.R.1499 would ban deals between brand and generic manufacturers that delay market entry of generics;
- H.R. 938 would grant increased authority to the FDA to approve other generic competitors when the first manufacturer with an approved generic hasn’t launched its product;
- H. R. 965 would establish civil remedies when brand manufacturers don’t provide enough reference samples of branded drugs for premarket testing to generic manufacturers and would give increased authority to the FDA to ensure brand manufacturers don’t use existing safety protocols (Risk Evaluation and Mitigation Strategy or REMS) to deny samples to generic competitors;
- H.R. 1520 and H.R. 1503 would provide generic manufacturers with more information about patents for branded products; and
- H.R.1781 would provide drug price and rebate data to governmental entities that advise Congress on Medicare and Medicaid payments (MedPAC and MACPAC).
The Business Group is reviewing the bills and is likely to send letters of support to some or all of them.
Impact on Employers and Employees
Many of these proposals are likely to accelerate generics to market, boost competition and reduce prescription drug prices for all, including employers and employees, if enacted.
Outlook
The likelihood of Congress taking action to increase competition and reduce prices for prescription drugs is growing. Some of these bills have been referred to other House Committees. Bipartisan support in the House and Senate will be key to passage. The President would likely sign them given indications of White House and HHS support.
More Topics
Policy & Advocacy
Pharmacy/Prescription Drugs
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