House Committee Slows Consideration of Drug Competition Bill
Consideration of the Lower Drug Costs through Competition Act by the House Energy and Commerce Committee, which has jurisdiction over the bill, has moved off the fast track.
While declaring the committee “eager to move forward with consideration" of the bill, Chairman Greg Walden (R-Ore.) on February 3 said he has agreed with Democratic colleagues’ formal request “to slow down.”
Rep. Kurt Schrader (D-Ore.), a member of the committee, introduced the bill on January 30 on behalf of himself, seven other Democratic representatives, and two Republican representatives.
By February 3, the mix of cosponsors was nine Democrats and three Republicans, in addition to Schrader.
The bill proposes to remove regulatory barriers to competition in the generic drug marketplace, incentivize competition in that sector, and have the Comptroller General review Risk Evaluation and Mitigation Strategy (REMS) programs.
“We neither support nor oppose” the bill, said Joseph Hill, director of the ASHP Government Relations Division.
He called the bill, H.R. 749, “a good first step, but we’d like to see something go a little farther than that.”
Foremost in need of work is the bill’s section on REMS programs, Hill said.
The review, with a report due to Congress by May 2018, requires the Comptroller General to determine the effects of restricted distribution systems for drug products with REMS programs on the entry of generic drug products into the marketplace and on pharmaceutical prices.
That study and report, Hill said, are unnecessary.
ASHP and its members already know that such restricted distribution systems are being used by pharmaceutical companies to gain an advantage in the marketplace, he said. Thus the situation needs to be addressed by FDA or another federal authority, not studied.
In addition to the section on REMS programs, the bill’s section on incentivizing competition in the generic drug marketplace through FDA’s issuance of priority review vouchers is of concern, Hill said.
“We don't know that there’s any safeguards in place that would prevent a manufacturer from manipulating or gaming the system,” he said.
Committee Chairman Walden stated in the February 3 press release that the Health Subcommittee will consider the bill later this month.
Hill said Walden's statement could mean the subcommittee will hold a hearing on the bill or could mean the subcommittee will hold a hearing on the larger issue of drug pricing.