Lawmakers Reschedule Mark Up of Drug User Fee Bill
Members of the House Energy and Commerce Committee on Tuesday rescheduled a Health Subcommittee mark up of draft legislation that would reauthorize the Prescription Drug User Fee Act after Republicans complained the committee was moving too quickly, CongressDaily reports.
Originally planned for Wednesday, Energy and Commerce Chair John Dingell (D-Mich.), committee ranking member Joe Barton (R-Texas), Health Subcommittee Chair Frank Pallone (D-N.J.) and subcommittee ranking member Nathan Deal (R-Ga.) rescheduled the subcommittee's mark up to June 19, with a full committee mark up scheduled for June 21, according to a committee spokesperson (Edney, CongressDaily, 6/13).
The new date is intended to give lawmakers time to work out differences about provisions of the draft bill.
Brin Frazier, a spokesperson for committee Democrats, said lawmakers "basically decided that there's a lot of it where they can do some alterations" (Armstrong, CQ Today, 6/13).
The bill includes a provision that would require a "Risk Evaluation and Mitigation Strategy" for all new medications approved by FDA that includes restrictions on direct-to-consumer advertising of new drugs.
Under the provision, the HHS secretary could require FDA to review and approve DTC ads for new medications before they air, a requirement that subcommittee Republicans maintain would violate the First Amendment.
Subcommittee Republicans and Bush administration officials also questioned language in the bill that indicates strict compliance with FDA rules would not protect pharmaceutical and medical device companies from product liability lawsuits filed in state courts (California Healthline, 6/13).