House Democrats To Resume Negotiations On Prescription Drug User Fee Reauthorization Legislation

Armen Hareyan's picture

Prescription Drug User Fee Reauthorization


House Democrats on Tuesday called off a plan to present their own FDA overhaul bill to the House Rules Committeeand resumed negotiations to reconcile differences between the House andSenate versions of legislation that would reauthorize the PrescriptionDrug User Fee Act, CongressDaily reports. PDUFA expires on Sept. 30 (Edney, CongressDaily,9/19).

The negotiations have focused on two provisions: one that wouldrequire pharmaceutical companies to receive FDA approval beforechanging drug labels to reflect new safety information and another thatwould reduce pediatric exclusivity from six months to three months ifthe drug brings in profits of more than $1 billion annually (Kaiser Daily Health Policy Report, 9/18).

House Energy and Commerce CommitteeChair John Dingell (D-Mich.) is expected to bring the bill to the flooron Wednesday if a compromise is not reached. He had hoped to achieve acompromise by Tuesday evening. House Energy and Commerce Health Subcommittee Chair Frank Pallone (D-N.J.) on Tuesday said he expects a bill will be passed this week (CongressDaily, 9/19).

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