The Subcommittee on Health, chaired by Rep. Joe Pitts (R-PA), has scheduled a hearing for Monday, April 7, 2014, at 3:00 p.m. in room 2123 of the Rayburn House Office Building. The hearing is entitled “Improving Predictability and Transparency in DEA and FDA Regulation." Witnesses to be announced.
Subcommittee members will review three bills: H.R. 4299, the Improving Regulatory Transparency for New Medical Therapies Act, H.R. 4069, the Ensuring Patient Access and Effective Drug Enforcement Act, and H.R. 4250, the Sunscreen Innovation Act.
H.R. 4299, introduced by Pitts and Health Subcommittee Ranking Member Frank Pallone (D-NJ), would amend the Controlled Substances Act (CSA) to improve efficiency, transparency, and consistency of the Drug Enforcement Agency’s process for scheduling new drugs approved by the Food and Drug Administration. It would require DEA to make a final determination 45 days after receiving FDA’s scheduling recommendation for a new drug. Additionally, it would generate more transparency in the application process for clinical trials by requiring that DEA make a final determination within 180 days or provide the applicant with details about what outstanding issues remain unresolved.
H.R. 4069, introduced by full committee Vice Chairman Marsha Blackburn (R-TN) and Rep. Tom Marino (R-PA), would improve enforcement efforts regarding prescription drug diversion and abuse. The legislation would help prevent prescription drug abuse and diversion and ensure patient access to necessary medications by creating a more collaborative partnership between drug manufacturers, wholesalers, retail pharmacies and federal enforcement and oversight agencies.
H.R. 4205, introduced by Rep. Ed Whitfield (R-KY) and Rep. John Dingell (D-MI), would expedite the FDA’s approval process for new sunscreen ingredients while maintaining strict safety standards. The FDA has not approved a new sunscreen ingredient in nearly two decades. This legislation would streamline the approval process and provide transparency with regular reports to Congress regarding progress and implementation. This legislation would require that applications currently pending approval be completed within eight months and that new applications be reviewed within 11 months. Senators Johnny Isakson (R-GA) and Jack Reed (D-RI) have introduced the Senate companion, S. 2141, to this bill.as they are posted.
