Congressional Hearing on “Improving Predictability and Transparency in DEA and FDA Regulation” On Monday, April 7th at 3PM; Three Bills Appear on the Agenda

April 7, 2014

By Karla L. Palmer

The Energy and Commerce Committee’s Subcommittee on Health (chaired by Representative 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 titled “Improving Predictability and Transparency in DEA and FDA Regulation.” Industry and government witnesses include, among others, Janet Woodcock, M.D. (Director CDER, FDA), Mr. Joseph T. Rannazzisi (Deputy Assistant Administrator, Office of Diversion Control, DEA);  Dr. Nathan B. Fountain (Chair, Medical Advisory Board, Epilepsy Foundation), and Mr. John M. Gray (President and CEO, HDMA).

Subcommittee members will review three bills described below: H.R. 4299, “Improving Regulatory Transparency for New Medical Therapies Act,”; H.R. 4069, “Ensuring Patient Access and Effective Drug Enforcement Act;” and H.R. 4250, the “Sunscreen Innovation Act”.

H.R. 4299, blogged about here, would amend the CSA to improve efficiency of the DEA’s process for scheduling new drugs approved by the FDA. Introduced by Representative Pitts (R-PA) and Ranking Subcommittee Member Frank Pallone (D-NJ), the bill would require DEA to make a final determination within 45 days after receiving FDA’s scheduling recommendation for a new drug.  Additionally, it would generate more transparency in the drug 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 Vice Chairman Marsha Blackburn (R-TN), Rep. Tom Marino (R-PA), would improve enforcement efforts regarding controlled substance drug diversion and abuse.  The legislation would help prevent controlled substance abuse and diversion, yet ensure patient access to necessary medications by creating a collaborative partnership between drug manufacturers, wholesalers, retail pharmacies and federal enforcement and oversight agencies.  

The bill also seeks to better define standards set forth in the CSA including the definition of “consistent with the public health and safety” as having a “substantial relationship” to the CSA’s “purpose of preventing diversion and abuse of controlled substances.”  In addition, the legislation would further define “imminent danger” as meaning “a significant and present risk of death or serious bodily harm that is more likely than not to occur in the absence of an immediate suspension order.” (Emphasis added.)   This enhanced definition of “imminent danger” may be a fallout from DEA decisions to issue immediate suspension orders against at least two drug distributors and at least one nationwide retail pharmacy in the past few years where the subject of those immediate suspension orders involved conduct that occurred — and typically had resolved – well prior to DEA’s serving of the immediate suspension orders, causing the parties to challenge the DEA’s definition and interpretation of what constitutes “imminent danger.” 

The legislation would also require employers (specifically distributors and manufacturers of schedule I though V drugs)  to obtain as a condition of the registration criminal background checks and drug testing for employees with access to controlled substances. The employee background checks must be obtained periodically (not more frequently than every two years) and at the time of hiring (if hired after the date of the enactment of the legislation). Those that fail to comply with the background check provision would be subject to civil penalties. 

The legislation would also permit registrants the opportunity to submit a corrective action plan prior to revocation or suspension of a registration under 21 U.S.C. § 824(c).  Specifically the amendment would require the DEA to provide notice to the registrant of the grounds for revocation or suspension including the citation to specific violations, and give the registrant an opportunity to submit a corrective plan within a reasonable period of time to demonstrate how the registrant plans to correct the grounds for revocation or suspension.  The DEA would then make a determination whether in light of the plan, revocation or suspension proceedings should be discontinued or deferred or additional changes need to be made to the corrective plan. 

Finally, the legislation would also establish the “Combat Prescription Drug Abuse Working Group” to include not more than 20 members (pharmacy, patient groups, manufactures, distributors, hospitals and health care providers, law enforcement, DEA representatives, states attorneys general representatives, and public policy experts, among others).  The (non-paid) Working Group members would, among other things, review and report to Congress on efforts to reduce prescription drug abuse and diversion, examine recommendations for transfer of controlled substances between schedules, and make specific recommendations to reduce diversion and abuse of prescription drugs.  The Working Group would also be responsible for various reports and recommendations for FDA, DEA and various other federal and state agencies on several topics identified in the legislation. 

H.R. 4205, introduced by Representative 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 almost two decades. As we previously reported, the legislation would attempt to streamline the drug approval process for sunscreens and provide transparency – through regular reports to Congress. The legislation would require that pending applications are completed within eight months and that new applications reviewed within 11 months.