Subcommittee Examines Four Bills Over Two Days of Hearings
WASHINGTON, DC – The Energy and Commerce Subcommittee on Health this week reviewed several bills that aim to improve the public health and increase transparency. The Health Subcommittee has a strong record of bipartisan success in the public health sphere with eleven public laws championed by this committee in the 113th Congress. At hearings this week over a two-day span the subcommittee reviewed legislation aimed at improving the predictability and transparency in regulations at the Drug Enforcement Agency and the Food and Drug Administration.
“I want to commend my colleagues for working together to develop these legislative solutions. We look forward to working in a bipartisan manner to perfect them so we can move them swiftly through the legislative process. We have had a strong record of bipartisan success this Congress in our work to improve public health, and these bills further our efforts,” said full committee Chairman Fred Upton (R-MI).
H.R. 4299, the “Improving Regulatory Transparency for New Medical Therapies Act” – Introduced by Health Subcommittee Chairman Joe Pitts (R-PA) and Ranking Member Frank Pallone (D-NJ)
Pitts explained, “It now takes, on average, well over a billion dollars and 14 years from the time a drug is discovered to the time of approval. … Under the Controlled Substances Act, there is no deadline for the DEA to make a scheduling decision, and the delays in DEA decisions have increased nearly five-fold since 2000. This lack of predictability in the timing of DEA scheduling decisions leads to unnecessary uncertainty in the drug development process and needless delays in patients’ access to new therapies.”
Dr. Nathan Fountain, Chair of the Medical Advisory Board for the Epilepsy Foundation, said, “This bill is a simple solution to the problem and will ensure that drugs will not sit around waiting to be scheduled and patients won’t be forced to wait on potentially life-changing drugs. H.R. 4299 will allow more innovative treatments to reach the market and give a clear timeline for drug availability from FDA through DEA.”
H.R. 4069, the “Ensuring Patient Access and Effective Drug Enforcement Act” – Introduced by full committee Vice Chairman Marsha Blackburn (R-TN) and Rep. Tom Marino (R-PA)
In describing the measure, Blackburn commented, “Our legislation clarifies two definitions within the Controlled Substances Act (CSA) which is essential to providing a clear path forward for enforcement agencies. We specify that the phrase ‘consistent with the public health and safety’ corresponds to a ‘substantial relationship to …preventing diversion and abuse of controlled substances.’ We also further define ‘imminent danger’ by providing clarification and harmonizing the CSA with other statutes using the ‘imminent danger’ standard such as the Federal Mine Safety and Health Act. Why do definitions matter? Because Congress — this subcommittee — has a responsibility to make sure the law is crystal clear for both DEA and legitimate businesses who want to understand what the rules are so they can do the right thing. Our job is to make sure they’re on the same page.”
H.R. 4250, the “Sunscreen Innovation Act” – Introduced by Rep. Ed Whitfield (R-KY) and Rep. John Dingell (D-MI)
“FDA has not expanded its approval list of sunscreen ingredients since 1999 even though many innovative products have been used safely for years abroad,” said Whitfield. “In fact, there are eight pending applications, all of which have been used in other parts of the world, some of them have been under the process of being scrutinized for 12 years.”
Wendy K.D. Selig, President and CEO of the Melanoma Research Alliance said, “The legislation is a pragmatic way of alleviating the current backlog of sunscreen ingredients and streamlining the TEA process for all sunscreen ingredients. Its enactment would be a victory for all parties – FDA would be administering a process that ensures safe and effective products reach the market as soon as possible; manufacturers would know that their product application would receive timely review and would be incentivized to invest in innovation to prevent more melanomas; and most importantly, Americans could get access to the most innovative sunscreen products.”
H.R. 389, the “Transparency in Tobacco User Fees Act” – Introduced by Rep. Brett Guthrie (R-KY)
Dr. Marcia Crosse, Director of Health Care at the Government Accountability Office, testified, “In 2009, the Tobacco Control Act granted FDA authority to regulate tobacco products such as cigarettes. The act authorizes FDA to assess and collect user fees from each tobacco manufacturer and importer for FDA activities related to tobacco product regulation. … The Food and Drug Administration (FDA) spent (obligated) less than half of the $1.1 billion in tobacco user fees it collected from manufacturers and others from fiscal year 2009 through the end of fiscal year 2012; however, FDA’s spending increased substantially in fiscal year 2013. Through December 31, 2013, FDA spent nearly 81 percent of the approximately $1.75 billion in fees collected by that time.”
Guthrie said, “I have a bill, H.R. 389, that would exercise oversight over the Center for Tobacco Products and require they submit a report to Congress on their activity. It is a good government, commonsense approach to ensure that this agency of government works and is accountable to Congress and the committee that is vested with its authority. Tobacco user fees are not subject to reauthorization so there is little opportunity for the industry to enter into discussions with FDA the way pharmaceutical companies or device manufacturers can. As the oversight body, I believe we should be able to see how these funds are being used, the number of applications being reviewed or still pending, and get a clear picture of the division’s work.”
Crosse told Guthrie, “I think it’s appropriate for Congress to have information on the operations of the Center [for Tobacco Products].”