Pallone Statement from Health Subcommittee Markup

WASHINGTON, D.C.—Congressman Frank Pallone, Jr. (NJ-06), senior Democrat on the House Energy and Commerce Health Subcommittee, issued the following statement today at a markup on three bills, H.R. 4299, “Improving Regulatory Transparency for New Medical Therapies Act,” H.R. 4709, “Ensuring Patient Access and Effective Drug Enforcement Ac,” and H.R. 4631, “Combating Autism Reauthorization Act of 2014.”

Today we are marking up three important bipartisan health bills.

I am proud to join with you, Chairman Pitts on H.R. 4299, “Improving Regulatory Transparency for New Medical Therapies Act.” The bill aims to improve the DEA scheduling process for new FDA-approved drugs under the Controlled Substances Act and the registration process for the use of controlled substances in clinical trials.

Without weakening FDA oversight, this Committee has worked together, most recently on FDASIA, to give manufacturers and patient groups a more predictable process, allowing patients to get timely access to the latest innovation therapies available. Unfortunately, we have learned that when a medicine has abuse potential, the DEA’s authorities under the Controlled Substances Act are hindering this progress.

Our bill would require DEA to make a final determination 45 days after receiving FDA’s scheduling recommendation for a new drug. Additionally, it would generate greater transparency in the application process for drug makers who want to manufacture drugs for clinical trials.

We all agree DEA has an important role to play in combatting the abuse and diversion of drugs. But in examining this problem during our Subcommittee hearing, it seems to me that there is an unnecessarily repetitive process at the DEA for brand new products. As a result, there is a delay of critical drugs getting to patients who need them. I hope members will support this common sense correction to DEA authorities.

In addition, we will markup H.R. 4709, “the Ensuring Patient Access and Effective Drug Enforcement Act of 2014.” This is an updated version of a bill the Subcommittee examined in April. The bill aims to improve and better coordinate enforcement efforts within the drug supply chain regarding prescription drug diversion and abuse.

Prescription drug abuse threatens the safety and health of too many people in this country. Like the Pitts-Pallone bill, the goal of this legislation is not to impede DEA’s critical mission of catching bad actors who break laws and divert dangerous drugs. However, by creating a more collaborative partnership between drug manufacturers, wholesalers, retail pharmacies, and the DEA, the bill seeks to limit unnecessary supply chain disruptions that may be affecting patient access to needed medications.

Specifically, it would allow supply chain members an opportunity to submit a corrective action plan prior to having their license revoked or suspended by DEA. It also requires a report to Congress on the impact of enforcement activities and opportunities for agency and stakeholder collaboration to combat prescription drug abuse.

Lastly, I am pleased to support H.R. 4631, the “Combating Autism Reauthorization Act of 2014.” Established over a decade ago, this longtime bipartisan effort was a direct response to the rising concern about the increased prevalence of autism in this country. In fact, the most recent report by the Centers for Disease Control and Prevention (CDC) on the prevalence of autism says that 1 in 68 children have autism. This new estimate is roughly 30 percent higher than the estimate for 2008. Meanwhile, in my home state of New Jersey, 1 in 45 children have autism. Now, we don't know what one factor is causing this increase. Some of it may be due to the way children are identified, diagnosed, and served in their local communities, but exactly how much is unknown.

That is why extending the current programs already underway is still critical. These programs include research and surveillance activities, education, early detection, and intervention efforts and the work of the Interagency Autism Coordinating Committee. In addition, today we will consider a manager’s amendment with a number of updates to current law. The amendment reflects ongoing bipartisan and bicameral efforts to achieve consensus legislation.

I want to commend Congressman Smith and Congressman Doyle for sponsoring this legislation. I also want to acknowledge the ongoing efforts of our Senate colleagues -- Senators Harkin, Alexander, Menendez, and Enzi – who continue to work with our staff and the staff of Congressman Smith and Congressman Doyle to ensure the bill moves forward expeditiously. I look forward to working with everyone to accomplish that goal.

Thank you.