Improving Regulatory Transparency for New Medical Therapies Act

Floor Speech

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Mr. PALLONE. Mr. Speaker, I am pleased to lend my support to H.R. 639, the Improving Regulatory Transparency for New Medical Therapies Act. This important public health bill aims to bring better reliability and transparency to medical therapies, while continuing to ensure that they reach patients in need quickly, but most importantly safely and effectively.

When a new drug is approved by the FDA, a company can begin marketing the product upon its approval. However, for a subset of drugs, FDA recommends to the DEA they be included in the Controlled Substance Act--or ``scheduled,'' if there is abuse potential. Until DEA makes a final decision, a drug cannot be released to the public.

Unfortunately, there is no deadline for the DEA to make a decision. As a result, the process has lengthened over time, in some instances lasting years before a decision is made. So even if a drug is considered safe and effective, patients and physicians are being forced to wait to access these therapies. This bill would continue to allow DEA to conduct its own analysis, but would remove much of the uncertainty from the process. It also would speed up the DEA registration process allowing the manufacture and distribution of controlled substances for use only in clinical trials.

I want to thank Chairman PITTS for working with me on this bill last Congress, and committing to move forward early this Congress. Thank you to Mr. GREEN as well for joining us on this important bill.

I am glad that we have been able to work with both DEA and FDA, our Senate counterparts and the bill sponsors, to ensure that the goals of this bill is met.

I urge members to support H.R 639 and I look forward to its swift passage.

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