Hearing of the House Judiciary Committee - Markup of H.R. 4299, the "Improving Regulatory Transparency for New Medical Therapies Act''

Hearing

Chairman Goodlatte: H.R. 4299, the ""Improving Regulatory Transparency for New Medical Therapies Act," introduced by Congressmen Joe Pitts and Frank Pallone, is intended to streamline the process for scheduling new drugs under the Controlled Substances Act. Congress designated the Attorney General as the agency head with the discretionary authority to schedule new controlled substances.

Under current law, controlled substances that have not been marketed previously in the United States and that have a potential for abuse must first be approved by the Food and Drug Administration (FDA), and then must be scheduled under the Controlled Substances Act by the Drug Enforcement Administration (DEA) before the drug can be prescribed to patients.

To conduct their review, both federal agencies employ an eight-factor analysis that is found in section 811 of the Controlled Substances Act. The factors include:

-a drug's potential for abuse;

-scientific evidence of its pharmacological effect, if any;

-the state of current scientific knowledge regarding the drug or other substance;

-its history and current pattern of abuse;

-the scope, duration, and significance of abuse;

-the risk to the public health posed by the drug;

-its psychic or physiological dependence liability; and

-whether the substance is an immediate precursor of a currently controlled substance.

After completing its review, the FDA transmits its findings to DEA, along with a recommendation as to in which schedule the drug should be controlled. DEA then conducts its own statutorily-mandated analysis. The FDA findings related to scientific and medical matters are binding on the DEA, but the FDA's scheduling recommendation is simply that -- a recommendation.

In recent years, some drug manufacturers have complained that DEA's analysis of new controlled substances has taken longer than in previous years, thus delaying patient access to new therapies. As introduced, H.R. 4299 removes DEA from the review process for new drugs and requires it to issue an interim final rule within 45 days of receiving FDA's scheduling recommendation.

The bill achieves its stated goal of streamlining the scheduling of new controlled substances by binding the DEA to the FDA's recommendation, thereby stripping DEA of its statutorily-mandated review and removing the Attorney General's discretionary authority to schedule controlled substances.

But under the structure proposed by H.R. 4299, the Attorney General -- acting through the DEA -- would continue to be responsible for defending scheduling decisions in court and enforcing the regulations and penalties associated with illegal diversion and distribution of controlled substances. To effectively enforce the Controlled Substances Act, the DEA must be armed with its own evidentiary analysis. To require it to rely solely on the recommendations of a wholly separate agency would be untenable.

This legislation also amends the DEA approval process for controlled substances used in clinical trials. H.R. 4299 allows registration applicants to indicate, on their application, that they intend to use controlled substances only in connection with clinical trials of a drug. In those instances, the DEA must either approve the application within 180 days, or provide notice to the applicant of the outstanding issues that must be resolved before a final decision can be made, and the estimated date that final decision will be made.

Section 3 misunderstands how the application process for clinical trial registration works. Under current law, practitioners who wish to conduct a clinical trial using a drug in Schedules II through V do not need a separate registration. Manufacturers and distributors comprise approximately 0.1% of current DEA registrants, so it is unnecessary to provide a separate registration process for that specific activity. As with the scheduling of new drugs, the issue of approving drugs for use in clinical trials is not one of process, but one of timing.

Improving patients' access to medication and injecting certainty in the drug approval and scheduling processes are both laudable goals, and worthy of our consideration today. I intend to offer a substitute amendment to provide greater certainty to the scheduling process while addressing the issues I have just outlined.

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