H.R. 639, Improving Regulatory Transparency for New Medical Therapies Act, as amended

H.R. 639

Improving Regulatory Transparency for New Medical Therapies Act, as amended

Sponsor
Rep. Joe Pitts

Date
March 16, 2015 (114th Congress, 1st Session)

Staff Contact
Communications

Floor Situation

On Monday, March 16, 2015, the House will consider H.R. 639, the Improving Regulatory Transparency for New Medical Therapies Act, as amended, under suspension of the rules.  H.R. 639 was introduced on February 2, 2015 by Rep. Joe Pitts (R-PA) and was referred to the Committee on Energy and Commerce, and in addition, to the Committee on the Judiciary.  The Energy and Commerce Committee ordered the bill reported, with an amendment, by voice vote, on February 12, 2015.

Bill Summary

H.R. 639 seeks to improve and streamline the Drug Enforcement Agency’s (DEA) process for scheduling new drugs approved by the Food and Drug Administration (FDA) to allow safe, effective, and innovative treatments to get to patients more quickly.

The bill amends the Controlled Substances Act (CSA) to require the DEA to act on recommendations from the FDA to add a drug or substance that has never been marketed in the United States to a schedule of controlled substances within a specified period.[1]  Specifically, the bill requires the DEA to schedule the new drug within 90 days of receiving FDA’s recommendation for scheduling, or 90 days from FDA’s approval of the drug, whichever is later.

H.R. 639 also streamlines the registration process for manufacturing controlled substances for use solely in clinical trials to expedite their availability to patients.  The bill requires the Attorney General, within 180 days of receiving an application for registration to manufacture a controlled substance for use in a clinical trial, to make a final decision on whether to approve the application or provide notice to the applicant to show cause why registration should not be denied, revoked, or suspended.

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[1] Energy and Commerce, Markup Document:  Background Memo, at 2.

Background

Under current law, new drugs and substances that previously have not been marketed in the United States, and that have the potential for abuse, must be scheduled by the DEA under the Controlled Substances Act before they can be marketed.  However, the CSA currently does not provide a deadline for the DEA to act after receiving a recommendation for scheduling from the FDA.  Consequently, lengthy delays by the DEA for acting on such recommendations have delayed the availability of such drugs for use by patients and postponed product launches by manufacturers due to the lengthy and unpredictable review times associated with DEA scheduling decisions.  The DEA has not made any scheduling decision for a new drug that was contrary to the FDA recommendation over the past fifteen years.[2]

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[2] House Report 113-565, Part 1, at 2.

Cost

A cost estimate for H.R. 639 is not available at this time.  The Congressional Budget Office provided a cost estimate for a similar bill (H.R. 4299) in the 113th Congress, which found that implementing that bill would have no significant costs to the federal government.

Additional Information

For questions or further information contact the Republican Conference at 5-5107.