Improving Regulatory Transparency for New Medical Therapies Act

(​H.R. 639/S. 481)

This bill amends the federal FD&C Act and the Public Health Service Act to allow the Food and Drug Administration (FDA) to delay the effective date of approval of a drug or a biological product for which it has recommended controls under the Controlled Substances Act with the Department of Justice, until the DOJ issues a final interim rule for the drug. This delay also applies to the conditional approval and indexing of animal drugs. This legislation also amends the Controlled Substances Act to require the DOJ to issue a final interim rule for a drug product recommended for controls by the FDA no later than 90 days after the agency receives a recommendation for controls or the FDA approves the drug. The final interim rule is effective immediately.
Status: Rep. Joseph Pitts (R-Pa.-16) introduced H.R. 639 on Feb. 2, 2015, and it was referred to the House Committees on Energy and Commerce and the Judiciary. Sen. Orrin Hatch (R-Utah) introduced S. 481 on Feb. 2, 2015, and it was referred to the Senate Health Education, Labor and Pension (HELP) Committee. On March 16, 2015, the legislation passed in the House and was sent to the Senate, where it was referred to the Senate HELP Committee. On Oct. 25, 2015, the Senate HELP committee discharged the bill by unanimous consent and it went on to pass in the full Senate with an amendment. The House agreed to the amendment without objection on Nov. 11, 2015. The bill was signed into law by the president on Nov. 25, 2015.
AVMA Position: Support
Primary Contact: Dr. Ashley Morgan