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When pharmaceutical companies want to introduce a new medicine to U.S. patients, it must first go to the Food & Drug Administration (FDA) for approval. After this, these medicines go to the Drug Enforcement Agency (DEA), where that agency must approve them, too.

This bill aims to accelerate the approval process by requiring the DEA to come to a scheduling decision within 60 days of a drug product passing FDA approval.

This legislation would also speed up the process to bring new drugs under a clinical trial. The DEA would be given a 180 day window to approve or deny an application to manufacture a controlled substance (Schedule III, IV or V) for clinical trial.

","official_title":"To amend the Controlled Substances Act with respect to drug scheduling recommendations by the Secretary of Health and Human Services, and with respect to registration of manufacturers and distributors seeking to conduct clinical testing.","short_title":"Improving Regulatory Transparency for New Medical Therapies Act","popular_title":null,"short_summary":"(This measure has not been amended since it was passed by the Senate on October 26, 2015. The summary of that version is repeated here.)\n\nImproving Regulatory Transparency for New Medical Therapies Act\n\n(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to delay the effective date of approval of a drug, biological product, or animal drug for which the Food and Drug Administration (FDA) recommends controls under the Controlled Substances Act until the Department of Justice (DOJ) issues a final interim rule for the drug. This delay also applies to conditional approval and indexing of animal drugs.\n\nThis bill 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 not later than 90 days after DOJ receives a recommendation for controls or the FDA approves the drug. The final interim rule is effective immediately.\n\nFor purposes of submitting an application to...","summarized":true,"cost":null,"cost_commentary":"A CBO cost is currently unavailable, though if enacted, an increase in labor hours at the DEA would seem likely, and this might in turn raise the DEA's budget. ","impact":"Sick patients, new pharmaceuticals and other medicines awaiting DEA approval, healthcare providers, researchers in clinical trials, the FDA, and the DEA.","argument_for":"Would help ensure that new treatment options reach patients in a timely manner. ","argument_against":"Rushing approval of experimental medicines has the potential to backfire widely and lethally. 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Should New Drugs Be Approved (Or Denied) Faster?