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Regulatory Focus™ > News Articles > Senate Committee Advances Bill Redefining When a Drug is Officially Approved

Senate Committee Advances Bill Redefining When a Drug is Officially Approved

Posted 01 October 2015 | By Zachary Brennan 

Senate Committee Advances Bill Redefining When a Drug is Officially Approved

A bill that would effectively provide manufacturers with more certainty on the marketing exclusivity of approved drugs needing DEA clearance advanced unanimously through a Senate committee Wednesday.


In order for a drug to be marketed, it must not only be approved by the US Food and Drug Administration (FDA), but the US Drug Enforcement Agency (DEA) must also schedule the drug to a particular class under the Controlled Substances Act (CSA).

Under current law, a drug's exclusivity period begins when FDA approves the product, though companies often wait long periods for DEA to schedule the drug, which effectively cuts short the time on market without generic competition. Those exclusivity periods typically range from three to 15 years.

Last year, Eisai sued the FDA when it refused to increase the exclusivity periods for two of its drugs that waited for DEA scheduling for a year after approval. However, a US District Court Judge on Wednesday ruled in favor of FDA, saying "the exclusivity period for a new drug begins when the FDA issues its letter approving the drug, even if the drug’s manufacturer must await DEA’s scheduling determination before it can bring the drug to market."  

New Legislation

However, this new bill, which passed the House in March and is known as the Improving Regulatory Transparency for New Medical Therapies Act, would start the clock on marketing exclusivity after the date of DEA scheduling, rather than after the FDA approval.

In addition, the bill would amend the CSA to require the DEA to schedule a drug no later than 90 days after it receives a recommendation for controls or the FDA approves the drug.

Clinical researchers would also see some benefits from the bill, as it would allow them to indicate on their DEA application that the controlled substance will only be used for clinical trials of a drug. DEA would also be required to review applications to manufacture a controlled substance (Schedule III, IV or V) for use in a clinical trial within 180 days of receiving the application, and Schedule I or II drugs within 180 days, not including a notice and comment period and a 90-day application window.

Sen. Orrin Hatch (R-UT) said in a statement: "These common-sense pieces of legislation place a greater emphasis on transparency and timeliness while preserving DEA’s authority to prevent unsafe therapies from entering the supply chain."

The bill, which passed the Senate Health, Education, Labor, and Pensions (HELP) Committee Wednesday, now heads to the full Senate for discussion and a possible vote.

S. 481: Improving Regulatory Transparency for New Medical Therapies Act

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