• Senate Committee Passes Bill that Redefines Marketing Exclusivity Period to Allow for DEA Scheduling
  • November 13, 2015 | Author: Scott S. Liebman
  • Law Firm: Loeb & Loeb LLP - Washington Office
  • The Senate HELP Committee unanimously passed a bill that would push back when the marketing exclusivity period begins for an FDA-approved drug, and proposes measures that require the DEA clearance process to be timelier.

    The Senate Health, Education, Labor and Pensions (HELP) Committee unanimously passed the Improving Regulatory Transparency for New Medical Therapies Act, a bill that would benefit drug manufacturers by providing more certainty on the marketing exclusivity of their approved drugs that require DEA clearance.

    After FDA approval, some drugs need to be scheduled by the DEA into a class under the Controlled Substances Act (CSA). Under current law, a drug’s marketing exclusivity period begins once it has received FDA approval, but since the DEA classification process can take some time, this effectively cuts short the time that a drug can go to market without generic competition.

    The new bill, which passed the House in March, would see the marketing exclusivity clock start after the DEA scheduling rather than after the FDA approval. It would also amend the CSA, requiring that the DEA schedule a drug no later than 90 days after it has received recommendation for controls or after the FDA approves the drug.

    Others who will benefit from the bill include clinical researchers, as they will be able to indicate on their DEA application that the controlled substance will be used exclusively for clinical trials of the drug. The DEA would be required to review applications to manufacture a controlled substance (Schedule III, IV or V) for clinical trial use within 180 days of receiving the application, and 90 days for Schedule I or II drugs, not including a notice and comment period and a 90-day application window.

    Now that the bill has passed the Senate HELP Committee, it will head to the Senate for a vote.