On September 30, 2015, the Improving Regulatory Transparency for New Medical Therapies Act moved one step closer to becoming federal law by passing the Senate Health, Education, Labor and Pensions Committee.  The bill, which was introduced on February 2, 2015 and passed in the House on March 16, 2015, is now heading to the full Senate for discussion and possible vote.

We herald the progress of this bill with particular enthusiasm given that it has arrived on the same day as the D.C. District Court’s decision to grant the FDA’s Motion for Summary Judgment in the case initiated by Eisai, Inc.  Eisai is a drug manufacturer who was forced to wait a year for the DEA to schedule two of its drugs that had already received FDA-approval. After unsuccessfully taking up the issue with the DEA and facing an entire year of lost market exclusivity, Eisai took the FDA to court, challenging the FDA’s interpretation that a period of new chemical entity exclusivity begins when the FDA approves the product.  However, the court found itself bound to defer to the FDA’s position.

The court’s decision in Eisai suggests that the only relief in sight for manufacturers may be through legislative action.  The Improving Regulatory Transparency for New Medical Therapies Act promises to provide the solution that manufacturers like Eisai have been hoping for.  The Act would provide manufactures with clarity and security on timing for the following milestones:

  • Market exclusivity begins after the date of DEA scheduling, rather than after FDA-approval.
  • The DEA must schedule a controlled substance no later than 90 days after it receives a recommendation for controls or FDA-approval.
  • The DEA must act on applications to manufacture a Schedule III, IV, or V drug for use in a clinical trial within 180 days of receiving the application.
  • The DEA must act on an application to manufacture a Schedule I or II drug for use in a clinical trial within 90 days of the close of the notice period, which must be opened no later than 90 days after the application is accepted for filing.