PATIENT Act of 2015

Promoting Access for Treatments Ideal in Enhancing New Therapies Act of 2015 or the PATIENT Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to extend to five years the three-year marketing exclusivity period provided to certain new drugs that include an active ingredient that was already approved by the Food and Drug Administration.

A drug is provided this extended exclusivity period if it is approved for a new indication or use, or the drug has been reformulated or redesigned to:

• promote greater patient adherence to an approved treatment regime,
• reduce the public health risks associated with the drug,
• reduce side effects or adverse events,
• provide benefits to the health-care system, or
• provide other comparable patient benefits.