This week, PIRG joined an amicus brief defending the FDA’s decision to approve a clinically superior drug to compete with Jazz Pharmaceuticals’ twice-nightly medication to treat narcolepsy, a condition that affects individuals’ ability to sleep. The lawsuit against the FDA asserts that a competing drug, Lumryz, should not have been approved. However, with a once-a-night treatment for narcolepsy, Lumryz provides a clinical benefit Jazz’s medication does not – a full night’s rest.
The Orphan Drug Act, the law under which the FDA approved both drugs, encourages innovation for prescription drugs for conditions affecting small populations of patients by granting a period of exclusivity to market and sell the medication. Jazz argues that approving Lumryz violates their exclusivity, but PIRG believes this is exactly the type of innovation that should be encouraged in drug development. The amicus brief outlines the differences between the drugs, particularly the benefit of a single-dose medication for narcolepsy.
Patients deserve a competitive market that supports true innovation for patients’ benefit. The FDA made the right choice in approving Lumryz. With the backing of amicus briefs like this one, the courts should side with the FDA and the patients who will benefit from clinically superior options on the market.
High Value Health Care, Advocate, U.S. PIRG Education Fund
Maribeth educates lawmakers and the public about problems in health care and pushes for workable solutions. When she's not researching or lobbying, Maribeth likes to read, play games, and paint.