Congress Should Review Success Of Hatch-Waxman Act, Study Advises

Congress should review whether the Hatch-Waxman Act is achieving its intended purpose of balancing incentives for generics and innovation, according to a study published in the November issue of the journal Health Affairs.

The Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Act, allowed for an expedited Food and Drug Administration approval process for generic drugs.

The study, “Evolving Brand-Name and Generic Drug Competition May Warrant a Revision of the Hatch-Waxman Act,” said that Congress should consider amending the law so that some of its provisions are brought more in line ...