FDA to encourage generic competition

Associated Press

TRENTON, N.J.

The U.S. Food and Drug Administration is opening a new front in its efforts to reduce high drug prices by encouraging development of generic versions of hard-to-make medicines.

Complex drugs and drug-device combinations generally are very expensive, and some are widely used. Often, they don’t get generic competition right after their patent expires, as happens routinely with pills.

Difficulty in creating copies or near-copies of such drugs and getting them approved may deter generic companies from even trying, FDA Commissioner Dr. Scott Gottlieb wrote in a blog post.

Examples of older complex drugs cited by Gottlieb that still lack generic competition include the Advair inhaler and injected medicines Forteo for osteoporosis, Victoza for high blood sugar and Copaxone for multiple sclerosis.