Chaffetz pharmaceutical measure to remove barriers to the development of combination drugs

Jan 22, 2015

WASHINGTON, DC – Intended to spur the development of drugs previously considered economically infeasible, HR 406 was introduced by Congressman Jason Chaffetz today.  The bill would extend to new combination drugs containing molecules already approved by the FDA the same five-year market exclusivity as a drug product containing an entirely new active ingredient.

The existing Hatch-Waxman law gives new drugs a period of five years of “market exclusivity” to help them defray the cost of undergoing the FDA new drug approval process.  Therefore, regardless of the patent situation of a new drug, the company can count on having five years as the exclusive seller of the product.  Thirty years ago when Hatch-Waxman was enacted, all new drugs were “new chemical entities,” that is, new molecules that had never before been approved.  No one at the time considered the possibility that a new drug might be created combining existing molecules (that is, molecules that had already been approved).   more