New policy for old drugs

Coffee Brown, University of New Mexico, Talk Radio News

Sens. Chuck Schumer (D-N.Y.), Susan Collins (R-Maine), Sherrod Brown (D-Ohio), and Mel Martinez (R-Fla.) announced the Promoting Innovation and Access to Life-Saving Medicine Act, to make generic alternatives available as “biologics” go out of parent.

Schumer joked that he couldn’t make an acronym out of the initials, then explained biologics are drugs produced from living cells, (such as Premarin from horses, vaccines from killed or weakened microbes, Insulin from bacteria, or the anticipated results of stem cell research).

Collins said the act is needed because currently the FDA has no pathway to evaluate and approve this class of drugs. Many lifesaving biologics are long out of patent, but are still expensive because generics can’t get approved. “The price tag (for insulin) might well drop by as much as 25 percent,” she said.

Brown and Martinez agreed that there was strong bipartisan support for the act.

“We probably have four different opinions here about here on the best way to proceed on healthcare reform, but everyone agrees a prerequisite is to bring costs down,” Schumer said.

The summary of the bill contained a clause limiting “exclusivity” (like a patent) to five years for the original molecule and three years for some modifications.