Baker seeks to press FDA over slow generic drug approvals

By State House News Service | April 11, 2016, 17:06 EDT

Gov. Charlie Baker is looking for a way to get the notoriously slow-moving federal Food and Drug Administration to speed up processing of generic drug reviews. (State House News Service photo)

BOSTON – Gov. Charlie Baker is “toying” with the idea of turning to the state’s all-Democrat congressional delegation for help impressing upon the Obama administration the need to speed up the Food and Drug Administration’s generic drug approval process to help drive down costs, he said Monday.

Baker met with the Democratic legislative leaders as a hearing was under way on a proposal from Sen. Mark Montigny (D-New Bedford) to develop a list of “critical” prescription drugs and require their manufacturers to report production, research and development, marketing and advertising costs, as well as various prices charged.

Montigny’s bill would also let the state Health Policy Commission cap prices on those drugs if it determined they were too expensive.

Baker said 90 percent of all prescriptions and 70 percent of all drug spending is for generics, which he said have seen the “biggest run-up in prices” in recent years. According to Baker, it takes the FDA 48 months to approve a new generic drug for use, with over 4,000 generics in the pipeline.

“I’ve been toying with the idea to see if we can’t get our congressional delegation to put some heat on the Obama administration to deal with the fact that the calcification of the approval process at the FDA is creating real heartburn, not just for consumers but for folks who would like to put drugs into the market to serve that generic market and create the kind of competition on price that’s sort of fundamental to our ability to control prices,” Baker told reporters.

The Republican governor is a former chief executive of Harvard Pilgrim Health Care, one of the state’s largest health management organizations.

Written by Matt Murphy