Generic Drugmakers Get Year-End Gift As FDA Backs Off Product-Liability Rule Proposal
At issue was proposed regulation that would have allowed generic drug companies to update their product labeling when new information about a medicine's safety is revealed, a move that could open drugmakers up to lawsuits. Commissioner Scott Gottlieb and the FDA’s drug-center director Janet Woodcock said in a statement, “We heard from manufacturers that they believed this change would have imposed on them significant new burdens and liabilities."
The Wall Street Journal:
FDA Withdraws Proposed Rule That Would Have Exposed Generic-Drug Makers To Liability
The Food and Drug Administration gave a year-end gift to the generic drug industry by backing off a proposal that would have opened up generic companies to possible product-liability lawsuits over drug safety. The FDA had proposed a new federal rule in 2013 that would have allowed people to hold generic-drug companies legally liable for the side effects of medicines. Thursday’s action by the agency withdrew the proposed rule, and keeps generic companies largely impervious to lawsuits. (Burton, 12/13)
Stat:
FDA Yanks Controversial Rule To Allow Generic Makers To Update Product Labels
In explaining its reasons, the agency worried the rule could create “unintended consequences” by confusing patients and doctors if some generic companies did not revise labeling on a timely basis, or if generic and brand labels appeared different. FDA officials also pointed to concerns expressed by generic makers that they would have to raise prices to cover added costs for complying with the rule. “This is a very careful balancing act,” FDA Commissioner Scott Gottlieb said in a media call. “The rule would have imposed some costs and burdens. ... There would have been potential drawbacks and downsides. It’s one of the reasons we may look toward Congress and broader efforts to get additional resources to do the things we currently can’t do.” He noted, however, the agency plans a new program to update labels on certain generic cancer drugs. (Silverman, 12/13)
In other pharmaceutical news —
Reuters:
Senate Democrats Introduce Bill To Allow Government To Block Drug Price Rises
Four Democratic U.S. senators introduced a bill on Thursday that would allow the government to block drug price increases that it decides are unjustified. The bill sponsored by Senators Richard Blumenthal, Kamala Harris, Amy Klobuchar and Jeff Merkley, all Democrats, would allow the Department of Health and Human Services to prohibit drug price increases that it deems excessive. (12/13)