Congressional Democrats are ramping up two bills intended to put generic drugmakers on par with their Big Pharma counterparts as far as governing how they change product labeling to report updated safety information. The bills are designed to counter a 2011 U.S. Supreme Court decision that protected generic companies from liability over new safety warnings, because their labels copy the ones used by their branded counterparts.
The legislation will require generic pharmaceutical companies to follow the same guidelines that brand name companies use as far as updating product safety on their labels, according to a Pharmalot story on the issue, which details the bills and the reason some see them as necessary in the first place.
As the story explains, the legislation comes about a year after the U.S. Supreme Court ruled 5-4 that generic pharmaceutical operations don't have to beef up their product labeling once they are alerted to side effects, defeating two lawsuits that argued that state laws could require such changes, even minus an FDA sign-off. Critics of the decision feared that the discrepancy would leave a patient unable to sue a generic manufacturer if the label didn't have sufficient safety warnings (they can sue under guidelines for brand name drugs.) That means patients' legal rights would essentially depend on whether they receive a generic or brand name drug if something went wrong.
Sen. Patrick Leahy of Vermont co-sponsored the Senate bill. Rep. Chris Van Hollen of Maryland and Rep. Bruce Braley of Iowa will be introducing the House version, according to the story.
- read the Pharmalot piece