Generic headaches grow

AS IF pharmaceutical brand originators didn’t have enough to worry about with generic copies of their drugs, now it appears that the brand originator can get into trouble when a generic causes harm that had not been identified and warned about by the original research company.

The Massachusetts Supreme Judicial Court on Friday said in a decision that Merck & Co. can be sued for recklessness in failing to update the labels of generic versions of their drugs, according to a report by Regulatory Focus.

The decision follows a similar one made in California against Novartis that said brand-name manufacturers can be liable, though both these decisions depart from other recent rulings that would not hold brand-name sponsors responsible for labels of generic versions of their drugs.

But while the California decision against Novartis brought up the issue of negligence, in Massachusetts, the decision hinged on whether Merck was reckless by intentionally failing to warn the consumer of known side effects of the drug and its generic version.

The complex issues are by no means consistently applied across the globe and the US Food and Drug Administration (FDA) is yet to finalise its ruling that would require generic drugmakers to update their labels when new information becomes known.

Although the Massachusetts court declared Merck could be sued for commonlaw recklessness if it intentionally failed to update the label on its drug knowing about an issue, it said the company could not be pursued for negligence per se.

See the full discussion at raps.org.