FDA Pressed on Generic Drug Labeling Rule

A consumer advocacy group is warning the Food and Drug Administration that industry pressure to delay a generic drug labeling rule could damage patient safety.

Public Citizen on Thursday suggested the agency may be succumbing to influence from brand-name and generic drug industry groups that have fought against a proposal that would allow generic makers to update labels if post-market safety problems arise.

Under current law, brand name and generic drugs must share the same label information as the original reference drug. But, the group says, when generics take over the market, brand name makers lose incentive to monitor post-market safety, leaving the job up to the generic makers – which lack the authority to update labels without FDA approval.

“At issue is whether generic drug manufacturers have any responsibility for providing doctors and patients with new-found information about risks posed by the companies’ products,” Public Citizen said.

In 2011, the group petitioned the agency, asking it to propose a rule that would clear the way for generic makers to update labels without agency approval. In 2013, the agency proposed the rule, stating in December of last year that it expects to release the final rule in December. The agency recently reopened the comment period and is holding a public meeting March 27.

GPha and PhRMA submitted an alternative proposal to the agency last fall that would bar safety warnings without agency approval for both generic and brand-name drugs. Some lawmakers have also sounded warnings against the proposed change. In a letter to the agency last summer, Rep. Steve Israel, D-N.Y, and former Rep. Timothy Bishop, D-N.Y., said the proposed rule could “cause the same generic medication produced by multiple manufacturers to have different labels and different warnings and could lead to serious confusion among patients and providers.”

See the original article on the CQ Roll Call website.