FDA Raises Safety Measures for Drugs

The same House Democrat who originally opened the door for generic drugs to be sold as alternatives to brand name products said Tuesday that they should also be held to the same safety standards.

For 30 years, generic drugmakers have relied on safety labels from brand name companies, posting identical warnings on their own products. But the Food and Drug Administration (FDA) is now pushing generic drugmakers to take more responsibility for their products.

The FDA proposed a rule last November that would require generic drugmakers to develop their own safety labels.Rep. Henry Waxman (D-Calif.), who co-authored the generic drug law in 1984, said the new FDA rules would help ease consumers concerns about the potential dangers of generic drugs.“We don’t want to scare consumers to think, ‘Oh, if I take a generic, I may be taking something that’s not as safe,’” Waxman said during a House Energy and Commerce subcommittee hearing.Waxman argued that if generic drugmakers develop their own safety labels, they would have more incentive to warn consumers about newly-discovered safety issues that arise, which has traditionally been the responsibility of brand name drugmakers.