FDA raises safety measures for generic drugs

The same House Democrat who originally opened the door for generic drugs to be sold as alternatives to brand name products said Tuesday 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 is now pushing generic drugmakers to take more responsibility for their products.

The FDA proposed a rule in 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 Health 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.

Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, testified that the rule would speed up the process so doctors and their patients would be warned about potential safety issues more quickly.

“That needs to get onto the label as quickly as possible,” Woodcock said.

Under current law, generic drug manufacturers are not allowed to change the warning labels on their products, so they are dependent on brand name drugs to provide accurate information.

Brand name drugmakers can change the labels on their products first and then submit them to the FDA for approval. Only after this process can generic drugmakers issue the same changes. This is a process that can sometimes take more than a year, and in the meantime, the safety labels on generic drugs do not match those on brand name drugs, Woodcock explained.

“While in principle they are the same, they are not literally and exactly the same right now,” Woodcock said.

Woodcock said consumers who use generic drugs should have access to the latest information.

“The FDA believes it's time to provide generic drugmakers with the means to promptly update their labels,” Woodcock said.

In extreme cases, the safety labels never get updated, because the brand name drug has dropped out of the market and all that remains are generic drugmakers, which, by law, cannot make changes. Woodcock said there are about 420 drugs that fit this description.

But the FDA's rule would do more than provide doctors and their patients with more timely information about the safety of generic drugs. It would also open up the manufacturers of these drugs to lawsuits.

In 2011 and again in 2013, the Supreme Court ruled that generic drugmakers couldn't be held responsible for labels they don't control, even though brand name drug manufacturers can be held liable. But this rule would give them the power to change their labels, if new safety information becomes available, and therefore, they could also be found liable for mistakes.

Because of this, Republicans are afraid the costs of generic drugs will go up to pay for higher liability insurance premiums and the costs of safety studies.

“FDA has admitted that the proposed changes will open generic manufacturers up to greater liability under state tort lawsuits,” said Rep. Joseph Pitts (R-Pa.), chairman of the Health subcommittee. “The added costs of litigation will also cause generic prices to rise exponentially.”

Generic drugs account for about 84 percent of the U.S. market's prescription drugs, according to a study by IMS Health.