Dems: FDA should be able to recall drugs

House Democrats on Thursday repeatedly called for federal regulators to be given the authority to recall drugs.

Pending legislation would grant that power to the Food and Drug Administration for food, but not for drugs. Statements from lawmakers at a panel hearing Thursday made it clear many Democrats want to go further.

ADVERTISEMENT
“I think the elephant in the room is that you don’t have recall authority. I think that’s really an issue that needs to be addressed,” Rep. Jackie Speier (D-Calif.) told federal regulators testifying Thursday at a House

Oversight Committee hearing on massive voluntary recall of children’s medicines by Johnson and Johnson.

The recall followed dozens of complaints about foreign particles in its medicines, including metal flakes in infants’ Tylenol.

Pending legislation imposing new rules on food safety would give regulators mandatory recall authority, easier access to company records and civil monetary penalties, but drugs wouldn’t be covered under the new rules.

The Food and Drug Administration currently does not have these authorities for food or drugs, although it can seek court action, which can be a lengthy process.

Rep. Diane Watson (D-Calif.) suggested adding the clause “anything ingested through the mouth” to pending food safety legislation that includes recall authority, so that it would cover drugs as well.

During the hearing, lawmakers repeatedly asked Joshua Sharfstein, the principal deputy commissioner for the Food and Drug Administration (FDA), what extra authority federal regulators need to do their job better.

Sharfstein said additional regulatory powers could have led to a faster recall after the FDA in February put Johnson and Johnson on notice that it had “rising concerns” about the manufacturing process at one of the company’s units. The firm announced its recall on April 30.

“With other tools, could we have gotten their attention faster?” Sharfstein said. “I think those are fair questions to ask.”

A legislative liaison with the FDA told The Hill that while the food bill could create momentum for the agency to get extra drug regulation powers, simply expanding the food bill to cover drugs is probably unworkable when the bill, a priority for the White House, is just a few steps away from final passage. Rather, passing a separate drug bill with a similar expansion of regulatory powers may make more sense.

Thursday’s hearing was called after a Johnson and Johnson unit, McNeil Consumer Healthcare, last month recalled 136 million bottles of more than 40 variations of children’s medicine, including Children’s Tylenol, Children’s Motrin, Children’s Benadryl and Tylenol Infants’ Drops.

Federal regulators are still looking into whether the contaminated medicine is responsible for any infant deaths, although the panel made it clear that federal regulators to date have not found any connection.
Sharfstein told the panel that the risk of children having gotten sick as a result of the production problems was “remote,” but that he “cannot say … with complete certainty” that none were harmed.

ADVERTISEMENT
The FDA also informed the panel Wednesday night that McNeil knew of a potential problem with one of its Motrin products in 2008 and sent contractors to stores to buy them back instead of issuing a recall. The panel’s chairman, Rep. Edolphus Towns (D-N.Y.), said the buyback “warrants further investigation.”

But Colleen Goggins, worldwide chairman of the Johnson and Johnson Consumer Group, said the FDA was informed of the issue at the local level and did not object.

 “Clearly,” Goggins said, “FDA was aware of this.”