A Republican congressman is accusing the FDA of failing to keep a close enough eye on Johnson & Johnson's troubled Puerto Rico factory. Rep. Darrell Issa, who chairs the House Committee on Oversight and Government Reform, wrote FDA Commissioner Margaret Hamburg, complaining that regulators haven't visited the problem plant since September. Nor has FDA staff in Puerto Rico reviewed J&J's progress at complying with a consent decree agreed upon in March, Issa said.
After a long series of drug recalls, J&J promised it would overhaul operations at the Puerto Rican plant, as well as those at a Fort Washington, PA, facility it had already shut down for revamping. The consent decree is designed to bring the two out-of-line facilities back to snuff. But Issa alleges the agency isn't doing its part to make sure J&J complies, saying the FDA has shown a "deeply troubling" lack of oversight, Bloomberg reports.
FDA officials in Puerto Rico say they don't have enough resources to follow up on J&J's consent decree, Issa says in his letter. "I find this excuse deeply troubling and inconsistent with the resources made available to the FDA in the legal consent decree." And that, he said, raises "several questions about the mismanagement of safety concerns at FDA's San Juan office."
J&J has come in for plenty of criticism as recalls mounted and manufacturing deficiencies were uncovered over the past 18 months. But the FDA has drawn its share of flak as well. Lawmakers and others have said the agency mishandled J&J's recalls and that it wasn't proactive enough about digging into the company's quality problems.
- see the Bloomberg story