Lawmakers grill FDA chief on meningitis outbreak

{mosads}Hamburg has faced intense criticism for the FDA’s light hand in regulating the growing number of non-traditional compounders.

She argued Tuesday that her agency needs stronger authority to prevent firms like the NECC from causing another health crisis.

“The tools we have for regulating these firms are simply not the right fit,” Hamburg told the Energy and Commerce subcommittee on Oversight. “A new breed of pharmacy compounders has outgrown the legal framework.”

The meningitis outbreak began last fall when the NECC produced and shipped batches of steroid injections that were tainted with fungal meningitis. The shots were administered around the country to treat back and joint pain, producing hundreds of cases of meningitis within months.

Congress soon caught wind of the illnesses, and lawmakers first tangled with Hamburg at a hearing in November.

The FDA chief called Tuesday for new powers to regulate firms like the NECC, which fall between compounder and drug manufacturers. States traditionally oversee the former category, while federal authorities oversees the latter.

“We need these companies to be held to a national, uniform standard for safety that we can inspect against,” Hamburg said of large compounders. “They need to register with us, and we certainly want them to report adverse events to us.”

“We owe it to the public and the victims to provide better protection in the future,” she added. 

The hearing corresponded with the release of a GOP report blaming the FDA for years of inaction against potentially dangerous compounders.

The report reviewed more than 27,000 documents supplied by the agency and concluded that regulators should have more aggressively pursued known safety concerns at the NECC and its sister company, Ameridose.

“We now know that doctors, patients, providers, and whistleblowers tried to warn FDA for years that NECC and Ameridose were operating as manufacturers and marketing their products nationwide without patient prescriptions,” said Energy and Commerce Committee Chairman Fred Upton (R-Mich.) in a statement.

“The FDA was also warned about sterility and safety issues with the companies’ products. Rather than do its job and protect the patients who were taking NECC and Ameridose drugs, FDA chose not to act. We found that FDA focused on perfecting their legal reasons for inaction instead of protecting families.”

On Tuesday, lawmakers from both parties blamed Hamburg and her agency for negligence. But the sides appeared split on whether to offer the FDA new regulatory powers.

Democrats argued conflicting court decisions on drug compounders have created a legal gray area that lawmakers must rectify.

“FDA [has] had to struggle with how to pick up the pieces of a statute in tatters,” said Rep. Henry Waxman (D-Calif.), the top Democrat on Energy and Commerce. “It is Congress’s job to fix the law when it is inadequate or when courts invalidate it.”

Republicans, meanwhile, cited a series of recent compounding inspections by the FDA as proof that the agency needs no help to fulfill its mission of protecting patients.

“This flurry of well-publicized activity exposes the FDA’s charade,” said Oversight subcommittee chairman Tim Murphy (R-Pa.). “No law has changed. The only change is the FDA decided to act.”

—This post was expanded at 2:17 p.m.