By Elise Viebeck
he leader of a House subcommittee said he’ll pursue Food and Drug Administration (FDA) documents related to a deadly meningitis outbreak unless the agency hands them over.
Rep. Cliff Stearns (R-Fla.) leads the Energy and Commerce subcommittee on Oversight, which hosted FDA Commissioner Margaret Hamburg at a hearing this week.
Hamburg spoke about challenges facing regulators who oversee compounding pharmacies, the kind of firm behind the meningitis outbreak. Several times, Republicans hammered her over an unfulfilled document request.
“If she will answer our request for emails and documentation, we would have more confidence. At this point they have not given us any information,” Stearns said late Thursday. “If we don’t get the information then we’re going to be upset and we’re going to pursue it.”
Stearns has led the charge for document subpoenas in the past. Last year, his subcommittee voted to subpoena White House documents related to the Solyndra, the failed California solar panel company.
In this case, lawmakers have called for emails related to FDA oversight of the New England Compounding Center (NECC), which created the tainted steroid injections that have killed 32 people and sickened hundreds.
Rep. Henry Waxman (D-Calif.), the top Democrat on Energy and Commerce, dismissed GOP criticism over the records request on Thursday, calling it a “big to-do about not much of anything.”
He also blamed Republicans for laying into Hamburg in the hearing.
“I thought their [tone] was inappropriate because the election is over. It sounded like Republicans trying to beat up on somebody because she’s in the Obama administration.
“Yet, ironically enough, their complaints were about the FDA not being as strong as it should have been when it was the Bush administration in power.”
At issue in this case is the division of power between state and federal regulators when it comes to drug compounders, which create custom medications for patients with special needs.
In testy exchanges Wednesday, Republicans pushed Hamburg to explain why her agency did not follow up with the NECC after noting hazardous practices at the company in 2006.
Hamburg said that conflicting court decisions have complicated the FDA’s authority and made enforcement actions difficult.
Later, she called on Congress to clarify the agency’s role in overseeing compounders relative to state pharmacy boards — a push Democrats are friendly to.
Rep. John Dingell (D-Mich.), a committee member who tangled with Hamburg on Wednesday, said he has confidence in her as commissioner.
“Of course,” he said, adding, “We don’t have to worry about getting the documents we need. We’ll get them.”
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