GOP lawmakers push FDA on documents for meningitis probe

By Elise Viebeck - 11/19/12 02:08 PM ET

Republicans on the House Energy and Commerce Committee have set a deadline for health officials to supply documents related to the national outbreak of meningitis.

GOP members have criticized the Food and Drug Administration (FDA) for failing to provide records related to its oversight of the New England Compounding Center (NECC), the pharmacy behind at least 33 meningitis deaths.

In a letter Monday, Energy and Commerce Chairman Fred Upton (R-Mich.) and other GOP members told the agency that it has until Nov. 30 to hand over emails related to the NECC.

"Your agency has not provided any internal communications or memoranda in response to the committee’s bipartisan request letter of Oct. 17, 2012," the lawmakers wrote to FDA Commissioner Margaret Hamburg.

"We need these documents to identify any possible weaknesses in FDA’s regulatory system that can be immediately corrected administratively or legislatively."

Hamburg has called on Congress to strengthen the FDA's oversight of drug compounders in light of the meningitis outbreak.

Last week, she argued before an Energy and Commerce subcommittee that the agency's hands were tied because of conflicting court decisions.

Committee Republicans tangled with Hamburg over the document request in the hearing, saying the records are essential to ascertain whether the FDA needs greater powers over drug compounders.

"Without gaining insight into whether FDA used its existing authority effectively, providing clearer or additional authority to FDA may not solve the actual, underlying problem," the Republicans wrote Monday.

Rep. Cliff Stearns (R-Fla.), who signed the letter, has hinted he might move to subpoena FDA documents if the agency does not comply.

Stearns leads the Energy and Commerce Subcommittee on Oversight, one panel probing the meningitis outbreak.

"If we don't get the information then we're going to be upset and we're going to pursue it," he told The Hill late Thursday.

Energy and Commerce Ranking Member Henry Waxman (D-Calif.) dismissed GOP criticism over the records request as a "big to-do about not much of anything."

"The committee will get whatever documents it wants and should get," Waxman said.

Congress began probing the NECC during the election recess, as fatalities from the firm's products mounted.

The letter to Hamburg came from Upton, Stearns and GOP Reps. Joe Barton (Texas), Joe Pitts (Pa.) and Michael Burgess (Texas).