The U.S. Food and Drug Administration called for congressional action to strengthen the agency's authority over compounding pharmacies, as lawmakers prepared for two days of hearings on a deadly fungal meningitis outbreak linked to compounded steroids.
In a Tuesday statement issued to Reuters, the U.S. regulator also acknowledged that it had agreed with Massachusetts state officials in 2003 to designate the company now at the heart of the outbreak as a compounding pharmacy exempt from the strict safety standards FDA imposes on drug manufacturers.
The decision put state regulators in charge of overseeing developments at Framingham, Massachusetts-based New England Compounding Center after problems surfaced in 2002.
Where to draw the line between drug manufacturing and drug compounding is a central question for Congress. The House of Representatives and the Senate are hosting separate hearings to determine whether to give the FDA new authority over compounding pharmacies to head off future public health crises.
The current outbreak, linked to tainted steroid injections from New England Compounding Center, has afflicted 438 people, including 32 who have died, according to the U.S. Centers for Disease Control and Prevention.
"FDA's authority over compounding pharmacies is more limited by law and needs to be strengthened," the agency's statement said. "We look forward to working with Congress to prevent this from happening again."
Those sentiments were echoed on Tuesday by a new report from the minority Democratic staff of the House Energy and Commerce Committee panel for oversight and investigations, which will hold the week's first meningitis hearing on Wednesday.
The second hearing is scheduled for Thursday before the Senate Health, Education, Labor and Pensions Committee. FDA Commissioner Margaret Hamburg is scheduled to testify in front of both panels.
"Legal authority over compounding has been complicated by court decisions that have cast doubt on FDA's authority to regulate compounders," the House Democratic report said. "Compounders operate in a regulatory gap between state regulated pharmacies and federally regulated drug manufacturers."
Drug compounding is a little-known practice in which pharmacists traditionally alter or recombine drugs to meet the special needs of specific patients. It is overseen mainly by state authorities that are often ill-equipped for the job.
The activity has evolved in recent decades to include large-scale production that some experts view as drug manufacturing that should be subject to FDA regulation.
Not everyone agrees that the FDA needed new authority to stop New England Compounding Center from operating, however.
Advocacy group Public Citizen earlier this month called on the Obama administration to launch an independent probe into the FDA's lack of action against NECC. The group alleges that the FDA already has the authority it needs, but that agency officials failed to take steps that could have prevented the current outbreak.
On Monday, the majority Republican staff on the House committee released its own report that said government regulators decided in 2003 that NECC was not a drug manufacturer that would have been subject to direct FDA oversight.
The agency acknowledged in its statement that FDA and Massachusetts state officials agreed NECC was operating as a compounding pharmacy after inspections in 2002 and 2003 that followed reports of health problems linked to two sterile drugs, including steroid injections.
"Since states have day-to-day authority of compounding pharmacies," the FDA said on Tuesday, "the state of Massachusetts oversaw corrective actions by the firm with regard to its sterility practices."