MAY 24, 2013
WASHINGTON – The FDA’s push to gain more authority over large-scale compounding pharmacies like those at the center of last fall’s fungal meningitis outbreak continues to gain opposition from House Republicans.
On Thursday, the day after a Senate committee cleared a bill giving the FDA greater power to regulate certain compounders, Republicans in the GOP-controlled House chamber reiterated during an Energy and Commerce Health Subcommittee hearing on the issue that such authority isn’t needed.
The lawmakers maintained that the agency had all the authority it needed to prevent the outbreak – which has killed 55 people and sickened more than 750 – through greater monitoring of compounders that act like manufacturers.
In the immediate weeks after the outbreak, FDA officials said their authority over compounders like the Framingham, Mass.-based New England Compounding Center (NECC) was muddied by conflicting appellate court decisions. While the practice of pharmacy is regulated by the states, drug manufacturing is overseen by the FDA.
The NECC – known by state and federal regulators to have a shaky track record – shipped more than 17,000 vials of tainted methylprednisolone acetate, which are believed to have caused the outbreak that started last fall.
But subcommittee vice-chairman Mike Burgess, MD (R-Texas), on Thursday pointed to the fact that the FDA has inspected nearly 50 compounding pharmacies since late last year, taking serious enforcement action on some.
“If the FDA has the authority today, they had it 6 months ago,” Burgess said in his opening statement. “The Food and Drug Administration was aware that this compounding facility was making poor products for years. They never followed up on warning letters.”
Multiple lawmakers, including Burgess and Rep. Joe Barton (R-Texas), said they wouldn’t support a bill when the FDA has the power it already is asking for.
“I cannot in good conscience entertain discussion of legislation when not one person has been fired, reprimanded, or held accountable,” Burgess said of last fall’s outbreak.
The Energy and Commerce Oversight and Investigations Subcommittee spent several months investigating and requested hundreds of emails and documents related to the FDA’s regulation of compounders. It found in a report issued last month the FDA had all the authority it needed to prevent last fall’s outbreak and simply failed to act.
Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, admitted the FDA should have done more to stop NECC and is doing more to oversee high-risk compounders today. Inspections have revealed serious sterility issues at certain compounding facilities, she said, adding that another outbreak might occur unless compounders are given more scrutiny.
But legislation is needed to at least force such large-scale compounders to register with the FDA and submit adverse event reports like traditional drug manufacturers.
“Right now we don’t know who they are. We don’t know where they are. And we don’t know what they’re making,” Woodcock told lawmakers.
Lawmakers in the Senate have taken a different stance on the FDA’s authority and have tried to give the agency greater power over large-scale compounders.
Under the bill they reported out of the Senate Health, Education, Labor and Pensions Committee Wednesday, the FDA’s authority would extend to compounders who produce sterile drugs without a prescription and ship those drugs across state lines.
“We must stop questioning whether FDA needs new authority,” Rep. Frank Pallone (D-N.J.), the top Democrat on the health subcommittee, said Thursday. “It has been made abundantly clear that conflicting court opinions and ambiguous language in the law show that the FDA does not have adequate authority to oversee compounders.”
Rep. Ed Markey (D-Mass.), who doesn’t sit on the Energy and Commerce Committee but whose district encompasses the NECC, introduced legislation Thursday to give the FDA what it has been asking for.
The Verifying Authority and Legality in Drug Compounding Act would make the FDA the sole regulatory authority over compounders that produce sterile products without or in advance of a prescription and ship it across state lines – much like the Senate bill does.
Barton said the FDA has the obligation to work with state regulators if federal regulators see a potential problem but think the power to enforce action lies with a state. Otherwise, Woodcock’s prediction of an NECC-like outbreak could be a matter of when and not if.
Said Barton, “I would encourage you to facilitate that communication because I don’t want if to become when.”