WASHINGTON – The FDA had all the authority it needed to take action against the compounding pharmacy at the center of last fall’s fungal meningitis outbreak, the results of a Congressional investigation showed.
However, the agency failed to act; 53 people died, and more than 700 were infected, Republican lawmakers said in a report issued Tuesday.
Framingham, Mass.-based New England Compounding Center (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.
“In the 6 years following [a] 2006 Warning Letter, FDA failed to take any enforcement action against NECC or Ameridose despite receiving complaint after complaint, often relating to the safety of the companies’ drugs,” the report stated. “Though several inspections and related enforcement actions were considered during this time period, they were repeatedly delayed and ultimately cancelled.”
The Republican-issued report cited “inefficiency, indecisiveness, skewed priorities, and a lack of leadership” as leading to the deaths of more than 50 people.
Since Oct. 1, the FDA has inspected 50 compounding facilities. It has issued 30 deficiency forms and one warning letter, and caused five firms to recall products. The FDA on Monday alerted healthcare providers that sterile drug products by ApotheCure and sterile lyophilized products from NuVision Pharmacy could be at high risk for contamination.
“We now know that there was nothing in the law that prevented the FDA from acting because in the last few weeks before this hearing, the FDA has conducted a highly visible campaign of inspections,” Tim Murphy, PhD (R-Pa.), chair of the House Energy and Commerce Oversight and Investigations subcommittee, said Tuesday. “No law has changed. The only change is the FDA decided to act.”
At a hearing continuing the committee’s investigation into the outbreak, FDA Commissioner Margaret Hamburg, MD, – as she and the FDA did last fall – called for greater legal clarity in the agency’s authority over compounding pharmacies.
While compounding pharmacies are regulated by state boards of pharmacies, manufacturing is overseen by the FDA, and the line separating the two has been blurred by court cases rejecting the agency’s actions, Hamburg said. That limited authority helped the NECC sidestep FDA oversight as a manufacturer, resulting in the production of contaminated products.
The FDA wants high-risk compounders like NECC to register with the FDA and for compounded products to be labeled as such.
“I’m worried if we don’t work together there may be more problems like this in the future,” she said.
Hamburg cited two recent incidents where the FDA had to secure search warrants and inspect compounding pharmacies with federal marshals. In other cases, she said the agency had to threaten warrants.
Democrats on the committee last week asked that a representative of the International Academy of Compounding Pharmacists, which the lawmakers said lobbied and fought to restrict the FDA’s authority over compounding pharmacies, be called before the subcommittee to testify. The organization was not at the committee, and Hamburg was the only witness.
Democrats on the committee Tuesday expressed continued support for clarifying the FDA’s authority over compounders will some type of legislation — – sentiment not echoed by Republican counterparts.
Murphy, calling the outbreak one of the worst public health disasters in the country’s history, repeatedly questioned Hamburg about why the FDA in 2011 suspended enforcement actions and inspections against all compounding pharmacies until it finalized guidance for industry on where to draw the line between compounding and manufacturing.
Hamburg said Tuesday she was unaware of the action. “I regret we didn’t do more, and I regret I wasn’t more engaged,” she said, adding agency lawyers were pondering a Supreme Court challenge and the possible outcomes to a challenge.
In response to questions from Murphy about what the FDA has changed in light of the outbreak and before any possible congressional action, Hamburg said the FDA has reorganized itself to strengthen its oversight over compounders.
“I, for one, am not convinced the FDA has taken steps to clean its own house,” Murphy said.
Rep. Mike Burgess, MD (R-Texas), asked why the FDA was so concerned about the law and what lawyers had to say about the FDA’s authority.
“We’re public health people,” Rep. Mike Burgess, MD (R-Texas), said. “We should be taking care of people.”
Hamburg later said the agency shouldn’t have been as cautious about the law. “Public health should not be impeded by those kind of legal, regulatory ambiguities,” she said.