Workers inside the State Health Operations Center in the Tennessee Department… (Kristin M. Hall/AP )
Federal and Massachusetts officials said Thursday that they lacked clear authority to take action earlier against a now-shuttered specialty pharmacy that set off safety alarms at least six years ago and is now at the center of a burgeoning meningitis outbreak.
In a teleconference with reporters, the officials described a murky, archaic regulatory apparatus that hampered their ability to keep pace with the rapid changes in compounding pharmacies. That industry, which traditionally has consisted of mom-and-pop operations making customized medicines for individual patients, has expanded to include high-volume pharmacies that rival the production of drug manufacturers.
Deborah M. Autor, deputy Food and Drug Administration commissioner for global operations and policy, said it was “really unfortunate that it sometimes takes a tragedy” to bring about change and called on industry officials and lawmakers to adopt a new “regulatory scheme that appropriately controls the risk.” She also said the company could face criminal prosecution.
The officials were responding to questions about why state and federal authorities didn’t move more aggressively against New England Compounding Center in Framingham, Mass., after the FDA found problems during an inspection in 2006. Massachusetts Attorney General Martha Coakley announced an investigation of the NECC after state health officials said the company appeared to violate state licensing requirements.
Fourteen people have died and 170 have been infected from batches of steroid injections contaminated with fungus that were made by the NECC. About 14,000 people received the injections, though it’s not clear how many of those shots were tainted, Centers for Disease Control and Prevention officials said. Some lawmakers already are calling for a criminal probe and new authority for the FDA as a result of the outbreak.
The CDC officials also reported the first infection in a joint — an ankle — that may have been caused by the tainted medicine. More cases of both types of infection are expected.
Fungus causing human disease is notoriously slow to grow and hard to identify. Thirteen cases have been caused by a fungus of the genus Exserohilum and one by the genus Aspergillus. Fungus has been detected in about 50 vials from the company and from clinics that got the product.
J. Todd Weber, the CDC physician leading the investigation of the outbreak, said these are the first meningitis cases caused by Exserohilum ever reported.
The infections have occurred in 11 of the 23 states that got potentially contaminated methylprednisolone acetate from NECC. The medicine is a high-potency, long-acting steroid used to suppress inflammation and relieve pain in people with herniated disks and certain types of arthritis.
The CDC recommendations for treatment of the fungal infection call for two drugs that have to be given intravenously for months. Weber said the drugs are “very strong and can be very difficult for patients to tolerate.”
In 1997, legislation was enacted spelling out the roles of the state and federal governments in regulating compounding pharmacies. But the federal role faced court challenges. As a result, it’s “a murky area,” former FDA commissioner David A. Kessler said.
Other former FDA officials said the agency has sufficient authority over the compounding pharmacies.
“They have all the regulatory authority they need,” said Peter Barton Hutt, a former FDA chief counsel who is now a senior counsel with the law firm Covington & Burling. “They couldn’t ask for any more. What they need are better resources and better coordination.”
He argued that the NECC case was less a result of inadequate authority and more of ineffective communication between state and federal regulators. “Both of them were aware of the problem and neither followed up to make sure the problem was solved,” he said. “Clearly something went wrong there.”
Mary K. Pendergast, who was FDA deputy commissioner from 1990 to 1998, said the agency barely has enough resources to inspect large pharmaceutical plants. “There’s a legitimate worry of spreading resources too thinly,” she said.
As a result, she said, “They play Whac-a-Mole with compounding. If there’s a problem, they whack at it. That’s not necessarily an irrational approach when you consider the bigger problems they’re dealing with.”
Federal and state officials said that the day-to-day operations of compounding pharmacies are governed by state boards of pharmacy. When it comes to FDA authority over compounding pharmacies, much depends on the quantity and type of products.
The agency has long known that compounded drugs can pose safety risks. A 2006 agency survey found that one-third of the compounded drugs sampled had problems, including contamination and incorrect strengths. From 1990 to 2005, the agency learned of at least 240 serious illnesses and deaths associated with improperly compounded products.