The new warning is based on only two cases, and it was not known for sure whether the company’s drugs had caused the infections. Officials did not say how many people may be at risk, but the number is potentially significant, and a statement from the agency warned doctors, “The F.D.A. recognizes that some health care professionals may receive a high volume of calls from patients or be concerned about having to notify many patients as a result of today’s announcement.”
The company, the New England Compounding Center in Framingham, Mass., has already been linked to a meningitis outbreak that has killed 15 patients and infected 199 others in 15 states. The drug implicated in that outbreak is methylprednisolone acetate, a steroid used in spinal injections for back and neck pain. The drug is believed to have been contaminated with a fungus called Exserohilum, which causes a type of meningitis that is severe but not contagious.
Now, several other drugs made by the company are also possible suspects in infections. A heart-transplant patient exposed to a product that is used during open-heart surgery developed a chest infection with a different fungus, Aspergillus, the Food and Drug Adminstration said. The product is a cardioplegic solution, which is chilled and poured into the opened chest to stop the heart while surgeons work on it. Such solutions have caused problems in the past, according to the F.D.A., which reported that it issued a warning letter in 2006 to a firm that had produced a solution that caused fatal infections in three heart-surgery patients.
The agency emphasized that the heart case was still being investigated, and that it was possible that the infection had come from a source other than the cardioplegic solution. A second heart-surgery patient who had an Aspergillus infection and was initially reported to have received a solution made by the New England Compounding Center had been treated with solution made by another company.
Another patient contracted meningitis after receiving a spinal injection of another one of the company’s steroid solutions, triamcinolone acetonide.
The statement from the F.D.A. also warned of possible contamination in drugs made by the company that are injected into the eye or used during eye surgery.
The agency is recommending to doctors that all patients exposed to any of these products from the New England Compounding Center be notified of the risks and told to be on the alert for signs of infection, even though it is not clear whether the products caused the two additional infections.
Symptoms of other infections may include fever, swelling, increasing pain, and redness and warmth at the injection site. Eye infections may cause vision problems, pain, redness in the eye or discharge from the eye. Patients infected during heart surgery may have chest pain or drainage from their incisions.
The New England Compounding Center has shut down and recalled all its products. At least five states, besides Massachusetts, have suspended the company’s license: Michigan, New Hampshire, Ohio, Maryland and Virginia.
Senator Richard Blumenthal, a Democrat from Connecticut, said on Monday that the fresh information “further underscores the need for an immediate criminal investigation.” The Massachusetts attorney general’s office has declined to comment.
A spokeswoman for the New England Compounding Center said on Monday that the company would “continue to cooperate with the F.D.A.”
The meningitis outbreak has opened a debate among legal scholars about how much authority the Food and Drug Administration has over the compounding industry.
Compounding — traditionally a practice in which pharmacies mix medicine for an individual patient — is regulated by states. But in recent decades, some pharmacies began to push the legal limits, becoming mini-drug companies largely out of reach of federal authorities. Federal officials say they do not know what share of the compounding market large-scale pharmacies represent.
“Our drug experts went into some of these operations, and they said, ‘Whoa, these don’t look like ordinary pharmacies,’ ” said Gary Dykstra, who was the F.D.A.’s deputy associate commissioner for regulatory affairs in the 1990s.
Some scholars argue that the agency had more power than it is willing to admit and simply failed to use it.
“They have adequate authority to act, full stop,” said Peter Barton Hutt, a lawyer at Covington & Burling L.L.P. in Washington, who has written extensively on compounding law. “The issue is priorities and resources. Large-scale compounding expanded because the F.D.A. was focusing on other things.”
Even when the United States Supreme Court overturned the first clear legal definition of compounding in 2002, the F.D.A. could still invoke the 1938 Food Drug and Cosmetic Act, which forbids new, unapproved drugs to be sold across state lines, Mr. Hutt argued. The act was passed after more than 100 people died from an antibiotic that was prepared using a poisonous solvent.
But others contended that the agency had been more timid in pursuing compounders since the Supreme Court decision, in part because building a case meant figuring out how to defend it in court, and anchoring an argument is difficult because there are no laws or regulations formally defining compounded medications.
“There’s no bright line in statute distinguishing what the F.D.A. can regulate,” said Daniel Carpenter, a political scientist at Harvard University who specializes in regulatory law. “The only real attempt to draw one was in 1997, and that was struck down. Now to make a case they have to confront an army of industry lawyers.”
Politics were also important. Mr. Dykstra said the industry was adept at applying political pressure, which combined with the litigation, he argued, drained the enthusiasm in F.D.A. leadership to investigate.
“All the inspection work and the amount of time the F.D.A. was putting into it started to dry up,” said Mr. Dykstra, now a professor at the University of Georgia College of Pharmacy.
According to the Center for Responsive Politics, the main trade association, the International Academy of Compounding Pharmacists has spent about $1.1 million on lobbying since 2000. It has also contributed, through a political action committee, to lawmakers’ campaigns.
Original article on The New York Times