One of the things we see with the “don’t regulate us” fervor espoused by many politicians is a truly dangerous environment for consumers. An emerging area of serious danger is in barely regulated and monitored compounding pharmacies. What seems like a small percentage mistake in an improperly mixed medication can be fatal.
Checks Find Unsafe Practices at Compounding Pharmacies
by Andrew Pollack, The New York Times
April 12, 2013
After a crash inspection program, federal regulators said Thursday that they had found numerous unsafe practices at about 30 compounding pharmacies, the same type of facility responsible for the tainted drug that caused a deadly meningitis outbreak last year.
Among the problems found were unidentified black particles floating in vials of supposedly sterile medicines, rust and mold in clean rooms where such drugs are made, improper air flow, and clothing that left workers’ skin exposed.
Howard Sklamberg, director of the office of compliance for the drug division of the Food and Drug Administration, said such unsafe practices could cause contamination of drugs. He said the number of problems found at the compounding pharmacies, which were in 18 states, was higher than what is typically seen at conventional pharmaceutical manufacturers.
F.D.A. officials also said the agency had to get a warrant from federal court to inspect one of the 30 compounding pharmacies. Four other operations resisted being inspected but gave in without a court order, agency officials said.
“It may surprise some people to know that, even in light of the recent tragic events, some of the firms we inspect still challenge our authority to conduct full inspections of their facilities,” Dr. Margaret A. Hamburg, the F.D.A. commissioner, wrote in a post on the agency’s blog on Thursday.
Mr. Sklamberg said the F.D.A. was exploring actions it might take against the pharmacies if the problems were not corrected.
More than 50 people died from fungal meningitis and another 680 were sickened after receiving injections last year of a contaminated steroid made by the New England Compounding Center. Compounding pharmacies originally made specialized formulations of drugs for patients with particular needs, like a liquid form of a medicine for someone who cannot swallow a pill. But in recent years, the number of compounders has multiplied, and some have become essentially mass manufacturers, distributing huge quantities of medicines all over the country.
A House subcommittee will hold a hearing on Tuesday at which Dr. Hamburg is expected to be questioned as to whether the F.D.A. could have prevented the meningitis outbreak by better policing the compounding pharmacies.
The agency maintains that it has limited legal authority to oversee compounders, which are regulated by state boards of pharmacy even though many ship drugs across state lines.
“Because they don’t register with us, we don’t know who they are, we don’t have a list of what products they produce,” Mr. Sklamberg said in an interview Thursday.
The F.D.A.’s disclosure of the inspection reports and of the resistance its inspectors faced could bolster its case for legislation, already under development in the Senate, to give it more authority over compounding pharmacies.
It could also backfire. Some Republicans who have expressed skepticism about the need for legislation are likely to point to the recent inspections as evidence that the F.D.A. already has the authority it needs, and that it could have done similar inspections in the past.
The F.D.A. had inspected specific compounding pharmacies only when a problem was reported or suspected. Mr. Sklamberg said that regularly inspecting compounding pharmacies in the past would have strained the agency’s resources, given the extra effort required.
Some compounding pharmacies might brush off the F.D.A. findings as being part of a push to win legislation.
“It behooves them to make sure they find observations or violations or deficiencies,” said Scott A. Livingston, a lawyer representing Olympia Compounding Pharmacy in Orlando, Fla., for which the F.D.A. said it required a warrant.
Mr. Livingston said the pharmacy allowed the inspection and access to documents. He said the warrant was required only because the pharmacy, concerned about patient privacy, did not want to provide the F.D.A. with copies of those documents to take with them.
Perhaps seeking to take some heat off the F.D.A., four Democrats on the House Energy and Commerce Committee on Thursday said the head of the compounding industry’s trade group, the International Academy of Compounding Pharmacists, should also testify at Tuesday’s hearing.
The Democrats said the trade group’s internal memos showed that it lobbied aggressively for almost two decades to restrict F.D.A. oversight.
But Representative Tim Murphy, a Pennsylvania Republican and the chairman of the Subcommittee on Oversight and Investigations, seemed inclined to keep the focus of the hearing on the F.D.A.