In a contentious hearing of the House Committee on Energy and Commerce, the commissioner, Dr. Margaret Hamburg, testified that a tangle of conflicting court decisions and the lack of a clear definition of compounding in the law had limited the agency’s ability to build a case against compounding pharmacies that fail to meet basic safety standards.
“There is an enormous lack of clarity, and we should seize this opportunity to address it,” Dr. Hamburg said.
In many cases, such pharmacies are not required to give investigators access to their books, agency officials say. Federal regulators sometimes have to appeal to local courts to gain access to the pharmacies or their records, although, by law, large drug manufacturers must submit to regular inspections. Compounding pharmacies are now regulated primarily by the states.
Dr. Hamburg’s remarks signaled that the Obama administration will press for new legislation in response to the meningitis outbreak, which was caused by contaminated pain medication made by a compounding pharmacy in Massachusetts. So far, 461 people have fallen ill, and 32 of them have died.
The central question is whether the F.D.A. has enough power to crack down on large-scale compounding companies that behave more like drug manufactures than the neighborhood pharmacies that mix medicines for individual patients — the traditional purview of compounders.
Republicans on the committee said the outbreak appeared to have been preventable under existing regulations.
“After a tragedy like this, the first question we all ask is, ‘Could this have been prevented?’ ” said Representative Cliff Stearns, Republican of Florida, who is chairman of the Subcommittee on Oversight and Investigations. After reviewing documents, he said, “The answer appears to be yes.”
The agency’s critics maintain that the 1938 Food Drug and Cosmetic Act provides it with plenty of authority, but that the F.D.A. failed to use it to shut down the Massachusetts pharmacy, the New England Compounding Center.
Barry Cadden, the chief pharmacist at the company, and one of the principal owners, invoked his Fifth Amendment right to remain silent in response to every question posed to him during the hearing.
The agency has had dealings with the compounding center in the past, including an inspection in 2002 after reports of problems and a warning letter to the company in 2006. The agency argued that those steps failed to head off the meningitis outbreak in part because the company took advantage of gray areas in the law to elude oversight.
“Throughout this time, N.E.C.C. has repeatedly disputed F.D.A.’s jurisdiction over its facility,” Dr. Hamburg said in her written testimony.
Republicans on the committee repeatedly cited the 2006 warning letter and the agency’s recent criminal investigation, which involved federal agents seizing computers from the company’s offices.
“We’re just not buying it, doctor,” said Representative Michael C. Burgess, Republican of Texas. “You lack the authority to do anything, yet you send a letter like this?”
Democrats came to Dr. Hamburg’s defense.
“We need to work together to come up with a solution, but instead what I’m hearing from my Republican colleagues is they want to prosecute the Food and Drug Administration,” said Representative Henry A. Waxman, Democrat of California. “If there’s any ambiguity, it’s our job to clear it up. Why are we looking for anybody to blame other than the company?”
Representative Edward J. Markey, Democrat of Massachusetts, who has proposed legislation to close what he calls regulatory loopholes, said he believed the committee would eventually come together and pass a bill.
Dr. Hamburg proposed requiring large-scale compounders to register with the F.D.A. and report any problems with their products to the agency. She also recommended new labeling requirements that would make clear the origin and the risks of compounded drugs.
Large-scale pharmacy compounding has greatly expanded since the early 1990s, partly because hospitals are increasingly outsourcing the making of the compounded drugs that they need and also because of widespread shortages of medicines made by the big drug manufacturers.
Jess Bidgood contributed reporting from Boston.
Article source: http://www.nytimes.com/2012/11/15/health/fda-asking-for-more-control-over-drug-compounding.html?partner=rss&emc=rss