Maybe Washington is going to actually to crack down on compounding pharmacies, the apparent culprits in a fungal meningitis outbreak that has killed more than two dozen people.
Continuing its investigation of the public health tragedy, U.S. House Energy and Commerce Committee leaders this week announced that the Subcommittee on Oversight and Investigations will convene a hearing on Nov. 14.
http://energycommerce.house.gov/press-release/committee-schedules-hearing-deadly-meningitis-outbreak
In its original press release, the subcommittee said it had also invited James Coffey, Director of the Massachusetts Board of Registration in Pharmacy, and Barry Cadden, Director of Pharmacy and owner of the New England Compounding Center (NECC), to appear at the hearing. That is the facility that was the source of a tainted steroid that had caused deaths and sickened hundreds of people.
Although Cadden was invited, he apparently didn’t want to come. So on Tuesday House Energy and Commerce Committee Chairman Fred Upton, after consulting with ranking member Henry Waxman, issued a subpoena for Cadden to testify at next week’s hearing.
“Through his counsel, Cadden has declined to appear voluntarily,” the committee said in a press release.
Upton and Waxman also issued a joint statement.
“With more than 400 people infected and 30 deaths, it is critical that we hear directly from the head of the facility linked to the outbreak,” they said. “Since Mr. Cadden has indicated he will not appear voluntarily, we are left with no choice but to issue a subpoena. We urge Barry Cadden to put the public health first and answer the committee’s questions about the deadly outbreak.”
FDA Commissioner Margaret Hamburg is also scheduled to testify next week. Apparently, she didn’t have to be subpoenaed.
Upton, Waxman, Subcommittee Chairman Cliff Stearns, and Subcommittee Ranking Member Diana DeGette put out a joint statement Monday.
“Our committee has a long, bipartisan history of conducting drug safety oversight,” they said.
“Since the meningitis outbreak, we have been in close contact with the involved agencies and parties, but many unanswered questions remain. The NECC has a history of problems, some of which were documented in an FDA warning letter in 2006 – we want to know what went wrong at this facility, the views and actions of its regulators, and what steps can be taken to ensure such an outbreak never happens again.”
The FDA has virtually no authority over compounding pharmacies, a situation that several lawmakers want to remedy with new legislation,
