The House of Representatives Energy and Commerce Committee issued the subpoena to Barry Cadden, co-owner of the Massachusetts-based New England Compounding Center and its chief pharmacist before the compounding pharmacy surrendered its license in the wake of the outbreak.
"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," said Committee Chairman Fred Upton and Ranking Member Henry Waxman in a statement. "Since Mr. Cadden has indicated he will not appear voluntarily, we are left with no choice but to issue a subpoena."
James Coffey, Director of the Massachusetts Board of Registration in Pharmacy, which regulates pharmacists in Massachusetts, has also been invited to testify at a hearing scheduled for November 14.
A spokeswoman did not immediately respond to a question as to whether Coffey had agreed to attend.
Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration, is scheduled to testify.
Hamburg, Cadden and others, including officials from the U.S. Centers for Disease Control and Prevention, have also been invited to testify about the outbreak before the Senate Health, Education, Labor and Pensions Committee at a separate hearing scheduled for November 15.
Meanwhile, NECC's legal team has been busy in federal court defending the company against a mounting number of lawsuits.
NECC lawyers, for example, say NECC did nothing wrong and have been caught in a crossfire of conflicting federal and state laws concerning specialty pharmacies. In addition, NECC lawyers argue various states have themselves enacted differing and in some cases conflicting regulations on the practice of pharmacies.
"Permitted practices in some states may be arguably impermissible manufacturing by FDA and other states," NECC lawyers said Monday in documents filed in U.S. District Court in Massachusetts.
But Peter McGrath said NECC and its attorneys are just buying time to plan how to contend with looming lawsuits and investigations.
Last month, McGrath, a former federal prosecutor, filed suit in state court in Massachusetts seeking to freeze the assets of NECC and its owners, including Cadden. His attachment, filed on behalf of an unnamed New Hampshire man, seeks several million dollars.
NECC wants that case moved to U.S. District Court because of the federal questions involved over what makes a drug manufacturer.
NECC said it expects a Judicial Panel on Multidistrict Litigation to rule within the next two to four months on whether to consolidate a number of lawsuits in one court. The decision could come soon after a hearing is held January 31 in Orlando, Florida.
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Source: AP (Clarke, 11/7)
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