FDA seeks to regulate specialty drug makers after meningitis deaths

The Food and Drug Administration is seeking greater authority to regulate drug makers such as the Massachusetts company that produced steroid injections tied to a deadly outbreak of fungal meningitis, officials said Wednesday at a congressional hearing in which one of the firm’s owners invoked his constitutional rights and refused to testify.

Barry Cadden, a co-founder of the New England Compounding Center in Framingham, Mass., briefly appeared before the House Energy and Commerce oversight subcommittee hearing. In a dramatic moment during the televised proceeding, Cadden refused to discuss his company’s role in an outbreak that has killed at least 32 people.

“Under advice of counsel, I respectfully decline to answer under basis of my constitutional rights and privileges, including the 5th Amendment,” Cadden said citing his right to avoid self-incrimination.

Cadden’s move had been expected because his attorney, in a letter to the committee, noted ongoing state and federal investigations into the company prevented Cadden from testifying. Cadden “strongly desires” to speak, his attorney, Bruce A. Singal, wrote.

Congress is investigating the outbreak. There was a bipartisan sentiment that action needs to be taken to strengthen the hand of federal regulators in dealing with companies such as New England Compounding Center, whose activities are regulated by the state, even though its products are sold nationwide. It is unlikely, however, that Congress will deal with the issue in the current lame-duck session, which will focus on tax and spending issues.

“I was stunned and angered to learn that an inspection of the NECC by the FDA and the Mass Board over 10 years ago identified contamination in the very same drug at issue in the current outbreak,” Rep. Fred Upton (R-Mich.), chairman of the House Energy and Commerce Committee, said. “Ten years later, we are in the midst of an unthinkable, worst-case scenario.”

FDA head Margaret Hamburg agreed with the scale of the problem.
“This is the worst and most tragic case and should be the last,” she said of the meningitis outbreak. “It should be a wake-up call that there is a gap in regulatory oversight. We really need strong, clear and appropriate legislation. We can’t have a crazy quilt,” she said of different rules in different states.

Under current policies, a compounding, or specialty pharmacy is regulated by the state where it operates. A compounder traditionally responds to a doctor’s request and produces the needed medication. A manufacturer makes large quantities of a drug in the expectation of a need or a market and is subject to federal regulation.

Massachusetts regulators have moved to revoke New England’s license arguing that it had performed more like a manufacturer.

New legislation could help define exactly where to draw the line between the different types of pharmacies, Hamburg said in response to comments from some of the panel members.

New England Compounding was “clearly a manufacturer and not a compounder,” argued Rep. Morgan Griffith (R-Va.). “This was not a small compounding pharmacy, but a manufacturer under the law.”

“We need to clarify that with new legislation,” Hamburg said.

The company suspended operations at the beginning of October and recalled thousands of doses of the steroid, methylprednisolone acetate, after regulators found that the vials were tainted and were the cause of fungal meningitis cases in 19 states. The steroid is a painkiller, principally injected in patients’ backs and in some peripheral joints. In all, almost 450 cases have been reported, resulting in 32 deaths, according to the Centers for Disease Control and Prevention.

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