Showing frustration during a state legislative hearing Monday, Senator Mark Montigny challenged the leader of a trade group for compounding pharmacies that has lobbied to preserve state oversight of the industry, rather than accept some regulation by the US Food and Drug Administration.
Drug manufacturers are within the federal agency’s jurisdiction, but states have retained primary oversight of compounding pharmacies, including the Framingham one that produced tainted steroids blamed for sickening 620 people, including 39 who have died. Some critics of the compounding industry, which is supposed to custom-make drugs for individual patients, say states are not capable of fully monitoring what has become a complex and fast-growing field.
“It’s not a coincidence why that carve-out exists,” said Montigny, a New Bedford Democrat who is chairman of the Post Audit and Oversight committee and the only member who attended the panel’s hearing. He spent much of the four-hour session asking David Miller, chief executive of the International Academy of Compounding Pharmacists, about the hundreds of thousands of dollars it has spent lobbying Congress in the past decade.
The organization increased its spending in the years before 2007, Montigny said. That’s when the late Senator Edward M. Kennedy of Massachusetts sponsored a bill that would have given federal regulators more power, including the ability to inspect compounding pharmacies. That effort failed.
“There is no carve-out,” Miller responded, saying federal law has never given the FDA authority to interfere with the pharmacy profession.
Montigny said Miller’s organization followed “the textbook model” for lobbying to block legislation to keep it that way.
The hearing is one of several held on Beacon Hill and in Washington in the past two months, as lawmakers look for ways to tighten oversight in reaction to the national outbreak of fungal meningitis stemming from drugs produced at New England Compounding Center in Framingham.
Miller repeatedly attempted to point out similarities between what his organization and industry critics are advocating, including a clearer definition of compounding versus drug manufacturing, and possibly a separate state permitting process for pharmacies that make products that must be sterile enough to be used as injections or infusions.
While the hospitals and doctors who purchased drugs from New England Compounding also must hold some responsibility, Miller said, the behavior of the company’s leaders was inexcusable and “antithetical to the oath that each one of them took as a pharmacist.”
Miller said pharmacies that operate as manufacturers should be under federal oversight, but he said he would fight to keep the jurisdiction for the rest of the profession with the states.
“I very strongly hope you fail,” Montigny said.
Montigny, who is a veteran of health care policy debates in the state, also had strong words for Dr. Lauren Smith, who is serving as interim commissioner of the Department of Public Health, which oversees pharmacy regulation.
He said he is concerned about a change of culture at the department, influenced by the political power of the health care industry. He pointed to rules issued by the department earlier this year that he said went further than legislators intended in weakening a ban on gifts that drug and device sales representatives may give to doctors.
“Right now, the culture has been identified by scandal,” he said.
Smith said the state has conducted unannounced inspections at 22 of the 36 compounding pharmacies in the state that produce sterile products. The rest should be completed by mid-January, she said.
The state board of pharmacy repeatedly failed to act when alerted to problems at New England Compounding. Smith said the department is considering hiring an independent auditor to evaluate it and other professional boards overseen by the department, which include those that license and discipline dentists, nurses, and physician assistants.