Senator Scott Brown joined 10 other senators in sending a July letter to the US Drug Enforcement Administration advocating a top legislative priority of the compounding pharmacy industry, which is under scrutiny following a deadly meningitis outbreak.
The July 24 letter did not directly relate to the injectable steroids that have been blamed for 14 deaths and at least 185 sicknesses nationwide. But it addressed an issue central to that controversy: how these lightly regulated pharmacies can deliver their drugs and who can receive them.
The firm at the center of the meningitis outbreak, the New England Compounding Center, was sending drugs in bulk to doctors, a move that Governor Deval Patrick said has misled regulators. Compounding pharmacies are supposed to mix medications for an individual patient, based on a prescription from a doctor. But some have acted like drug companies, shipping thousands of doses to clinics and doctors’ offices, a practice Massachusetts officials say may violate state regulations.
Gregory Conigliaro, a co-owner of the New England Compounding Center in Framingham, and his wife threw a fund-raising event for Brown six weeks after the letter was written, at their home in Southborough. Brown’s campaign said he has received about $10,000 from the firm’s executives and relatives, which he donated to charity this week after the outbreak, which was traced to New England Compounding Center on Oct. 4. The senator is in a tight reelection battle against Democrat Elizabeth Warren.
For years, compounding pharmacies have delivered controlled substances, in bulk, to clinics, veterinarians, and other health facilities for use there, according to two specialists in the field. But in recent years, the DEA has interpreted federal law as requiring those pharmacies to deliver the drugs to patients whose names are on the prescription, or to owners, in the case of animals. The DEA argues that it is not a change in interpretation, enforcement, or policy and that agents pursue leads about violations whenever they are known.
The industry position, echoed by Brown Friday, argues that the DEA’s interpretation creates a paramount safety concern. Industry officials say that medical professionals are in a better position to protect the drugs, which include strong opiates, from misuse or improper environmental conditions. Many must be injected by physicians and are sensitive to heat and light.
“As you know, they sometimes fall into the wrong hands,” Brown said at an event Friday in Dorchester, where he received endorsements from a coalition of police unions. “I was advocating getting it to the doctors, which I don’t think loosens regulations.”
Changing or clarifying DEA enforcement policy is also important to helping the industry avoid a legal gray area that could jeopardize its business, said Jesse C. Vivian, professor of pharmacy practice at Wayne State University in Detroit and general counsel for the Michigan Pharmacists Association. Vivian and others say enforcement is now selective, meaning compounding pharmacies are at risk if DEA agents choose to crack down on them.
“What they’re really looking for is to legitimize what in fact they’re doing right now,” said Vivian, who is not involved in the industry’s lobbying effort, but believes the DEA is treating the industry unfairly.
The letter to the DEA’s top official, Michele M. Leonhart, was signed by a bipartisan group of senators. When a smaller group of senators signed a similar letter in 2011, Brown did not join them.
The July letter implores the DEA to open what is known as a rule-making process, which would allow the agency to take public input on whether it is interpreting current law correctly. “DEA’s lack of action is a source of serious concern for us, our constituents, and the regulated community,’’ wrote the senators, including Brown.
“It is difficult to argue that controlled substances are more safely maintained by family members or animal owners than they are by trained, licensed, regulated doctors who would administer those substances only to legitimate patients,” it continued.
Brown emphasized Friday that the type of drugs covered by the letter are different from the steroids involved in the meningitis outbreak, and he once again urged a full investigation of the outbreak. He said that the Food and Drug Administration, not the DEA, oversees the safety of drugs at the center of the meningitis problem.
Brown referred inquiries about who asked him to sign the DEA letter to his campaign. Friday night, an aide said: “This was a bipartisan letter circulated by Senator [John] Cornyn [Republican of Texas]. It raised legitimate public policy concerns, so Senator Brown added his name.”
Brown said there was absolutely no connection between his signing the letter and his fund-raising from industry officials. “It’s a tragedy, and for anyone to try and politicize it is just wrong,” he said. “I’ve had hundreds and hundreds of fundraisers. There’s absolutely no connection. That’s the old spaghetti-on-the-wall-trick, see what sticks.”
His campaign has said he would donate the $10,000 that came from company executives to the Meningitis Foundation of America.
The compounding pharmacy industry’s lobby, the International Academy of Compounding Pharmacists, lists the delivery issue raised in the letter as the first of three legislative priorities on its website. In June, a month before the letter was written, members of the organization descended on Capitol Hill to make their case, according to the website, seeking face-to-face visits with lawmakers. A spokesman for the organization did not respond to two calls and an e-mail requesting comment.
The DEA says it has no latitude in changing its enforcement of the Controlled Substances Act, which governs how drugs can be delivered, unless Congress acts.
“We have to enforce the law the way it’s written,” spokeswoman Barbara Carreno said.