Two months before a Massachusetts compounding pharmacy was implicated in a nationwide meningitis outbreak, Senator Scott Brown signed a letter with 10 other senators calling for looser regulations on the distribution of certain drugs that would have opened the way to more bulk sales to doctors.
The industry has come under heavy scrutiny after a Framingham compounding pharmacy was linked to the outbreak that has killed 14 people and sickened at least 170.
On Thursday, Brown said that the letter “speaks for itself as a bipartisan effort that is completely unrelated to what happened to these people.”
In the letter, the senators urged the chief of the Drug Enforcement Administration to allow compounding pharmacies to dispense controlled substances directly to patients’ doctors, or veterinarians in the case of animals. Currently, those firms can only deliver the drugs directly to patients.
The new policy sought by the industry would not have affected the particular steroid linked to the meningitis outbreak, because those drugs are not considered controlled substances under federal regulations, according to Barbara Carreno, a DEA spokeswoman. Still, transfer and delivery of drugs produced by such pharmacies is at the core of the questions raised during the meningitis outbreak.
The New England Compounding Center was sending drugs in bulk to doctors, a move that Governor Deval Patrick said mislead regulators and operated outside of the pharmacy’s license.
The national compounding pharmacy industry argues that it would be safer to deliver controlled substances -- which include strong opiates -- directly to professionally trained physicians, veterinarians, or hospitals rather than to patients. They maintain that health professionals are better equipped to protect the drugs from misuse or improper environmental conditions.
Brown campaign spokeswoman, Alleigh Marré, said the letter was intended “to ask the DEA to formalize its rules in order to address concerns about patient safety. But it is the [Food and Drug Administration] and local authorities, not the DEA, that oversee the safety of the drugs at the center of the current meningitis scare,” Marré said. She also pointed to a measure Brown supported that allowed for stricter enforcement of drug manufacturing by the FDA.
News of the letter came as Brown addressed a separate issue involving the owners of the New England Compounding Center, the pharmacy implicated in the meningitis outbreak. In September, Gregory Conigliaro, the co-owner of the pharmacy, whose injectable steroids have been traced to the outbreak, held a fundraiser for Brown with his wife at their Southborough home, Brown’s campaign confirmed.
Brown announced on Wednesday that he would donate $10,000 he received from the owners and executives of the pharmacyto the Meningitis Foundation of America.
Marré said the campaign would not be donating all of the contributions received at the fundraiser, only those from company officials. The campaign, when asked, would not specify how much total cash it collected that night.
“Senator Brown supports a full and thorough investigation to determine responsibility for this tragedy and to ensure nothing like it ever happens again,” she said in a statement.
At a press event Thursday, Brown said said it was unfair to draw connections between him and the pharmacy. “To politicize that situation and try to say somehow there’s a connection there, it’s really just, it’s sad,” he said. “I think we’ve done the appropriate thing in donating the money.
The July 24 letter was signed by senators from both parties, well before the meningitis outbreak was publicly linked to linked to the New England Compounding Center on Oct. 4. The letter scolds DEA administrator Michele M. Leonhart for refusing to negotiate with the pharmacy industry.
“We do not understand the agency’s refusal to allow for the constructive transfer of controlled substances under appropriate circumstances,’’ the senators said in the letter. “DEA’s lack of action is a source of serious concern for us, our constituents, and the regulated community.’’
The 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 wesbite, seeking face-to-face visits with lawmakers. A spokesman for the organization did not respond to two calls and an email requesting comment.
The DEA says it has no latitude in changing its enforcement policy unless Congress acts.
“We have to enforce the law the way it’s written,” Carreno said.
Marré did not immediately say how much was raised at the fundraising event. Reuters, citing an event invitation, reported that those who gave $500 were offered a signed copy of Brown’s memoir, “Against All Odds.” Those who gave $1,000 would get a VIP private reception with the senator. For $2,500, donors would get the book, the reception, and a photo with Brown.
Federal records show Conigliaro donated $3,500 to Brown this election cycle, plus $400 just before the 2010 special election. He also donated $2,500 to Mitt Romney’s presidential campaign last year, according to records.
Records also show a $2,500 donation from Lisa Conigliaro Cadden to Brown. She is the sister of Conigliaro and the wife of Cadden and is listed on records as treasurer, secretary and vice president for the New England Compounding Center.
During an appearance on the campaign trail Thursday, Brown was asked whether he knew Lisa Cadden, who lives in Wrentham.
“It doesn’t ring a bell,” Brown said. “I know a lot of people and I’ve been to a lot of events for me.”