Tuesday, December 3, 2013

Rep seeks tough pharmacy watch

Massachusetts lawmakers must step up in the face of lax federal oversight to protect patients from contaminated drugs, which last year spawned a deadly fungal meningitis outbreak linked to a Framingham compounding pharmacy, according to a state legislator leading the charge for tougher laws.

“We went in with the understanding that we were going to be on a heavier hook than the feds,” said state Rep. Jeffrey Sanchez (D-Jamaica Plain), chairman of the Joint Committee on Public Health. “This just confirms it.”

President Obama signed a compounding pharmacy bill into law last week, but the federal legislation lacks any real oversight because it calls for large-scale compounding pharmacies to register on a voluntary basis with the FDA for inspections.

Tainted steroid injections from the now-shuttered New England Compounding Center have been blamed for the fungal meningitis outbreak that killed 64 people and infected 751 others in 20 states.
Sanchez, who soon will head into a conference committee to sort out differences between his House bill and a Senate version, said he has high hopes lawmakers will hammer out a deal to protect patients.

“When we come out with the bill I feel confident that we will be able to get at this so it doesn’t happen again. The problem with NECC was ... there was no reporting protocol,” Sanchez said. “If something happens like what happened with NECC and you get sick, you’ll be able to contact someone.”

State lawmakers also pumped more than $1 million into this year’s budget to hire more regulators for surprise inspections, 
Sanchez said.

The International Academy of Compounding Pharmacists released a statement saying the group does not believe a voluntary approach protects the public.

“IACP supports state efforts to strengthen oversight and inspection of compounding pharmacies,” the IACP said in the statement. “We also seek to ensure that states commit adequate resources to state oversight agencies, which the Massachusetts legislation does.”

Sanchez said he’s not feeling pressure from lobbyists to radically alter the legislation, which could come up for a vote in January.

“I think there is a general acceptance and understanding that change is coming relative to compounding pharmacies,” Sanchez said. “This bill was set up as one of the toughest in the country. We’ll come out with a model that can be used for the rest of the country.”


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