WASHINGTON – State pharmacy officials on Thursday threw their support behind a proposal giving the Food and Drug Administration authority over large compounding pharmacies, in an effort to head off more outbreaks tied to contaminated medications.
The head of the National Association of Boards of Pharmacy told Senate lawmakers that his group welcomes FDA action against pharmacies like the one that triggered a deadly meningitis outbreak last year. The group’s endorsement is a key step in bringing stricter oversight to the compounding industry, which has long operated in a grey area between state and federal regulation.
“We welcome the clarifications provided by the proposed legislation to the regulatory uncertainties that currently exist and were one of the primary factors leading to the meningitis tragedy,” said the association’s director, Dr. Carmen Catizone, in testimony before the Senate’s health committee.
More than 50 people have died and over 700 others have been sickened by a wave of fungal infections linked to a large Massachusetts compounding pharmacy. Inspections last September found unsanitary conditions at the company’s facility. And regulators said the company was operating outside its state-issued pharmacy license, manufacturing tens of thousands of drug vials and shipping them without prescriptions.
Compounding pharmacies mix customized injections, creams and other medications in formulas specified by doctors. They have traditionally been overseen by the 50 state boards of pharmacy across the U.S. But those bodies have struggled to police larger compounding operations that have emerged in recent years, producing medications in bulk and shipping them across state lines.
The New England Compounding Center, the pharmacy at centre of the meningitis outbreak, shipped more than 17,600 doses of the pain injection implicated in the case.
Catizone told Senators that these large compounders are essentially manufacturers, and should be regulated by the FDA. The Senate proposal, drafted by a bipartisan group of lawmakers, calls these operations “compounding manufacturers,” and requires them to register with FDA and meet the same quality control standards as pharmaceutical giants like Pfizer Inc. and Eli Lilly & Co. Traditional compounding pharmacies, generally small operations that work with individual doctors, would continue to be regulated by state pharmacy boards.
Previous congressional efforts to regulate compounding pharmacies have been scuttled before, despite a steady string of outbreaks linked to compounded medications. Since 2001, there have been 75 reported deaths and more than 1,020 illnesses connected with compounded drugs, according to an assessment released by the Pew Charitable Trusts at the hearing.
“I think it’s unconscionable that we have failed to regulate this industry for so long and I am committed to moving forward,” said Sen. Elizabeth Warren, D-Mass.
The Senate proposal, first released in draft form last month, is seen as the most likely vehicle for federal action because it has the support of both Democrats and Republicans. The bill was drafted by Sens. Tom Harkin, D-Iowa, and Al Franken, D-Minn., and Sens. Lamar Alexander, R-Tenn., and Pat Roberts, R-Kan.
Despite broad agreement between lawmakers and regulators to move forward, disagreements remain over how much power to grant the FDA.
The FDA’s top drug regulator, Dr. Janet Woodcock, called the bill “a huge step in the right direction,” but urged lawmakers to go further. Specifically, she said that her agency needs unimpeded access to compounding pharmacies’ internal records — which have traditionally only been subject to state pharmacy inspection. Woodcock noted that FDA inspectors must sometimes obtain a search warrant from local courts before pharmacy owners will turn over their records.
“Sometimes when there’s an outbreak and we go in they’ll say, ‘No you can’t come into our pharmacy,'” Woodcock told the Senate committee. “Not having the ability to look at their records during an outbreak could really impede our ability to protect the public health.”
But Catizone, the state pharmacy board director, pushed back against this suggestion, saying the policy could interfere with state efforts to investigate or prosecute a case while “the FDA has seized evidence or information.”
Sen. Harkin, chairman of the Senate Health Education, Labor and Pensions Committee, said lawmakers will make adjustments to the bill with the goal of having a final draft before Memorial Day.