U.S. senators considering fundamental changes to how the practice of pharmacy compounding is regulated heard almost unanimous support for reform at a Washington committee hearing Thursday.
And a top federal drug official, who has studied a fungal meningitis outbreak that has killed 55 people and sickened about 700 since the fall, said a draft bill co-written by Sen. Pat Roberts of Kansas could not only improve drug safety but save lives as well.
“If, in fact, action is not taken, this will happen again,” said Janet Woodcock, director of the Center for Drug Evaluation and Research for the Food and Drug Administration. “It’s not a question of whether. It’s a question of when.”
The law, if enacted, would be the first piece of federal legislation to require stricter regulation of compounding since Kansas City pharmacist Robert Courtney pleaded guilty a decade ago, admitting that he had diluted thousands of doses of chemotherapy medications.
Compounding is a traditional part of pharmacy practice in which pharmacists create customized medications from scratch, but without having to meet the same safety and quality standards that large drug manufacturers must follow.
The Kansas City Star first exposed concerns about the safety of compounded drugs in a 2002 series. And although senators soon began studying changes to federal law, fierce opposition from the compounding industry killed those reform attempts.
That opposition softened during last fall’s meningitis outbreak, which was traced to contaminated steroid injections prepared by the New England Compounding Center in Massachusetts.
The new law would clarify that the FDA is responsible for enforcing safety and manufacturing standards for large compounders, like the one in Massachusetts, that produce sterile medications in bulk, without prescriptions, and then sell them out of state.
State pharmacy boards would continue to regulate traditional compounding in smaller settings, such as neighborhood pharmacies.
Even the leader of the International Academy of Compounding Pharmacists, which consistently has opposed greater federal authority over the industry, said that the new legislation is promising.
“We’re close,” said David G. Miller, the academy’s chief executive officer. “We’re not there yet, but we’re close.”
Miller and Roberts, a Republican, sparred over whether hospital pharmacies that transfer sterile compounded medications to their own out-of-state satellite clinics needed to be subject to federal regulation. Such pharmacies now are regulated by state boards of pharmacy.
Miller said they must in order to make the law consistent with the new proposed regulations for large compounding manufacturers.
Roberts, however, questioned whether Children’s Mercy Hospital in Kansas City should face more federal regulation just to send medications to its clinic in Kansas City, Kan.
Agreeing with Roberts, experts from the FDA, the National Association of Boards of Pharmacy, the American Society of Health-System Pharmacists and the Pew Charitable Trusts urged the committee to keep hospital pharmacies under state control.
Roberts said in a statement afterward that he was pleased with the comments.
“We wanted industry and patient feedback on the draft, and now we will take that into consideration to make this bill even better,” Roberts said.
Democratic Sen. Tom Harkin of Iowa, the committee’s chairman, said he hoped to have a final version of the bill ready by the end of the month.
“I think we’re close to what we need to do,” Harkin said.