WASHINGTON – The Senate appears ready to move on a bill that aims to provide greater oversight to large-scale compounders like the one at the center of last fall’s fungal meningitis outbreak.
Lawmakers received feedback Thursday on how they can fine-tune a draft bill that creates a new class of compounding pharmacies for those who act more like manufacturers. Stakeholders – including the FDA, a public-policy think tank, and pharmacy groups – were generally supportive of the draft senators released late last month.
“Just from the general tone of what I hear, I think we’re very, very close to having what we need,” Sen. Tom Harkin (D-Iowa), chair of the Senate Health, Education, Labor, and Pensions Committee, said at a hearing on the issue.
Harkin said in his opening statement he hopes to have a bill ready to be considered by the committee before Memorial Day, which is 2 weeks away.
The draft legislation would place under the FDA’s authority compounders who produce sterile drugs without a prescription and ship those drugs across state lines.
The New England Compounding Center (NECC) in Framingham, Mass., would have fit such a definition. Last fall, the now-infamous company shipped batches of tainted methylprednisolone acetate which later killed 55 people and sickened nearly 750. Inspections after the facility closed showed numerous instances of bacterial presence and mold growing in rooms meant to produce sterile products.
Currently, states have oversight of all pharmacies – traditional and compounding alike – but the FDA said it needs greater legal power to police those who act more like manufacturers – such as NECC – and produce drugs for batch shipping.
The draft bill would require reporting of adverse events of compounded drugs, provide clear authority for the FDA to inspect compounders, and require that compounded drugs be clearly labeled as such.
“If, in fact, action is not taken, this will happen again,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “It’s not a matter of whether. It’s a matter of when.”
Woodcock called for more access to records from all firms engaged in compounding so the agency can investigate if companies posing as traditional pharmacies are actually skirting FDA oversight.
Carmen Catizone, RPh, DPh, executive director of the National Association of Boards of Pharmacy in Mount Prospect, Ill., said allowing the FDA access to records that are regulated by states could create confusion between what’s FDA territory and what is state jurisdiction.
“We ask the committee to keep this provision intact and to help recognize and differentiate in compounding and manufacturing, and state authority and federal authority,” Catizone said.
He also said FDA needs to be given power to regulate compounders who don’t ship products out of their state – an authority left to states in the Senate draft. Compounders that only ship within state lines and hospital pharmacies would be exempt from FDA oversight.
“We believe the same risk exists with intra-state compounding as inter-state,” Catizone said, adding compounders who keep products within state lines are sometimes as large or larger than those who ship across state lines.
David Miller, RPh, chief executive of the International Academy of Compounding Pharmacy in Missouri City, Texas, said hospital pharmacies should not be exempt from FDA oversight. He pointed to Johns Hopkins Health System in Baltimore, Md., with clinics all over the mid-Atlantic as an example.
“If we are to stop what happened at NECC where a business shipped medications inter-state without prescriptions and not following state law, whether that was a hospital pharmacy transferring it from their Baltimore campus to a clinic in Richmond, Va., we believe that action is the same as you have defined for a compounding manufacturer,” Miller said.
Congress in the past has tried to tackle compounding pharmacies, but legislation has been killed or watered down in the past.
“Unfortunately, the same folks who acted to prohibit our efforts to address the compounding issue in 2002, 2007 are back at it again,” Sen. Pat Roberts (R-Kan.) said. “I want everyone to know … our legislation does not prohibit access to life-saving medication or therapies for patients.”
For example, the draft doesn’t ban compounding of any drug, but does allow the FDA to maintain a list of drugs that shouldn’t be compounded for safety reasons, Roberts said. Also, the draft would allow the compounding of all drugs on the FDA’s drug shortage list.
Lawmakers in the House have said during multiple hearings since last fall’s outbreak that the FDA had all the authority it needed to prevent the NECC’s actions. However, lawmakers there still plan to tackle legislation. Lawmakers in the House haven’t set such a deadline for a bill and haven’t released draft legislation like the Senate has.