The International Academy of Compounding Pharmacists told the Senate health committee last week that expanding FDA's authority to a new regulatory category would be “premature” and that an agency proposal to determine which facilities would fall into this new area should be employed to draw a line between compounding and manufacturing. FDA has privately floated to lawmakers a three-prong test involving whether the product is a sterile preparation, shipped interstate and compounded prior to a prescription, according to a letter IACP sent to the committee and obtained by Inside Health Policy.
IACP says it “strongly opposes” using undefined terms such as traditional and non-traditional compounding, reflecting on a proposal FDA publicly outlined to lawmakers last year during congressional hearings. FDA has since developed a test determining which facilities would fall into such a category, but IACP said such a test would be better employed to draw a line between manufacturing and compounding, while also suggesting improvements to the test itself.
Even as FDA ramps up enforcement by targeting sterile compounders, the agency continues its push for more legal clarity and potentially fees to help fund the additional oversight. Further, two firms last week recalled all of the sterile products.
The agency's proposed test, IACP explains, involves three steps: whether the product is a sterile preparation, shipped across state lines and prepared in advance of receiving individual patient prescriptions. If a facility produces products falling under all three, it would be within the new regulatory category, the group says, characterizing FDA's proposal but noting that it has not been formally outlined.
“Rather than create a new category of 'drug compounding' oversight, as the proposal appears to do, IACP believes whatever 'tests' are used, if any, should instead be used to address the FDA's uncertainty over what constitutes manufacturing,” according to IACP's letter, dated Wednesday (March 20). “Since FDA is already empowered by Congress to govern the manufacture of drugs, FDA has the existing authority to apply drug manufacturing regulations as they see fit within the law.
“The Academy believes that giving expanded FDA authority in a totally new area is premature, especially when the Agency still has not fully explained why it failed to follow-up with its own warning letters and inspections of New England Compounding Center,” the group says, referencing the facility at the center of a deadly meningitis outbreak that spurred congressional action. This approach would give clarity to FDA and pharmacists without expanding FDA's authority over a state-regulated practice, IACP says.
The group goes on to raise issues with the three-prong test itself. Overall, the test should include a requirement that the agency coordinate its actions and communications with state boards of pharmacy, the compounding pharmacist group says. IACP expresses concern that the focus on sterile preparations could later expand to non-sterile compounded drugs. Further, interstate shipping is not a relevant indicator that a facility is manufacturing, the group says. Instead, IACP opts to leave state boards of pharmacy to make the determination that a pharmacy has crossed the line into manufacturing.
“If after inspection, hearings, and appropriate due process as provided for within individual state laws, the state Board is in the best possible position to decide whether a pharmacy is engaged in manufacturing -- regardless of whether that pharmacy is shipping medications in inter-or intra-state commerce.”
IACP also seeks to protect anticipatory compounding and office-use dispensing, saying the third prong of FDA's proposed test could eliminate these practices, which are encoded in many state laws, the group says.
“The mere act of preparing a compounded medication prior to the receipt of a valid prescription or medical order issued by an authorized prescriber incorrectly places the focus on the preparation, rather than on the dispensing, shipment or distribution of a compounded medication,” IACP says. “The true test should be whether or not a pharmacy has distributed a prescription medication in the absence of such a prescriber directive as defined within sate law.”
IACP also notes that its comments to the committee are not in support or opposition to FDA's proposal, but if a more formal policy is outlined, the group would officially comment. The group's feedback, however, unveils more insight on the key stakeholder's stance on federal issues. The compounding pharmacist group has outlined a proposal to beef up state laws to make compounding oversight more consistent, but efforts on the federal level have come in the form of collaboration with key congressional committees.
IACP is not the only stakeholder to take issue with FDA's proposal to create a new regulatory category and use of the term “non-traditional compounding.” Public Citizen, for example, has said FDA's proposal would create a “legal gray zone” and the agency could instead use its current authorities to pursue manufacturers disguised as compounders. The National Association of Boards of Pharmacy has pushed creating a new category of manufacturing, rather than compounding, but other groups have said such a plan could lower the bar for FDA's drug approvals. Further, Professional Compounding Centers of America, a supplier whose clients are among IACP's membership, says FDA is not at fault for the lax oversight that led to the outbreak and compounding oversight solely rests with state boards of pharmacy.
FDA Commissioner Margaret Hamburg said Friday (March 22) that the agency has inspected more than 30 facilities over the past two months. Still, inspectors were delayed or denied full access to records during some of the inspections, she said in re-issuing a call for legislation on the agency's blog.
“I firmly believe that new legislation is necessary to help FDA effectively oversee firms engaged in widespread distribution of sterile compounded drug products in advance of or without receiving a prescription,” she says in the agency's blog. “To that end, FDA is working with Congress, states, industry, and all interested stakeholders to develop a basic framework to protect public health. The Senate committee with jurisdiction over this issue has been working hard on a bipartisan basis to craft such a framework, and we are hopeful that their efforts will yield strong legislation for patients across the nation.”
She further calls for legislation “that establishes appropriate, minimum federal standards for firms that compound sterile drug products in advance of or without a prescription and ship them interstate,” she says, echoing the three prongs discussed by IACP and the committee. A funding mechanism -- through registration fees or other fees -- would be necessary to support the new oversight activities, she said.
In its submission to the committee, IACP touches on FDA's inspection authority. When pharmacies cite exemptions from federal oversight, the agency could use other legal recourse to obtain records, the group says. “IACP has seen no evidence that the FDA has been unable to obtain access to the records they seek under the existing process,” according to the letter. “The Agency has provided no data on the number of pharmacies it has inspected, the number of pharmacies which did or did not claim the exemption, the number of court orders, warrants, or subpoenas that were requested to obtain those records after an exemption was claimed, or whether any of those court requests were declined.”-- Alaina Busch (firstname.lastname@example.org)