Clarifying the Food and Drug Administration’s current muddled authority would strengthen the regulation of compounded medications, a government watchdog agency said recently.
Thenew report from the Government Accountability Office
is an update of its 2003 study of pharmacy compounding, produced in response to a Kansas City Star series that identified safety concerns with such medications.
Sen. Pat Roberts of Kansas and then-Sen. Kit Bond of Missouri called for that initial report after The Star’s series and the federal prosecution of Robert Courtney, a former Kansas City pharmacist, for diluting chemotherapy medications.
Roberts is sponsoring a bill in the Senate that calls for greater FDA oversight of pharmacies that compound high-risk sterile medications and ship them between states.
Drug compounding is an important part of traditional pharmacy practice in which a pharmacist combines, mixes or alters ingredients to create a medication tailored to the needs of an individual patient.
For years, Roberts and others in Congress worked to improve the safety of compounded drugs but met steady resistance from industry and trade groups.
But a 2012 outbreak of fungal meningitis linked to contaminated compounded spinal injections, which sickened more than 700 people and killed 63, has given the issue fresh urgency in Washington.
The updated GAO report, commissioned by U.S. Reps. Elijah Cummings of Maryland and John Tierney of Massachusetts, confirms much of what The Star reported and what government officials and public health advocates have known for a decade.
Conflicting federal court rulings have hampered the FDA’s ability to take enforcement action against compounders, the study noted. And no agreement exists between the agency and national pharmacy organizations as to whether compounders that make large quantities of drugs and sell them without prescriptions across state lines should be regulated by the states or the FDA.
“This lack of consensus and differing FDA authority to oversee compounded drugs across the country has resulted in gaps in oversight of drug compounding,” the researchers concluded.
GAO investigators also found fault with the FDA’s internal record-keeping system. Its databases do not permit federal health officials to identify all its inspections of compounding pharmacies. Such issues were clear more than a decade ago, when The Star asked the agency to turn over all its reports of “adverse events” linked to compounded drugs, that is, instances in which someone was sickened or killed by such medications.
The FDA reported then that it could find no such reports.
State regulators, which traditionally have overseen pharmacy practice, also are working at a disadvantage. The report said that while Iowa recently began working with a national organization to inspect out-of-state pharmacies that ship compounded medications into the state, other states often do not have the resources to conduct even routine inspections.
“Instead, these states inspect pharmacies only in response to a complaint or a reported adverse drug event,” the report noted.