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Food and Drug Administration and Compliance Issues
Thursday, May 23, 2013
In Wake of Meningitis Investigation Findings, Health Panel Reviews Safety and Importance of Compounded Drugs
WASHINGTON, DC â€“ The Subcommittee on Health, chaired by Rep. Joe Pitts (R-PA), today examined the current state of drug compounding in the United States. The hearing was a continuation of the committee's investigation of the fungal meningitis outbreak, and whether the Food and Drug Administration (FDA) could have prevented the outbreak, which resulted from contaminated injections made by the New England Compounding Center (NECC). The committee's investigation has revealed that the FDA was aware that the NECC was engaged in manufacturing and not traditional compounding, and the agency failed to act on many of the numerous warning signs and complaints it received. Members today discussed the importance of traditional compounding and what steps need to be taken to ensure patients have access to safe drugs.
"During her testimony at the November hearing, FDA Commissioner Dr. Margaret Hamburg repeatedly expressed uncertainty about FDA's authority over compounding pharmacies, partially due to conflicting opinions on the matter issued by two different Circuit Courts of Appeals in 2009. This uncertainty, however, has not stopped FDA from engaging in multiple enforcement activities against compounding pharmacies engaged in practices similar to those of NECC's since the outbreak took place," said Chairman Joe Pitts. "In addition, the FDA in October 2012 was prepared to issue new guidance related to compounding enforcement under its authority under Section 503.Â Since the outbreak, however, the FDA has called for new authority that creates a new category of compounding manufacturers."
American Enterprise Institute Resident Fellow Dr. Scott Gottlieb explained, "FDA has authority to target compounders that cross the line between the practice of pharmacy and engage in drug manufacturing under the guise of a pharmacy license. â€¦If FDA doesn't exercise its authority evenly, which means not allowing firms to compound identical versions of FDA approved products, then FDA will give incentive for drug makers to re-mask themselves as "non traditional compounders' to skirt the new drug requirements."
Director of the FDA's Center for Drug Evaluation and Research Dr. Janet Woodcockadmitted, "We investigated outbreaks, we investigated reports, and we did respond reactively to problems, but we did not proactively do everything we could."Â
Not only did the FDA choose not to act, the committee's investigation also revealed that the agency failed to share complaints with state regulators so they could take action against the companies.
Joseph H. Harmison, owner of Harmison Pharmacies, testifying on behalf of the National Community Pharmacist Association, expressed concern with the FDA's failure to share this vital information. Harmison stated, "The FDA should share all inspection data in a timely fashion with state Boards of Pharmacy. Furthermore, FDA should communicate to state Boards of Pharmacy whether the response from the entity inspected addresses all concerns and is sufficient without necessary further action or whether further action is needed to address these concerns." Harmison concluded, "before expanding federal authority it is imperative that Congress look at whether current laws and regulations are being properly enforced."