Health Subcommittee Continues Examination of Drug Compounding

July 16, 2013

WASHINGTON, DC – The Subcommittee on Health, chaired by Rep. Joe Pitts (R-PA), today examined various legislative options for reforming the regulation of drug compounding and clarifying the authority of state and federal regulators. The subcommittee previously examined drug compounding on May 23, and the ongoing effort builds on the Oversight and Investigations Subcommittee’s investigation into the 2012 deadly fungal meningitis outbreak stemming from tainted steroid injections produced by the New England Compounding Center (NECC). Among the legislative proposals discussed at the hearing was a discussion draft by Rep. Morgan Griffith (R-VA) that would clarify the Food and Drug Administration’s (FDA) authority while protecting the role of traditional compounders. Members heard testimony from a number of witnesses including Dr. Janet Woodcock, Director for Drug Evaluation and Research at FDA.

“Shortly after the contamination came to light, the committee began an investigation into the matter, requesting documents from the Food and Drug Administration and the Massachusetts Department of Public Health examining whether the outbreak could have been prevented and reviewing existing federal and state regulatory authority over compounding pharmacies acting as manufacturers,” said Pitts. “Both this subcommittee and the Oversight and Investigations Subcommittee have held multiple hearings on the issues surrounding compounded drugs…The Griffith draft includes targeted provisions that both clarify FDA’s authority as it relates to Section 503 of the Food, Drug and Cosmetics Act while ensuring that traditional compounding remains within the purview of state boards of pharmacy.”

Speaking on behalf of the National Community Pharmacists Association and 23,000 independent pharmacies, B. Douglas Hoey noted that traditional compounding pharmacies play an important role in our nation’s health. “When manufactured drugs aren’t an option, independent community pharmacists prepare customized medications for patients in accordance with a prescriber’s prescription based on the patient’s individual needs,” said Hoey.

David Gaugh, Senior Vice President for Sciences and Regulatory Affairs with the Generic Pharmaceutical Association discussed the importance of ensuring that compounding drug facilities are treated with the same scrutiny for safety as manufacturing facilities. “As such, all large-scale manufacturers of sterile injectable medicines should be required to prove that they can manufacture these medicines consistently and safely by submitting documentation to the FDA and submitting to both preapproval and routine risk-based cGMP inspections,” said Gaugh.

Full Committee Chairman Rep. Fred Upton (R-MI) added, “We also want to ensure that bad actors can no longer use the good name of pharmacies to hide activity that is essentially large-scale drug manufacturing. The FDA gold standard for approval should give patients the assurance that the drugs they use are safe and effective. Activities akin to large-scale manufacturing must be regulated as such in order to uphold the integrity of our nation’s drug supply.”

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