Pharmacy Compounding Will Remain Center Stage as FDA’s Focus Intensifies on Drug Quality, Hamburg Tells FDLI

Pharmacy compounding will remain center stage as FDA’s focus on drug quality continues to intensify, FDA Commissioner Margaret Hamburg told attendees at the 2013 Food and Drug Law Institute (FDLI) Annual Conference in late April in Washington, D.C.

The FDLI annual meeting has historically provided a forum for FDA commissioners to deliver a “state of the agency” address encompassing legal, legislative and regulatory developments across the centers for drugs, biologics, devices, foods, veterinary products, and tobacco and the agency’s field operations.

It is noteworthy that this year Hamburg chose to spend nearly one-third of her presentation explaining the emphasis the agency is placing on pharmaceutical quality and its relationship to the drug shortage and pharmacy compounding problems – underscoring the prominent position this nexus of issues holds on the agency’s radar screen (see box below).

“Quality,” she emphasized, is a broad-based concept, including “the careful practices used to make products, and the integrity of the supply chain that delivers these products to their users. Quality depends on…the companies that manufacture the products, the suppliers who furnish their many components and ingredients, and the distributors who bring these products to our stores, our clinics and our homes.”

Hamburg focused on “some serious quality lapses in recent years” that have presented significant public health challenges – most notably those involving drug shortages and the compounding of “shockingly unsafe drugs.”

Although the causes for shortages can differ, she pointed out, the “predominant” cause has been problems with product quality – identified in nearly two of every three drug shortage cases.

The agency has made “considerable progress” in mitigating and preventing shortages by stepping up efforts to encourage drug and biological product manufacturers to report any circumstances that could lead to a shortage, including temporary interruptions in manufacturing or impending disruptions in supply.  The early notification requirements were further codified in Title X of the 2012 FDA Safety and Innovation Act (FDASIA), which focuses on drug shortages (IPQ “The News in Depth” October 9, 2012).

In addition to her extended discussion on “the renewed focus” that she believes “we all need on quality,” the commissioner described the major impact that FDASIA and the other two recent “landmark pieces of legislation” – the Family Smoking Prevention and Tobacco Control Act of 2009 and the Food Safety Modernization Act (FSMA) – are having on the agency (IPQ “The News in Depth” April 25, 2013).

In reporting at the FDLI meeting on developments at the Center for Drug Evaluation and Research , CDER Director Janet Woodcock echoed Hamburg in highlighting the emphasis her center is placing on the quality component of its regulatory oversight role and went into further detail on FDASIA, biosimilars, and other facets of CDER’s effort to drive forward the quality dimension of its mission (ibid.).

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See related IPQ stories:

FDASIA Implementation and a Sharpened Focus on Quality Dominating Center for Drugs’ Agenda

FDASIA Title VII Empowers FDA in Supply Chain Arena; Congress Adds Other Tools to Help on Drug Shortages and Theft

FDASIA’s Catch-All Title XI Includes Provisions on Medical Gases and Nanomaterials

FDA Inspection Blitz Reveals Weakness in Sterile Practices at Large Compounders

Letter from CDER’s Woodcock to PharMEDium Serves as Notice to Compounders and Hospitals on Need for Product/Patient Linkage

Iowa, Massachusetts, California and Virginia Intensify Compounding Pharmacy Crackdown

Mass. Closes More Compounders; Grand Jury Probes NECC; New Infection Types Reported; FDA Reaches out to States

FDA Inspection Findings of Sterile Practice Breeches at Ameridose Mirror Those at NECC

Congressional Hearings Expand Meningitis/NECC Probe; More Light Shed on Regulatory Gaps

IPQ November 2012 Special Report on the Crisis in Pharmacy Compounding and its Implications