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IPQ Monthly Update — April, 2013

May 6th, 2013

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The annual conference of the Food and Drug Law Institute (FDLI), held in downtown Washington in mid-April, again provided an important venue for FDA to deliver a “state of the agency” address on the key legal, legislative and regulatory developments during the previous year and what to expect in the year to come.  The Monthly Update for April includes companion stories focusing on the insights that Commissioner Margaret Hamburg and CDER Director Janet Woodcock provided into the heightened priority that drug quality issues are being given in the overall agency agenda.

While the center director has been a vocal advocate for the importance of the quality piece of the regulatory pie recently, the preoccupation of the commissioner with drug quality at the FDLI meeting is particularly noteworthy.

Hamburg highlighted the nexus of concerns around pharmacy compounding, drug shortages and quality and how the agency is responding to them.  The story goes on to provide a further update on pharmacy compounding developments including: ● Hamburg’s discussion of FDA’s legislative needs at a mid-April Congressional hearing on pharmacy compounding ● a recent survey by the Office of Inspector General (OIG) of hospital use of sterile compounded products ● recent large recalls by three compounders and the associated FDA inspection findings, and ● compounding issues surfacing in Canada.

Woodcock provided insight in her remarks at FDLI into the impact the FDA Safety and Innovation Act (FDASIA) is having on CDER as it tries to come to grips with understanding and implementing the act’s multifaceted provisions, including those on breakthrough therapies, biosimilars, and generic drug user fees. She also explained the course CDER has charted to help drive pharma quality improvement.

Completing the US section of the Monthly Update is the first in a series of stories IPQ is running on the regulatory challenges presented by combination products and how FDA/industry communications are evolving to better address them.

The story in this issue looks at the emphasis FDA is placing on getting the dialogue with combination product sponsors going early in development to avoid the pitfalls that are showing up later in the review process when they are much more difficult to address. The story encompasses a couple of new draft guidances the agency has issued – on syringe connection problems and on combination post-approval changes – along with advice from a key CDRH reviewer and other experts on how combination product sponsors can navigate the pre- and post-approval CMC shoals.

Shifting from FDA policy developments to quality regulatory interactions on the international stage, the April issue provides an update on the ongoing effort of ASEAN to harmonize CMC and GMP requirements within its 10 member states in accord with the advancing ICH regulatory paradigm.

The story focuses, in particular, on the latest component of that effort – a draft guidance on QbD-based process validation modeled on FDA’s PV guidance and ICH Q8-10. Developed under Singapore’s lead, the ASEAN draft is now undergoing member state review.  In the story, a key Singapore regulator explains how the PV effort fits in with ASEAN’s mission and provides an in-depth review of the drug and biotech quality regulatory processes and developments in Singapore.

The second international story explores the growing problem of multiple agency inspections of the same site and the ideas that are surfacing on where a pathway to a more efficient, effective and risk-based international approach may lie. An analysis by Boehringer Ingelheim of its experience at a key product launch facility in Germany, presented at a PIC/S meeting with industry in Europe, has helped shed light on the significant redundancy in the various agency inspections, where the differences lie and what issues need to be dealt with to better align them, as the IPQ story explains.

To view the April Monthly Update, click here.

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