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Regulatory News | 16 December 2014 | By Alexander Gaffney, RAC
Almost a year after announcing the re-creation of its Pharmacy Compounding Advisory Committee (PCAC), the US Food and Drug Administration (FDA) has announced that it has selected 12 experts who will serve on the influential committee as it considers how best to regulate the pharmaceutical compounding sector.
The re-creation of the PCAC was called for under the Drug Quality and Security Act (DQSA), which sought to update the way in which FDA regulated pharmaceutical compounding following a deadly outbreak of fungal meningitis linked to compounded products.
Unlike more traditional pharmaceutical manufacturers—think Pfizer, for example—compounding pharmacies make custom versions of already-approved pharmaceuticals with the stated purpose of meeting unique patient needs. A compounding pharmacy might make a smaller dose of a drug than is commercially available, for example.
The PCAC is set to play a central role in helping FDA to more tightly regulate the pharmaceutical compounding sector.
For example, the PCAC will be advising FDA regarding a list of drugs known as the "difficult-to-compound" list, which compounders will not be allowed to make. As Regulatory Focus has previously reported, this list will potentially be a source of controversy as brand-name pharmaceutical manufacturers try to argue their products are "difficult to compound" in order to stave off compounded competition.
Read about how manufacturers are trying to add their drugs to the "difficult-to-compound" list to stave off potential competition here.
While FDA is drafting up a list of candidates for the difficult-to-compound list, it will consult with the PCAC before issuing a final difficult-to-compound list by regulation.
As announced in January 2014, the committee is set to be made up of 12 voting members selected from the National Association of Boards of Pharmacy (NABP) and the United States Pharmacopoeia (USP), and representatives of patient and public health advocacy organizations. The committee will also include non-voting representatives from the pharmaceutical industry and a voting consumer representative.
Members will serve four-year terms.
On 16 December 2014, FDA announced that it has finally chosen all members of the new PCAC.
Jurgen Venitz, MD, PhD (Chairperson)
Expertise: PharmacologyAssociate Professor, Virginia Commonwealth University
Associate Professor, Virginia Commonwealth University
Ned S. Braunstein, MD (Industry Representative)
Expertise: Molecular Immunology, Clinical RheumatologyVice President and Head of Regulatory Affairs, Regeneron Pharmaceuticals, Inc.
Expertise: Molecular Immunology, Clinical Rheumatology
Vice President and Head of Regulatory Affairs, Regeneron Pharmaceuticals, Inc.
Michael A. Carome, MD, FACP (Consumer Representative)
Expertise: Consumer AdvocacyDirector, Health Research Group, Public Citizen
Expertise: Consumer Advocacy
Director, Health Research Group, Public Citizen
Gigi S. Davidson, BSPh, DICVP
Expertise: Clinical PharmacyDirector, Clinical Pharmacy Services, North Carolina State University
Expertise: Clinical Pharmacy
Director, Clinical Pharmacy Services, North Carolina State University
Robert DeChristoforo, MS, FASHP
Expertise: PharmacyChief, Clinical Center Pharmacy Department, NIH
Chief, Clinical Center Pharmacy Department, NIH
John J. DiGiovanna, MD
Expertise: DermatologyStaff Clinician, National Cancer Institute, NIH
Staff Clinician, National Cancer Institute, NIH
Padma Gulur, MD
Expertise: AnesthesiologyProfessor, University of California
Professor, University of California
Stephen W. Hoag, PhD
Expertise: Pharmaceutical ScienceProfessor, University of Maryland
Expertise: Pharmaceutical Science
Professor, University of Maryland
William A. Humphrey, BSPharm, MBA, MS
Expertise: Clinical PharmacyDirector, Pharmacy Operations, St. Jude Children’s Research Hospital
Director, Pharmacy Operations, St. Jude Children’s Research Hospital
Elizabeth Jungman, JD
Expertise: Public Health AdvocacyDirector of Drug Safety and Innovation, The Pew Charitable Trusts
Expertise: Public Health Advocacy
Director of Drug Safety and Innovation, The Pew Charitable Trusts
William Mixon, RPh, MS, FIACP (Industry Representative)
Expertise: Pharmacy CompoundingOwner-Manager, The Compounding Pharmacy
Expertise: Pharmacy Compounding
Owner-Manager, The Compounding Pharmacy
Katherine Pham, PharmD, BCPS
Expertise: Pediatric Clinical PharmacyNeonatal Intensive Care Unit Pharmacy Specialist, Children’s National Medical Center
Expertise: Pediatric Clinical Pharmacy
Neonatal Intensive Care Unit Pharmacy Specialist, Children’s National Medical Center
Allen J. Vaida, BSc, PharmD, FASHP
Expertise: Medication SafetyExecutive Vice President, Institute for Safe Medication Practices
Expertise: Medication Safety
Executive Vice President, Institute for Safe Medication Practices
Donna Wall, PharmD
Expertise: Clinical PharmacyClinical Pharmacist, Indiana University Hospital
Clinical Pharmacist, Indiana University Hospital
Tags: PCAC, Pharmacy Compounding Advisory Committee, Difficult-to-Compound List, AdComm, Advisory Committee