She might not get as much press attention as, say, former Commissioner Scott Gottlieb, or CDER director, Janet Woodcock, but to pharma managers involved with the Drug Supply Chain Security Act (DSCSA), Dr. Ilisa Bernstein as been the face of FDA for many years—all the way back to the “e-pedigree” days of the mid-2000s, and years before DSCSA itself was passed. The American Pharmacists Assn., the lead professional group for pharmacists, has announced that effective Oct. 14, Bernstein will become APhA’s SVP, pharmacy practice and government affairs. The APhA news release says that she “will be responsible for leading implementation of the association’s strategies related to professional affairs, pharmacy practice, advocacy, and government affairs.”
“Dr. Bernstein brings to APhA and the profession many years of leadership and policy development within the FDA and outstanding experience with Congress and federal agencies,” said APhA EVP and CEO Thomas Menighan.
Bernstein had a 30-year tenure at FDA, starting as a clinical pharmacology reviewer of investigational and new drug applications. Most recently, she was deputy director of FDA’s Office of Compliance in CDER, leading policies, compliance, and enforcement in areas such as drug compounding, supply chain security, drug quality, drug shortages, and post-market drug safety. Bernstein has also been director of pharmacy affairs for FDA and senior advisor for regulatory policy in the Office of the Commissioner.
DSCSA compliance, which represents a multi-billion-dollar, global investment by the pharma industry and its trading partners, is approaching a key milestone in its 10-year journey from new legislation (in 2013) to completion in 2023. Industry—mostly wholesalers and distributors—are preparing for a November deadline for having effective “saleable returns” systems in place, such that products returned from pharmacies can be re-introduced into commercial distribution. There are also looming deadlines for what has been called the “Phase 2” interoperable system, which will require engagement with pharmacies and health systems. All of this is supposed to be functioning in 2023, but a lot of it is yet to be defined.