November 29, 2018
FOR IMMEDIATE RELEASE
Bulk Pharmaceuticals Task Force
SOCMA’s BPTF Executive Director Shares Perspective on API Supply Issues,
Impact on PharmaChem Sector
FDA Workshop addresses underlying issues related to drug shortages
ARLINGTON, VA – John DiLoreto, Executive Director of the Bulk Pharmaceuticals Task Force and advisor to SOCMA’s PharmaChem Sector, delivered a fresh perspective on the pharmaceutical supply problem as a trickle-down effect of multiple factors within the fine and specialty chemical sector during a panel discussion on Manufacturing and Supply Challenges in Washington, D.C.
The workshop, Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions, was hosted Tuesday by the Duke Margolis Center for Health Policy in cooperation with the U.S. Food & Drug Administration (FDA), and provided a platform for stakeholders from the pharmaceutical supply chain to discuss the underlying issues related to drug shortages and potential mitigation of drug shortage problems.
“There can be a direct correlation between chemical supply with the supply of an active pharmaceutical ingredient (API),” DiLoreto said. “The starting point of pharmaceutical manufacturing begins with the raw materials in the specialty and fine chemical sector, which is undergoing a period of mergers and acquisitions (M&A). If a supply line is disrupted by M&A activity or by plant closures like those companies in China impacted by more stringent enforcement of environmental regulations, there is potentially one less raw material supplier to produce the API. We can also expect to see a negative impact on the supply chain over time with the imposition of tariffs on raw materials and APIs.”
Along with five other panelists, DiLoreto spoke to the need for active collaboration and transparency between public and private entities in order to prevent drug shortages. “On the regulatory side, I suggested we Identify drugs that are the highest priority whether it is based on outcomes or national security in response to potential bio terrorism,” DiLoreto said. “It also shouldn’t be out of the question for the federal government to subsidize costs and expedite regulatory reviews of manufacturers of drugs in shortage situations.”
Other key topics throughout the day focused on federal efforts to prevent drug shortages, and the economics of drug shortages on providers and patients. A recording of the event is available online.
The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of SOCMA, is an industry trade organization for manufacturers of active pharmaceutical ingredients (APIs), their intermediates and excipients.