Webinar with Valerie Jensen, Associate Director of FDA’s Drug Shortage Staff
On December 1, 2022, the Alliance for a Stronger FDA hosted a widely attended webinar on drug shortages with Valerie Jensen, the Associate Director of FDA’s Drug Shortage Staff. In her wide-ranging review of this important topic, Ms. Jensen discussed reasons for shortages, the role of the Drug Shortage staff, steps taken to respond to these shortages, and other key questions. She also responded to several audience questions. More information about FDA’s drug shortage program can be found here.
Ms. Jensen noted that drug shortages occur for many reasons, often due in part to increased demand rather than production or supply chain constraints. This led to numerous supply issues that were impacted by COVID-19. While these types of issues had not occurred previously, they are an important aspect of current increased demand for products for the treatment of respiratory illnesses.
This past year 123 shortages have been listed, a bit above normal. Some shortages are intermittent. There have been thirty-eight new shortages since 2021. These challenges are ongoing.
The Drug Shortage Staff serves as a coordinator in dealing with these issues. They work to mitigate shortages and to bring in experts to help resolve them. FDA finds it valuable to include, as appropriate, outside stakeholders, including professional organizations, patient groups, and FDA’s international counterparts.
The 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) requires that FDA be notified of shortages. FDA does a market assessment and performs a medical necessities determination. Are there alternatives that can meet the demand? FDA collaborates with the producing company and others in the market to expedite the review of ingredients or new items. They look for regulatory flexibility, and mitigation strategies to help alleviate any shortage. FDA also looks to international counterparts if the shortages cannot be fully managed domestically.
Drug shortages evolved in part over recent years because of an increase in demand. The notification of supply disruption does not require a notification of increased demand, but FDA guidance suggests that producers provide such demand information. Some shortages cannot be prevented – plants shut down; ingredient shortages occur. FDA looks for flexibility to provide expedited review in these situations. Ms. Jensen said the key is earlier notification, and monitoring data and trends.
The drug shortage staff interacts with other portions of the FDA team. She cited work with CBER on vaccines and blood products including solutions for the dilution of drugs, CDER with issues regarding tubing and other treatment application needs. Jensen referenced work with CVM, and risk management plans required by the CARES Act.
During the question and answer period, Ms. Jensen responded to several matters including:
the ending FDA’s authorities tied to the Public Health Emergency,
other potential solutions for dealing with shortages including the 2019 Report Drug Shortages: Root Causes and Potential Solutions;
coordination with other agencies, like DEA;
how to anticipate shortages;
her perspective on the sourcing of materials;
requirements for imported drugs responding to US shortages;
incentives for companies to fill gaps;
the policy for considering expedited review;
the use of the Defense Production Act to deal with shortages;
shortages of hospital drugs; and
a prequalification program for “shortage-backup facilities in specific dosage forms.
The Alliance has already started planning a series of webinars for 2023. We will again focus on FDA leadership, including the Commissioner, the Directors of FDA Centers, reforms of FDA’s food and nutrition efforts, and other FDA efforts of importance to Alliance members. We will provide information about each of these webinars in upcoming issues of Friday Update.
Editorial Note: This week’s Analysis and Commentary section was written by the Alliance’s Executive Director, Steven Grossman.