FDA Issues Report on Drug Shortages, Including Impact of MfgBy
The US Food and Drug Administration (FDA) has issued its annual report on drug shortages by outlining the extent of drug shortages in calendar year 2020 and the steps the agency has taken to mitigate shortages, including those relating to the COVID-19 pandemic.
For calendar year 2020, the FDA’s Center for Biologics Evaluation and Research (CBER) and FDA’s Center for Drug Evaluation and Research (CDER) worked with manufacturers to successfully prevent 199 drug shortages, according to the report. In addition, the number of new shortages tracked by CBER and CDER in calendar year 2020 was 43, compared to a peak of 251 new shortages during calendar year 2011. In addition, as of the end of calendar year 2020, there were 86 ongoing CBER- and CDER-tracked shortages, referring to the number of ongoing shortages yet to be resolved from previous years.
Although there has been a leveling off in new shortages over the past few years, in its report, the FDA says that calendar year 2020 still was a challenging year for drug shortages. The agency says it continues to see the residual effects from the closing of two manufacturing facilities in 2017 and 2018 by major drug manufacturers for remediation purposes, which resulted in the loss of manufacturing capacity needed for the supplies of numerous drugs. In addition, the COVID-19 pandemic affected the pharmaceutical supply chain in calendar year 2020, such as through the increase in demand for many drug products.
Impact of COVID-19 on drug shortages
In its report, the FDA outlined new challenges arising from the pandemic that impacted the supply of drugs in 2020, including transportation issues, employee absenteeism due to outbreaks of COVID-19 at manufacturing plants, and high demand for certain drugs needed for hospitalized patients with COVID-19.
To respond to this risk, the Drug Shortage Staff of CDER asked manufacturers to evaluate their entire supply chain, including key starting materials, active pharmaceutical ingredients, packaging components, and finished dosage forms. Manufacturers are required to notify FDA of certain permanent discontinuances and interruptions in manufacturing, but in response to the COVID-19 pandemic, during calendar-year 2020, the FDA also requested, on a voluntary basis, additional information, including inventory levels, production plans, and distribution quantities to better understand drug supply chains.
The FDA report outlines further actions taken by the agency in calendar year 2020 in product and manufacturing reviews to mitigate drug shortages due to COVID-19. These actions are outlined below.
Additional FDA action: product reviews
In its report, the FDA says that in calendar year 2020, CDER expedited reviews for more than 100 original abbreviated new drug applications (ANDAs) for drugs for the treatment of patients with COVID-19 and more than 150 ANDA supplements under COVID-19 prioritization programs. During calendar year 2020, FDA approved 48 original ANDAs and 94 supplemental ANDAs for drug products frequently used in hospital intensive-care units for treatment of COVID-19. In addition, CDER exercised regulatory flexibility and discretion in 45 instances to increase supplies of heparin, albuterol, etomidate, midazolam, propofol, and other needed medications.
CDER’s Drug Shortage Staff is currently focusing its shortage efforts on the drugs used in hospital intensive-care units for patients on ventilators, including sedatives, opioid analgesics, neuromuscular blocking agents, vasopressors, anticoagulants, dialysis agents, antibiotics, beta-2 agonist inhalers, and intravenous fluids.
Additional FDA action: manufacturing
In its report, the FDA says that in calendar year 2020, CDER expedited assessments of manufacturing supplements to facilitate the manufacturing capacity for COVID-19 therapeutic biologics. CDER also issued in March 2020 a guidance for industry, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, requesting that manufacturers not only report permanent discontinuances and interruptions in manufacturing, but also report disruptions due to increased demand.
The FDA says it is working with manufacturers to increase supplies to meet current demand by expediting its review of applications and utilizing regulatory flexibility and discretion for additional supplies, including, in rare instances when all alternatives are exhausted, imports from FDA-registered sources approved in other countries.
The FDA is also working to implement the drug shortage-related provisions of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which was signed into law in March 2020, to aid response efforts and ease the economic impact of COVID-19. The CARES Act provided additional authorities to the FDA to enhances its ability to identify, prevent, and mitigate possible drug shortages by, among other things, enhancing FDA’s visibility into drug supply chains.
The FDA’s full report on drug shortages for calendar year 2020 can be found here.
Source: US Food and Drug Administration