The US Food and Drug Administration (FDA) has been kept on its toes by the COVID-19 pandemic, thanks to applications for treatments, vaccine developments, manufacturers selling unauthorized products, and more. The following are just some of the updates issued in recent days.
Pharmaceutical shortages
The FDA has dispatched its Report on Drug Shortages for Calendar Year 2020 to Congress. The report includes a section detailing the agency’s response to drug shortages in specific response to COVID-19.
According to the document, the agency’s responses include instructing manufacturers to notify the FDA of permanent discontinuances and temporary interruptions in manufacturing processes. The FDA also requests pharmaceutical manufacturers to evaluate their supply chain.
Additionally, the FDA reports it has turned to a range of tools (such as expediting reviews, exercising enforcement discretion, and publishing various guidances) with the goal of increasing patient access to medications in shortages, or preventing potential shortages. The FDA also has stated it is striving to implement the drug shortage-related provisions of the Coronavirus Aid, Relief, and Economic Security Act.
Medical product supply
The FDA reports it has taken “creative and flexible” actions designed to address the availability of critical medical products, in response to COVID-19. What’s more, the agency states, non-traditional manufacturers and community responders have stepped up to assist in addressing shortages and gaps in medical supplies during the pandemic, an action that has led to the availability of millions of masks, face shields, and other medical devices.
In September, the agency funded a study (conducted by America Makes) to examine the impact of 3D printing on the nation’s pandemic response. The report profiles success stories, notable challenges, and lessons learned. The FDA is reviewing the report to take stock of gaps in the response, to improve response to future health emergencies.
Drug application milestone
Recently, the FDA hit the 1,000 mark of approved original and supplemental generic drug applications aimed at helping treat patients with COVID-19. The Center for Drug Evaluation and Research (CDER) prioritized review of generic drug applications for COVID-19 patients, including antibiotics, sedatives aimed at ventilated patients, anticoagulants, and pulmonary medicines.
According to the agency, the milestone reached in response to treating COVID-19 illustrates the FDA’s mission of improving access to treatment options.
Janssen EUA
The FDA has issued an emergency use authorization (EUA) for Janssen’s COVID-19 vaccine, for an additional batch of vaccine drug substance manufactured at the Emergent facility. To date, a total of four batches of Janssen drug substance produced at its Emergent facility have been authorized.
The FDA reports it conducted a thorough review of facility records and results of quality testing. Based on this review (and in light of the country’s current COVID-19 public health emergency), the agency came to the conclusion that the vaccine batches are suitable for use. However, the FDA is not yet prepared to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, though the FDA continues to address issues there with Janssen and Emergent BioSolutions management.
Fake and faulty products
The FDA issued a warning letter to manufacturer Pacific Center of Health/Pacific Center of Health & Acupuncture, advising the company to stop selling unapproved products with unproven COVID-19 claims. Additionally, the agency sent warning letters to 12 other firms, chiding them for selling adulterated and misbranded tests, face masks, respirators, and other products geared toward mitigation, prevention, treatment, and diagnosis of COVID-19 in humans:
- Amplicon Land
- BMHshop
- Dongguan City Xinyuan Nonwoven Co.
- Fixture Display LLC
- Irvin, Inc.
- Manhattan Stitching Company
- Mask Supply Store
- maskshell.com
- Nature’s Distributing; Club Clean Inc/BuyMedicalMasksNow.com
- Professional World Store
- World Packaging Solutions
- Zhejiang Xichen Medical Technology Co.