Despite the growing concerns about the potential for the community spread of COVID-19 in the U.S., the FDA-FTC public workshop on competition in the biologics marketplace went ahead as scheduled March 9, playing to a full house with some audience members sitting in an overflow room. And all the invited speakers and people registered to speak during the open public hearing session showed up.

But a day later, things are changing at the agency. Citing the global spread of the novel coronavirus, the FDA’s Janet Woodcock said the Center for Drug Evaluation and Research (CDER) is canceling or postponing external meetings, conferences and workshops scheduled from March 10 through April. Woodcock also encouraged CDER staff to hold meetings with external stakeholders through teleconference, when possible.

Other FDA centers also are postponing meetings. In addition, the agency canceled foreign official travel and limited domestic travel to “mission-critical only,” Woodcock said.

The same day, FDA Commissioner Stephen Hahn expanded the agency’s halt of routine inspections from just China to all international facilities. “After careful consideration, the FDA is postponing most foreign inspections through April, effective immediately,” Hahn said. “Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis.”

Last month, the agency postponed or found workarounds for routine surveillance inspections in China and postponed the for-cause inspections scheduled for the month after reviewing all available information on a case-by-case basis. At the time, Hahn anticipated having to postpone routine inspections scheduled in China this month.

In a normal year, the FDA conducts about 500 inspections of drug, medical device and food manufacturers in China alone. According to testimony Woodcock presented to the House Energy and Commerce Subcommittee on Oversight in December, CDER conducted 966 foreign drug inspections in fiscal 2019.

The FDA’s travel ban and decision to temporarily halt most overseas inspections stem from the U.S. State Department’s Level 4 travel advisories that prohibit foreign travel for U.S. government employees, CDC travel recommendations and access restrictions some countries are imposing on foreign visitors.

“Another critical factor in taking this [inspection] action is the confidence we have in our ability to maintain oversight over international manufacturers and imported products using alternative tools and methods,” Hahn said.

The alternatives include denying entry of unsafe products into the U.S., physical examinations or product sampling at the country’s borders, reviewing a manufacturing facility’s previous compliance history, using information sharing with other regulators as part of mutual recognition and confidentiality agreements, and requesting records "in advance of or in lieu of" on-site drug inspections.

Greater impact

“We are aware of how this action may impact other FDA responsibilities, including product application reviews,” Hahn said. “We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government.” He added that the FDA will resume foreign inspections as soon as feasible.

As for CDER, Woodcock recognized that the interruption in travel will temporarily alter how the center does business. “We need to maintain continuity of operations and accomplish as much of our work as possible,” she said in a memo to her staff.

The FDA’s drug and device centers have several meetings on the calendar through April. Announcements for events scheduled this week indicate they have been indefinitely postponed “due to extenuating circumstances”:

  • March 10 – public meeting on patient-focused drug development for stimulant use disorder;
  • March 11 – Nonprescription Drugs Advisory Committee meeting to review the current use of over-the-counter antiseptics in the food handler setting;
  • March 12 – annual U.S.-Japan Cellular and Gene Therapy Conference.

However, announcements for events set for later this month and in April have yet to indicate a change in scheduling. These include:

  • March 23 – CDER workshop on identifying concepts and terminology for multicomponent biomarkers;
  • March 30 – public meeting on patient-focused drug development for vitiligo;
  • March 31 – public workshop on the use of patient preference information in medical device regulatory decisions;
  • April 1 – public meeting on the FDA’s communications about medical device safety;
  • April 2-3 – Blood Products Advisory Committee meeting on strategies to reduce the risk of Zika virus transmission by blood and blood components;
  • April 3 – Health Canada and FDA Joint Public Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use;
  • April 7 – MDUFA meeting;
  • April 13-15 – public workshop on good simulation practices in health technologies;
  • April 15-16 – Generic Drugs Forum;
  • April 20 – 12th annual FDA Sentinel Public Workshop;
  • April 21 – Pulmonary-Allergy Drugs Advisory Committee meeting on Glaxosmithkline plc’s NDA for COPD drug Trelegy Ellipta (fluticasone furoate, umeclidinium and vilanterol inhalation powder);
  • April 23 – Medical Imaging Drugs Advisory Committee meeting on Avid Radiopharmaceuticals’ NDA for flortaucipir F18 intravenous injection, a radioactive diagnostic agent developed to estimate the density and distribution of aggregated tau neurofibrillary tangles of Alzheimer’s disease (Avid is a subsidiary of Eli Lilly and Co.);
  • April 23-24 – Orthopaedic and Rehabilitation Devices Panel meeting on the classification of facet screws systems and three currently unclassified pre-amendment devices;
  • April 23-24 – 13th annual FDA/Advamed Medical Devices and Diagnostics Statistical Issues Conference;
  • April 29 – Pediatric Advisory Committee meeting.

Other government actions

In other coronavirus-related news, the U.S. Trade Representative dropped the tariffs on certain medical products to ensure a sufficient supply of items such as gloves, thermometers and medical caps that are necessary for the U.S. to prepare for a broader outbreak.

Meanwhile, the Biomedical Advanced Research and Development Authority (BARDA) is contributing nearly $700,000 to accelerate the development of Hologic Inc.’s COVID-19 molecular diagnostic. The test is designed to be used with Hologic’s Panther Fusion system, which can process up to 1,000 tests in 24 hours and could make COVID-19 results available to clinicians in less than three hours.

According to BARDA, development of the test is expected to be completed in a matter of weeks. Then it would be submitted to the FDA for emergency use authorization. "While the Centers for Disease Control and Prevention and our nation's public health laboratories are making valiant efforts in testing and surveillance of coronavirus infections, these labs could become overwhelmed as the number of suspected cases grows,” BARDA Director Rick Bright said. “Rapid high-throughput tests are critical to provide quick results for more Americans and to aid the nationwide public health response."

The Hologic test is the first COVID-19 product selected for development through BARDA’s streamlined selection process, EZ-BAA, which the agency recently expanded to include diagnostics using platforms already cleared by the FDA.

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