Citing industry concerns about visitors and the health of FDA staff and those who conduct inspections for the agency under contract at the state level, the agency announced Wednesday that it is temporarily postponing all routine surveillance facility inspections in the U.S. However, for-cause domestic inspection assignments will be evaluated and will proceed if considered mission-critical, FDA Commissioner Stephen Hahn said. Last week, the agency postponed most foreign facility inspections through April.
The Institute for Clinical and Economic Review (ICER) postponed indefinitely public meetings to review treatments for sickle cell disease, previously scheduled for March 26, and for cystic fibrosis (CF), previously scheduled for April 30. ICER said it is extending the public comment period on the CF Draft Evidence Report to March 25 and plans to publish the revised report on or about April 23. The institute also said that, after it publishes the draft evidence reports for nonalcoholic steatohepatitis on March 19 and for ulcerative colitis on April 15, additional deadlines and opportunities for public input will be pushed back approximately two to three months. ICER’s assessment of supervised injection facilities, already expected to last two months longer than a typical review, remains unchanged. Other ICER reviews, including those for bladder cancer, digital apps for opioid use disorder and hemophilia A, have been paused and are expected to resume in two to three months.
The FDA approved safety labeling changes to sodium glucose co-transporter-2 (SGLT2) inhibitors used to treat type 2 diabetes. To avoid increased risk of ketoacidosis in patients, the agency recommended temporary discontinuation at least three days prior to scheduled surgery for canagliflozin (Invokana, Janssen Pharmaceutical Co.), dapagliflozin (Farxiga, Astrazeneca plc) and empagliflozin (Jardiance, Boehringer Ingelheim GmbH/Eli Lilly and Co.) and at least four days prior to scheduled surgery for ertugliflozin (Steglatro, Merck & Co. Inc.). Clinicians were advised to monitor blood glucose levels carefully after halting the SGLT2 inhibitors and to manage patients appropriately before surgery. The FDA said any of the medications may be restarted once a patient’s oral intake returns to baseline and other risk factors for ketoacidosis are resolved.