This Week at FDA: Restructuring at inspections office, new guidances and staff, and more

Regulatory NewsRegulatory News | 03 February 2023 |  By 

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, the agency announced the launch of a new food program which includes restructuring its product inspections office. It also released a slew of guidances for devices and drugs.
After heavy criticism over the past year over its handling of the infant formula crisis, the US Food and Drug Administration (FDA) announced it is launching a new Human Foods Program and restructuring its Office of Regulatory Affairs (ORA), which conducts inspections of regulated products, sampling and reviews products entering the US. The agency has proposed a feedback loop structure for ORA that it says will help streamline inspection work across the various product centers.
During the infant formula crisis, several top lawmakers demanded the FDA assign a deputy commissioner for human foods who reports directly to the FDA commissioner and that is exactly what the agency is proposing.
This week the FDA also published several guidances covering topics such as laser products including leveling tools and laser pointers, developing drugs for early Lyme disease, and considerations for conducting externally controlled drug trials.
There are several personnel changes happening at the FDA as well. Wilson Bryan, director of the Office of Tissues and Advanced Therapies (OTAT), announced he was retiring in March after more than two decades at the job. The news comes as OTAT is going through a major overhaul and hiring a slew of new officers.
According to AgencyIQ, Celia Witten, current deputy director of the Center for Biologics Evaluation and Research (CBER), is set to take on the role of OTAT acting director after Bryan steps down.
Troy Tazbaz announced on LinkedIn that he was stepping in as the new director of the Digital Health Center of Excellence, taking on the job from acting Director Brendan O'Leary. There hasn’t been a permanent director for the center since Bakul Patel left the FDA to work for Google in May 2022.
This week the Biden administration stated it plans to end the COVID-19 public health emergency (PHE) in May, but according to experts, that may not make much of a difference since many of the regulations implemented during the pandemic are being addressed in other ways. Furthermore, issues such as free COVID-19 vaccines and treatments for the public are ending not because the PHE is coming to an end but because Congress has cut funding for them.
Drugs & Biologics
After the FDA rejected two hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) oral drugs to treat anemia, this week it announced the approval of GSK’s Jesduvroq (daprodustat). It has been approved to treat patients with anemia caused by chronic kidney disease who have been on dialysis for at least four months.
Patients now can receive Paxlovid (nirmatrelvir/ritonavir) without the need to test positive for COVID-19, according to the FDA. The agency reissued an authorization letter stating patients 12 and older now only need a physician’s diagnosis of mild-to-moderate COVID-19 to qualify receiving the drug.
Sen. Tina Smith, D-MN, and Rep. Cori Bush, D-MO, re-introduced a bill to ensure continued access to medication abortion in states where it is still legal. According to the co-sponsors, the Protecting Access to Medication Abortion Act (PMAA) is meant to protect current FDA guidelines that allow prescription of medication abortion via telehealth and certified pharmacies.
In a related action, four senators – Sen. Mazie Hirona, D-HI; Sen. Margret Wood Hassan, D-NH; Sen. Elizabeth Warren, D-MA; and Sen. Richard Blumenthal, D-CT – have written to Danco Laboratories, urging them to file a supplemental New Drug Application (sNDA) to add miscarriage management to the label for mifepristone, in order to ensure access to drug in states that have restricted or banned medication abortion. Mifepristone is used off-label with misoprostol to manage early miscarriage.
The troubles for Philips continues to pile on as the company this week announced it plans to cut 6,000 more jobs by 2025 to reduce costs after significant losses last year. The company will cut 3,000 jobs this year alone and said that changes to its operations will make it more agile and competitive while reducing costs.
Philips’ woes are due in part to the forced recall of 2 million ventilators and other breathing devices due to concerns that parts of the devices were breaking apart and obstructing patient airways. The company received a stern rebuke from the FDA for what regulators say are inadequate responses to alert physicians and patients about the risk of the products.
Philips says it plans to create a team of internal subject-matter experts to address the safety issues and will engage outside quality system experts to better conform to FDA requirements.
The FDA announced this week that Medtronic is recalling more than 22,000 hemodialysis catheters due to a defect that could result in leakages and the mixing of arterial and venous blood, increasing recirculation or causing blood clots. The agency said the flaw could cause serious adverse health outcomes, including bleeding or the need for surgical removal and replacement of the affected catheter.


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