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, we learned that FDA has filled two leadership roles at the agency, and that it will host an upcoming patient-focused drug development (PFDD) meeting focused on long COVID. It also announced the authorization of the first at-home test for COVID-19 and influenza.
On Friday, FDA announced that Jull Furman will serve as the permanent director of the Center for Drug Evaluation and Research’s (CDER) Office of Compliance after standing in as acting director following the retirement of Donald Ashley last November.
As a member of CDER’s executive team, Jill will lead her staff in carrying out numerous priorities for this year. These include strengthening the compounding program; collaborating cross-agency to improve the quality of non-application drugs, such as over-the-counter monograph and unapproved drugs; and taking measures to reduce the public health crisis posed by dangerous controlled substances, including opioids. Jill will also continue to oversee Compliance’s efforts to fully implement and operationalize the Drug Supply Chain Security Act requirements,” said CDER Director Patrizia Cavazzoni.
The agency also named Tracey Forfa to lead its Center for Veterinary Medicine. Forfa had been acting in the position since December 2022, following the retirement of Steven Solomon. “After a robust recruitment and interview process, I’m pleased to announce Tracey’s selection as Center Director,” said FDA Commissioner Robert Califf. “I know she will continue to apply the Center’s guiding principles: protecting public health; regulating based on the best evidence and science; leveraging and collaboration; operating transparently; continuous quality improvement; and strong stakeholder engagement.”
FDA on Friday announced that it has authorized the Lucira COVID-19 & Flu Test as the first over-the-counter (OTC) at-home test that can detect both the SARS-CoV-2 and influenza A and B viruses. Center for Devices and Radiological Health (CDRH) Director Jeff Shuren called the authorization “a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home.”
FDA announced that it will host a PFDD meeting on long COVID on 25 April to gather input from patients and patient representatives on how the condition impacts their lives, current treatment approaches and what symptoms are most important to manage.
Califf also penned a review of the major issues and challenges facing the agency one year after returning to its helm. Among the issues Califf discussed are user fee program implementation, developing a hybrid work environment at the agency, combating misinformation, the agency’s human foods and tobacco programs, and restructuring the Office of Regulatory affairs.
Speaking of misinformation, this week we read an article from the AP’s Matthew Perrone looking into FDA’s efforts to combat online misinformation, which has proliferated during the pandemic. Experts who spoke to Perrone questioned the impact and reach of FDA’s efforts, which have included posting short videos and memes meant to counter false information.
Drugs & biologics
FDA issued draft guidance on Friday on developing drugs to treat neovascular age-related macular degeneration. The guidance is meant to “foster greater efficiency” in developing such drugs, according to a Federal Register notice. The guidance addresses eligibility criteria, trial design considerations and efficacy endpoints.
We also learned this week that Pfizer and BioNTech have applied for full approval of their updated bivalent COVID-19 vaccine as a primary series and as a booster after receiving emergency use authorization (EUA) for the shots last year.
In other news, Amneal Pharmaceuticals was hit with a Form 483 report listing multiple good manufacturing practice (GMP) violations at the firm’s sterile drug facility in Ahmedabad, India. During a December inspection, investigators found staff not wearing protective eyewear, such as goggles, appropriately. “There were open spaces observed where the goggle straps are tightened and an open space at the bottom of the goggles such that the face of the operators could be observed,” stated the report. In addition, trolley wheels carrying sterile products had a buildup of dirt-like materials.
The agency also issued an untitled letter to Joshua Kent Miles, the owner of Lynn Oaks Compounding Pharmacy in Thousand Oaks, CA. The report found deficiencies in the firm’s practices for producing drug products, which “put patients at risk,” the agency said. Investigators found the firm produced drugs without valid prescriptions and “prepared, packed, or held” drugs under insanitary conditions. Hazardous drugs were produced without adequate containers, and the firm failed to clean work surfaces and utensils to prevent cross-contamination. The firm also used a non-pharmaceutical grade component in formulating a drug product. In addition, vermin were observed in the production areas. The firm has 30 days to fix the problem noted in the letter.
FDA on Thursday approved Sanofi’s hemophilia A treatment Altuviiio (antihemophilic factor (Recombinant), Fc-VWF-XTEN fusion protein-ehtl), the company said. Sanofi said the treatment is “the first and only hemophilia A treatment that delivers normal to near-normal factor activity levels (over 40%) for most of the week with once-weekly dosing, and significantly reduces bleeds compared to prior factor VIII prophylaxis.”
FDA’s vaccine advisors will meet over the course of two days next week to review Pfizer and GSK’s biological license applications (BLAs) for their respective respiratory syncytial virus (RSV) vaccines in adults ages 60 and older.
Moderna announced this week that its experimental personalized mRNA vaccine used in combination with Merck’s Keytruda (pembrolizumab), has been granted breakthrough therapy designation for adjuvant treatment of patients with high-risk melanoma following complete resection.
This week, Friends of Cancer Research (FOCR) published a paper that outlines a framework it said will “align patient reported outcome (ePRO) data capture across ePRO tools to assess the value of ePROs for improving patient outcomes,” which the advocacy group said will speed efforts to generate “robust” real-world data (RWD).
FDA announced two upcoming public meetings focused on the electronic submission of adverse events reports to the FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) standards. The meetings will take place virtually on 4 April 2023 and 7 November 2023.
STAT reports that major clinical research organization Charles River Laboratories was subpoenaed by the Department of Justice as part of its the agency’s investigation into monkey smuggling scheme.
In other news, FDA recommended a recall of Delsam Pharma’s Artificial Eye Ointment following reports of potential bacterial contamination, to which the manufacturer agreed. The recall follows a warning earlier this month advising consumers and health practitioner not purchase or use this artificial eye ointment, as well as EzriCare Artificial Tears due to potential bacterial contamination. Both products are manufactured by Global Pharma Healthcare.
This week the Center for Devices and Radiological Health (CDRH) updated half a dozen guidances that address x-rays, lasers and ultrasonic products. The agency told Focus that the updates were all minor and were made to be consistent with a final rule that went into effect on 21 February entitled, Radiological Health Regulations: Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser and Ultrasonic Products.
FDA is seeking organizations that are interested in helping it develop a medical device active surveillance system that uses existing electronic health data to assess the safety of medical devices. The agency is treating the “sources sought” notice as a means of market research, though FDA said it “anticipates establishing a contract for the development and execution of a medical device active surveillance system to vendor(s) with the appropriate expertise to design, develop, and run such a system.”
FDA has sent out letters to health care providers cautioning them of the potential for toxic airborne chemicals that may be released from neonatal incubators. The agency said it is still reviewing literature on the issue and is working with manufacturers to better understand the products. In the meantime, regulators said that health care providers should continue to use the products but take certain actions such as reviewing plans for proper air ventilation in neonatal settings.
CDRH announced it has updated two of its compliance programs. The first, Inspection and Field Testing of Radiation-Emitting Electronic Products, instructs FDA field and center staff on conducting inspections and field testing to ensure radiation-emitting medical devices comply with the Electronic Product Radiation Control (EPRC) provisions of the Federal Food, Drug, and Cosmetic Act. The second program, Inspection of Domestic and Foreign Manufacturers of Diagnostic X-Ray Equipment, focuses on x-ray products.
The center also updated its list of examples of medical device misconnections to note that the agency has recognized voluntary consensus standards for connector designs that are meant to enhance the safety of such devices, including the ISO 80369 series.