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This Week at FDA: Pediatric use for Lilly’s COVID mAbs; Will Woodcock stay on?

Posted 03 December 2021 | By Michael MezherKari Oakes 

This Week at FDA: Pediatric use for Lilly’s COVID mAbs; Will Woodcock stay on?

Welcome to month two of our weekly digest of regulatory news from the US Food and Drug Administration (FDA) and other corners of the health care product world. This week saw the expansion of Eli Lilly’s emergency use authorization (EUA) for two of its monoclonal antibodies (mAbs) to treat COVID-19 in pediatric patients and the narrow backing of Merck’s oral COVID-19 antiviral molnupiravir by FDA’s Antimicrobial Drugs Advisory Committee. We’re also reading that Robert Califf has asked Janet Woodcock to stay in a leadership position at FDA if he is confirmed as commissioner.
Monoclonal antibodies authorized for children with COVID
Today, FDA announced its expansion of the emergency use authorization (EUA) for Eli Lilly’s monoclonal antibodies (mAbs) bamlanivimab and etesivimab to include use of the combination infusion to treat mild to moderate COVID-19 in all pediatric patients, including newborns. The population included in the EUA had previously been those aged 12 years and up and weighing at least 40 kg. The two mAbs may now also be used for post-exposure prophylaxis in high-risk younger children and infants.
In other news
Two additions to FDA’s Manual of Policies and Procedures (MAPP) were released today that lay out what happens when applicants are in arrears in paying user fees: FDA may eventually refuse to accept or act on applications from applicants on the arrears list. A revision to the MAPP for non-payment of user fees required under the Prescription Drug User Fee Amendments (PDUFA) is accompanied by a new parallel MAPP for nonpayment of user fees under the Biosimilar User Fee Amendments of 2017 (BSUFA II). A helpful change control table in the PDUFA MAPP indicates that the revisions reallocate responsibilities under the MAPP to a different FDA office; updates were also made to several sections including those addressing policy and procedures. New sections on background and responsibilities were added as well.
Zooming out a bit, FDA was largely left out of the Department of Health and Human Services Office of Inspector General’s Semiannual Report to Congress, with only two items pertaining to the agency flagged in the report. The report does note some mostly risks relating to the potential for “illegal, improper, or erroneous” purchases in the agency’s travel card program but finds the program overall to be a “low risk” and makes no recommendations. The report also cites a recent HHS OIG report looking at high-expenditure orphan drugs in Medicare and calls for “policymaking, oversight, and research communities to seek answers” on the impact of the orphan drug program on other federal programs. FDA took issues with the initial report, pointing out that “the high-expenditure drugs included in [the] sample are not representative of the spectrum of orphan-designated drugs” and that the report “does not speak to the role that orphan-drug designation plays in drug pricing, if it plays one at all.”
Device update
In enforcement news, FDA sent a warning letter to Ohio-based oxygen concentrator maker Invacare Corporation for issues related to its reviews and investigations of complaints, it’s adherence to corrective and preventative actions (CAPA) procedures, and for failing to submit required malfunction reports within the statutory deadline. The warning letter follows a month-long investigation in May and June 2021.
FDA sent a letter to health care providers advising them of potential biocompatibility concerns with NuVasive Specialized Orthopedics’ titanium-based Precice Devices. The advisory follows an urgent field safety notice and recall to notify health care professionals and users of updated labeling for the devices. The updated instructions for use for the company’s Precice Freedom, Precice Intra-medullary Limb Lengthening Device, Precice Short and Precice Unyte clarifies that the devices are intended only for use in patients 18 years and older who weigh 50 pounds or more while undergoing treatment and specifies that no more than two devices should be implanted at a time.
In other device news, MITRE and the Medical Device Innovation Consortium (MDIC) have released a medical device cybersecurity threat modeling “playbook” following a series of device cybersecurity boot camps held over the last two years. The playbook, which was developed with funding from FDA, offers guidance to device makers on developing or evolving their approach to creating threat models for their devices.
FDA also issued five final orders classifying devices authorized through the de novo process in recent years, codifying the generic type for each device. All five devices were classified into class II (special controls) and the generic device types include isocapnic ventilation devices, esophageal tissue characterization system, trunk and limb electrical stimulator to treat headaches, conditioning tool for eating disorders, and intraoperative orthopedic strain sensors.
What we’re reading
The New York Times reported this week that Merck’s oral COVID-19 antiviral molnupiravir “could be authorized in the United States within days, and available within weeks,” if FDA decides to follow the recommendation of its Antimicrobial Drugs Advisory Committee. On 30 November, the committee voted narrowly to recommend authorization of a 5-day course of the pill for COVID-19 patients at risk of severe illness. Lower efficacy than originally reported, together with concerns about host genetic damage from a DNA-intercalating drug, weighed on the minds of some committee members, though the committee saw the potential good in authorizing an oral medicine that could be taken at home.
If Robert Califf, President Joe Biden’s nominee for FDA Commissioner, assumes that role, will Janet Woodcock stay on in a leadership role? STAT reports that Califf has asked her to stick around, and notes that the principal deputy commissioner seat has been vacant since Amy Abernethy departed the agency in April. Woodcock’s prior longtime role as head of the Center for Drug Evaluation and Research has now been filled by Patrizia Cavazzoni; Woodcock also has 35 years at FDA under her belt and might just choose to retire upon Califf’s appointment.
The Wall Street Journal reports that FDA is taking steps to facilitate speedy reviews of drugs and vaccines targeted at the Omicron variant and has met with drugmakers to discuss the types of studies and data necessary to evaluate such products.
President Joe Biden’s plan to keep the Delta and Omicron coronavirus variants at bay hinges on vaccine boosters for adults, getting children vaccinated and increasing the availability of testing while making at-home tests available at no cost, either via reimbursement through private insurance or by giving them out at health centers and rural clinics.
FDA hiring and call for committee members           
This week, FDA announced that it is seeking nominations for nonvoting industry representatives to sit on the National Mammography Quality Assurance Advisory Committee. Individuals can nominate themselves, or an organization can put forward a nominee. The committee is tasked with advising FDA on developing standards, procedures and regulations relating to mammography accreditation, compliance, and consumer complaint investigation. The committee also keeps FDA apprised of new developments in breast imaging and looks at the adequacy of the nation’s mammography and medical physicist capacity. Nominations are due 30 days after the 3 December publication date of the announcement.
FDA is also seeking voting members to sit on its Technical Electronic Product Radiation Safety Standards Committee.  This committee advises FDA on performance standards for radiation-emitting electronic products, such as fluoroscopic, radiographic, and computed tomography equipment; consumer products such as microwave ovens and sunlamp products are also under the committee’s purview. Preference will be given to nominations received by the end of January 2022.
The Office of Vaccines Research and Review (OVRR) within FDA’s Center for Biologics Evaluation and Research (CBER) is seeking multiple principal investigators for viral vaccines, who will “be expected to develop a research program applicable to human viral vaccines” that might include addressing emerging viruses, among other potential research areas of interest. Principal investigators in OVRR’s Division of Viral Products are internally funded and will both conduct their own research and oversee reviews of both licensed and experimental vaccines. The investigators will have access to the full array of research facilities at FDA’s White Oak campus in Silver Spring, MD; positions may be filled by non-US citizens if they have been in the US for at least 3 of the past 5 years.


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