This Week at FDA: Hope for user fee reauthorization, EMA says COVID-19 pandemic not over yet

This Week at FDAThis Week at FDA | 23 September 2022 | 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. The biggest development of the week is news that Congress actually may pass a user fee reauthorization bill. Regulators also have published several major guidances this week including one on electronic submission of 510(k) applications.
While the US Food and Drug Administration has warned that it would need to lay off staff in the first half of September if Congress did not reauthorize its user fee programs, the agency has not yet done, so indicating its optimism that a bill will be passed before carryover funds run out. This week, several news outlets reported that Senate Republicans and Democrats have struck a deal to include a clean reauthorization bill in a stopgap spending bill that will allow the user fee programs to continue after their 30 September expiration.
Although President Biden declared  “the pandemic is over” on CBS 60 Minutes on 18 September, his own health officials have towed a more cautious line. Conversely, on the other side of the pond, the European Medicines Agency (EMA) said  the pandemic is ongoing and Member States need to continue to operate on that premise.
The FDA also published a number of important guidances, including a much-anticipated final guidance on how to submit 510(k) applications electronically. After years of testing, the agency’s final guidance is meant to help medtech sponsors submit applications via FDA’s electronic Submission Template And Resource (eSTAR) system by clarifying terminologies, processes and expectations.
The FDA also published a draft guidance on ethical considerations when conducting pediatric clinical trials. It proposes an ethical framework for protecting children in clinical research and explains fundamental concepts for the ethical framework that institutional review boards (IRB), sponsors and industry should take into consideration.
Another big story this week is the FDA has restarted surprise inspections of oversees facilities which have been on pause since the COVID pandemic started. “In terms of (inspection) activity (in India) we are getting closer to pre-pandemic levels," Sarah McMullen, FDA country director – India, told The Economic Times at a recent event in Mumbai.
Drugs & Biologics
The EMA issued a statement this week confirming that all biosimilars approved in the European Union are interchangeable with other approved biosimilars referencing the same biologic, as well as the reference biologic. The move is part of the agency’s efforts to get regulators in the various EU Member States on the same page.
FDA Commissioner Robert Califf told attendees at a webinar hosted by the agency’s Small Business and Industry Assistance (SBIA) program that they are looking for new ways to assess bioequivalence and increase early interactions with industry to promote more first-cycle approvals of complex generics. One approach the agency is looking into is developing alternative avenues for evaluating a drug’s bioequivalence that would eliminate unnecessary human studies.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has recommended the agency approve a fecal microbiota transplant (FMT) product made by Rebiotix for recurrent Clostridium difficile (C. diff) infections. In a 13-4 decision, the panel of external experts said RBX2660 was effective in treating patients with recurrent C. diff infections who failed first-line antimicrobial therapy.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 9 to 4 against approving Spectrum Pharmaceuticals' poziotinib for the treatment of patients with a form of non-small cell lung cancer. The panel cited marginal efficacy, high level of toxicities, and lack of dose optimization in its decision. The company said it was disappointed  and is considering its options.
On the approval side, Fennec Pharmaceuticals’ Pedmark (sodium thiosulfate) got the green light from FDA for the treatment of cisplatin-related ototoxicity in pediatric patients aged one month or older with solid, non-metastatic tumors.
The Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a report that the FDA repeatedly changed its emergency use authorization (EUA) policies to address the need for COVID-19 testing, leading to inaccurate tests getting on the market. The report focused on FDA policies between January and May 2020, which included allowing developers to distribute tests before they had obtained an EUA, if they notified the FDA and validated the tests.
The FDA also announced this week that as part of its ongoing public virtual townhall meetings addressing development of COVID-19 tests, it will also take questions on developing tests for monkeypox. The next town hall will be held on 28 September.
The FDA issued a safety alert for cybersecurity vulnerabilities on insulin pumps with wireless capabilities. This time the alert was for Medtronic’s MiniMed 600 series insulin pumps where a vulnerability could allow malicious hackers to change dosing that could lead to serious injury or death. So far, no adverse events have been reported in association with the vulnerability and Medtronic says hackers can only access the devices if within a short distance of the pumps.


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