This Week at FDA: It’s raining user-fee guidances, Hallelujah!

Regulatory NewsRegulatory News | 07 October 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 big news this week is the firehose of guidances the US Food and Drug Administration (FDA) has unleashed in response to Congress renewing its user fee programs.
While we typically expect to see a steady release of guidances from the FDA before user fees go into effect, updating the medical industry on what to expect, the agency dumped a pile of regulations soon after Congress passed an eleventh-hour bill renewing the user fee programs. They include medical device guidances to reflect revised timelines for responding to premarket approval (PMA), 510(k) and De Novo applications under the latest Medical Device User Fee Amendments (MDUFA V) program.
Regulators also published a slew of guidances that address the FDA’s commitments under the Generic Drug User Fee Amendment (GDUFA III) to improve communication with sponsors including by holding mid-cycle review meetings (MCRM) and enhanced mid-cycle review meetings (EMCRM).
But perhaps the most anticipated news this week is the FDA’s user fee tables for FY2023 that details how much sponsors will have to pay to get their products reviewed. The delay in reauthorizing the user fees meant many sponsors were in a holding pattern submitting their premarket applications. Most notably, the tables reveal the significant increase in user fees the FDA has been able to extract from the medtech industry in MDUFA V.
Internally, the FDA has been putting emphasis on its work to tackle the opioid crisis. In recent months, the agency has announced a number of actions including going after web sites that illegally sell opioids. This week FDA Commissioner Robert Califf announced the agency has launched an external review into how it has approved opioids in the past.
The news comes after the FDA recently released a report from an internal review of its handling of the infant formula crisis where it said it resulted from a combination of human error, antiquated technology, and poor communication and accountability. The findings and mea culpa did not sit well with Sen. Richard Burr (R-NC), ranking member of the Senate Health, Education, Labor and Pension (HELP) committee. This week, he sent a letter to Califf stating the FDA is not taking accountability for its shortcomings and asks for details on how the agency intends to address those shortcomings.
Drugs & Biologics
Alongside its GDUFA III-related guidances the FDA says it is also holding a workshop focused on drug master files (DMF) on 30 November. The agency says the workshop will address two topics including the two DMF enhancements under the new user fee deal. The agency will also discuss the future state of DMF submissions and assessments including having a discussion of Knowledge-Aided Assessment and Structured Application (KASA), Structure-Data (SD) files and Global Substance Registration Systems (GSRS) database.
In COVID-19 news, the FDA updated its factsheet for AstraZeneca’s Evusheld antibody combination for preventing severe COVID-19 in immunocompromised patients. The update comes amid reports Evusheld is not effective against the latest subvariant of omicron, BA.4.6. The agency now says Evusheld can increase the risk of COVID-19 infection for variants that the product does not neutralize.
In what is gearing up to be a very confrontational three-day hearing, the FDA and drugmaker Covis have released highly contrasting documents on Covis' drug Makena, which has accelerated approval designation and is intended to reduce premature births. The agency wants the drug pulled from the market, noting that it has not proven significant efficacy and its continuation on the market risks undermining the accelerated approval pathway. Covis argues the drug may be effective in Black women and wants more time to prove its efficacy.
The lobby group MedTech Europe has joined with other trade groups to warn that the European Artificial Intelligence Act could have a “significant impact” on companies that are already under “regulatory strain.” The organization warns the new law may impose “technical and financial burdens” and exacerbate notified body capacity constraints and. They are calling for changes to align the proposal with the existing New Legislative Framework (NLF).
The lobby group also says a proposed revision to the European Commission’s Product Liability Directive that will extend user compensation eligibility to products such as medical smartphone apps could “needlessly disrupt” innovation in the EU.
The FDA announced it is partnering with the Department of Veterans Affairs' innovation incubator VA Ventures to advance medical device development. The agency says the organizations will work toward developing and disseminating new tools designed to test the safety and effectiveness of medical devices and emerging technologies.
The FDA is also proposing a rule that would give it new authority to destroy medical devices valued at $2,500 or less that have been refused admission into the US. The agency says the owner or consignee would be given notice and an opportunity to appear and introduce testimony prior to the destruction but ultimately the rule would give regulators powers to "better protect the public health by preventing re-importation and deterring future shipments of refused devices subject to administrative destruction."


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