This Week at FDA: OST reorg, OTP hiring update, new guidances

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 reorganized an office within its medical device center, got an update on hiring within a key office in the Center for Biologics Evaluation and Research (CBER), and more.

FDA has reorganized its Office of Strategic Partnerships and Technology Innovation (OST) in the Center for Devices and Radiological Health (CDRH). While the office was previously broken down into three divisions, the agency says it will now have five suboffices, each with its own divisions.

On the ongoing issue of drug shortages, Reuters reported on a survey by the American Society of Health-System Pharmacists (ASHP), which found that almost a third of hospitals in the US are rationing, delaying or canceling treatments due to drug shortages. The survey found that the situation is especially dire for chemotherapy drugs, as more than half of the respondents said they had to restrict their usage due to insufficient supplies.

Despite receiving more than a billion dollars from Congress to study and treat long-COVID, STAT reported that experts and patients think the National Institutes of Health's (NIH) research on the topic may have been a waste of time and money. Most of the funding has been spent to conduct observational research that has not added any significant insight into how to help those suffering from the condition, those that spoke to STAT said.

As Congress works to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA), STAT also reported that a group of experts and advocates are calling on lawmakers to include dialysis machines as part of the U.S. Strategic National Stockpile (SNS). They argued that patients have suffered during past natural disasters and public health crises, such as the COVID-19 pandemic, because there wasn't enough dialysis equipment to go around.

The Biomedical Advanced Research and Development Authority (BARDA) said it is starting a new initiative called the Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium) to expand domestic manufacturing and ensure the US can respond more quickly to future public health emergencies based on what it has learned during the COVID-19 pandemic. The agency added that it is looking for a Consortium Management Firm (CMF) to run the project.

Drugs & Biologics

CBER Director Peter Marks told BioSpace that the agency's efforts to reorganize and fill vacancies at its Office of Therapeutic Products (OTP) are going well. He said that most of the OTP leadership positions have been filled, and CBER is making good progress to fill up to 500 entry- and mid-level positions for its sub-offices over the next year or two.

FDA finalized a 2018 guidance mandated by the Drug Supply Chain Security Act (DSCSA) that details how it will address waiver, exceptions, and exemption (WEE) requests. The agency also elaborated on how it plans to review and potentially renew previously approved WEEs every two years.

The Congressional Research Service published a report reviewing FDA’s definition of an active ingredient, and delving into recent legal challenges and legislative changes to the definition to shore up the agency’s regulatory interpretation of what constitutes a new active ingredient. How an active ingredient is defined has significant ramifications for companies seeking exclusivity for new chemical entities (NCEs).

At the end of last week, FDA approved Sage Therapeutics' Zurzuvae (zuranolone) as the first oral drug to treat postpartum depression (PPD). Despite the approval, Reuters reported that the company's stock took a hit because the agency only approved the drug for PPD but declined to expand the indication to major depressive disorder (MDD).

Janssen Biotech's cancer drug Talvey (talquetamab-tgvs) was given accelerated approval by FDA. More specifically, the agency is allowing the conditional use of the drug to treat "adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody."

FDA and the Clinical Trials Transformation Initiative (CTTI) announced they are holding a two-day public workshop starting 29 November to discuss how to improve the enrollment of underrepresented populations in clinical trials. Increasing trial diversity has been a priority of the Biden administration, and the meeting was mandated under the Food and Drug Omnibus Reform Act of 2022 (FDORA).

FDA also announced it will hold a two-day public workshop starting on 13 September that is meant to educate stakeholders about how the agency's Generic Drug User Fee Amendments (GDUFA) Science and Research Program informs its regulatory decisions. The workshop is supposed to focus on a broad range of issues that affect generic drugs, including abbreviated new drug applications (ANDAs) and recent GDUFA III updates.

Regulators at FDA want feedback from stakeholders about potential regulatory research topics that they should prioritize in drug regulations and why. They also want to know how stakeholders would like to receive updates about their regulatory research work. Those interested can submit comments until 8 September.

FDA published several guidances this week, including a draft guidance that describes the process for conducting formal meetings between it and sponsors or applicants under the latest Biosimilar User Fee Amendments (BsUFA III). It also published a draft guidance that outlines its thinking on how to get postmarket data on underrepresented populations from clinical trials for drugs and biologics that have already been allowed on the market.

The agency has updated its Standard Operating Policy and Procedure (SOPP) guide used by the Center for Biologics Evaluation and Research (CBER) to assign names for biological and drug products.

Medtech

According to its regulatory filings, Illumina is being investigated by the US Securities and Exchange Commission over its $7.1B acquisition of Grail. Reuters reports that the company faced scrutiny from US and European regulators even back in 2021 when it bought back the cancer diagnostics company.

FDA has updated its catalog of regulatory science tools with four new tools and nine updated tools that sponsors can use to understand how FDA assesses new medical devices. The tools are used when there are no standards or qualified Medical Device Development Tools (MDDTs) that reviewers can use to evaluate devices.

FDA also finalized a guidance on what documentation medical device sponsors should include in their premarket applications if their product comes with off-the-shelf software.

This Week at FDA: OST reorg, OTP hiring update, new guidances

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