This Week at FDA: Tarver named CDRH chief, GOP report critical of HHS’ COVID vaccine promotion

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, FDA named the new permanent director of its medical device center, House Republicans published a report criticizing the Biden administration's promotion of COVID-19 vaccines, and a much-anticipated draft guidance on communicating scientific information about unapproved uses of drugs is a step closer to being finalized.

In major news this week, FDA has named Michelle Tarver as the new permanent director of its Center for Devices and Radiological Health (CDRH), nearly three months after taking on the role on an acting basis after former CDRH head Jeff Shuren announced his plans to leave the agency by the end of the year. Tarver has been crucial in the agency’s ongoing efforts to ensure equity in medical product development and its efforts to focus on advancing healthcare solutions in the home.

Republicans in the House Energy and Commerce Committee published a report claiming that the National Institutes of Health spent $900 million promoting COVID-19 vaccines in ways that overpromised what the vaccines could do while overstating the risk of SARS-CoV-2 for children and young adults. The report includes several recommendations, including requiring the Department of Health and Human Services to abide by the FDA’s product labeling guidelines.

The Office of Management and Budget (OMB) is reviewing an October 2023 revised draft guidance on how companies can communicate scientific information on unapproved uses of approved and cleared medical products to healthcare providers. The proposed revised guidance expanded the scope of communication firms can engage in to include firm-generated presentations of scientific information from published reprints and materials from independent clinical practice resources.

FDA's Office of Prescription Drug Promotion has submitted a proposed study to OMB for review. The study builds on past research on drug advertising and would look at the role of adherence and patient preference claims in prescription drug promotion.

Novo Nordisk has asked FDA to add the diabetes and weight-loss drug semaglutide to its Demonstrable Difficulties for Compounding (DDC) list, arguing that it is too complex for compounders to safely manufacture.

Drugs & biologics

The Center for Drug Evaluation and Research (CDER) has updated its manual of policies and procedures on how it classifies resubmissions of New Drug Applications, Biologics License Applications, and efficacy supplements in response to complete response letters to reflect the Office of New Drugs current organization structure, user fee agreement commitments, and CDER workflow procedures and best practices.

CDER will host a virtual meeting on 4 December to discuss clinical pharmacology considerations when developing novel therapeutic modalities. In particular, the agency intends to talk about its final guidances on oligonucleotide therapeutics and antibody-drug conjugates during the meeting.

The center will also host a virtual workshop on 13 December to discuss methodological and other challenges when using patient experience data to develop patient-focused drugs. The workshop will include discussions on different types of patient experience data and how the agency uses such data in its regulatory decision making.

The Pharmacy Compounding Advisory Committee (PCAC) will meet on 4 December in person to discuss several bulk drugs to be included in the 503A Bulks List. They include drugs used for obesity, growth hormone deficiency, Hepatitis B and C, cancers, and more.

The Vaccines and Related Biological Products Advisory Committee will meet virtually on 12 December to discuss Respiratory Syncytial Virus (RSV) Vaccine safety in children and get briefed on the Laboratory of Immunoregulation (LI) and Laboratory of Retroviruses (LR) research programs in the Center for Biologics Evaluation and Research (CBER). While the FDA experts will meet in open session for most of the meeting, they will meet in closed session after hearing about the research programs due to concerns the topic of conversation could lead to an invasion of privacy.

Iterum Therapeutics announced that FDA has approved its antibiotic drug Orlynvah (oral sulopenem) to treat uncomplicated urinary tract infections. The infections are caused by microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, and the drug is intended for adult women with limited or no alternative oral antibiotic therapies available to them.

Medtech

FDA has extended the comment period for the draft guidance entitled, "Chemical Analysis for Biocompatibility Assessment of Medical Devices" by an extra 30 days to 19 December. The agency said it made the decision at the request of stakeholders, who said they needed more time to respond.

CDRH is holding its next virtual town hall meeting on medical device sterilization on 30 October. The series of town halls is intended to allow the agency and stakeholders to discuss reducing the use of ethylene oxide to sterilize medical devices, as the Environmental Protection Agency has issued rules limiting the use of the gas.

Baxter Healthcare has updated the use instructions for its Life2000 Ventilation System in a class I recall due to concerns the devices may fail to issue low gas pressure alarms when the pressure gas source is not connected to the ventilator. While the company develops a software update for the problem, it said users should take certain steps, such as ensuring the pressure gas source is connected to the ventilator before using the product.

Smiths Medical has issued a class I recall for certain lots of the BLUSelect, BLUgriggs, and BLUperc tracheostomy tubes due to a manufacturing defect that could cause the pilot balloon to disconnect from the tracheostomy inflation line. The issue could lead to aspiration and death, and users have been asked to stop using the identified devices.

FDA issued a safety communication for consumers not to use Hologic's BioZorb Markers and BioZorb LP Markers after the company initiated a recall in response to reports that patients implanted with certain lots of the device could experience adverse reactions including pain, infection, rash, device migration, device erosion, seroma, and discomfort. The implantable devices are used for radiographic marking in soft tissue sites such as breast tissue.

This Week at FDA: Tarver named CDRH chief, GOP report critical of HHS’ COVID vaccine promotion

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