This Week at FDA: COVID boosters approved, guidances galore, and more

Clarification: Story updated 18 September to note that under the class I recall of Abbot's Proclaim and Infinity IPG devices, no products need to be returned to the company or replaced.

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 continues its deluge of end-of-year guidances, the agency approved the much-anticipated COVID-19 vaccine boosters, and more.

The big news this week is the US Food and Drug Administration (FDA) authorized Pfizer-BioNTech and Moderna's updated COVID-19 shots. That decision was quickly followed by a recommendation from the Centers for Disease Control and Prevention (CDC) for the boosters that specifically target the Omicron variant XBB.1.5. Public health officials have been concerned in recent months about a potential increase in COVID-19 cases this fall and new subvariants that are found to be highly mutated.

FDA continued to publish a slew of new guidances for the second week. This week started with the publication of a revised final guidance on procedures that Institutional Review Boards (IRBs) should use when evaluating submissions for expanded access treatments, and another guidance for sponsors developing drugs for endogenous Cushing's syndrome, a rare disorder that causes overproduction of glucocorticoid.

Seven more guidances on human medical products were published throughout the week, including ones on biosimilar labeling, postmarketing requirements (PMRs) and postmarketing commitments (PMCs) reporting, and developing weight loss medical devices.

The Federal Trade Commission (FTC) issued a statement that it plans to go after drugmakers who improperly list patents in the FDA’s catalog of Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book. The agency said the practice could harm competition from less expensive generic drugs and artificially inflate prices.

On a similar issue, STAT News reported that Sen. Maggie Hassan, D-NH, is spearheading legislation that would require drugmakers to certify that they have given the same information to different agencies when seeking marketing approval and patent protection for their product. The objective would be to ensure FDA, and the US Patent and Trademark Office (USPTO) can work together effectively to stop companies from trying to monopolize the market.

In a blog post, Patrizia Cavazzoni, director, of the Center for Drug Evaluation and Research (CDER), and Amy Ramanadham, CDER staff director for Drug Safety Operations, said the medical community needs to improve the quality of pregnancy safety studies to generate better data on the drugs used by pregnant people. They noted that the Duke-Margolis Center for Health Policy is holding a two-day public workshop starting 18 September to discuss pregnancy safety studies and the agency plans to publish a workshop report based on the findings next year, as well as initiate five demonstration studies that will ultimately lead to a new pregnancy study framework.

The White House published a statement on efforts to address the shortage of certain cancer drugs. The administration said FDA is working with manufacturers to find ways to increase production and using the agency's enforcement discretion to import certain drugs.

FDA sent warning letters to Walgreens, CVS Health and six other companies for manufacturing or marketing unapproved eye products. The products in question are being marketed for diseases such as conjunctivitis, cataracts and glaucoma, but have not been approved by the agency.

This week the FDA also said it will host a virtual public meeting on 5 October that will include anecdotes from family members advocating for patients with rare diseases. They will discuss their experience working with researchers and industry in helping develop treatments.

Drugs & Biologics

In May, FDA proposed updating its medication guide labeling requirements that would require drugmakers to provide patients with a simple one-page document explaining the safety and efficacy of their product. In an op-ed in STAT, experts expressed concern that the agency "will blow the opportunity with poor design and inadequate testing of the one-pager." They are concerned regulators may ask for too much detail in the one-pager, which will only confuse patients.

Reuters reports that FDA Non-prescription Drug Advisory Committee unanimously voted that phenylephrine was not effective as a nasal decongestant and that there was no need to conduct any more trials to prove its effectiveness. Following the committee’s decision, the agency issued a statement clarifying that the drug has not been deemed unsafe, and ultimately, agency regulators will make a final decision based on the committee's input and other evidence before deciding on the fate of the drug.

Seeking Alpha reports that Alnylam Pharmaceuticals stocks took an 8% dive the morning after FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) recommended an additional indication for Onpattro (patisiran) to treat cardiomyopathy of ATTR amyloidosis. The panel voted 9-3 to recommend the approval but expressed doubts about its effectiveness.

Medtech

Top FDA officials, including Williams Maisel, chief medical officer at the Center for Devices and Radiological Health (CDRH), published an article in npj Digital Health arguing that digital health technologies, especially artificial intelligence/ machine learning (AI/ML), may lead to biases and exacerbate health disparities if they are not used appropriately. The article proposes concepts that can address biases.

On the topic of using AI/ML, Medtech Dive reported on a prospective study in Lancet Digital Health that concluded that AI/ML imaging technology used with a double reading by one radiologist was as good at detecting breast cancer as a double reading by two radiologists. The results could have positive implications for companies developing clinical decision support (CDS) software.

FDA has updated the labeling for Merck's cancer drug Temodar (temozolomide) so it can be used to treat refractory anaplastic astrocytoma and as an adjuvant treatment for anaplastic astrocytoma. The decision to update the labeling stems from the Oncology Center of Excellence (OCE) Project Renewal which consults external cancer experts to ensure cancer drug labels stay up-to-date based on the latest research.

Abbott Medical has initiated a class I recall for its Proclaim and Infinity implantable pulse generators (IPG) after receiving complaints that patients were unable to exit magnetic resonance imaging (MRI) mode, which could render it inoperative. The devices deliver low-intensity electrical impulses to nerve structures, and so far, the company says it has received reports of 186 incidents and 73 injuries but no reported death. *While the company has notified physicians and regulators of the issue, it said that the products do not need to be returned to Abbott or replaced.

This Week at FDA: COVID boosters approved, guidances galore, and more

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