This Week at FDA: New DSCSA exemptions, hemophilia prophylactic approved, and more

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 agreed to offer some broad exemptions from certain Drug Supply Chain Security Act (DSCSA) requirements and approved a new hemophilia drug for prophylaxis.

In major news this week, FDA has agreed to give companies more time to comply with the enhanced distribution security requirements under the DSCSA. Industry and lawmakers have been calling for the agency to delay enforcing aspects of the law to avoid potential product shortages.

Politico reported that mpox cases are resurging with a deadlier strain two years after a global outbreak that affected more than 100 nations.. The latest strain has killed more than 900 people, mostly children in Africa, and according to Politico, US public health officials are concerned the virus could soon spread to the US.

FDA is looking for drug companies who want to volunteer to participate in its site visitation program for fiscal year 2025. The program allows agency officials to observe and learn about how the pharmaceutical industry operates commercial manufacturing facilities, pilot plants, and testing operations.

Hurricane Helene recently devastated parts of the eastern US, including major medical product manufacturing facilities in North Carolina. FDA announced it is working to temporarily import products in short supply due to Helene's effect on those facilities.

Drugs & biologics

FDA approved Pfizer's Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in people 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors. The drug is the first non-factor and once-weekly treatment for hemophilia B.

Genentech's cancer drug Itovebi (inavolisib) was approved by FDA to treat endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with palbociclib and fulvestrant. The agency also approved FoundationOne's Liquid CDx assay as a companion diagnostic device to diagnose breast cancer before treating with the drug.

FDA warned consumers against buying Trinity Gold, marketed to help joint and muscle pain on several web sites. While the herbal dietary supplement is sold as vegetarian capsules, the agency says its own analysis found it contains acetaminophen, diclofenac and phenylbutazone, which may cause issues such as liver damage, skin reactions, cardiovascular events, gastrointestinal problems, and bone marrow toxicity.

Similarly, FDA issued a consumer warning for Umary and Amazy products that are marketed as dietary supplements to treat pain and other conditions because its analysis found dangerous hidden drug ingredients not listed on the product label. In particular, the agency found diclofenac and omeprazole that could cause gastrointestinal, cardiovascular and serious skin reactions.

FDA provided clinical trial snapshots for several drugs including Esai's Leqembi (lecanemab-irmb) to treat Alzheimer’s disease; AstraZeneca's Truqap (capivasertib) to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in combination with fulvestrant; and IVERIC bio's Izervay (avacincaptad pegol intravitreal solution) to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The trial snapshots provide a look into the data the agency reviewed when deciding to approve the drugs.

Medtech

Healgen's Rapid Check COVID-19/Flu A&B Antigen Test received de novo authorization as an over-the-counter (OTC) test to diagnose patients who may have COVID-19 or influenza A/B. FDA notes it is the first OTC influenza test to be given marketing authorization outside of an emergency use authorization (EUA).

Mercury Medical has issued a class I recall for its Neo-Tee Resuscitators due to concerns that the inline controller in the device could come apart, leading to a loss of positive pressure. If the controller comes apart, it could affect the ability of the device to properly ventilate patients and lead to death due to lack of oxygen.

While FDA faces legal challenges to its decision to phase out its regulatory discretion to oversee laboratory-developed tests (LDT), it continues to implement its rule. The agency published a frequently asked questions (FAQ) web page that includes resources for sponsors and how it plans to interact with stakeholders on the issue.

FDA published notices for several products that were given marketing authorizations, approvals and clearances this year. They include Pi-Cardia's ShortCut percutaneous catheter for cutting or splitting heart valve leaflets; RecensMedical's OcuCool ophthalmic cooling anesthesia device; Diapharma Group's Technozym ADAMTS13 activity test system to diagnose thrombotic thrombocytopenic purpura (TTP) in adults and thrombotic microangiopathy (TMA) in children; Bone Health Technologies' Osteoboost belt to treat declining bone strength and bone density; Cordis US' MYNX Control venous vascular closure device (VCD) expanded indication to close puncture sites in femoral veins after catheterization; Alcon Research's UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System and UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery System to treat uncomplicated retinal detachments; and Guardant Health's Shield colorectal cancer in-vitro diagnostic test.

FDA published a final guidance on developing endosseous dental implants and abutments using its Safety and Performance Based Pathway. The agency notes that under the pathway sponsors can use the performance criteria laid out in the guidance rather than conduct a direct comparison of their device to a predicate device.

This Week at FDA: New DSCSA exemptions, hemophilia prophylactic approved, and more

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