This Week at FDA: HHS vaccine injury initiative, midterms could reshape congressional committees overseeing FDA, 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, the Department of Health and Human Services (HHS) announced an agency-wide initiative to study and address vaccine injuries, and the congressional committees that oversee FDA could see high turnover after the midterm elections.
On Monday, HHS opened a new clinic at the National Institutes of Health (NIH) campus in Bethesda to focus on studying and treating patients who experience health issues following vaccination, as announced by HHS. This initiative is part of a broader effort spearheaded by HHS Secretary Robert Kennedy Jr. to improve the federal government’s response to health problems associated with vaccines, with a particular emphasis on gathering better evidence regarding potential vaccine-related injuries.
The rollout advances some of Kennedy’s personal policy priorities just weeks before a midterm election that will determine the balance of congressional power for the next two years, according to Politico.
Two influential House committees overseeing health care policies are anticipated to see several new members following the midterm election, STAT reports. The potential for a “blue wave” and the departure of multiple lawmakers could lead to numerous openings on the Energy and Commerce and Ways and Means committees, while a similar shakeup is possible in the Senate.
FDA said that its safety review of the mifepristone abortion pill is expected to be completed by March 2027, as reported by CNN. In a legal filing on Wednesday, the agency provided a court-ordered update on its progress, marking the first time it has shared “substantive information” regarding the controversial reevaluation ordered by Kennedy last year. Following the review, FDA will decide whether to impose new restrictions or implement other changes on the drug’s use.
Drugs and Biologics
FDA has published final guidance on postapproval manufacturing changes for biosimilar and interchangeable biosimilar products. This guidance is presented in a question-and-answer format and addresses common questions from applicants about postapproval manufacturing changes. It finalizes a draft version issued in July 2024.Top of Form
The agency on Friday approved Asahi Kasei's drug pritelivir for persistent herpes simplex virus sores in certain patients with weakened immune systems on Friday, according to Reuters. The oral drug was developed by German drugmaker Aicuris, which Asahi Kasei acquired in April.
This week, FDA approved Genentech’s Tecentriq (atezolizumab) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adults and pediatric patients two years of age and older with Stage III mismatch repair deficient (dMMR) colon cancer. The agency also approved Seagen’s Tukysa (tucatinib) in combination with trastuzumab and pertuzumab as maintenance treatment for adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction therapy.
On Thursday, the Center for Biologics (CBER) released an internal memo, known as SOPP 8406, outlining the procedures for verifying application payments under the Prescription Drug User Fee Act (PDUFA). The memo also specifies the billing activities that fall under the responsibility of the FDA’s Office of User Fees (OUF).
FDA announced the recall of two lots of Brevital Sodium 500 mg/vial (Methohexital Sodium for Injection, USP) from Par Health at the hospital level. This recall is due to the presence of particulate matter identified as cellulose. This particulate matter poses a significant risk, as it may potentially cause life-threatening health issues, including blockages in pulmonary blood vessels, occlusions in other blood vessels, or inflammation of the walls of veins.
FDA will host a webinar on 14 October to discuss navigating the draft guidance on Bayesian methods. The event starts with a pre-recorded video followed by a discussion.
The Friends of Cancer Research will hold their annual meeting on 10 November in Washington, DC.
Medical Devices
On Monday, Click Therapeutics announced that FDA has granted 510(k) clearance for its product, Motivista. This is a prescription digital therapeutic designed to treat the negative symptoms of schizophrenia as an adjunct to clinician-managed outpatient care, including antipsychotic therapy, for patients aged 18 years and older who have clinically stable positive symptoms. The company stated that Motivista is the first FDA-authorized treatment specifically indicated for the negative symptoms of schizophrenia in the United States.
On Friday, FDA announced that it has classified three devices under the class II special controls category This action was taken because FDA has determined that these class II designations will “provide a reasonable assurance of the safety and effectiveness” of these devices. The order went into effect on Friday. The order affects the infant pulse rate and oxygen saturation monitor for over-the-counter use, the hematopoietic cell enrichment kit, and the system for detecting nucleic acid from non-viral microorganisms causing sexually transmitted infections using home-collected specimens.
Nova Biomedical has initiated a global correction for its StatStrip Glucose Hospital Meter System due to a software issue that could result in a glucose reading being linked to the wrong patient. Before issuing the recall notice, the company received one adverse event (AE) report in the US related to this problem.
