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 watched as more actions unfolded in the legal battle over mifepristone, and covered FDA’s move to simplify the COVID-19 vaccination schedule and authorize another round of bivalent shots for older adults and immunocompromised individuals.
The Supreme Court is expected to issue a decision later today on the Biden Administration’s request to prevent restrictions on the drug from taking effect while the administration appeals. The drug lobby group PhRMA has filed an amicus brief with the Supreme Court in support of FDA, while a group of nearly 150 Republican lawmakers have filed their own amicus brief against the administration. In the meantime, GenBioPro, a maker of a generic version of mifepristone, has sued FDA to block it from pulling mifepristone off the market, arguing that the agency has denied it due process if it were to withdraw the drug, The New York Times reports.
In a string of moves meant to simplify the vaccination schedule for mRNA COVID-19 vaccines, FDA announced that it has amended the emergency use authorizations (EUAs) for the Moderna and Pfizer-BioNTech vaccines to enable adults 65 and older to receive a second dose of a bivalent mRNA vaccine four months after their last dose. Unvaccinated individuals are now eligible to receive a single dose of a bivalent vaccine, rather than the multiple-dose primary series offered earlier in the pandemic. The agency said that most individuals are eligible for a single dose of the bivalent vaccine, and those who have already received one are not eligible for a second dose. The schedule is a little more complicated for children; the number of doses children ages 6 months through 5 years of age depends on whether they are unvaccinated or vaccinated with one, two or three doses of a monovalent vaccine.
This week, FDA announced it will host a meeting co-sponsored by the Duke-Margolis Center for Health Policy entitled “Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches.” The meeting fulfills a commitment under the latest Prescription Drug User Fee Act (PDUFA) VII agreement and will touch on best practices, barriers to adoption, regulatory strategies and the agency’s Advanced Manufacturing Technologies Designation program.
According to ProPublica, FDA’s foreign drug manufacturing inspections have not picked back up after the pandemic forced the agency to significantly restrict its inspectional activities. “In fiscal year 2019, the year before the COVID-19 pandemic limited travel and movement, the FDA inspected 37% of the nearly 2,500 overseas manufacturers; in 2022, the agency only inspected 6% of around 2,800. And in India, where the contaminated eyedrops originated, the FDA inspected only 3% of manufacturers in 2022 — significantly less than in 2019, when 45% of plants were inspected,” ProPublica writes.
Politico Pro reports Emergent BioSolutions plans to sell its nonprescription version of its opioid overdose reversal drug Narcan for less than $50 for a two-pack of the drug.
Drugs & biologics
On Monday, FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) voted in favor of approving Entasis Therapeutics’ new drug application (NDA) for its antibiotic to treat multidrug-resistant infections. The firm was acquired by Innoviva in 2022.
During a meeting of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC), the agency received pushback on its plan to study long-acting opioids to treat chronic pain, STAT reports.
The Center for Drug Evaluation and Research (CDER) detailed its effort to develop quantitative structure-activity relationship (QSAR) models meant to predict drug permeability across the blood brain barrier.
FDA released its latest quarterly data on its regenerative medicine advanced therapy (RMAT) designations for the first half of FY 2023. So far, the agency has received 16 requests for designation, and it has granted four and denied six requests.
The agency will host a public workshop on recombinant protein-based COVID-19 vaccines on 27 April.
FDA on Thursday approved Genentech’s Polivy (polatuzumab vedotin-piiq) as part of a five-drug regimen in first-line diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL) with an International Prognostic Index (IPI) or 2 or greater.
Reuters reports that Eli Lilly believes that new evidence on amyloid plaque removal will convince the Centers for Medicare and Medicaid Services to lift coverage restriction on new Alzheimer’s drugs.
Medtech
Abbott Laboratories said that non-urgent and elective procedures have recovered following years of such procedures being delayed due to the COVID-19 pandemic, boosting the company’s outlook, Reuters reports.
FDA’s Center for Devices and Radiological Health (CDRH) will host a three-day virtual hiring event from 23-25 May.
CDRH also released its latest quarterly third party review organization performance report covering Q2 FY 2023.
FDA announced Class 1 recalls for tow medical devices this week: Avanos Medical Inc’s Ballard Access Closed Suction System for Neonates/Pediatrics with Elbow Manifold and Fresenius Kabi’s Ivenix Infusion System.
The Supreme Court is expected to issue a decision later today on the Biden Administration’s request to prevent restrictions on the drug from taking effect while the administration appeals. The drug lobby group PhRMA has filed an amicus brief with the Supreme Court in support of FDA, while a group of nearly 150 Republican lawmakers have filed their own amicus brief against the administration. In the meantime, GenBioPro, a maker of a generic version of mifepristone, has sued FDA to block it from pulling mifepristone off the market, arguing that the agency has denied it due process if it were to withdraw the drug, The New York Times reports.
In a string of moves meant to simplify the vaccination schedule for mRNA COVID-19 vaccines, FDA announced that it has amended the emergency use authorizations (EUAs) for the Moderna and Pfizer-BioNTech vaccines to enable adults 65 and older to receive a second dose of a bivalent mRNA vaccine four months after their last dose. Unvaccinated individuals are now eligible to receive a single dose of a bivalent vaccine, rather than the multiple-dose primary series offered earlier in the pandemic. The agency said that most individuals are eligible for a single dose of the bivalent vaccine, and those who have already received one are not eligible for a second dose. The schedule is a little more complicated for children; the number of doses children ages 6 months through 5 years of age depends on whether they are unvaccinated or vaccinated with one, two or three doses of a monovalent vaccine.
This week, FDA announced it will host a meeting co-sponsored by the Duke-Margolis Center for Health Policy entitled “Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches.” The meeting fulfills a commitment under the latest Prescription Drug User Fee Act (PDUFA) VII agreement and will touch on best practices, barriers to adoption, regulatory strategies and the agency’s Advanced Manufacturing Technologies Designation program.
According to ProPublica, FDA’s foreign drug manufacturing inspections have not picked back up after the pandemic forced the agency to significantly restrict its inspectional activities. “In fiscal year 2019, the year before the COVID-19 pandemic limited travel and movement, the FDA inspected 37% of the nearly 2,500 overseas manufacturers; in 2022, the agency only inspected 6% of around 2,800. And in India, where the contaminated eyedrops originated, the FDA inspected only 3% of manufacturers in 2022 — significantly less than in 2019, when 45% of plants were inspected,” ProPublica writes.
Politico Pro reports Emergent BioSolutions plans to sell its nonprescription version of its opioid overdose reversal drug Narcan for less than $50 for a two-pack of the drug.
Drugs & biologics
On Monday, FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) voted in favor of approving Entasis Therapeutics’ new drug application (NDA) for its antibiotic to treat multidrug-resistant infections. The firm was acquired by Innoviva in 2022.
During a meeting of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC), the agency received pushback on its plan to study long-acting opioids to treat chronic pain, STAT reports.
The Center for Drug Evaluation and Research (CDER) detailed its effort to develop quantitative structure-activity relationship (QSAR) models meant to predict drug permeability across the blood brain barrier.
FDA released its latest quarterly data on its regenerative medicine advanced therapy (RMAT) designations for the first half of FY 2023. So far, the agency has received 16 requests for designation, and it has granted four and denied six requests.
The agency will host a public workshop on recombinant protein-based COVID-19 vaccines on 27 April.
FDA on Thursday approved Genentech’s Polivy (polatuzumab vedotin-piiq) as part of a five-drug regimen in first-line diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL) with an International Prognostic Index (IPI) or 2 or greater.
Reuters reports that Eli Lilly believes that new evidence on amyloid plaque removal will convince the Centers for Medicare and Medicaid Services to lift coverage restriction on new Alzheimer’s drugs.
Medtech
Abbott Laboratories said that non-urgent and elective procedures have recovered following years of such procedures being delayed due to the COVID-19 pandemic, boosting the company’s outlook, Reuters reports.
FDA’s Center for Devices and Radiological Health (CDRH) will host a three-day virtual hiring event from 23-25 May.
CDRH also released its latest quarterly third party review organization performance report covering Q2 FY 2023.
FDA announced Class 1 recalls for tow medical devices this week: Avanos Medical Inc’s Ballard Access Closed Suction System for Neonates/Pediatrics with Elbow Manifold and Fresenius Kabi’s Ivenix Infusion System.
Source: News