This Week at FDA: AdComm reforms, FTC warning letters, and marijuana rescheduling
This Week at FDA | 03 May 2024 |
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 said it will seek feedback from the public on how it can optimize the use of its advisory committees, which the agency convenes to get input from external experts on some of the most difficult scientific and medical questions it faces.
For more than a year, FDA Commissioner Robert Califf has touted the need for reforms to the agency’s advisory committee system following multiple high-profile decisions in which the agency moved against the recommendation of its committees. Now, the agency has announced a virtual meeting on 13 June to inform its moves to reform its policies and procedures for advisory committees. Among other things, the agency wants to know how it can change advisory committee processes to clarify that the committees’ votes are non-binding on the agency’s decisions.
“Although all decisions are made by FDA staff, the discussions that take place at advisory committee meetings are important pieces that are considered as part of the FDA’s decision-making,” said FDA Principal Deputy Commissioner Namandjé Bumpus.
The Federal Trade Commission (FTC) on Tuesday announced it has sent warning letters to 10 drugmakers, alleging that they improperly or inaccurately listed some 300 patents in the Orange Book. The affected drugmakers include AstraZeneca, Novo Nordisk, Boehringer Ingelheim, Covis Pharma, Glaxo-Smith Kline, Novartis, Teva, and Amphastar Pharmaceuticals.
“By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,” said FTC Chair Lina Khan. Califf added that “it is the responsibility of branded drug manufacturers to ensure that Orange Book submissions contain information only on the types of patents for which information should be submitted to FDA.”
The Associated Press on Tuesday reported that the Drug Enforcement Administration (DEA) plans to down schedule marijuana from Schedule I to Schedule III, which would open the door to companies looking to develop marijuana and marijuana-based products for FDA-regulated medical use.
Senate Finance Committee Chair Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) on Friday released draft legislation they say will help address prescription drug shortages. The discussion draft would create a new Medicare program for hospitals and doctors that would incentivize purchasing agreements the lawmakers say would be more “transparent, reliable, and resilient.”
The agency also announced that its medical product centers will host their annual Regulatory Education for Industry (REdI) conference on innovation in product development from 29-30 May.
Drugs & biologics
On Monday, FDA granted traditional approval to Seagen and Pfizer’s Tivdak (tisotumab vedotin-tftv) to treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The drug previously received accelerated approval for the same indication in September 2021.
Both the Office of New Drugs (OND) and Office of Translational Science (OTS) within the Center for Drug Evaluation and Research (CDER) released their 2023 annual reports this week.
FDA approved X4’s Xolremdi (mavorixafor) as the first drug to treat patients 12 or older with WHIM (warts, hypogammaglobulinemia, infections and myelokat) syndrome. Only about 60 cases of the disease have been reported in the medical literature, FDA said, and the drug works to increase the number of circulating mature neutrophils and lymphocytes in patients.
This week, FDA published a new manual of policies and procedures (MAPP) detailing the prioritization of solicited drug master file (DMF) amendments associated with abbreviated new drug applications (ANDAs) or prior approval supplements (PAS) that are not concurrently under assessment. The new MAPP takes effect on 8 May 2024.
FDA has released several new meeting minutes from its discussions with industry related to the OTC Monograph Drug User Fee Program (OMUFA).
The agency advised patients and healthcare practitioners about the risk of intrahepatic cholestasis of pregnancy (ICP) for thiopurine drugs, azathioprine, 6-mercaptopurine, and 6-thioguanine. The drugs carry the risk for hepatotoxicity and their labels contain a warning about the risk of fetal harm when used during pregnancy. FDA said it is requiring manufacturers of these drugs to update their labels with additional information about their risks during pregnancy, including information about postmarketing cases of ICP reported in pregnant women taking the drugs and a recommendation that pregnant women stop taking the drugs if they develop ICP.
Earlier this week, the Center for Biologics Evaluation and Research (CBER) issued a final guidance for immediate implementation recognizing the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128, Version 4.0.0 for blood and blood component container labels.
On 16 August, FDA will host a meeting to review issues involved in conducting clinical trials of treatments meant to address the negative symptoms of schizophrenia.
CDER has published a new webpage dedicated to its recently announced Quantitative Medicine Center of Excellence (QM CoE) on Thursday.
Medtech
This week, FDA qualified the first digital health technology as a medical device development tool (MDDT), the Apple Atrial Fibrillation History Feature. The tool can be used as a biomarker to help evaluate AFib burden as a secondary endpoint in clinical trails of cardiac ablation devices.
The agency also sent warning letters four medical device makers, including three international firms and one domestic company, citing three of the firms, P.T. Sankei Medical Industries, Spectrum Medical Ltd, and Pinnacle BioLabs, for unapproved device and quality system regulation violations.
The fourth company, Gelderland, Netherlands-based Future Diagnostics Solutions B.V., was warned for corrective and preventive actions (CAPA), product controls, medical device reporting, among other issues raised during an inspection in January 2023.
Senseonics’ Eversense continuous glucose monitoring system was granted de novo authorization by FDA on Tuesday. The device is the first fully implantable CGM and has been designated an integrated CGM by the agency.
FDA announced three Class I medical device recalls this week, including for BioMérieux Inc.’s VITEK 2 AST Kit and SonarMed Inc.’s Airway Acoustic Sensors and Airway Monitors.
For more than a year, FDA Commissioner Robert Califf has touted the need for reforms to the agency’s advisory committee system following multiple high-profile decisions in which the agency moved against the recommendation of its committees. Now, the agency has announced a virtual meeting on 13 June to inform its moves to reform its policies and procedures for advisory committees. Among other things, the agency wants to know how it can change advisory committee processes to clarify that the committees’ votes are non-binding on the agency’s decisions.
“Although all decisions are made by FDA staff, the discussions that take place at advisory committee meetings are important pieces that are considered as part of the FDA’s decision-making,” said FDA Principal Deputy Commissioner Namandjé Bumpus.
The Federal Trade Commission (FTC) on Tuesday announced it has sent warning letters to 10 drugmakers, alleging that they improperly or inaccurately listed some 300 patents in the Orange Book. The affected drugmakers include AstraZeneca, Novo Nordisk, Boehringer Ingelheim, Covis Pharma, Glaxo-Smith Kline, Novartis, Teva, and Amphastar Pharmaceuticals.
“By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,” said FTC Chair Lina Khan. Califf added that “it is the responsibility of branded drug manufacturers to ensure that Orange Book submissions contain information only on the types of patents for which information should be submitted to FDA.”
The Associated Press on Tuesday reported that the Drug Enforcement Administration (DEA) plans to down schedule marijuana from Schedule I to Schedule III, which would open the door to companies looking to develop marijuana and marijuana-based products for FDA-regulated medical use.
Senate Finance Committee Chair Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) on Friday released draft legislation they say will help address prescription drug shortages. The discussion draft would create a new Medicare program for hospitals and doctors that would incentivize purchasing agreements the lawmakers say would be more “transparent, reliable, and resilient.”
The agency also announced that its medical product centers will host their annual Regulatory Education for Industry (REdI) conference on innovation in product development from 29-30 May.
Drugs & biologics
On Monday, FDA granted traditional approval to Seagen and Pfizer’s Tivdak (tisotumab vedotin-tftv) to treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The drug previously received accelerated approval for the same indication in September 2021.
Both the Office of New Drugs (OND) and Office of Translational Science (OTS) within the Center for Drug Evaluation and Research (CDER) released their 2023 annual reports this week.
FDA approved X4’s Xolremdi (mavorixafor) as the first drug to treat patients 12 or older with WHIM (warts, hypogammaglobulinemia, infections and myelokat) syndrome. Only about 60 cases of the disease have been reported in the medical literature, FDA said, and the drug works to increase the number of circulating mature neutrophils and lymphocytes in patients.
This week, FDA published a new manual of policies and procedures (MAPP) detailing the prioritization of solicited drug master file (DMF) amendments associated with abbreviated new drug applications (ANDAs) or prior approval supplements (PAS) that are not concurrently under assessment. The new MAPP takes effect on 8 May 2024.
FDA has released several new meeting minutes from its discussions with industry related to the OTC Monograph Drug User Fee Program (OMUFA).
The agency advised patients and healthcare practitioners about the risk of intrahepatic cholestasis of pregnancy (ICP) for thiopurine drugs, azathioprine, 6-mercaptopurine, and 6-thioguanine. The drugs carry the risk for hepatotoxicity and their labels contain a warning about the risk of fetal harm when used during pregnancy. FDA said it is requiring manufacturers of these drugs to update their labels with additional information about their risks during pregnancy, including information about postmarketing cases of ICP reported in pregnant women taking the drugs and a recommendation that pregnant women stop taking the drugs if they develop ICP.
Earlier this week, the Center for Biologics Evaluation and Research (CBER) issued a final guidance for immediate implementation recognizing the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128, Version 4.0.0 for blood and blood component container labels.
On 16 August, FDA will host a meeting to review issues involved in conducting clinical trials of treatments meant to address the negative symptoms of schizophrenia.
CDER has published a new webpage dedicated to its recently announced Quantitative Medicine Center of Excellence (QM CoE) on Thursday.
Medtech
This week, FDA qualified the first digital health technology as a medical device development tool (MDDT), the Apple Atrial Fibrillation History Feature. The tool can be used as a biomarker to help evaluate AFib burden as a secondary endpoint in clinical trails of cardiac ablation devices.
The agency also sent warning letters four medical device makers, including three international firms and one domestic company, citing three of the firms, P.T. Sankei Medical Industries, Spectrum Medical Ltd, and Pinnacle BioLabs, for unapproved device and quality system regulation violations.
The fourth company, Gelderland, Netherlands-based Future Diagnostics Solutions B.V., was warned for corrective and preventive actions (CAPA), product controls, medical device reporting, among other issues raised during an inspection in January 2023.
Senseonics’ Eversense continuous glucose monitoring system was granted de novo authorization by FDA on Tuesday. The device is the first fully implantable CGM and has been designated an integrated CGM by the agency.
FDA announced three Class I medical device recalls this week, including for BioMérieux Inc.’s VITEK 2 AST Kit and SonarMed Inc.’s Airway Acoustic Sensors and Airway Monitors.
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