This Week at FDA: WH reviewing candidates for FDA commissioner, Diamantas’ rare disease outreach, 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 Trump administration is reviewing candidates for FDA commissioner, the agency is trying to repair relations with the rare disease community, and Vanda will have an opportunity to defend its jet lag drug at a public hearing next month.
With the departure of former FDA Commissioner Marty Makary last month and the appointment of Kyle Diamantas as acting commissioner in his stead, FDA observers have been keen to learn who the Trump administration might nominate for a permanent role. While there has been some talk of Diamantas taking on the role, Endpoints News reported that, according to sources, he isn't interested in stepping up to the role on a permanent basis.
CNN reported on Thursday that Norman “Ned” Sharpless, who briefly served as FDA commissioner during President Trump's first term, is being considered again, along with some other candidates. Interestingly, Sharpless has been an outspoken critic of Health and Human Services Secretary Robert Kennedy Jr.'s vaccine policies.
Reuters reported that earlier this week, Diamantas met with representatives of rare disease groups in a bid to fix relationships after they soured under Makary after FDA declined to approve several rare disease treatments. Jeff Allen, CEO of Friends of Cancer Research, said the move exhibited "real leadership" and was a clear sign that the agency was repairing itself.
The Office of Management and Budget (OMB) noted that it is currently reviewing an FDA rule on a proposed pilot program to expedite the approval of investigational new drugs (IND). The agency received the rule for review on 3 June.
FDA is hosting a public hearing on 20 July to discuss a proposal to refuse to approve a supplemental new drug application (sNDA) 205677-004 from Vanda Pharmaceuticals for its non-24-hour sleep-wake disorder drug HETLIOZ (tasimelteon) to also treat jet lag disorder. The agency issued a complete response letter (CRL) in 2019 stating the sNDA was not approvable in its current form, and the company subsequently requested a hearing to argue its case.
FDA published several guidances this week, including a Level 2 guidance detailing the statutory and regulatory requirements for postapproval abbreviated new drug applications (ANDAs). It also points to other relevant guidances and resources that ANDA holders should use as references.
After publishing a much-anticipated guidance on human factors content last week, the FDA announced this week that its non-In Vitro Diagnostic (nIVD) and In Vitro Diagnostic (IVD) eSTAR platforms now include the contents of the guidance. While the guidance goes into effect on 1 August, the agency said sponsors can voluntarily start using the early submission request process in eSTAR (preSTAR).
FDA has issued a warning to consumers not to use over-the-counter (OTC) skin-lightening products because they may contain high levels of mercury and/or hydroquinone, which could lead to serious consequences, including kidney and neurological damage. The agency recommended consumers talk to their doctors before taking treatments for skin conditions and noted that it has not approved any OTC skin lightening products.
Earlier this week, FDA updated several of its webpages related to real-world evidence (RWE), including a page that lists examples of RWE being used in regulatory decision-making at the agency’s three medical product centers in the premarket and postmarket settings. The Center for Devices and Radiological Health (CDRH) also published a webpage that details its efforts to promote the use of RWE, including through guidance, training, and its efforts to develop the National Evaluation System for health Technology (NEST).
Drugs & Biologics
The Center for Biologics Evaluation and Research (CBER) has published two updated Standard Operating Policy and Procedures (SOPP). It updated an SOPP on how reviewers should respond to information request communications for pending applications. The agency update includes clarification that simple information requests (IR) do not need the committee chair’s review before issuing communication, the IR letters are to be signed by the regulatory project manager (RPM), and it removed a policy that allowed a supervisor to grant permission for experienced reviewers to send comments to the RPM without supervisory approval.
CBER also updated an SOPP on how it processes payments under the Prescription Drug User Fee Amendments (PDUFA) program. The agency said it updated terminology for exemptions, exceptions, and exclusions, corrected exception types, clarified which products are not subject to user fees, and made other clarifying edits.
The Center for Drug Evaluation and Research (CDER) announced it has accepted the first letter of intent (LOI) under its Innovative Science and Technology Approaches for New Drugs (ISTAND) DDT Qualification Program for an in silico drug development tool (DDT) intended to use artificial intelligence (AI) for a digital liver model to predict Drug-Induced Liver Injury (DILI). The agency noted that the New Approach Methodology (NAM) of the DDT aligns with its objective of minimizing animal testing in nonclinical settings.
Medtech
CDRH launched a series of courses for patients, healthcare providers, the medtech industry, and other stakeholders on medical devices and the role of patient advisors throughout the product life cycle. So far, the agency has published a video and accompanying resources on the topic and recommends that interested parties complete the course in one sitting, as it will not save their progress.
The device center recently announced it is classifying three orthopedic devices into class II (special controls) following submissions via the de novo pathway. The devices include absorbable metallic bone fixation fasteners, resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial, and shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis.
This week, FDA announced several recall-related actions, including two early alerts, a correction, and an update to an ongoing recall. The two early alerts include one for select lots of Insulet’s Omnipod Pods used with its insulin pumps and an early alert for Abiomed’s 14Fr Low Profile Catheter Introducer Kits.
In a correction posted on Wednesday, FDA said that Becton Dickinson is instructing customers not to use the Bupivacaine ampules provided in three of its BD Spinal Tray kits; the remaining components of the kits may still be used.
Lastly, in an update posted on Wednesday, FDA alerted patients, caregivers, and healthcare providers to recommend they consider using alternative treatment options to the Hintermann Series H3 Total Ankle Replacement due to a higher-than-expected risk of device failure and other issues observed with the device.
With the departure of former FDA Commissioner Marty Makary last month and the appointment of Kyle Diamantas as acting commissioner in his stead, FDA observers have been keen to learn who the Trump administration might nominate for a permanent role. While there has been some talk of Diamantas taking on the role, Endpoints News reported that, according to sources, he isn't interested in stepping up to the role on a permanent basis.
CNN reported on Thursday that Norman “Ned” Sharpless, who briefly served as FDA commissioner during President Trump's first term, is being considered again, along with some other candidates. Interestingly, Sharpless has been an outspoken critic of Health and Human Services Secretary Robert Kennedy Jr.'s vaccine policies.
Reuters reported that earlier this week, Diamantas met with representatives of rare disease groups in a bid to fix relationships after they soured under Makary after FDA declined to approve several rare disease treatments. Jeff Allen, CEO of Friends of Cancer Research, said the move exhibited "real leadership" and was a clear sign that the agency was repairing itself.
The Office of Management and Budget (OMB) noted that it is currently reviewing an FDA rule on a proposed pilot program to expedite the approval of investigational new drugs (IND). The agency received the rule for review on 3 June.
FDA is hosting a public hearing on 20 July to discuss a proposal to refuse to approve a supplemental new drug application (sNDA) 205677-004 from Vanda Pharmaceuticals for its non-24-hour sleep-wake disorder drug HETLIOZ (tasimelteon) to also treat jet lag disorder. The agency issued a complete response letter (CRL) in 2019 stating the sNDA was not approvable in its current form, and the company subsequently requested a hearing to argue its case.
FDA published several guidances this week, including a Level 2 guidance detailing the statutory and regulatory requirements for postapproval abbreviated new drug applications (ANDAs). It also points to other relevant guidances and resources that ANDA holders should use as references.
After publishing a much-anticipated guidance on human factors content last week, the FDA announced this week that its non-In Vitro Diagnostic (nIVD) and In Vitro Diagnostic (IVD) eSTAR platforms now include the contents of the guidance. While the guidance goes into effect on 1 August, the agency said sponsors can voluntarily start using the early submission request process in eSTAR (preSTAR).
FDA has issued a warning to consumers not to use over-the-counter (OTC) skin-lightening products because they may contain high levels of mercury and/or hydroquinone, which could lead to serious consequences, including kidney and neurological damage. The agency recommended consumers talk to their doctors before taking treatments for skin conditions and noted that it has not approved any OTC skin lightening products.
Earlier this week, FDA updated several of its webpages related to real-world evidence (RWE), including a page that lists examples of RWE being used in regulatory decision-making at the agency’s three medical product centers in the premarket and postmarket settings. The Center for Devices and Radiological Health (CDRH) also published a webpage that details its efforts to promote the use of RWE, including through guidance, training, and its efforts to develop the National Evaluation System for health Technology (NEST).
Drugs & Biologics
The Center for Biologics Evaluation and Research (CBER) has published two updated Standard Operating Policy and Procedures (SOPP). It updated an SOPP on how reviewers should respond to information request communications for pending applications. The agency update includes clarification that simple information requests (IR) do not need the committee chair’s review before issuing communication, the IR letters are to be signed by the regulatory project manager (RPM), and it removed a policy that allowed a supervisor to grant permission for experienced reviewers to send comments to the RPM without supervisory approval.
CBER also updated an SOPP on how it processes payments under the Prescription Drug User Fee Amendments (PDUFA) program. The agency said it updated terminology for exemptions, exceptions, and exclusions, corrected exception types, clarified which products are not subject to user fees, and made other clarifying edits.
The Center for Drug Evaluation and Research (CDER) announced it has accepted the first letter of intent (LOI) under its Innovative Science and Technology Approaches for New Drugs (ISTAND) DDT Qualification Program for an in silico drug development tool (DDT) intended to use artificial intelligence (AI) for a digital liver model to predict Drug-Induced Liver Injury (DILI). The agency noted that the New Approach Methodology (NAM) of the DDT aligns with its objective of minimizing animal testing in nonclinical settings.
Medtech
CDRH launched a series of courses for patients, healthcare providers, the medtech industry, and other stakeholders on medical devices and the role of patient advisors throughout the product life cycle. So far, the agency has published a video and accompanying resources on the topic and recommends that interested parties complete the course in one sitting, as it will not save their progress.
The device center recently announced it is classifying three orthopedic devices into class II (special controls) following submissions via the de novo pathway. The devices include absorbable metallic bone fixation fasteners, resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial, and shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis.
This week, FDA announced several recall-related actions, including two early alerts, a correction, and an update to an ongoing recall. The two early alerts include one for select lots of Insulet’s Omnipod Pods used with its insulin pumps and an early alert for Abiomed’s 14Fr Low Profile Catheter Introducer Kits.
In a correction posted on Wednesday, FDA said that Becton Dickinson is instructing customers not to use the Bupivacaine ampules provided in three of its BD Spinal Tray kits; the remaining components of the kits may still be used.
Lastly, in an update posted on Wednesday, FDA alerted patients, caregivers, and healthcare providers to recommend they consider using alternative treatment options to the Hintermann Series H3 Total Ankle Replacement due to a higher-than-expected risk of device failure and other issues observed with the device.
