This Week at FDA: Opioid labeling update, reorganization, and more
This Week at FDA | 15 December 2023 |
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 finalized safety labeling changes for opioid drugs, advanced a proposal to reorganize its human foods program and the Office of Regulatory Affairs and published several guidances.
On Friday, FDA signed off on safety labeling updates for opioids to add new statements, including warning patients and physicians that the risk of overdose increases with higher doses and noting that immediate-release opioids should not be used for long periods of time unless a patient is in severe pain that cannot be controlled by other means. Other updates include noting that many acute conditions may only require a few days’ worth of opioids and that extended-release/long-acting opioids should be reserved for severe and persistent pain.
“Approving these class-wide labeling updates facilitates safer use of these medicines and furthers our goal to reduce the risks of nonmedical use and overdose,” said Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research.
FDA also announced that it has sent its proposal to reorganize its Human Foods Program and the Office of Regulatory Affair to the Department of Health and Human Services (HHS) for review. The proposal includes creating a more consolidated process for handling consumer and whistleblower complaints and creating a new Office of the Chief Medical Officer to coordinate medical issues across product centers.
This week, FDA announced the creation of the Genetic Metabolic Diseases Advisory Committee that will include nine external voting experts who will be consulted on issues such as metabolic genetics, management of inborn errors of metabolism and metabolic diseases in small populations and children.
FDA launched a web page that will be used to publish details about the upcoming Over-the-Counter Medical User Fee Amendment (OMUFA II) negotiations set to begin in 2026. The user fee program is modeled after the Prescription Drug User Fee Amendment (PDUFA) program and was enacted as part of the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act.
STAT News reported that product recalls from FDA and the Consumer Product Safety Commission (CPSC) have more than doubled between 2018 and 2022. For FDA, the top reasons for recalls were due to allergens, foodborne illnesses, contamination and inadequate process and issues with packaging and labeling.
Drugs & Biologics
FDA published several drug and biologics guidances this week, including one on its Advanced Manufacturing Technologies Designation Program. It proposes how drugs and biologics sponsors can conform to requirements that make them eligible for the program.
It also issued a final guidance on how drug and biologics sponsors can present quantitative efficacy and risk information in direct-to-consumer (DTC) labeling and advertising. The agency also published a draft guidance on what clinical pharmacology information sponsors should consider including in their peptide drug product applications.
And, the agency updated its Study Data Technical Conformance Guide, which details recommendations on how drug sponsors can submit standardized study data that conform to the agency’s data standards as laid out in the FDA Data Standards Catalog.
Earlier this week, Moderna and Merck announced they have started a phase III trial of Moderna's mRNA V940 cancer treatment with Merck's Keytruda (pembrolizumab) to treat patients with non-small cell lung cancer (NSCLC). A few days later they announced positive results using the same combination treatment in a phase 2b trial to treat patients with stage III/IV melanoma following complete resection.
FDA announced the approval of a new indication for Merck’s Welireg (belzutifan) to treat advanced renal cell carcinoma following the use of a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).
The agency also approved USWM’s Iwilfin (eflornithine) to treat patients with high-risk neuroblastoma (HRNB) who have previously had a response to a multi-agent, multi-modality therapy, such as anti-GD2 immunotherapy. FDA said the approval is the first time a treatment has been approved to reduce the risk of relapse in children with HRNB.
Medtech
Over the past several years, FDA has increased its public-private partnership interactions through various collaborative communities. This week the Center for Devices and Radiological Health (CDRH) announced it has started participating in three new collaborative communities, including the AI Global Healthcare Initiative Collaborative Community, the Infection Management Collaborative Community and the Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD).
STAT News reported that the New England Journal of Medicine plans to launch an online journal focused on the use of artificial intelligence in clinical practice. It noted that the publication entitled, NEJM AI, will include review articles and policy perspectives.
Government & legislation
House lawmakers headed to recess this week without making progress on an FDA appropriations bill, though lawmakers on both sides of the aisle offered up other bills that would affect the agency.
Sens. Mike Braun (R-IN); Joe Manchin (D-WV); and Tammy Baldwin (D-WI) advanced a bill out of committee that would enable FDA to reject new drug applications for opioids that are not clinically superior to other drugs on the market.
Sen. Mark Kelly (D-AZ), Sen. Kyrsten Sinema (I-AZ) and Rep. David Schweikert, R-AZ, have proposed legislation that would boost research for Valley fever entitled the Finding Orphan-disease Remedies with Antifungal Research and Development (FORWARD) Act. The fungus that causes Valley fever is found in desert soil and infects the lungs and can be fatal.
Nine Republican senators wrote to FDA Commissioner Robert Califf criticizing FDA's standards for inspecting drugs and medical devices coming into the US and asked for more information on how the agency plans to improve the frequency of its inspections. Several Republican House committee leaders also wrote to Califf this week questioning the agency over its foreign drug inspections program.
With the announcement from Rep. Anna Eshoo (D-CA) that she plans to retire at the end of the term, it's unclear who will step into her post on the House Energy and Commerce (E&C) health subcommittee. However, Roll Call reports there are “early signs” Rep. Diana DeGette (D-CO) could succeed Eshoo on the committee.
FDA Law Blog, published by Hyman, Phelps & McNamara, noted that several Democratic governors wrote to President Joe Biden to ask him to reschedule cannabis from schedule I to a schedule III drug, noting that almost 9-in-10 Americans support the change. They argued the regulation and oversight of cannabis as a schedule III drug would ultimately make it safer and be a safer alternative to harder drugs such as illegal opioids.
Politico reported this week that the US Supreme Court has agreed to hear a case brought against FDA by the conservative group Alliance Defending Freedom that has argued the agency has overstepped its authority by allowing policies that let people order the abortion drug mifepristone online and receive them through traditional pharmacies.
The Biden administration this week announced it was going after the makers of 48 drugs that are covered under Medicare for raising prices faster than inflation. President Biden's Inflation Reduction Act (IRA) allows the federal government to penalize such companies if they are considered to raise drug prices unfairly.
Medtech Dive reported that the Biden White House and the Department of Health and Human Services (HHS) plan to develop minimum cybersecurity standards that stakeholders in the healthcare sector should conform to protect themselves from malicious actors. It also reported that the White House has already been working with HHS and the Centers for Medicare and Medicaid Services (CMS) to raise their own cybersecurity standards as part of their effort to improve cybersecurity across critical infrastructure sectors.
On Friday, FDA signed off on safety labeling updates for opioids to add new statements, including warning patients and physicians that the risk of overdose increases with higher doses and noting that immediate-release opioids should not be used for long periods of time unless a patient is in severe pain that cannot be controlled by other means. Other updates include noting that many acute conditions may only require a few days’ worth of opioids and that extended-release/long-acting opioids should be reserved for severe and persistent pain.
“Approving these class-wide labeling updates facilitates safer use of these medicines and furthers our goal to reduce the risks of nonmedical use and overdose,” said Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research.
FDA also announced that it has sent its proposal to reorganize its Human Foods Program and the Office of Regulatory Affair to the Department of Health and Human Services (HHS) for review. The proposal includes creating a more consolidated process for handling consumer and whistleblower complaints and creating a new Office of the Chief Medical Officer to coordinate medical issues across product centers.
This week, FDA announced the creation of the Genetic Metabolic Diseases Advisory Committee that will include nine external voting experts who will be consulted on issues such as metabolic genetics, management of inborn errors of metabolism and metabolic diseases in small populations and children.
FDA launched a web page that will be used to publish details about the upcoming Over-the-Counter Medical User Fee Amendment (OMUFA II) negotiations set to begin in 2026. The user fee program is modeled after the Prescription Drug User Fee Amendment (PDUFA) program and was enacted as part of the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act.
STAT News reported that product recalls from FDA and the Consumer Product Safety Commission (CPSC) have more than doubled between 2018 and 2022. For FDA, the top reasons for recalls were due to allergens, foodborne illnesses, contamination and inadequate process and issues with packaging and labeling.
Drugs & Biologics
FDA published several drug and biologics guidances this week, including one on its Advanced Manufacturing Technologies Designation Program. It proposes how drugs and biologics sponsors can conform to requirements that make them eligible for the program.
It also issued a final guidance on how drug and biologics sponsors can present quantitative efficacy and risk information in direct-to-consumer (DTC) labeling and advertising. The agency also published a draft guidance on what clinical pharmacology information sponsors should consider including in their peptide drug product applications.
And, the agency updated its Study Data Technical Conformance Guide, which details recommendations on how drug sponsors can submit standardized study data that conform to the agency’s data standards as laid out in the FDA Data Standards Catalog.
Earlier this week, Moderna and Merck announced they have started a phase III trial of Moderna's mRNA V940 cancer treatment with Merck's Keytruda (pembrolizumab) to treat patients with non-small cell lung cancer (NSCLC). A few days later they announced positive results using the same combination treatment in a phase 2b trial to treat patients with stage III/IV melanoma following complete resection.
FDA announced the approval of a new indication for Merck’s Welireg (belzutifan) to treat advanced renal cell carcinoma following the use of a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).
The agency also approved USWM’s Iwilfin (eflornithine) to treat patients with high-risk neuroblastoma (HRNB) who have previously had a response to a multi-agent, multi-modality therapy, such as anti-GD2 immunotherapy. FDA said the approval is the first time a treatment has been approved to reduce the risk of relapse in children with HRNB.
Medtech
Over the past several years, FDA has increased its public-private partnership interactions through various collaborative communities. This week the Center for Devices and Radiological Health (CDRH) announced it has started participating in three new collaborative communities, including the AI Global Healthcare Initiative Collaborative Community, the Infection Management Collaborative Community and the Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD).
STAT News reported that the New England Journal of Medicine plans to launch an online journal focused on the use of artificial intelligence in clinical practice. It noted that the publication entitled, NEJM AI, will include review articles and policy perspectives.
Government & legislation
House lawmakers headed to recess this week without making progress on an FDA appropriations bill, though lawmakers on both sides of the aisle offered up other bills that would affect the agency.
Sens. Mike Braun (R-IN); Joe Manchin (D-WV); and Tammy Baldwin (D-WI) advanced a bill out of committee that would enable FDA to reject new drug applications for opioids that are not clinically superior to other drugs on the market.
Sen. Mark Kelly (D-AZ), Sen. Kyrsten Sinema (I-AZ) and Rep. David Schweikert, R-AZ, have proposed legislation that would boost research for Valley fever entitled the Finding Orphan-disease Remedies with Antifungal Research and Development (FORWARD) Act. The fungus that causes Valley fever is found in desert soil and infects the lungs and can be fatal.
Nine Republican senators wrote to FDA Commissioner Robert Califf criticizing FDA's standards for inspecting drugs and medical devices coming into the US and asked for more information on how the agency plans to improve the frequency of its inspections. Several Republican House committee leaders also wrote to Califf this week questioning the agency over its foreign drug inspections program.
With the announcement from Rep. Anna Eshoo (D-CA) that she plans to retire at the end of the term, it's unclear who will step into her post on the House Energy and Commerce (E&C) health subcommittee. However, Roll Call reports there are “early signs” Rep. Diana DeGette (D-CO) could succeed Eshoo on the committee.
FDA Law Blog, published by Hyman, Phelps & McNamara, noted that several Democratic governors wrote to President Joe Biden to ask him to reschedule cannabis from schedule I to a schedule III drug, noting that almost 9-in-10 Americans support the change. They argued the regulation and oversight of cannabis as a schedule III drug would ultimately make it safer and be a safer alternative to harder drugs such as illegal opioids.
Politico reported this week that the US Supreme Court has agreed to hear a case brought against FDA by the conservative group Alliance Defending Freedom that has argued the agency has overstepped its authority by allowing policies that let people order the abortion drug mifepristone online and receive them through traditional pharmacies.
The Biden administration this week announced it was going after the makers of 48 drugs that are covered under Medicare for raising prices faster than inflation. President Biden's Inflation Reduction Act (IRA) allows the federal government to penalize such companies if they are considered to raise drug prices unfairly.
Medtech Dive reported that the Biden White House and the Department of Health and Human Services (HHS) plan to develop minimum cybersecurity standards that stakeholders in the healthcare sector should conform to protect themselves from malicious actors. It also reported that the White House has already been working with HHS and the Centers for Medicare and Medicaid Services (CMS) to raise their own cybersecurity standards as part of their effort to improve cybersecurity across critical infrastructure sectors.
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