[{"_1":2,"_111":-5,"_112":-5},"loaderData",{"_3":4,"_26":27},"root",{"_5":6,"_17":10,"_18":19,"_20":21,"_22":10,"_23":-5,"_24":-5,"_25":10},"user",{"_7":8,"_9":10,"_11":10,"_12":-5,"_13":-5,"_14":15,"_16":-5},"roles",[],"isAuthenticated",false,"isPremium","planName","subscriptionStatus","featureFlags",{},"insightsBudget","isDevelopmentHost","userPreferences",{},"recaptchaSiteKey","6LcvOJcUAAAAAHsB-gPGfGktcRlKpH7OTIU_dMTD","isImpersonating","impersonation","affiliateStatus","isFreedomPortal","routes/v2/article/layout",{"_28":29,"_30":31},"notFound",true,"relatedArticles",[32,75,87,99],{"_33":34,"_35":36,"_37":38,"_39":40,"_41":42,"_43":44,"_45":46,"_47":48,"_49":50,"_51":52,"_53":54,"_55":56,"_57":58,"_59":60,"_61":62,"_63":64,"_65":66,"_67":68,"_69":70,"_71":72,"_73":72,"_74":72},"mediaId",6211574,"mediaKeyId","3694954-cf3b7653cd38126eff345c7961a0b7bf","parentId",3694954,"title","Senators press FDA on childhood medication shortages and overseas inspections","audioSeconds",1075,"startMs",4170000,"endMs",5245000,"viewUrl","/Search/View?dp=1&key=3694954-cf3b7653cd38126eff345c7961a0b7bf&start=4170&end=5245","thumbnailUrl","https://assets.pipeline.soar.com/3694954-cf3b7653cd38126eff345c7961a0b7bf/thumbnail_4170000.jpg","articleUrl","/articles/6211574/Senators-press-FDA-on-childhood-medication-shortages-and-overseas-inspections","mediaUrl","https://secure.pipeline.soar.com/6211574-ab934f821c0f15d2bc5d22a52ead4d3f/orig.mp4?Expires=1774887135&Signature=B60z5lr8JnQfvlWVg1QghIdS8-Ry4p5e0EgNkDYiaIRcj2xxYoEomB74DtbITbYkFZ~9hyTCuXweoHEph2dvCVoCC9hFX742eFQ~6ojWR1IN723bzQxKU24gdcAqRVMuk-ikCvfHOLi0cH2gaMMrQzS1ol5I3ThJXjaDa3oLm2WcnSjyLakGbYrcK8s3fDgwYaTS0UeTlY7cbqYyxgTIU4sio~enOTnhU-PX3WXnPAQC9aBj8przm5uW5ER-ojrYNyHV0Mclo-29Ge-fyNfX0dzjv89SdKWAhW6tOt3p46eW8qaeGsTPryo-IOuOM~4ULItz9XfhknOu5w8NQu~xWg__&Key-Pair-Id=KUT5TJCACFTXG","author","U.S. Senate Committee on Health, Education, Labor, and Pensions","date","2025-06-04T00:00:00Z","article","Senators raised concerns about supply‑chain disruptions for common over‑the‑counter medications, oversight of overseas manufacturing and the agency's ability to detect demand‑driven shortages.

Lede: Senator Maggie Hassan and others told the committee recent winters produced shortages of children's acetaminophen and ibuprofen, leaving families without commonly used medicines. Dr. Jacqueline Corrigan said FDA shortage staff worked to resolve the 2023 market strain and that the agency has authorities to address interruptions in manufacturing and active pharmaceutical ingredient supply but lacks equivalent mandatory reporting for increased demand.

Nut graf: The exchange focused on how to improve early warning signals and whether additional reporting requirements for demand surges could help FDA act earlier to prevent shortages. Senators also asked how FDA prioritizes inspections of foreign facilities that manufacture OTC products sold in the United States.

Key points from the hearing: Corrigan said in 2024 FDA recorded 11 new shortages and that the agency prevented more than 250 prospective shortages through early actions. She told senators that existing law requires reporting when a firm expects an interruption in supply (for example, manufacturing problems or API shortages), but there is no mandatory reporting requirement for manufacturers to notify FDA in advance of sudden increases in demand.

On inspections, Corrigan said the agency uses a risk‑based model for domestic and foreign inspections and will update that model under AMUFA to better account for OTC monograph facilities. She noted a procedural difference under AMUFA compared with other user‑fee programs: in some other programs FDA can inspect a facility at a defined time point before a product reaches market, while in the OTC monograph space firms may begin distribution and FDA may then assess facilities, prompting record requests and targeted inspections.

Senator Banks raised concerns about contaminated nonsterile eye drops from overseas and sought FDA warning letters and follow‑up; Corrigan said the agency monitors adverse events, issues warning letters and conducts inspections as part of its risk‑based approach.

What's next: Senators asked FDA to consider statutory or regulatory changes to provide earlier signals for demand surges and to strengthen inspection prioritization; Corrigan said the agency will consider those proposals and update its risk model and record‑request processes under reauthorization commitments.

Ending: The committee signaled bipartisan interest in tightening supply‑chain surveillance and clarifying inspection authorities for OTC manufacturers selling into the U.S. market.

","mediaType","Video","parentTitle","Reauthorization of the Over-the-Counter Monograph Drug User Fee Program ","oneSentenceSummary","Lawmakers questioned FDA CDER acting director about past shortages of children's fever and pain medicines, reporting gaps for demand spikes, and how the agency prioritizes overseas inspections and facility assessments.","taxTitle","Health, Education, Labor, and Pensions: Senate Committee, Standing Committees - House & Senate, Congressional Hearings Compilation, Legislative, Federal","taxId",1995,"location","","headline","shortSummary",{"_33":76,"_35":36,"_37":38,"_39":77,"_41":78,"_43":79,"_45":80,"_47":81,"_49":82,"_51":83,"_53":84,"_55":56,"_57":58,"_59":85,"_61":62,"_63":64,"_65":86,"_67":68,"_69":70,"_71":72,"_73":72,"_74":72},6211578,"Senators question FDA on decades‑long delay approving new sunscreen filters",2219,2221000,4440000,"/Search/View?dp=1&key=3694954-cf3b7653cd38126eff345c7961a0b7bf&start=2221&end=4440","https://assets.pipeline.soar.com/3694954-cf3b7653cd38126eff345c7961a0b7bf/thumbnail_2221000.jpg","/articles/6211578/Senators-question-FDA-on-decadeslong-delay-approving-new-sunscreen-filters","https://secure.pipeline.soar.com/6211578-69cc3a6eef254a4b3041e86f3c769bc1/orig.mp4?Expires=1774887135&Signature=g5WmoEfkIE3yjaWMzl31rfXs1hpDVi2d8~GXlKijEvcfKUf0ilkPU6JqI1qCiT9zX6H09aFRIkfCwR6lEzxzxBEZTFO51idJEybJdGzOa60pXw3o0DP0IcX3HK48pbILv4nclI2XK4b-y6S9mgu7~OeOYuNwTvd2RdFHEpg9H9fdq35MYUpbZNvDGadPjuyDJ7KDCNKjd9DQAm0jwuvKfThTcSkUKZhFnFhd5DCCzClyjnNn5Jg3jXMxjbrs-cUrTWiD3burVT7b~CdNoVCHraemlBUWdnmDw3p4sCKrbdV1tjMU2PeaykYfjslDtopgFHeOVWu~CK3YoOFNNVwpNg__&Key-Pair-Id=KUT5TJCACFTXG","Senators at a Senate HELP hearing pressed the acting director of the FDA's Center for Drug Evaluation and Research about why the United States has not approved a new sunscreen UV filter since 1999 and what steps the agency is taking to accelerate safe approvals.

Lede: \"Is it correct that the FDA has not approved a new filter since 1999?\" Senator Roger Marshall asked. Dr. Jacqueline Corrigan confirmed the factual point and told the committee that the agency has a proposed OTC monograph order under review for a new sunscreen ingredient.

Nut graf: The exchange highlighted scientific and regulatory considerations that distinguish U.S. sunscreen review from processes in Europe and Asia. Senators emphasized the public health value of broad sunscreen availability and pressed the agency for timetables and alternative testing strategies to evaluate systemic absorption and long‑term safety.

Details and agency position: Corrigan explained that sunscreen active ingredients are regulated as drugs in the United States because they are intended to prevent sun‑related skin damage and that ingredients with systemic absorption require additional testing. \"Any drug that we approve that's topical but that has systemic absorption, we need to make sure that the systemic absorption has no untoward effects,\" she said, citing concerns such as endocrine disruption and tumor formation tests as part of required data packages.

Corrigan told senators the agency is reviewing an administrative order for a new sunscreen ingredient and will follow its planned timeline: a public comment period (45 days) and, for new ingredient reviews, a statutory review trajectory Corrigan said runs about 17 months. She added the agency is exploring alternative test methods and non‑animal approaches when validated.

Senators pressed for speed and safety. Senator Ashley Moody (R‑Fla.) noted high Florida sun exposure and tourism and called for an \"expeditious\" review; Corrigan said the agency will \"review that on time\" and meet the statutory goals for the submission under review. Senator Mike Marshall and others asked for clarity on the tests the agency requires and whether international use of other filters implies U.S. safety; Corrigan said international differences in classification and the absence of comparative effectiveness data mean foreign approvals are not a substitute for the FDA's required systemic‑safety data.

What's next: Corrigan said the agency will continue to request data from sponsors, pursue validated alternative test methods where appropriate, and complete the current monograph order review on its timetable. Senators asked for follow up on timelines and whether the agency can promote alternate test methods to accelerate review while ensuring safety.

Ending: The committee recorded bipartisan interest in quicker sunscreen approvals paired with rigorous safety data; the agency committed to follow up with additional details on its review timeline and testing expectations.

","Committee members pressed the FDA on why no new sunscreen UV filters have been approved since 1999 and sought timelines for the agency's current review and safety testing approach; acting CDER director said a new OTC order is under review and described testing expectations for systemic absorption.",{"_33":88,"_35":36,"_37":38,"_39":89,"_41":90,"_43":91,"_45":92,"_47":93,"_49":94,"_51":95,"_53":96,"_55":56,"_57":58,"_59":97,"_61":62,"_63":64,"_65":98,"_67":68,"_69":70,"_71":72,"_73":72,"_74":72},6211583,"Senators press FDA acting CDER director on workforce reductions and transparency",2236,1403000,3639000,"/Search/View?dp=1&key=3694954-cf3b7653cd38126eff345c7961a0b7bf&start=1403&end=3639","https://assets.pipeline.soar.com/3694954-cf3b7653cd38126eff345c7961a0b7bf/thumbnail_1403000.jpg","/articles/6211583/Senators-press-FDA-acting-CDER-director-on-workforce-reductions-and-transparency","https://secure.pipeline.soar.com/6211583-f9b551f2f0036d4b2220b8b3cdfef8b3/orig.mp4?Expires=1774887135&Signature=fz5Z5SbVRKcZeyADPism~lYnlRSl7BrdpHc5eBsZm2SbL~irdyi~dm-cRA6dV5qf4YR9FO~nfw3SadTBDffyZ42v5f6iq4XQg~VYxENdcikrhW~2IF3ffcrkZLg73hHdkPaDEzdzbFAgxVIxLXtsqINPBwxCh9FIoGUDP6on9mmFv0RDx5j5prJ~ngbU2uLPJuA6Ac~uIHw1YqhtgUL2Yz0rLXcW-vQwDQqVOu5SHIjWMjG9KUz6IptoOb7HwNUW7ppvLAiP6-rrrHzO7KYntEuPhGZvAfG0YMVJS0vr1Y0pwbdMXljtm5Dqdm~XMaQ4SXEwdN915fzrGYtQA6Rk6A__&Key-Pair-Id=KUT5TJCACFTXG","Senators from both parties used a Senate HELP Committee hearing on OTC drug policy to press the acting director of the FDA's Center for Drug Evaluation and Research (CDER) about recent agency workforce reductions and transparency.

Why it matters: Lawmakers warned that staff losses could slow reviews, inspections and other safety functions across FDA programs including OTC monographs, generics and new‑drug reviews. Several senators asked for precise counts of employees affected and how many were veterans; CDER's acting director repeatedly said litigation surrounding the reduction in force (RIF) limits what she can discuss.

Key exchanges: Senator Tim Kaine (D) said \"since the administration took office, 20,000 employees at the Department of Health and Human Services have been dismissed\" and that \"this includes over 3,500 FDA staff currently on administrative leave,\" and asked how the decisions were made and what the impact would be on CDER. Corrigan said she could not comment on specifics because of pending litigation and a preliminary injunction related to the RIF.

Senator Edward Markey (D) described reports from industry that reviews had slowed and said some firms report delays and uncertainty. Senator Angus King and others emphasized the oversight committee's need for basic personnel data to exercise congressional oversight. Corrigan repeatedly offered to provide additional information \"when that litigation is resolved\" and said reviewers remain in place and that CDER is \"meeting our timelines\" though she acknowledged occasional misses for complex reviews.

Transparency concerns extended beyond employee counts. Senators asked about Freedom of Information Act staffing, advisory committee use, and whether the FDA has retained the capacity to process incoming submissions and inspections. Corrigan said CDER continues to carry out core functions, emphasized ongoing efforts to preserve critical review capacity, and said agency leadership was working to allow targeted hires even amid a hiring freeze.

What's next: Multiple senators requested follow‑up documents and numbers on affected staff, veterans, and agency timeline performance. Corrigan said CDER would provide additional information when not restricted by ongoing litigation.

Ending: The hearing left unresolved questions on the full scope of personnel changes and their operational impact; senators indicated they would pursue written follow‑ups and documentary requests.","Multiple senators raised concerns about recent workforce reductions at HHS and the FDA and sought data on the effects of those cuts on reviews and program performance; Dr. Jacqueline Corrigan said litigation limits what she can disclose but defended continued review activity.",{"_33":100,"_35":36,"_37":38,"_39":101,"_41":102,"_43":103,"_45":104,"_47":105,"_49":106,"_51":107,"_53":108,"_55":56,"_57":58,"_59":109,"_61":62,"_63":64,"_65":110,"_67":68,"_69":70,"_71":72,"_73":72,"_74":72},6211588,"Senate HELP hearing presses for reauthorization of OTC monograph user fee program",697,1141000,1838000,"/Search/View?dp=1&key=3694954-cf3b7653cd38126eff345c7961a0b7bf&start=1141&end=1838","https://assets.pipeline.soar.com/3694954-cf3b7653cd38126eff345c7961a0b7bf/thumbnail_1141000.jpg","/articles/6211588/Senate-HELP-hearing-presses-for-reauthorization-of-OTC-monograph-user-fee-program","https://secure.pipeline.soar.com/6211588-b0344e6af77a2e18c7847db9fb32dca0/orig.mp4?Expires=1774887135&Signature=EpGfvpkNM~oQBndNGVvq9Jl9Dqa8zeQaHVLKZfC-8xuDnM-23GhMAOmauVBUpW0ifnSoZSwYZIZcLhuglZOpMP9GWy~VwhIGTX5EelLr6WPj128uhp69I9NthG5ho1UCYEnjWHlGDkWtnFEF5xBSLJDC3pn9ibPqdVtrCOMBm2wwwWpVou-OfiKT4DrfVPtUVteZBxLTW4XF-ogGs2TjHbJPPF0PeqOnh5p7~C~TUjPjKpMHIZApyT8hZSSmbZFpRuohY5YILW6WZQK18VuC6xs0Kv1IvtvPUjTm1yUv1y2CQhXG5fLm38vBcCqZPZLV5MBeWGwzbLonOSKcE8DA5w__&Key-Pair-Id=KUT5TJCACFTXG","The Senate Committee on Health, Education, Labor, and Pensions heard testimony urging Congress to reauthorize the Over‑the‑Counter (OTC) Monograph User Fee Program, commonly referred to in testimony as AMUFA, before it expires at the end of the fiscal year.

Acting director Jacqueline Corrigan of the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) told the committee the program has helped modernize OTC review and bring new tools to consumers. \"These are the products that millions rely on every day,\" Corrigan said, and argued that AMUFA'funded staff and processes are needed to maintain safety and continue innovation.

Why it matters: Senators from both parties framed AMUFA as a public‑health and consumer‑protection tool that also affects drug cost and availability. Supporters said the reauthorization would preserve staffing and the new administrative‑order pathway that allows FDA to clarify what is required to market OTC drugs, while opponents and questioners pressed the agency on its pace and resource needs.

Corrigan summarized accomplishments under the program: electronic submission pathways, five guidance documents, 33 final orders and five proposed administrative orders posted to date, and 85 staff hired to support OTC work. She said AMUFA enabled consideration of new dosage forms (chewables, orally dissolving tablets, films) and an administrative order pathway that can permit new sunscreen ingredients to be reviewed under an OTC framework. \"If Congress does not authorize a MUFA this year, the momentum would come to a grinding halt,\" Corrigan testified.

Committee members asked how AMUFA would be used going forward and pressed for measurable accountability. Senator Roger Marshall (R) asked whether the agency uses a dashboard of performance metrics; Corrigan responded that the agency tracks commitments and timelines and plans a three‑year agenda and public forecast to show progress. Several senators asked for specifics on AMUFA commitments, including staffing targets in a previously negotiated commitment letter; Corrigan cited a hiring freeze but said FDA leadership was working to permit hiring of needed reviewers.

Discussion also focused on how AMUFA could expand Rx‑to‑OTC switches. Corrigan described a forthcoming rule permitting conditions of use beyond the Drug Facts label (for example, an app or screening questions) when labeling alone is insufficient to ensure safe self‑selection. She said that such a rule could broaden the set of drugs eligible to go OTC without Congress changing statutes.

Several senators highlighted the tradeoff AMUFA addresses between faster OTC access and safety. Senator Tim Kaine (D) noted the program's role in cost savings and cautioned that OTC medications can cause adverse events: \"Older adults represent one third of over the counter drug users and over 65 percent of these adverse drug events,\" he said, pressing the need for oversight.

What's next: Corrigan asked Congress for timely reauthorization and described voluntary agency commitments in a negotiated AMUFA agreement designed to expand transparency, meeting management with sponsors, and investments in product quality and safety. Committee members requested follow‑up materials, including performance metrics and clarification of timelines for priority items such as pediatric acetaminophen weight‑based dosing.

Ending: The committee set a written question deadline for follow ups and indicated interest in marking up bipartisan reauthorization language that would renew and refine AMUFA oversight.

","Acting CDER director Jacqueline Corrigan urged reauthorization of the OTC Monograph User Fee Program (AMUFA), saying the program modernized review of over‑the‑counter drugs but must be renewed to preserve staff and momentum.","actionData","errors"]

Article not found

Senators press FDA on childhood medication shortages and overseas inspections

Senators question FDA on decades‑long delay approving new sunscreen filters

Senators press FDA acting CDER director on workforce reductions and transparency

Senate HELP hearing presses for reauthorization of OTC monograph user fee program