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Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Senior Reporter Maaisha Osman and Editor-in-Chief Nielsen Hobbs consider the impact of the Health and Human Services Department’s temporary order allowing compounding of unapproved peptides on the drug industry (1:58), including whether stakeholder could use the precedent to gain access to other products (4:05). They also analyze HHS’ dismissal of US Food and Drug Administration safety concerns (11:28). In addition, the group discusses the Pharmaceutical Research and Manufacturers of America’s opposition to releasing complete response letters and the future of legislative efforts to codify the practice (19:52). More On These Topics From The Pink Sheet HHS Peptide Policy Brushes Off US FDA Safety Concerns As Hypothetical: https://insights.citeline.com/pink-sheet/compliance/manufacturing/hhs-allows-compounding-of-six-unapproved-peptides-UEKWZWETHFG4XJXTVA4VUNE3PU/ Peptides Compounding Would ‘Undermine’ US FDA Drug Approval Process, Ex-Agency Official Argues: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/peptides-compounding-would-undermine-us-fda-drug-approval-process-ex-agency-official-argues-7RZQLE3HJ5B4FMB3AUREB5LUZU/ US FDA’s Complete Response Letter Postings A Gift To Chinese Competitors, PhRMA Says: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/us-fdas-complete-response-letter-postings-a-gift-to-chinese-competitors-phrma-says-IJ2VETAAGND5NH6CXWADH3R6TU/

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the reasons Iilun Murphy, director of the US Food and Drug Administration’s Office of Generic Drugs, decided to step down (:53) and whether the move should concern senior agency officials (2:51). They also consider the FDA’s plan to create a fit-for-purpose rare disease approval framework (12:19), how it will connect with the agency’s litany of programs for the products (14:52) and the potential difficulties of systematizing regulatory flexibility (18:22).   More On These Topics From The Pink Sheet US FDA Generic Drugs Office Director Steps Down Amid ‘Political Pressure,’ Admin Burden: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/us-fda-generic-drugs-office-director-steps-down-amid-political-pressure-admin-burden-RSIU23LDWZETDO5XYPAAPCIKVM/ US FDA’s Rare Disease Framework Envisions Systematic Regulatory Flexibility: https://insights.citeline.com/pink-sheet/rare-diseases/us-fdas-rare-disease-framework-envisions-systematic-regulatory-flexibility-CKPMVFWBEVF3DNERAJBZZ23EYA/ US FDA Eyes Adaptive Rare Disease Framework To Replace Piecemeal Flexibilities: https://insights.citeline.com/pink-sheet/rare-diseases/us-fda-eyes-adaptive-rare-disease-framework-to-replace-piecemeal-flexibilities-JU2IHKV76ZHYXDZQBW23BE3FRI/

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter and Senior Reporter Maaisha Osman discuss the drama unfolding at the US Food and Drug Administration related to a Health and Human Services Department plan to temporarily allow some compounding of unapproved peptides (:52). They also consider the impact of the FDA’s intent to acknowledge individual NDA and BLA filings (13:00) and whether the policy will have to endure legal challenges (26:48), as well as the potential clinical trial requirements for the psychedelic ibogaine and their potential impact on product development (28:27). More On These Topics From The Pink Sheet US FDA Staff Push Back Against Trump Administration Interim Peptide Dispensing Order: https://insights.citeline.com/pink-sheet/product-reviews/approvals/us-fda-staff-push-back-against-trump-administration-interim-peptide-dispensing-order-KE3EBXDBNBDKBJBSOBF772HUAY/ Transparency Growing: US FDA Plans Reg Allowing NDA, BLA Filing Disclosure: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/transparency-growing-us-fda-plans-reg-allowing-nda-bla-filing-disclosure-5OR6R4R54VFWRBCUKXJOSVMXZQ/ US FDA Signals Cardiac Safety Monitoring Will Be Ibogaine’s Regulatory Hurdle: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/us-fda-signals-cardiac-safety-monitoring-will-be-ibogaines-regulatory-hurdle-LGD2YI6EW5GPLBWHUDM3FMUIT4/

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Senior Writer Cathy Kelly discuss the limited impact the US Centers for Medicare and Medicaid Services’ Global Benchmark for Efficient Drug Pricing (GLOBE) model after it was finalized with only a handful of participants (:58), as well as several other questions still being asked about it (10:24). They also consider the impact of the Food and Drug Administration eliminating voting privileges for some advisory committee consumer representatives (15:15), the Health and Human Services Department eliminating some of the FDA’s legal oversight (24:13), and the FDA reopening its search for a cell and gene therapy office director (27:28). More On These Topics From The Pink Sheet Shrinking GLOBE: Medicare Part B Model Seems Increasingly Unlikely To Advance: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/shrinking-globe-medicare-part-b-model-seems-increasingly-unlikely-to-advance-2MFLVAIRWRG7JDEZQP2AQ7VZMY/ Possible GLOBE Participants Down To Four ... And Counting: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/possible-globe-participants-down-to-four-and-counting-4UYTIWXLRNAMXEIR7JNTRCNR3Q/ US FDA Wants Advisory Committee Members, But Not Voting Consumer Reps: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-wants-advisory-committee-members-but-not-voting-consumer-reps-5V4SKVJFB5FJLG2GPKKZJXZVLY/ Reorg Cuts US FDA Chief Counsel Oversight Position At HHS: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/reorg-cuts-us-fda-chief-counsel-oversight-position-at-hhs-5VPOXSOOLRCCVPGWEI2XECL6UE/ US FDA Continues Search For Cell, Gene Therapy Office Director, Lowers Education Requirement: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/us-fda-continues-search-for-cell-gene-therapy-office-director-lowers-education-requirement-IXJCWUATZBHKZLOTNFSCJBOHYE/

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs dissect US Food and Drug Administration commissioner nominee Heidi Overton’s answers during her Senate confirmation hearing and dominant themes (:58), rate the potential for her confirmation (13:14), as well as consider her responses to particular controversial issues like mifepristone safety (16:06) and more practical issues like advisory committee meetings (21:23). They also look at the remaining hurdles for Overton’s bid to take control of the agency (24:40). More On These Topics From The Pink Sheet Overton Calls MMR Vaccine ‘Not Lethal,’ Defends Trump’s Claim As Outreach To Vaccine Skeptics: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/overton-calls-mmr-vaccine-not-lethal-defends-trumps-claim-as-outreach-to-vaccine-skeptics-TO3WNT3NUZGJ5IDRRUBDHF5CIA/ US FDA Commissioner Nominee Overton Says Adcomms ‘Critical,’ Hedges On Mifepristone Safety: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-commissioner-nominee-overton-says-panels-are-critical-hedges-on-mifepristone-safety-RGSODPP5IRHLDA7A26TGOZ7LRI/ Former FDA Commissioners’ Backing May Help Overton Amid Stakeholder Opposition: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/former-fda-commissioners-backing-may-help-overton-amid-stakeholder-opposition-66MIFWT47ZDKDLYEFSBHMUEOEE/

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Editor-in-Chief Nielsen Hobbs and Prevision Policy Founding Member Mike McCaughan consider the impact of Michael Davis and Karim Mikhail’s promotions to permanent directors of the US Food and Drug Administration’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, respectively (1:05), as well as the impact a new commissioner could have on the positions (3:20). They also discuss the FDA’s limited advisory committee schedule and the potential reasons recent senior leadership changes have not spurred more meetings (18:22). More On These Topics From The Pink Sheet US FDA Names Permanent CDER, CBER Directors, Creates AI Deputy Commissioner Post: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-davis-mikhail-gain-permanent-cder-cber-director-positions-47N2SXKPHRB6BCBFLJGUF3Y2NA/ US FDA Advisory Committee Meetings Remain Rare Despite Leadership Changes: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-advisory-committee-meetings-remain-rare-despite-leadership-changes-LD3DFLJYQFDVFCERZXRBVECY3M/

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Senior Reporter Maaisha Osman, and Editor-in-Chief Nielsen Hobbs discuss Heidi Overton’s financial and educational background as she begins navigating the path to US Food and Drug Administration commissioner confirmation (1:01), as well as an FDA incentive program that she would not be able to use to recruit additional staff should she get the job (23:05). They also consider the reasons for recent changes to the COVID-19 vaccine postmarketing trials (26:59). More On These Topics From The Pink Sheet US FDA Nominee Overton Left Hopkins Residency, Pushed ‘Conservative’ Science, Has Few Pharma Ties: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-nominee-overton-left-hopkins-residency-pushed-conservative-science-has-few-pharma-ties-KTW56Z3D7RGCBMR5FDLEPK7Y6U/ US FDA Scraps Program That Paid Bonuses For Completing Speedy Drug Reviews: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-scraps-program-that-paid-bonuses-for-completing-speedy-drug-reviews-JF5MQA73GJHDZADHXQSTB6JA2A/ US FDA Spikes COVID-19 Vaccine Postmarketing Trials Due To ‘Feasibility Challenges’: https://insights.citeline.com/pink-sheet/vaccines/us-fda-spikes-covid-19-vaccine-postmarketing-trials-due-to-feasibility-challenges-PS54RXHTEBAZDEEMDQY6264BLA/

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the potential differences between Most Favored Nation drug pricing agreements for small and mid-size companies and the largest pharmas (1:03), as well as the impact of potential vaccine policy changes on the US public health apparatus (15:10). More On These Topics From The Pink Sheet MFN Deal Impact Unclear As White House Ready To Announce Agreements With Mid-Size Pharmas: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/mfn-deal-impact-unclear-as-white-house-ready-to-announce-agreements-with-mid-size-pharmas-ECRFYU4TOVBSPG63U26CWI5FIM/ HHS Builds A Legal Firewall Around Its Next Vaccine Moves With RFI On Federal Categories: https://insights.citeline.com/pink-sheet/vaccines/hhs-builds-a-legal-firewall-around-its-next-vaccine-moves-with-rfi-on-federal-categories-5HILL2G52BE3PI5BJTJ4UZ76RI/

Pink Sheet Editor-in-Chief Nielsen Hobbs, executive editor Derrick Gingery, and senior reporter Maaisha Osman discuss new FDA commissioner nominee Heidi Overton, her prospects for confirmation, and what her pick means for the agency. More On The Topic From The Pink Sheet FDA Commissioner Nominee Has The White House’s Trust. Winning Over Career Staff Is Another Matter: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-commissioner-nominee-has-the-white-houses-trust-winning-over-career-staff-is-another-matter-IIZWK46CFVHMBIZF5XM7L4PQ6U/ Trump To Nominate White House Advisor Overton As FDA Commissioner: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/outgoing-georgia-congressman-buddy-carter-eyed-for-fda-commissioner-RHIYQUYTIVGRTFEXYCHCWPG54Y/

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the important provisions of the new prescription drug and generic drug user fee commitment letters (:53), including the revenue cut coming in PDUFA VIII (7:16), as well as the new formal meeting names (13:53) and “America First” incentives (23:47) in GDUFA IV. More On These Topics From The Pink Sheet US FDA Will Start PDUFA VIII Collecting Less Revenue, But Will Fees Drop?: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-will-start-pdufa-viii-collecting-less-revenue-but-will-fees-drop-3VJC34BDRZFHHMY5N5YIODQRZ4/ Generic Drug User Fee Deal Creates Domestic-Focused Incentives, Could Lower Application Fees: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/generic-user-fee-deals-creates-domestic-focused-incentives-could-lower-application-fees-UOG7BGF2YNA3NMWHLFMM2C2BFU/ Generic Drug User Fee Agreement Streamlines Meetings, Creates ‘Complex Issue’ Goal Extension: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/generic-drug-user-fee-agreement-streamlines-meetings-creates-complex-issue-goal-extension-TZFGYWV2VNCF3M7GJWPOJZ66SI/

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the impact of nationalism on the regulatory process, which entered the fray once again when news of a potential AstraZeneca-Bristol Myers Squibb merger broke (:58), as well as the US Food and Drug Administration’s IND reform pilot program (11:22), including the potentially influential role of external qualified research institutions (16:20) and the resources the pilot will require (20:29). More On These Topics From The Pink Sheet Oncology Overlap, Nationalism Cast Doubts On Potential AstraZeneca/BMS Merger: https://insights.citeline.com/pink-sheet/policy-regulation/oncology-overlap-nationalism-cast-doubts-on-potential-astrazenecabms-merger-NL65J53QYNF57GBW53AZGSYD54/ Merged AstraZeneca, BMS Would Have Deep Solid Tumor And Blood Cancer Portfolio: https://insights.citeline.com/pink-sheet/r-and-d/merged-astrazeneca-bms-would-have-deep-solid-tumor-and-blood-cancer-portfolio-IF4Z7IRHEFDIRDUAZTZP2PHEDM/ US FDA’s IND Reform Pilot Could Use External Partners To Speed Trial Set-Up: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/us-fdas-ind-reform-pilot-could-use-external-partners-to-speed-trial-set-up-7QU7Y7US4FCJRLRWZWV4CLCQBA/

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the impact of the US Food and Drug Administration clarifying that journal articles written by former commissioner Martin Makary and others were not official guidance (:58). They also discuss the questions an FDA commissioner nominee could field from Senators based on the recent confirmation hearing for President Trump’s US Centers for Disease Control and Prevention and Health and Human Services Assistant Secretary for Preparedness and Response nominees (15:12). More On These Topics From The Pink Sheet US FDA Says Two Makary, Prasad Journal Articles And NPV FAQ Were Not Policy Or Guidance: https://insights.citeline.com/pink-sheet/legislation/us-fda-says-two-makary-prasad-journal-articles-and-npv-faq-were-not-policy-or-guidance-6MCDQTKVXFG7TJ7IWOT6YMW4CA/ US CDC, ASPR Nominees’ Confirmations In Question After Contentious Senate Hearing: https://insights.citeline.com/pink-sheet/agency-leadership/us-cdc-aspr-nominees-confirmations-in-question-after-contentious-senate-hearing-3TX2W6HSXRACJELUX2CYY6ICVY/

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the implications of potential regulations that would cement the FDA’s presumption that it can release complete response letters (:49) and effectively ban direct-to-consumer advertising (18:45), as well as a potential reorganization to create a senior FDA position in charge of all medical products (29:23). More On These Topics From The Pink Sheet US FDA To Clarify, Expand ‘Significant Discretion’ To Publish CRLs: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/us-fda-to-clarify-expand-significant-discretion-to-publish-crls-NYZ2YV2DCFD6HDJ3XTLRZPXSRY/ US FDA Moves To Eliminate ‘Adequate Provision’ For DTC Broadcast Ads: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/us-fda-moves-to-eliminate-adequate-provision-for-dtc-broadcast-ads-5Y32BOH25JEXVLE4ES2JMFHYLQ/ HHS Considering US FDA Reorganization With Medical Products Chief Overseeing Centers: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/hhs-considering-us-fda-reorganization-with-medical-products-chief-overseeing-centers-7DSI2OHYUBHXTO73OBBDJW2QQA/

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman and Editor-in-Chief Nielsen Hobbs discuss the potential impact of the US Food and Drug Administration’s new updated guidance describing the one-trial plus confirmatory evidence standard for effectiveness (:47) and the significance of advancing yet another priority of former Commissioner Martin Makary (6:47). They also talk about the details of the agency’s planned pilot program to streamline IND clearances, including questions about the program’s feasibility. (14:08). More On These Topics From The Pink Sheet US FDA Rewrites Effectiveness Playbook, Positions Single-Pivotal-Trial Pathway As New Normal: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/us-fda-rewrites-effectiveness-playbook-positions-single-pivotal-trial-pathway-as-new-normal-XUVWF3SKQNANDMY4IW5SXTJZYE/ US FDA IND Reform Pilot Would Let ‘Qualified’ Outside Institutions Give Advice To Speed Approval: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/us-fda-ind-reform-pilot-would-let-qualified-outside-institutions-give-advice-to-speed-approval-RIPFHRJUERCULKXWCQMXW3PX3M/