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    FDA’s accelerated approval program: Is change on the way?

    The U.S. Food and Drug Administration (FDA) launched its accelerated approval program in 1992, offering a pathway to bring life-saving drugs and biologics to the market faster. After nearly 30 years, could substantial reforms be on the way?   At RAPS Convergence 2021, David Dorsey of Janssen R&D, said Congress could choose to make changes to the accelerated approval program through the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA). Congress has...
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    CBO: Proposed Medicare pricing plan could curb drug development

    A new drug development model released by the Congressional Budget Office (CBO) estimates a Medicare drug pricing bill like the one proposed by Democrats in the US House of Representatives could result in between 21 and 59 fewer drugs brought to market over the next three decades.   The Elijah E. Cummings Lower Drug Costs Now Act ( H.R. 3 ), introduced in the 116th Congress during the 2019-2020 legislative session, would require the Secretary of Health and Human Servi...
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    Pazdur mounts defense of accelerated approval during Cures 2.0 panel

    During a listening session convened by the Friends of Cancer Research (FOCR) with Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) on their nascent Cures 2.0 package, Richard Pazdur, director of the US Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) defended the agency’s accelerated approval program.   (RELATED: Cures 2.0: Discussion draft signals impact on FDA, creation of ARPA-H , Regulatory Focus 23 June 2021)   Asked by DeGette w...
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    FDA defends Aduhelm's accelerated approval, while others call for reform

    Three papers published as Viewpoints in JAMA Internal Medicine this week highlight the rationale provided by the US Food and Drug Administration (FDA) on the agency’s approval of aducanumab (Aduhelm; Biogen Inc), implications the approval could have for the Medicare program, and a contemplation on the future of FDA’s accelerated approval pathway.   Writing on behalf of FDA, Billy Dunn, MD, director of the Office of Neuroscience with FDA, and colleagues said the agenc...
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    FDA focuses on efforts made to avert drug shortages in 2020

    New drug shortages in the US decreased in 2020, in part because of the US Food and Drug Administration’s (FDA’s) use of enforcement discretion to ensure an uninterrupted supply of critical medical products during the COVID-19 public health crisis.   Yet, the agency’s new drug shortages report to Congress said that while these actions helped avert shortages in the short-term, more work is needed to improve supply chain resiliency.   This report summarizes the agency...
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    EMA consults on ICH S12 guideline, shares comments on PFDD reflection paper

    The European Medicines Agency (EMA) on Thursday opened a public consultation on the International Council for Harmonisation’s (ICH) S12 guideline on nonclinical biodistribution (BD) considerations for gene therapies.   The S12 guideline recently reached Step 2b of the ICH process after being endorsed at the ICH Assembly virtual meeting earlier this month. (RELATED: ICH reports ‘significant milestones’ reached on guidelines ranging from impurity testing to eCTD standa...
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    FDA to study disclosure information for accelerated approval products in oncology

    The Office of Prescription Drug Promotion (OPDP) at the US Food and Drug Administration (FDA) wants to know how to better present disclosure information about products with accelerated approval to patients with cancer and their caregivers.   In two studies recently announced in the Federal Register , OPDP is seeking to confirm prior research on how patients interpret disclosure information for a product approved under FDA’s accelerated approval pathway on a direct-to-...
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    FDA calls in adcomm to review six more oncology accelerated approvals

    After drugmakers voluntarily withdrew four indications for their cancer drugs in recent months, the US Food and Drug Administration (FDA) on Thursday said it would convene an advisory committee to review six more oncology indications with accelerated approval after confirmatory trials failed to verify their clinical benefit.   Over the course of three days in April, FDA’s Oncology Drugs Advisory Committee (ODAC) will review six indications for Roche’s Tecentriq (atezol...
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    Industry-wide accelerated approval review yields four withdrawals

    Since late December, four drugmakers have voluntarily withdrawn indications for their cancer drugs amid an industry-wide review of accelerated approvals by the US Food and Drug Administration’s (FDA) Oncology Center of Excellence.   In each of their statements announcing the withdrawals, Bristol Myers Squibb, AstraZeneca, Merck and Roche said the withdrawal decisions were made in consultation with FDA as part of an industry-wide review of accelerated approvals with con...
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    FDA pilots program to encourage new drug development tools

    The US Food and Drug Administration (FDA) on Monday announced it will pilot a new program it hopes will spur the development of novel drug development tools (DDTs) that do not fit within the agency’s existing DDT qualification programs.   The qualification process for DDTs was revamped under the 21 st Century Cures Act and FDA currently offers specific qualification programs for biomarkers, clinical outcome assessments (COAs) and animal models for use under the Anim...
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    Updated: FDA delays collection of drug manufacturing volume data

    The US Food and Drug Administration (FDA) on Monday announced it will not begin collecting drug manufacturing volume data next month as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).   Section 3112 of the CARES Act establishes new reporting requirements for drug manufacturers intended to improve the response to drug shortages, including expanding shortage reporting requirements for life-saving drugs to include drugs that are “critical...
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    Regulators discuss accelerated approvals, Project Orbis at DIA

    Regulators from the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada gave their perspectives on different issues related to accelerated approval pathways in their respective jurisdictions at the DIA Global Annual Meeting.   All three regulators offer their own form of accelerated approval based on less comprehensive clinical data than a traditional marketing approval would require. In the US, that pathway is dubbed accelerated ap...