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    Drug preclusion and public health: The case for a narrow interpretation of ‘article’

    The definition of “dietary supplement” in the Food, Drug, and Cosmetic (FD&C) Act includes several provisions limiting what can be a legal dietary supplement based on the ingredients used and delivery form, as well as whether a substance has a history of drug use. This article explores the US Food and Drug Administration’s (FDA’s) use of this last provision, often called “drug preclusion.” The authors examine the history of the provision, Congress’s purported purpose for ...
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    ICH M12: Pharma industry wants clarity on rifampin dosing, more information on biomarkers

    The pharmaceutical industry would like the International Council for Harmonization (ICH) to clarify dosing information for rifampin and requests additional information on the use of biomarkers as a type of drug-drug interaction study (DDI), while the Pharmaceutical Research and Manufacturers of America (PhRMA) and Pfizer want more flexibility in developing a DDI strategy.   The comments were made in response to the US Food and Drug Administration’s (FDA) call for feedb...
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    FINALIST Maximizing the potential of the FDA assessment aid: Genentech’s experience

    The assessment aid (AAid), an initiative of the US Food and Drug Administration’s (FDA’s) Oncology Center of Excellence (OCE), was introduced in 2018 as a pilot program to help streamline the agency’s review of oncology drug applications. In this article, Genentech shares its experience with the AAid to date and provides recommendations for preparing the AAid and improving the process to fully realize its benefits. Keywords – assessment aid, FDA OCE pilots, oncology dr...
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    Pharma groups: FDA is exceeding its authority in risk management plan guidance

    The US Food and Drug Administration’s (FDA) draft guidance on risk management plans (RMPs) has overstepped the agency’s statutory bounds in requiring manufacturers of active pharmaceutical ingredients (APIs) as well as prescription drug manufacturers to submit risk management plans (RMPs) to avert drug shortages.   This requirement could impose the very drug shortages it is designed to prevent, instead of just targeting those products at risk of drug shortage, pharmace...
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    OPQ’s FY2021 report gives mixed review on state of drug quality

    The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) lists both negative and positive trends in its new report assessing the state of pharmaceutical quality in FY2021. Among the setbacks are the increasing number of drug recalls, under-reporting of quality issues in field alert reports (FARs) and a growing number of products failing sampling tests.   On the bright side, OPQ said its New Inspection Protocol Project (NIPP) program has increa...
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    FDA prevented record number of drug shortages in 2021

    The US Food and Drug Administration (FDA) prevented 317 drug shortages in 2021, the highest number since the agency began tracking drug shortages in 2012, according to a recent report released by the agency.   The agency’s Center for Drug Evaluation and Research (CDER) has been tracking drug shortages since the Food and Drug Administration Safety and Innovation Act (FDASIA) was passed in 2012, which requires FDA to release an annual report to Congress; FDA’s Center f...
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    FDA’s Office of Compliance details enforcement actions in 2021

    The US Food and Drug Administration (FDA) Office of Compliance (OCC) issued numerous enforcement discretion decisions to increase supplies of critically needed medicines for treating COVID-19 and increasingly relied on the use of inspection alternatives, such as product sampling and reviewing firms’ written response to records, instead of traditional onsite inspections in 2021.   These are some of the areas highlighted in OCC’s latest annual report released 2 May, de...
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    Quality metrics: FDA wants feedback on pared-down program

    The US Food and Drug Administration (FDA) on Wednesday outlined a pared-down plan to collect quality metrics data from drugmakers in an attempt to renew its earlier stalled effort to obtain manufacturing quality data as a means of mitigating potential drug shortages and promoting enhanced quality management in the pharmaceutical industry.   The agency stressed in an announcement that this program would be different from the original quality metrics draft guidance unv...
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    NASEM report: FDA should disclose drug and device manufacturing information

    To ensure resiliency in the medical supply chain, the US Food and Drug Administration (FDA) should publicly disclose the location of all manufacturing facilities that supply ingredients and parts for pharmaceuticals and medical devices approved in the US, according to a consensus study report from the National Academies of Science, Engineering and Medicine (NASEM).   This is one of seven recommendations in a 365-page report on building supply chain resiliency. The re...
  • Regulatory NewsRegulatory NewsRAPSRAPS' Latest

    Orphan drug experts discuss new book on developing rare disease treatments

    Developing therapies for rare diseases involves complex incentives, unique requirements, and often extensive patient engagement. The authors of RAPS’ Orphan Drug Development for Rare Diseases , Sundar Ramanan, PhD, MBA, and Sunny Kamlesh Dave, MPharm, recently took time to discuss with RAPS Senior Editor Gloria Hall the importance of orphan drugs, the peculiarities and challenges of obtaining an orphan drug designation (ODD), and what is covered in the book. During a “m...
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    December’s Regulatory Focus: Advertising, promotion, and labeling

    Feature articles during December focused on advertising, promotion, and labeling (APL), examining regulatory review of advertising on streaming media, the role of the regulatory A&P professional, the importance of metrics in APL, and the regulatory outlook for telehealth A&P. Also included is the second part of a two-part series on EU regulation of herbal products, examining quality, safety and efficacy, and postmarket surveillance.   Last year this time, the issue co-...
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    The regulatory outlook for telehealth advertising and promotion

    The global pandemic has increased the use of telehealth and accelerated its acceptance into mainstream healthcare. However, the regulatory landscape has yet to fully catch up with this expansion of telehealth. This article discusses some of the potential advertising and promotional regulatory implications as telehealth becomes a mainstay in the ever-evolving healthcare sector. The article explores the advertising and promotion of off-label drug prescriptions by telehealth ...