Browsing by keyword "FDA"
Now showing items 1-3 of 3
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A critical review of methods to evaluate the impact of FDA regulatory actionsPURPOSE: To conduct a synthesis of the literature on methods to evaluate the impacts of FDA regulatory actions and identify best practices for future evaluations. METHODS: We searched MEDLINE for manuscripts published between January 1948 and August 2011 that included terms related to FDA, regulatory actions, and empirical evaluation; the review additionally included FDA-identified literature. We used a modified Delphi method to identify preferred methodologies. We included studies with explicit methods to address threats to validity and identified designs and analytic methods with strong internal validity that have been applied to other policy evaluations. RESULTS: We included 18 studies out of 243 abstracts and papers screened. Overall, analytic rigor in prior evaluations of FDA regulatory actions varied considerably; less than a quarter of studies (22%) included control groups. Only 56% assessed changes in the use of substitute products/services, and 11% examined patient health outcomes. Among studies meeting minimal criteria of rigor, 50% found no impact or weak/modest impacts of FDA actions and 33% detected unintended consequences. Among those studies finding significant intended effects of FDA actions, all cited the importance of intensive communication efforts. There are preferred methods with strong internal validity that have yet to be applied to evaluations of FDA regulatory actions. CONCLUSIONS: Rigorous evaluations of the impact of FDA regulatory actions have been limited and infrequent. Several methods with strong internal validity are available to improve trustworthiness of future evaluations of FDA policies.
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Interchangeability of Biosimilars: What Level of Clinical Evidence is Needed to Support the Interchangeability Designation in the United StatesA biosimilar is a biologic drug that is "highly similar to a reference (originator) product, with no clinically meaningful differences between the two products in safety, purity, and potency". Regulatory approval of a biosimilar is based on analytical, structural, and functional comparisons with the reference product, comparative nonclinical (in vivo) studies, clinical pharmacokinetics and/or pharmacodynamics, and immunogenicity. In addition, comparative clinical efficacy and safety assessments are usually conducted and, taken together, comprise the "totality of the evidence" supporting biosimilarity. For a biosimilar to meet the additional designation of interchangeability in the United States (US), the applicant must demonstrate that the biological drug can be expected to produce the "same clinical result as the reference product in any given patient" and "if the biological drug is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological drug and the reference product is no greater than the risk of using the reference product without such alternation or switch". The challenges faced in conducting clinical studies to support a designation of interchangeability, as defined in the final interchangeability guidance from the US Food and Drug Administration, are considered. Potential alternative approaches to generating adequate and sufficient clinical data to support a designation of interchangeability are also presented.
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The US Food and Drug Administration's Proposed Rule to Increase Regulation of Indoor Tanning DevicesTanning bed use, particularly among teen girls and young adult women, has become a modern-day epidemic in the past 20 years. Numerous studies have established the link between indoor tanning use and skin cancer, including melanoma. Reducing the harms of indoor tanning is one of 5 goals outlined in the 2014 US Surgeon General’s “Call to Action to Prevent Skin Cancer.”Consistent with the Call to Action, on December 22, 2015, the US Food and Drug Administration (FDA) issued a proposed rule with the following restrictions for sunlamp products (ie, indoor tanning beds and booths): (1) to ban their use among individuals younger than 18 years; (2) to require prospective users to sign a risk acknowledgment certification; and (3) to provide user manuals to customers and tanning facility operators on request.
