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The US regulation of off-label uses of medicines
Published in Andrea Parziale, The Law of Off-label Uses of Medicines, 2023
After several crucial amendments enacted shortly after World War II,23 Congress extensively and unanimously amended the FDCA in 1962 after the European Thalidomide scandal – even though only a few US patients were affected.24 In particular, the Kefauver-Harris Amendment specified that new drugs must also have evidence of their effectiveness before being put into the market.25 This set another milestone in the history of pharmaceutical regulation. With this amendment, the US drug approval regulatory process started taking its contemporary shape and became a global standard for pharmaceutical regulation.26 Put in perspective, the FDCA set the essential features of any following pharmaceutical regulatory framework, including the European ones.27
The development of the Kampo medicines industry
Published in Stephan Kloos, Calum Blaikie, Asian Medical Industries, 2022
Ichiro Arai, Julia S. Yongue, Kiichiro Tsutani
In 1973, the MHW issued the first drug re-evaluation requirements, which applied to all medicines marketed before 1967, the year in which the Pharmaceutical Affairs Bureau of MHW issued the Basic Policy for New Drug Approval, requiring that manufacturers submit clinical data to support the efficacy and safety of their drug candidates and perform controlled (double-blind) trials30 (Sakuma 1988). This measure came in the wake of the implementation of the 1962 Kefauver Harris Amendments in the United States (Temin 1980). The purpose of the re-evaluations was to review, according to the most current standards of medicine and pharmaceutical science, the efficacy and safety of drugs already approved for use.
The Non-Prescription Products – Market-Profits and Public Health in Conflict
Published in Mickey C. Smith, E.M. (Mick) Kolassa, Walter Steven Pray, Government, Big Pharma, and the People, 2020
The Kefauver–Harris Amendment was described above as the genesis of a review of prescription products. The nonprescription industry foresaw an extension of the review to nonprescription products, one of the most dangerous threats they had ever faced. Up to this time, OTC manufacturers blithely marketed many thousands of products, with no Government Agency legally empowered to review and approve their ingredients for safety or efficacy. Advertisements were never reviewed for truthfulness. There was no guarantee that all ingredients were listed on labels. If the FDA were to require proof of safety and efficacy, and also truth in Advertising, the OTC industry’s free ride would halt. Profits would drop as dollars would be diverted to research. Highly profitable products might be forced from the market.
Blinding and expectancy confounds in psychedelic randomized controlled trials
Published in Expert Review of Clinical Pharmacology, 2021
Suresh D. Muthukumaraswamy, Anna Forsyth, Thomas Lumley
For causal inference to be made linking treatments and outcomes, and for estimates of ATE to be unbiased, the experimentalist must control a number of potential biases. The gold-standard RCT developed through cumulative progress over the course of the 20th century to reduce potential biases and strengthen causal inference in clinical research [11]. In the 1920s, randomization of participant groups to minimize selection bias became more common. Subsequently, Bradford-Hill introduced the notion of masking in the 1940s in the UK in a series of clinical trials investigating the antibiotic streptomycin for the treatment of tuberculosis [11,12]. The innovations of Bradford-Hill were tremendously influential, and these standards were successively adopted into legislative frameworks. In the USA, the Kefauver–Harris Amendments to the Food, Drug, and Cosmetic Act were passed in 1962 and the RCT became the tool by which pharmaceutical manufacturers could demonstrate efficacy and safety to regulators. By 1970 it was a requirement of the FDA that new drug applications submit RCT results as part of their submissions [11]. Although not specifically defined, it was clear from Congressional directives that well-controlled studies should include ‘as a minimum, the use of control groups, random allocation of patients to control and therapeutic groups, and techniques to minimize bias’ [13].
Expanded access to investigational drugs: balancing patient safety with potential therapeutic benefits
Published in Expert Opinion on Investigational Drugs, 2018
Elena Fountzilas, Rabih Said, Apostolia M. Tsimberidou
In 1938, the Federal Food, Drug, and Cosmetics Act required that all drugs be tested for safety before being approved by the US Food and Drug Administration (FDA) [4]. In 1962, the Kefauver–Harris amendments added that potential drugs should be proven effective in addition to safe in order to be approved and added strict controls on how to use investigational drugs [5,6]. Although these regulations are necessary, the process for investigational drug approval by the FDA is complicated, expensive, cumbersome, and lengthy [7,8]. Between 1995 and 2008, the median time from an Investigational New Drug application to FDA approval was approximately 7 years [7,9]. The average time for approval by the regulatory authorities in Europe (European Medicines Agency, EMA) and Canada (Health Canada) was even longer [10,11]. During the AIDS epidemic in the 1980s, there was a need to accelerate approval of HIV drugs, which led in 1987 to the institutionalization of expanded access programs [12,13].
Compounded bioidentical menopausal hormone therapy – a physician perspective
Published in Climacteric, 2021
In the USA, regulation of the compounding industry is complex and, as such, a brief historical overview is presented to highlight the ongoing challenges. Prescription drug safety in the USA was first addressed in 1938, with the Food, Drug, and Cosmetic Act that regulated drug safety and labeling14,36. In 1962, the Kefauver–Harris Amendments required drug manufacturers to also prove efficacy. Because of anticipated small volumes of compounded drugs, state pharmacy boards were charged with regulation of compounding, with some degree of FDA oversight. The FDA issued a Compliance Policy Guide in 1992 clarifying when compounding becomes illegal drug manufacturing.