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작성일자 2013-07-06
Kefauver initially stuck to his guns on issues of compulsory licensing and patents, but his persistence ultimately cost him control of his own bill. In June of 1962, officials from the Kennedy administration and the pharmaceutical industry presented the subcommittee with an alternate bill в” with no regulatory language about patents included. Kefauver cried foul, the Kennedy administration eased off its support, and S.1552 seemed to all observers to be a dead letter. It was only by chance timing that the summer of 1962 also produced a highly visible tragedy (thalidomide), a hero (Frances Kelsey), and enough ensuing public outcry to persuade Kefauver and Kennedy to embrace the gutted bill. According to current guidance from the FDA Center for Drug Evaluation and Research, conclusions that two drug products are bioequivalent should reflect significant agreement in pharmacokinetic parameters such that the entire 90% confidence interval associated with the generic-to-reference ratio of geometric means should fall within the bioequivalence limits of 80 to 125%.1 Budeprion XL 300 mg did not meet these criteria in our bioequivalence study, which involved 24 healthy fasting volunteers and used a single-dose crossover design (see graphMean Plasma Concentration of Bupropion (Budeprion XL and Wellbutrin XL) as a Function of Time in 24 Fasting Healthy Volunteers.). The extent of bupropion absorption after the administration of the generic product, as reflected in the area under the curve of the plasma concentrations plotted over time, was 86% of the absorption with the brand-name product (see graph), but the corresponding 90% confidence interval was 77 to 96%. In addition, the mean peak plasma concentration (Cmax) observed after the administration of Budeprion XL 300 mg was only 75% of that observed after the administration of Wellbutrin XL 300 mg (90% confidence interval, 65 to 87). In certain study participants, the Cmax and the area under the plasma-concentration curve for Budeprion XL were less than 40% of the values with Wellbutrin XL. The Cmax values for hydroxybupropion, the major active metabolite of bupropion hydrochloride, also failed to meet the FDA bioequivalence criteria. To further illustrate this point, we compared the time to approval for five innovative, high-risk medical devices available in France, Italy, and the United States (see tableComparison of Time to Market Access for Five Innovative Devices in France, Italy, and the United States.). These case studies indicate that the average time to market access for these devices was 26.3 months in France, 30.8 months in Italy, and 15.3 months in the United States. Another unintended consequence of the amendments was that the new structures of proof changed not only the behavior of the pharmaceutical industry but also the conceptual categories used by biomedical researchers around the world.5 Pharmaceutical research came to be overwhelmingly organized around the placebo-controlled, randomized, controlled trial. Although this system has greatly helped researchers gauge the efficacy of an individual drug, it has also rendered data on comparative efficacy much more difficult в” and much more expensive в” to find or produce. The Food and Drug Administration (FDA) has completed a head-to-head bioequivalence study of single doses of the generic drug Budeprion XL 300 mg (extended-release bupropion hydrochloride, manufactured by Impax Laboratories and distributed by Teva Pharmaceuticals) and the brand-name drug Wellbutrin XL 300 mg (Biovail). The agency has concluded that Budeprion XL 300 mg cannot be considered therapeutically equivalent to the brand-name product. We at the FDA are therefore changing our bioequivalence recommendations for extended-release bupropion products and have asked other manufacturers of 300-mg extended-release bupropion products to conduct additional bioequivalence studies. The U.S. process for approving innovative, high-risk medical devices has been criticized for taking longer than the European approval process.1 This contention is often used to support the argument that the Food and Drug Administration (FDA) should lower its standards for approving medical devices, since a slow approval process is delaying Americans' access to innovative and lifesaving technology. But a review of the data, using appropriate end points, suggests instead that it takes the same amount of time or less for patients to gain access to innovative, high-risk medical devices in the United States as it does in the four largest European markets (Germany, France, Italy, and Britain)2 в” largely because patient access is generally delayed until reimbursement decisions are made, which often takes substantially longer in Europe than in the United States. To compare the United States and Europe fairly on this front, three criteria must be considered: the level of device innovation, equivalent start and end points, and patient access as defined by time to reimbursement. First, we focused on innovative, high-risk devices because in the United States such devices require the strongest evidence of clinical benefit and are the subject of most debates about the relative effectiveness of approval processes in different countries. Furthermore, previous studies have shown that lower-risk devices achieve market access in a similar amount of time in the United States and in Europe. The NIH is committed to ensuring that prospective research participants в” and the people who speak for and love them в” are given clear, complete, and accurate information about the risks and benefits of participating in research. We are strongly committed to supporting critical research studies like SUPPORT, which inform clinical care by providing rigorous evidence for use in daily practice. This controversy has alarmed some of the parents of infants who were in the study, confused the biomedical research community, and befuddled IRBs. Several other studies seeking new insights to improve care for these vulnerable infants have been put on hold as the field tries to understand the OHRP findings. On July 2, 2012, the Department of Justice announced the largest settlement ever in a case of health care fraud in the United States. GlaxoSmithKline (GSK) agreed to plead guilty to three criminal counts and settle civil charges brought under various federal statutes; the company will pay a total of $3 billion to the federal government and participating states. Since 2009, the federal government has collected more than $11 billion in such settlements under the False Claims Act. Kefauver's bill met strong resistance as it made its way through the Subcommittee on Antitrust and Monopoly.2 The American Medical Association firmly opposed the regulation of efficacy by a government agency, arguing that вthe only possible final determination as to the efficacy and ultimate use of a drug is the extensive clinical use of that drug by large numbers of the medical profession over a long period of time.в3 The editors of the Journal, on the other hand, supported the efficacy provision and the expansion of generic drug names but opposed the patent provisions (considering them an вarbitrary discriminationв against the pharmaceutical industry) and the comparative effectiveness provisions (considering вproof of superiorityв necessary only if superiority was actually being вclaimed by the manufacturerв).4 The pharmaceutical industry amplified such concerns about comparative effectiveness, arguing that any a priori determination of which medicines were вme-tooв and which were true innovations would be arbitrary. Efficacy was hard enough to prove, they suggested; proving comparative efficacy would be вcompletely impracticable.в3 Given these data, the investigators had no reason to foresee that infants in one study group would have a higher risk of death than would those in the other group. The babies included in SUPPORT were, of course, facing substantial risks because of prematurity в” the same risks as premature babies who were not enrolled in the study в” but their care was never compromised for the sake of the study. The sample consent form for SUPPORT stated that each of the вpossible combinations of treatments is considered by some units to represent their desired approachв (www.nih.gov/icd/od/foia/library/Records.htm). This statement describes the clinical equipoise at the time of the study, which was, in fact, the justification for conducting a clinical trial. Although the OHRP took issue with the consent form, it stated that the study design was ethical в” a conclusion worth emphasizing. The increased risk of death was a significant and unexpected finding of the study; if it had been known before the study began, standard clinical care would not have encompassed the lower oxygen range, and it would have been unethical to conduct the study. Inappropriate formulations and packaging may contribute to low adherence, medication errors, and safety and efficacy problems. Additional considerations for a largely elderly population will include the need for easy administration, possible dose reduction, the effects of visual and motor impairment, and the likelihood of polypharmacy. If appropriate, protocols should be designed for evaluating patients' ability to manage their own medications. Regulators should also look favorably on nondrug technologies such as information and communication technology systems for monitoring adherence or clinical signs. In almost every country, the proportion of people over 60 years of age is growing faster than any other age group, as a result of longer life expectancy and declining fertility rates. In Europe, the median age is already the highest in the world, and in 2050 there are projected to be 88.5 million Americans 65 years old or older в” more than double the 40.3 million in the 2010 census. Second, an accurate comparison of time to market access requires measurement of the total time that elapses between application submission and market access. Previous studies have compared the chronologic dates of application submission and market access, but the date an application is submitted varies from country to country. The circumstances surrounding the SUPPORT study have unquestionably created controversy in the research community, but the situation has created an opportunity for a better understanding of the scientific and ethical issues that must be addressed when designing such studies in the future. We look forward to working with the OHRP, the research community, and patient advocates to improve the effectiveness and ethical standards of research involving human participants. Although we expect the age distribution of patients to be representative in studies presented for marketing authorization, postmarketing studies might also be required to consolidate knowledge regarding higher-risk subpopulations. Regulators should make better use of pharmacovigilance tools to strengthen the planning of the postauthorization phase and reduce preventable harm. One partial solution would be to impose penalties on corporate executives rather than just the company as a whole. Boston whistleblower attorney Robert M. Thomas, Jr., embraces this approach: вGSK is a recidivist. How can a company commit a $1 billion crime and no individual is held responsible?в The process started in 2006, when the EMA provided an opinion on the adequacy of guidance on the elderly regarding medicinal products. In 2011, the agency's Committee for Human Medicinal Products adopted the EMA geriatric medicines strategy,1 marking its commitment to improving our understanding of how best to evaluate the benefitв“risk ratio for a medication in older patients. In a letter dated March 7, 2013, the OHRP asserted that the study's consent form failed to convey that вthe level of oxygen being provided to some infants, compared to the level they would have received had they not participated, could increase the risk of brain injury or death.в3 That finding was influenced by research conducted in the 1950s, but in our view, it failed to assign proper weight to studies conducted in premature infants in the 2000s, which used more sophisticated oxygen-monitoring and oxygen-measurement devices, similar to those used in SUPPORT.4 The more recent studies showed no increased risk of death or neurodevelopmental impairment at saturation levels as low as 70%.5 Finally, these types of fraud are hard to detect from the outside. Internal documents are often critical to these cases. Most of the time, these documents are provided by internal whistleblowers. In a recent survey, researchers identified several ways in which the whistleblower provisions of the False Claims Act could be strengthened to encourage whistleblowers to come forward and to protect them from retaliation.5 Whistleblowers should be encouraged, not punished for their testimony. proscar injection order finasteride online use finasteride amlodipino interaction with proscar and tamsulosin proscar for prostate cancer finasteride 1mg tablet proscar and oily skin must taper off of proscar finasteride and donating blood us generic proscar finasteride and side effects proscar sideeffects finasteride breast diovan and proscar finasteride 1mg available in usa libido proscar peronies stop using 5 mg finasteride finasteride cas number conceiving children while taking finasteride finasteride tablet 5 mg
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