September 28, 2012
By Sarah Kitchell*
Certain Clinical Trials Monitoring Duties Delegated to FDA
Law360 (9/26) reports that the U.S. Department of Health and Human Services (HHS) is delegating some responsibilities for overseeing clinical trial reporting and monitoring to the U.S. Food and Drug Administration (FDA). A Federal Register notice published on September 26 describes the action, indicating that HHS has given FDA authority to determine whether any information submitted to ClinicalTrials.gov (the clinical trial registry and results databank) is "false or misleading in any particular [way]." The notice gives FDA authority to notify and request that the responsible party revise the misleading information within thirty days, but does not remove HHS' enforcement authority. (Note: registration is required to access the full article.)
Supreme Court Case May Affect Medical School Admission Diversity
American Medical News (9/24) reports on a case pending before the U.S. Supreme Court, Fisher v. University of Texas at Austin, which challenges the constitutionality of affirmative action programs in graduate school admissions. The article states that the Association of American Medical Colleges, American Medical Association, and other academic medical organizations filed an amicus brief in support of the University of Texas "urging the Supreme Court to uphold the use of race as part of a holistic review of a [medical school] candidate." According to the article, one of the arguments in the brief is that "the key to eliminating health disparities is developing a diverse workforce in healthcare" and that overturning the ability to use race and ethnicity in admissions decisions will hamper efforts to recruit minorities to medical schools. Court watchers are concerned, the article notes, that the fact that the Supreme Court is hearing the case may mean "the justices are considering overturning affirmative action policies" in admissions.
Trend: Top Medical Schools Develop and Strengthen Family Medicine Programs
Kaiser Health News (9/23) reports on a growing trend among elite medical schools to build family medicine departments in order to train a new generation of primary care physicians. The article notes that the federal healthcare law gives incentives for improving preventive and primary care, and hospitals and health systems are partnering with medical schools to develop and strengthen programs to train medical students to enter the specialty. These programs hope to increase the number of students choosing a primary care residency, which according to the article has already grown by 20% over the past three years.
Pharmaceutical Industry Turns to Russia for Recruitment of Trial Subjects
The New York Times (9/26) reports that pharmaceutical companies have begun to look to Russia to recruit new subjects for clinical trials. Legislation and governmental and public support for clinical trials in Russia creates a "remarkably advantageous development for the international pharmaceutical industry," which struggles to recruit willing test subjects in the United States and Europe. Russian patients, the article states, are "eager to join trials because often it is the only way to receive modern medical care." As evidence of this trend, the article cites a 96% increase in the number of trials approved by Russian regulators in the first half of this year compared with the same period last year.
Study: U.S. Medical Students Unaware of the Affordable Care Act
The Chicago Tribune (9/25) reports on a Mayo Clinic study published in the Archives of Internal Medicine that found that less than half of medical students surveyed expressed an understanding of the 2010 Affordable Care Act and more than 40% "had no opinion" on whether they supported the law or not. Study authors also found that the majority of students "agreed that doctors were professionally obligated to play a role in [the Affordable Care Act's] implementation" but that few medical schools included health policy in their curricula.
*We would like to thank Sarah Kitchell, Esquire (McDermott Will & Emery LLP, Boston, MA), for providing this week's update.