With the growth of academic indirect costs outpacing that of direct costs, the Government Accountability Office is warning that the ongoing trend could limit the number of research grants the National Institutes of Health funds in the future.
In a letter to Health and Human Services Secretary Kathleen Sebelius, several physician associations have requested that reprints of scientific peer-reviewed medical journal articles, abstracts and medical textbooks be excluded from the reporting requirements of the Physician Payment Sunshine Act that went into effect Aug. 1. The provisions require drugmakers to track payments of $10 or more to each recipient and then report aggregate payments of more than $100.
The FDA is getting ready to take its first step toward the metric system. International trials regularly measure and report lab tests using Systeme International (SI) units, which are the global standard, according to the FDA’s Center for Drug Evaluation and Review (CDER). But the majority of U.S. health care providers, as well as FDA reviewers, are trained using U.S. conventional units. Since the U.S. health care community has yet to move to SI units, CDER and the Center for Biologics Evaluation and Review are considering the conversion of certain lab test results as an interim step toward a transition to full SI unit reporting.
The FDA plans to submit a formal recommendation to the Department of Health and Human Services by early December to reclassify hydrocodone-containing drugs as Schedule II controlled substances.