The FDA launched the first phase of a pilot of its intercenter consult request (ICCR) process for products that combine drugs, devices or biological products. During the two-month phase 1, the ICCR pilot will start in select offices in the agency's three medical products centers. Additional offices in each center will be rolled into the pilot in subsequent phases. The agency aims to implement the program in all the offices by the end of the second quarter of 2017. The intent is to develop a robust process that enables efficient, effective collaboration on the review of combination products.

The U.S. Government Accountability Office (GAO) is recommending that Congress consider requiring all manufacturers of drugs paid at average sales price (ASP) to submit pricing data to CMS. It also urged CMS to periodically request source documentation from a sample of drug manufacturers to verify the ASP data they submit. The recommendations stem from a GAO study of expenditures for the Medicare Part B drug program in 2014. Medicare and its beneficiaries spent about $21 billion in 2014 on about 46 million administrations of 551 Part B drugs covered based on ASP. The GAO found that six drugs, each exceeding $1 billion in expenditures, accounted for 36 percent of all expenditures on Part B ASP drugs. However, 10 different drugs, each administered more than 1 million times that year, accounted for 37 percent of all administrations. Looking at the numbers another way, the GAO said that multisource drugs were used in 74 percent of the administrations, but single-source drugs accounted for 81 percent of the expenditures.

The Institute for Clinical and Economic Review, a U.S.-based nonprofit organization, is seeking comment on a draft scoping document that will guide the development of a report on drug therapies to treat rheumatoid arthritis. Developed with input from several patient advocacy groups, the document discusses the analytic framework to be used in the report, patient populations to be considered, interventions to be assessed, key outcomes and simulation models focusing on comparative value. Comments on the document are due by Aug. 22.

The NIH is seeking comments on a proposal to amend parts of its 2009 guidelines for human stem cell research and on the proposed scope of certain human-animal chimera research that will be considered internally by a new steering committee created to advise agency officials. Last year, the agency placed a funding moratorium on research involving the introduction of human pluripotent stem cells into blastocyst-stage nonhuman primate embryos. It is now considering expanding that prohibition to include pre-blastocyst-stage nonhuman primate embryos, according to a notice slated for publication in the Federal Register.