Budget pressures are leading to more intense scrutiny of the National Institutes of Health's (NIH) return on investment from early stage research that contributes to the development of blockbuster drugs. In a recent letter to the NIH, Sen. Ron Wyden (D-Ore.) noted that in 1995, the agency had abandoned a policy that required "a reasonable relationship between the pricing of a licensed product, the public investment in that product, and the health and safety needs of the public."
More research is needed in adults before anthrax vaccine trials with children can be ethically considered, the Presidential Commission for the Study of Bioethical Issues said in a report. A major ethical consideration with pediatric pre-event trials is that the children participating in the study wouldn't benefit directly. The report, "Safeguarding Children: Pediatric Medical Countermeasure Research," also discusses the ethics of pediatric research for other medical countermeasures.
Virginia is the first state to pass a law limiting biosimilar substitution at the pharmacy and setting up notification procedures. The legislation permits pharmacists to substitute biosimilars the FDA has licensed as interchangeable for the prescribed drug unless the prescriber or patient specify no substitutions.