Also included in the user-fee law is a provision targeting drug shortages. The legislation requires manufacturers to provide notification six months in advance of an anticipated disruption in the manufacturing of certain drugs. The number of new drug shortages declines in 2012; however, the total number of drugs in short supply continues to rise. According to the University of Utah Drug Information Service, there are 282 unresolved drug shortages recorded as of the end of September, up from 256 during the same time last year.
The user-fee legislation also requires the FDA to issue long-awaited regulations on the unique device identification system. The proposed rule is finally released in July, prompting providers and GPOs to push for a shorter rollout of the UDI system when the FDA proposed a seven-year phased rollout. Device manufacturers have called for extra time for high-risk devices to comply with the requirements.
The Federal Communications Commission, meanwhile, approves a proposal to allocate spectrum for medicine-related area networks, which could spur the development of an emerging class of medical devices. Boosters for the new wireless patient monitoring technology say it will lower costs and improve quality by reducing hospital-acquired infections, preventing unplanned emergency transfers and keeping elderly and chronically ill patients out of the hospital. It's also expected to create a lucrative new market for manufacturers, including GE Healthcare and Philips Healthcare, two proponents of the FCC's proposal.
In the fall, an outbreak of fungal meningitis turns attention to a class of drugs produced by compounding pharmacies with minimal FDA oversight and raises questions as to whether state agencies are up to that job. The infections, traced to a compounding pharmacy in Massachusetts that was producing drugs in large volumes for pharmacies in multiple states, prompt states to look for ways to tighten their grip on the companies. Federal lawmakers and officials struggle to understand and enhance the FDA's authority to more forcefully control the activities of compounders that behave more like drug manufacturers than traditional compounders.