Drug Supply Legislation

The President signed into law the reauthorization of the prescription drug user free act which takes effect October 1, 2012. The law contains language requiring manufacturers of certain drugs to report to the secretary of the U.S. Department of Health and Human Services (HHS) any plan to discontinue or interrupt the manufacturing of a drug that could lead to a meaningful disruption in the supply of that drug in the United States. In addition to requiring drug manufacturers to notify HHS of potential impending shortages, the law contains language that:

  • Gives the HHS secretary the authority to expedite review of a supplement to a new drug application and/or expedite an inspection or re-inspection of an establishment that could mitigate or prevent a drug shortage from occurring;
  • Directs the HHS secretary to establish and maintain “an up-to-date list of drugs that are determined … to be in shortage in the United States;”
  • Directs the secretary to “establish a task force to develop and implement a strategic plan for enhancing the secretary’s response to preventing and mitigating drug shortages;”
  • Directs the attorney general to submit to Congress a report on drug shortages;
  • Allows hospitals owned and operated by the same entity to repackage drugs into smaller units before the FDA issues final guidance; and
  • Directs the controller general to “conduct a study to examine the cause of drug shortages and formulate recommendations on how to prevent or alleviate such shortages.”
  • ASCA CEO Bill Prentice states, “While this legislation will not solve all of the problems that are causing drug shortages, it is a step in the right direction.”

Source: Surgistrategies