FDA Addresses Serious Drug Shortage Issues

Advancement of new efforts requires public, professional cooperation

Part of the Food and Drug Administration’s (FDA) mission is ensuring easy and safe access to medicine for consumers. So when drug shortages arise, the Administration needs to take immediate action, as they have this week with a clearly outlined plan for addressing such occurrences.

“A shortage of even one critical drug can have a significant effect on U.S. patients‘ health,” read an FDA statement this week. “So many of our efforts are focused on preventing shortages in the first place. But when shortages arise, we must also focus on identifying the root cause, and on taking steps to help make sure similar circumstances don’t happen again.”

As such, the following recommendations from a September summit were shared:

  1. Develop a list of critical drugs. Use the WHO Model Lists of Essential Medicines and other existing resources, as a starting point to define what a shortage is and develop a list of critical drugs needed
    1. ) for emergency response and
    2. ) for saving and preserving life.

    Using historical data and manufacturing input, address why these drugs have been on the shortage list. The critical list can be used to:

    1. Stabilize the availability of critical drugs by working with manufacturers and the Food and Drug Administration (FDA) to create redundant product in multiple locations in anticipation of natural disasters and other supply chain threats;
    2. Assess the quality of pharmaceutical manufacturers measured against the importance of drugs on the critical list.
    3. Work with the private sector for greater transparency surrounding the source of raw materials and manufacturing locations so providers can more easily assess pharmaceutical product quality.

    The FDA has proposed a star rating system for pharmaceutical manufacturers, which could increase transparency.

  2. Create a multi-stakeholder advisory panel with the FDA to address key issues, such as the possibility of creating a stockpile of critical drugs, the logistics of warehousing such excess pharmaceutical inventory and where the excess inventory should be stored.
  3. Enhance communication with the entire drug supply chain, including healthcare providers during, or in advance of, a public health emergency or other event that may create a drug shortage. FDA should provide the health care community with information simultaneously on the type of products that may be impacted and the expected duration of the impact. To prevent hoarding of inventory that could result from such communication, manufacturers could put product on allocation to ensure that remaining supply is distributed equitably.


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