FDA’s Newest Actions/Steps on Drug Shortages
Yesterday -- exactly two years to the date following President Obama’s executive order on reducing drug shortages -- the Food and Drug Administration announced “two important actions on drug shortages” -- the release of a strategic plan, and a proposed rule requiring “manufacturers of certain medically important prescription drugs” (including biologics) to notify the FDA of either the permanent or temporary disruption of supplies six months in advance.
Noting that “drug shortages remain a significant health issue in the United States, and addressing shortages remains a top priority for FDA” in the conclusion of its executive summary, the Strategic Plan for Preventing and Mitigating Drug Shortages was called for last year as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012.
The proposed rule -- which is open to public comment for 60 days -- implements expanded early notification requirements included in FDASIA, according to an FDA news release that noted that this requirement will give FDA time to:
- “Work with manufacturers to investigate the issue leading to the manufacturing disruption;
- Identify other manufacturers who can make up all or part of the shortfall; and
- Expedite inspections and reviews of submissions from manufactures of drugs that may prevent or mitigate a shortage.”
The strategic plan was submitted to Congress today and includes improving the FDA’s communications about shortages, such as launching a mobile app providing users with instantaneous information about drug shortages; clarifying manufacturers’ roles and responsibilities; and updating FDA’s internal procedures for responding to notifications of potential shortages. It also describes how the FDA plans to address manufacturing and quality issues.
The FDA said that the number of new shortages was 117 in 2012, down from 251 in 2011 prior to President Obama’s executive order.
I called a number of experts today regarding the relative significance of these steps in the overall lengthy process of actually preventing future drug shortages, and some of them noted that they had to think about it some more before responding and would call me back. So far none have followed up, but I will continue to write more on this topic as I hear more.
I am, however, scheduled to speak next week with American Society of Hematology President Janis L. Abkowitz, MD, whose organization has been actively involved in this matter during the past two years.