Host: Captain Mary Kremzner
Pharmacist #1: Captain Catherine Chew
Pharmacist #2: Lieutenant Lindsay Davison
Captain Kremzner: FDA’s role in the management of drug shortages has changed in recent years. The Food and Drug Administration Safety and Innovation Act (also known as FDASIA) was passed by Congress in 2012, and provides new authorities for FDA to manage drug shortages.
Hi, I’m Captain Mary Kremzner and this is Drug Info Rounds, brought to you by the pharmacists in the FDA’s Division of Drug Information.
Today, I am joined by two of my colleagues, Captain Catherine Chew and Lieutenant Lindsay Davison.
Captain Chew, will you start by providing some history around FDASIA?
Captain Chew: Advanced notification to FDA of a potential drug shortage or disruption in supply is essential. Without early warning, FDA can’t engage with the manufacturer and other stakeholders to begin to address the shortage, and maybe even prevent it. Prior to FDASIA, mandatory notification to FDA of a potential drug shortage or disruption in supply was limited. Among other things, FDASIA broadens the scope of early notification, which greatly improves FDA’s ability to manage shortages.
Captain Kremzner: Will you give us more details about FDASIA?
Captain Chew: One of the most significant changes in FDASIA related to drug shortages is the expanded scope of the early notification requirement. For example:
• FDASIA requires manufacturers to report to FDA both permanent discontinuances of certain critical drugs, as well as temporary interruptions in manufacturing that may lead to a shortage. The prior law only required reporting of discontinuances.
• FDASIA also requires all manufacturers of these critical drugs to notify FDA of discontinuances or interruptions in manufacturing. The prior law applied only to sole source manufacturers.
• In addition, FDASIA enables FDA to require mandatory reporting of discontinuances or interruptions in manufacturing of biological products. The prior law excluded all biological products from reporting requirements.
• Finally, FDASIA requires FDA to issue a public non-compliance letter to manufacturers who fail to comply with the early notification requirements. The prior law did not include any enforcement mechanism for early notification.
In addition to the changes to the early notification requirements, FDASIA also requires FDA to provide Congress with an annual report on drug shortages and a strategic plan.
Captain Kremzner: Let’s remind pharmacists that these new requirements complement FDA activities to mitigate drug shortages that were in place prior to FDASIA.
Lieutenant Davison: When FDA learns of a potential shortage, the Agency may use several different tools to prevent or mitigate the shortage. For example, FDA may:
• Work with sponsors to resolve manufacturing or quality issues that may be causing the shortage;
• Expedite inspections and reviews to alleviate the shortage;
• Identify alternative manufacturers who are willing to initiate or increase production of a drug in shortage;
• Approve extended expiration dating of inventory of a drug in shortage, if supported by data;
• Provide regulatory discretion for the temporary importation of a non-U.S. product, after ensuring the drug does not pose undue risks for U.S. patients, and ensure it is manufactured in a facility that meets FDA quality standards.
FDA determines how best to address each shortage situation based on its cause and the public health risk associated with the shortage. FDA also communicates regularly with patients and providers about shortages and we maintain a section on the FDA’s website that lists each product in shortage.
Captain Kremzner: Let’s review what is available on FDA’s Drug Shortages website.
Lieutenant Davison: The Drug Shortages website provides information about current shortages and includes information on the reason for the shortage, the anticipated date of availability, and contact information for the manufacturer. There is also information on resolved shortages and drugs to be discontinued. A link is also provided to the American Society of Health-System Pharmacists drug shortages page, which offers additional guidance on managing current shortages and how to purchase drugs in short supply.
Captain Kremzner: FDA is committed to working with manufacturers to sustain levels of production that will provide adequate amounts of drug to patients who depend on them. FDA appreciates all information and updates about shortages and what pharmacists are experiencing in their practice. Anyone can notify or update FDA of drug shortage at firstname.lastname@example.org.
If you have drug information questions, call or email FDA’s Division of Drug Information.