FDA Implements Measures to Overcome Drug Shortages – What Manufacturers Should Know

• By: Staff Editor
• Date: April 16, 2012

1. It makes every effort to prioritize review and inspections needed for any change that will help prevent a product shortage
2. It is better positioned to assist in preventing a drug shortage that may be caused by discontinuance.
3. It will work closely with the manufacturers, distributors and others to trace issues and help prevent a shortage in future.

1. Expedite the process of review of submissions (marketing applications for drugs, manufacturing practices, other issues like toxicity etc) from manufacturers.
2. Identify additional sources of supply or alternate suppliers who can supply drugs during shortage and exercise regulatory discretion for the temporary importation of foreign drugs.
3. FDA may review the data and consider regulatory action on issues like use of a product beyond its labelled expiration date and consider other safe and effective product if, available.
4. Coordinate with sponsors on resolution of manufacturing or quality issues.

• The Agency reminds manufacturers of prescription products of their mandatory reporting requirements and encourages them to voluntarily report to the Agency any disruptions in issues like supply, product quality problems, such as the presence of particulates or impurities, microbial contamination, and stability concerns that could lead to a product shortage.
• Manufacturers should report to FDA, any discontinuance of drug products that are life-supporting, life-sustaining, or intended for use in the prevention of a debilitating disease or condition.
• The guidance provides information about certain advance planning strategies that manufacturers can consider to prevent product shortages. According to the FDA, manufacturers can play a critical role in decreasing the impact of shortages by reporting to the Agency, any circumstances that might affect their ability to supply the market and potentially lead to a drug shortage.
• The Agency, however, states that it cannot work in collaboration with manufacturers or use the tools at their disposal to prevent such a shortage until a potential problem is detected.
• The Agency states that manufacturers by notifying, in advance of incidents that may result in a drug shortage, can help to expedite the process of action to prevent or alleviate shortages by the concerned authorities.
• The manufacturer should notify the Agency at least six months prior to the discontinuance except under conditions where

1. the manufacturer has submitted a written certification of a ‘genuine cause’
2. the Agency has affirmatively made a determination to allow a reduction in the notification period for one of the above reasons.

• The guidance provides information of both mandatory and voluntary notifications and also about:

1. reasons as to why the FDA needs to be notified
2. concerned authorities who are responsible for notifying the FDA
3. information to be reported
4. time lines and procedure for notifying
5. course of action by the FDA, with the reported information

• The guidance also mentions that the Agency is concerned about the increasing incidence of specific drug shortages (especially, those manufactured by only few firms and for which there are no good therapeutic substitutes) as they can result in significant public health concerns and will delay or deny needed care for patients suffering from chronic diseases.
• The guidance provides information that product quality concerns, manufacturing problems, difficulty in acquiring component parts or active pharmaceutical ingredients (API), increases in demand, and shipping delays etc are few causes of drug shortages and can result in the use of less desirable, often more expensive alternatives and the potential for medication errors and poor patient outcomes. It does not change manufacturers’ responsibility to report issues to the Agency under other applicable regulations.
• According to the guidance, manufacturers should notify FDA via electronic or by telephonic mode according to instructions on the FDA’s drug shortages website at http://www.fda.gov/Drugs/DrugSafety/DrugShortages.
• Manufacturers should make contingency plans for responding to situations that could lead to a shortage and not to report to FDA, the majority of situations that could lead to a drug shortage.

Additional Resources

Read the FDA guidance on drug shortage notifications in full.