by Brian Malkin
On March 15, FDA announced the availability of a new guidance, Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products. The guidance is intended to encourage manufacturers of medically necessary drug products (“MNPs”) and their components to develop contingency plans for use when emergencies cause high absenteeism in their production facilities.
According to the guidance, a MNP is “Any drug that is used to treat or prevent a serious disease or medical condition for which there is no other adequately available drug product that is judged by medical staff to be an appropriate substitute.” FDA indicated that high absenteeism may be associated with the emergency situation for which the MNP is indicated, e.g., influenza pandemic, where widespread illness outbreaks could result in production stoppages.
FDA recommends that the contingency plans include mechanisms to attempt to anticipate emergencies that can result in high rates of absenteeism and encourage by increasing inventory of MPNs and components to manufacture MPNs, increase cross-training of employees so they may be reassigned to manufacture MPNs if necessary, performing routine maintenance of equipment to manufacture MPNs and provisions for alternate suppliers of resources and goods to manufacture MPNs. In addition, contingency plans should include mechanisms to activate and deactivate the contingency plans and drills should be run internally to ensure that employees are familiar with the plans and when and how to implement them.
FDA requests that the guidance be provided to all suppliers and contractors associate with MNPs. The guidance provides that it expires on January 31, 2014.