US FDA issues new guideline on emergency plans
This article was originally published in SRA
The US Food and Drug Administration has issued final guidance aimed at encouraging manufacturers of so-called "medically necessary drug products" and their raw materials and components to develop contingency production plans for use during emergencies that result in high absenteeism at production facilities.
The FDA considers an MNP as any drug that is used to treat or prevent a serious disease or medical condition for which there is no other adequately available appropriate substitute.
The agency's new guidance – Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products1 – outlines what drug makers should consider when developing and implementing plans for production of MNPs during a crisis and discusses approaches for avoiding product shortages that could have negative impacts on public health during such emergencies.
The FDA notes that an emergency situation in one country, such as a widespread illness or large-scale disaster, like what is currently occurring in Japan, could result in worldwide shortages of MNPs or their ingredients due to production disruptions. Therefore, manufacturers need to be prepared to ensure continuity of operations during a crisis in which there may be a worker shortage.
Drug manufacturers also need to be aware of the contingency plans of their suppliers and contractors and should work with them to ensure the availability of materials and services that contribute to MNPs, the FDA advises.
Regulators recommend that biopharmaceutical firms develop a written emergency plan in advance of a disaster specific enough to address unique considerations at each of the company's locations. The plans should have the flexibility to shift operations, resources or personnel from one manufacturing facility to another and must identify people with the authority to activate or deactivate the plan and make other decisions during the emergency, the FDA says.
In addition to the written plans, manufacturers should take preventative measures, such as educating employees about personal hygiene, like hand-washing or coughing and sneezing etiquette, and providing vaccination services. Companies also should provide information to their employees about how to develop family emergency preparedness plans.
The FDA recommends that companies prioritise manufacturing operations based on medical necessity, giving high priority to MNPs, especially when the firm is the sole source of a product.
Regulators point out that the nature of MNPs could change depending on the situation, such as during an influenza pandemic, when antivirals likely would be moved up on the priority scale.
But the FDA also points out that medical necessity during an emergency is not limited to products directly related to the specific emergency, but also encompasses medicines necessary for maintenance of dependent populations, such as patients with diabetes, high blood pressure, congestive heart failure, asthma or cancer, as was the case during the 2005 Hurricane Katrina disaster that struck the US Gulf Coast.
The FDA also advises firms to conduct a prospective risk assessment and ensure that appropriate control measures are identified, approved by relevant decision makers and used in development of the company's emergency preparedness plan. The agency encourages drug makers to keep the FDA informed about how certain emergency situations have affected the company's production processes. It also advises manufacturers to document any emergency activities carried out.
References
1. Federal Register, 15 March 2011, 76(50), 14025-14026, http://edocket.access.gpo.gov/2011/pdf/2011-5949.pdf