The US Food and Drug Administration (FDA) is insisting that the pharma industry should report in advance on the possible shortage of prescription drugs or biological products coming under section 506C of the Federal Food, Drug, and Cosmetic Act (FD&C Act). A few weeks ago the regulatory authority  issued a guidance tilted ‘Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage.’

Drug shortages create public health concerns as it could delay or deny patients in treating cancer, infectious diseases and access to prescribed nutrition. The drugs are used in life-supporting, life-sustaining, or prevention of a debilitating disease.  It forces doctors to prescribe second-line alternatives, which could be less effective than first-line therapies. Analysis of 127 drug shortages between January 1, 2010 and August 26, 2011 indicated that around 60 per cent of the scarcity  could have been mitigated if manufacturers had undertaken enhanced redundancy or contingency planning, according to US FDA.

While the guidance does not establish legally enforceable responsibilities, it is  issued based on concern about rising incidence of drug shortages in the US, particularly those manufactured by a small firms having no good therapeutic substitutes available. Not all drugs face shortage, yet the scarcity in on the rise  over the last five years, tripling from 61 in 2005 to 178 in 2010. In 2011, FDA tracked over 250 drug shortages.

“In 2011, early notification by manufacturers allowed the FDA to help prevent shortages of 195 drugs, including 86 drugs produced by one company. However, FDA cannot begin to work with manufacturers to mitigate a shortage until we  know there is a potential problem,” stated the guidance report.

There is no single or simple, solution to resolve drug shortage. “But we are committed to work with drug manufacturers and distributors, hospitals and stakeholders to identify issues that lead to drug shortages. We can enhance processes to avoid shortages in the future and ensure continued patient access to vital safe- effective drugs. As part of this effort, we are issuing this guidance to help manufacturers better understand mandatory reporting obligations and to encourage voluntary reporting of additional issues that could lead to a shortage of a prescription drug or biological product, stated the report.

The document provide additional guidance to industry on the mandatory and voluntary notifications and also discusses certain advance planning strategies that manufacturers could consider to prevent drug shortages. It includes building redundancy into manufacturing capabilities, establish adequate controls over contract manufacturers and seek approval for alternative Active Pharmaceutical Ingredients (APIs) or component suppliers.

FDA stated that it is available to discuss with industry contingency plans for additional manufacturing sites, production lines, and suppliers to help prevent shortages. The industry should contact the regulator to be better prepared to prevent potential product shortages. Notifying FDA in advance would allow the regulator to work with manufacturers and take early action to prevent shortages, stated the report.

Causes of drug shortages may include product quality concerns, manufacturing problems, difficulty in acquiring component parts/ APIs, increased demand, and shipping delays, among others. FDA recognizes that some drug shortages can be neither predicted nor prevented. However, effective communication and early notification from manufacturers could help to decrease the impact of shortages by reporting to the FDA the circumstances that might affect their ability to supply the market and potentially lead to a drug shortage.