A companion to the HHS report on the economics of drug shortages [see related story] is an FDA analysis of its role in resolving them. President Barack Obama also mentioned this report in the announcement of Monday's executive order.
In A Review of FDA's Approach to Medical Product Shortages, the agency counts 99 drug shortages it has averted this year and 38 in 2010. Its most common actions to prevent shortages were expediting review of manufacturing sites, suppliers and specification changes (71%), "exercising regulatory flexibility and discretion" (20%) and asking other drugmakers to increase production (7%), the report states.
When a shortage has occurred, the FDA's most common actions were requesting production increases of other manufacturers (31%), working with manufacturers to identify ways to mitigate the dangers of products with quality issues (28%) and expediting review of regulatory submissions (26%). The regulator notes it also permitted the controlled importation of similar products approved abroad but not in the U.S. (5%).
Of 127 shortages it studied, sterile injectables accounted for the majority (80%). Major therapeutic areas affected were oncology (28%), antibiotics (13%) and electrolyte/nutrition drugs (11%).
Additional actions the agency can take to minimize future shortages include adding staff to its drug shortages program, urging drugmakers to notify the agency of supply disruptions as soon as possible, and developing guidance and regulations to enhance the information that manufacturers provide, the report says.
- here's the FDA analysis