On October 31, 2013, the FDA released a strategic plan to help prevent drug shortages and proposed a new rule that would require manufacturers of “medically important” prescription drugs and biologic products to notify the agency of potential supply problems.
The agency’s actions spring from a 2011 order issued by President Obama to solve the drug shortage problem. In addition, the 2012 FDA Safety and Innovation Act (FDASIA) called on the agency to improve its responsiveness to shortages and address their underlying causes. The FDA announced that it would work with manufacturers to fix quality control problems, which are behind many drug shortages.
The FDA also recommended that drug companies take measures to ensure that their medications would remain available in the event of a manufacturing shortage. In addition, the FDA urged those that purchase medications to take quality into account when choosing a supplier; failing to do so places an undue emphasis on price, the agency suggested, leading manufacturers to neglect quality standards.
The agency noted that the number of new drug shortages declined to 117 in 2012 from 251 in 2011. It also noted that President Obama’s order and FDASIA have led to a 6-fold increase in the number of drug shortage notifications it receives and claimed that the agency helped prevent 195 drug shortages in 2011 and 282 drug shortages in 2012.