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FDA: shortage mitigation measures working thanks to drugmakers

By Gareth MacDonald+

06-Feb-2014

Shortage mitigation worked in 2013 says FDA
Shortage mitigation worked in 2013 says FDA

US drug regulators have claimed recent law changes that enhance communication with pharmaceutical manufacturers helped prevent 140 potential drug shortages in 2013. 

The US Food and Drug Administration (FDA) made the claims in a report submitted to Congress last night in which it described drug shortages as a significant public health issue and one of its top priorities for the coming year.

Because of recent important actions by the President and Congress, FDA has been able to learn of possible shortages before they occur and take steps to prevent or mitigate them. During the first three quarters of 2013, CDER helped prevent 140 potential new shortages.”

These important actions included the executive order issued by President Barack Obama in October 2011 that called for a multifaceted approach and the introduction of greater reporting requirements for key manufacturers related to discontinuation or production disruptions.

Similarly, FDASIA has also had a positive impact on efforts to prevent drug shortages according to the agency.

In addition, under the early notification requirements contained in FDASIA, there were only 38 new shortages for the first three quarters of 2013, compared to 117 during calendar year 2012.”

The FDA also said that the strategic plan issued last October had further enhanced its ability to head of drug shortages before they occur, citing the ability to expedite reviews of replacement products as a key initiative.

Discontinuance

The other key anti shortage initiative – the requirement that manufacxturers notify the FDA if they intend to stop making drugs – is also working according to the FDA.

Under US law “if a manufacturer fails to provide notification of a discontinuance or interruption in manufacturing as required by FDASIA, FDA must issue a letter to that manufacturer stating that the notification requirement was not met… To date, FDA has not yet issued a letter.”

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