Pharmaceutical Shortages Persisting as Manufacturing Problems Continue

Pharmaceutical Shortages Persisting as Manufacturing Problems Continue

September 28th, 2013 // 2:53 am @

Some new drug shortages have been prevented with new early notification procedures, but many drug shortages are still going on because of cGMP manufacturing problems, according to some of our hospital sources.

A new program that was put together by the generic drug makers in the US to stop shortages is not working because there are not enough manufacturers in the marketplace at this time. However, industry continues to work with FDA on a proposal from the agency to gather more data about manufacturing quality to stop drug shortages in the future.

Early warnings about any possible drug shortages, which was solidified in the FDASIA act last year (FDA Safety and Innovation Act), is helping the agency to prevent some shortages. New shortages, a total of 88 since the end of July are at the lowest level in 7 years. It also is well below the high of 268 new shortages.

New FDASIA provisions that are designed to cut down on drug shortages have helped to prevent some of the new shortages. However, there is not any evidence that provisions are being brought into play that are going to solve some of the current drug shortages. A report from the Government Accountability Office that was mandated by FDASIA could help to make the agency better understand what is causing drug shortages and may lead to better actions.

Most of our sources agree that cGMP manufacturing problems, and a lack of firms producing them, are what is causing drug shortages. There are still many shortages of various nutrition and electrolyte products that are related to the shut down of Luitpold Pharma due to quality issues.

FDA does have the ability to increase the speed of inspections and many other regulatory actions when there is a shortage. But there is not anything in FDASIA that will help to increase the speed of how long it take companies to make any improvements.


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