Obama Executive Order on Drug Supply Misses The Point

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Patrick Stone, President, TradeStone QA

The Obama Administration’s recent Executive Order Reducing Prescription Drug Shortages states that some health care providers may hoard drugs that are in short supply.

I am wondering how this is possible if the drugs are not even available to hoard? In this Executive Order it specifically states that root cause analysis and solutions may be out of FDA control. Only the US Congress may appropriate funds for HHS/FDA work force initiatives.

According to the Executive Order, pharmaceutical manufacturers are requested to report timely drug manufacturing discontinuances. But the order clearly misses some important points. The problem is that FDA already knows about drug discontinuance when they order a hold on product or issues a 483 for GMPs with a warning letter follow up.

Moving drug manufacturing out of our country further compounds this drug shortage. It may take years for a drug firm to re-start operations after a move from the US. The fact our US government gives incentives to big drug manufacturers to leave the US with huge tax breaks is also part of this problem.

Generic Drug TabletShipping drug manufacturing to India and China for cultural exchange or to bring up the standard of living is a slow process filled with FDA/GMP regulatory pitfalls. Expedited regulatory review must take place where the pharmaceuticals are manufactured, many of which are overseas.

I am not sure how this is possible when most of the FDA’s funds are already earmarked for FSMA food priorities and congressional mandates. I do applaud Sec. 4 mandating the FDA to communicate with the US Department of Justice (DOJ) on price gouging and hoarding to seek enforcement actions. I am still wondering how hoarding will be possible if the drugs in short supply are not available at all.

This short and sweet Order will hopefully prod the US Congress to address this problem with the full force of the US constitutional authority. Time is a luxury factor we do not have. As I stated before in a previous blog, the pharmaceutical industry and FDA must collaborate to mitigate further risk to national security.

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

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