The FDA it is believed has inadvertently caused drugs long-used in the US to be withdrawn from the market, while its good manufacturing practice (GMP) rules have clogged up the drug production process and raised costs. Problems with complying with GMP rules are seen as a major cause of drug shortages as a result of stoppages in production or recalls.

Other reasons for drug shortages are blamed on actual or anticipated action by the FDA’s Unapproved Drugs Initiative. This initiative is designed to increase enforcement against drugs that lack FDA approval. These drugs are unapproved as they pre-date the Food, Drug and Cosmetic Act of 1938. The cost and complexity of filing a New Drug Application for these unapproved drugs may be acting as a disincentive for entering or maintaining a market presence in the US.

The time taken for the FDA to review Abbreviated New Drug Applications (ANDAs) and supplemental applications, which are required for changes to FDA-approved drug products, e.g. change in source for active pharmaceutical ingredients API or change in manufacturer, was also thought to be a cause of drug shortages.

In its defence, the FDA is asking manufacturers to report changes in production that might impact their ability to meet market demand. This will hopefully enable the agency to work with other firms who manufacture the drug, asking them to ramp up production, if possible, in order to prevent or mitigate a shortage. Currently firms are not obliged to warn the FDA about any impending problems with supply of drugs.

Drug shortages in the US have tripled in the last six years reaching 178 in 2010 – a record high. However, good news is on the horizon with US-based generics manufacturer APP having committed to a US$38 million expansion of it’s manufacturing facility in Grand Island, New York, USA.

The APP plant produces some of the ‘Most Wanted’ types of drugs on the FDA short supply list: injectables for oncology and anti-infectives, in addition to anaesthetic/analgesic and critical care products.

Editor’s comment

This investment by APP should hopefully help to fight against the growing list of drug shortages reported by the FDA, but maybe the FDA could also look at the role it has to play in drug shortages.

Please feel free to share your thoughts via email to editorial@gabionline.net or in the comments section below. What are your views on drug shortages in the US Do you think that the FDA could do more to alleviate such shortages? What else could be done to ensure that essential drugs are available to the general public?

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