Drug shortages have been in the news quite a bit lately, and there have been some major developments in that arena this week. President Obama just signed an Executive Order yesterday which speaks directly to this critically important issue, and it's worth taking a few minutes to describe what the Order will do.
First, the Order reinforces the advance notice companies give of manufacturing issues that might create a shortage. Catching potential problems early is key: in 2011 alone, 99 shortages have been prevented due to companies notifying the FDA voluntarily about manufacturing issues that could lead to shortages. It's in everyone's best interest - patients, health care providers, and pharmaceutical manufacturers - to ensure a shortage doesn't happen, therefore our companies will continue to work with the FDA to provide notice of any manufacturing problems.
Second, the Order would speed up the FDA's approval application for certain drugs that could alleviate or lessen a drug shortage. Ensuring the FDA can do its job is key, and that's something we've always supported as an industry.
Finally, the Order would begin an investigation into what's known as the "grey market" of prescription drugs, where secondary or primary wholesalers may be price gouging when they buy up the available supply of a medicine once it's known to be in shortage, and resale that product at an extremely high markup. Price gouging by secondary wholesalers is unacceptable, and investigating these grey market behaviors will shed some light on serious safety concerns, to ensure these medicines are being properly and safely handled.
Reducing drug shortages is a must; it's the cornerstone of our industry to ensure that patients have access to medicine they need. Even though the majority of drug shortages are generic medicines, cooperation by everyone involved in the manufacturing process is essential, and we look forward to working with all stakeholders on these new developments.