Drug shortages dominate 2011 headlines

Ask average consumers to identify the biggest trend in pharmaceuticals, and they'd likely come back with one word: Shortages. Supply problems affected everything from oncology drugs to anesthetics. The former made headlines because hundreds of cancer patients had their treatments delayed or revamped. The latter, because U.S. death-penalty states couldn't get the drugs used in executions.

More drugs ran short in 2011 than ever before, thanks to a variety of manufacturing problems and financial challenges. Drug plants ran afoul of FDA manufacturing practices, hampering production. The number of suppliers for certain low-margin generics dwindled, sometimes to a single manufacturer. Raw materials for some drug ingredients ran short. Rival drugmakers tried to ramp up output to fill the supply gaps, but couldn't boost production overnight.

The shortages grew so acute—and so public—that President Obama signed an executive order demanding that the FDA, in effect, "do something." Lawmakers proposed new rules. The Government Accountability Office concluded that the only way to address drug scarcity would be to give the FDA more power. The agency could then require drugmakers to raise red flags when they hit snags that could result in shortages—and to demand action to prevent potential shortages or fix existing ones. Whether Congress would actually grant such powers is another question.

Special Report: Top drug shortages by treatment category

Suggested Articles

The FDA has granted Amarin's Vascepa a possible blockbuster label expansion for CV risk reduction in patients with or without CV disease.

In a high-stakes patent lawsuit between CAR-T companies Bristol-Myers Squibb and Gilead Sciences, BMS has come up with a victory. 

It’s been a year of ups and downs for Pfizer’s Xeljanz. But the company is hoping to close on a high note, with help from a new extended-release pill.