In 2010, the FDA counted a record 178 shortages, but the total in 2011 is around 200, Valerie Jensen RPh, associate director for the Drug Shortage Program in the FDA’s Center for Drug Evaluation and Research, said during an agency webinar.
The majority of shortages have been of older sterile injectable drugs, Jensen said. They include chemotherapy drugs as well as emergency medicine drugs and electrolytes that are needed to help maintain nutrition for some patients.
Only seven companies produce most sterile injectables, which, although complicated to manufacture, are mainly inexpensive generics, she said. The agency can’t force manufacturers to increase production, she added.
About half of the 2010 shortages of injectables were due to product quality issues, such as impurities, Jensen said. About one in five were due to manufacturing delays or capacity issues. The remainder were due to such problems as obtaining raw materials. For example, she said, several manufacturers lost supplies because of the Japan earthquake this year.
Heading off Shortages
While the number of drug shortages has increased this year, so has the number of shortages the FDA has been able to prevent, Jensen said. Last year the agency headed off 38 shortages, this year at least 99.
That’s due in part to manufacturers doing a better job of giving the agency a heads up when they expect shortages, Jensen said. “As soon as a company knows about an issue, we’d like to know about it,” she says.
But such reporting isn’t mandatory. Jensen said there’s only one situation in which companies are required to alert the FDA about impending shortages: when they are planning to discontinue production of a “life-supporting” or “life-sustaining” drug and they’re the only manufacturer. Even then, Jensen said, there’s no penalty for not reporting.
However, Congress is considering an amendment to the Food, Drug and Cosmetic Act that would require early notification of the FDA by prescription drugmakers if they’re planning to stop making a drug. Even if there is more than one manufacturer, shortages can arise when one drops out of the market.
The FDA can take any of a number of steps to get around or end drug shortages, Jensen said.
Expedited review of new manufacturers or suppliers.
Regulatory discretion. In other words, Jensen said, the FDA decides the benefit of the drug outweighs quality or manufacturing issues. For example, she said, there was a “horrible shortage” this year of cytarabine, an anti-leukemia drug for which there is no alternative. The problem: An active ingredient was crystallizing. The FDA allowed the drug to be distributed with instructions about how to warm it to dissolve the crystals.
Encouraging other manufacturers to ramp up production.
Pharmacists have been contacting the agency about unfamiliar distributors offering to sell them scarce drugs at a higher-than-usual price, Jensen said, but the agency has no authority over this so-called “gray market.”