According to a recent story from MedPage Today, the Food and Drug Administration (FDA) has tracked about 100 drug shortages this year, down almost half from this time last year, an agency official said.
“Last year, at this exact time we were over 180,” Capt. Valerie Jensen, RPh, associate director of the drug shortage program in the FDA’s Center for Drug Evaluation and Research (CDER), said last week at the American Osteopathic Association Health Policy Forum here. FDA tracked 251 shortages all of last year and 181 in 2010, Jensen said.
We have been covering drug shortages for over a year now. This positive news may show that FDA’s action and new authority given to the agency under FDASIA are working.
Jensen credited the drop in shortages to drug manufacturers improving quality, reducing the need for FDA action and recalls. “We have fewer new shortages, but I want to caution that … some of these firms that [were] having problems are still having problems,” Jensen said.
The FDA also has increased efforts in recent years to communicate and work with drug companies to prevent or stop shortages, Jensen said. The agency can work with companies to correct their quality issues or solve supply issues.
“We’re also working with the other companies making those drugs, and we’re asking them to ramp up production,” Jensen said. “We can’t require them to increase production, but we can ask them to.” The FDA’s drug center has 11 people staff its drug shortages team.
“Jensen also said the FDA was working on creating a way for providers to sort through the FDA’s mountain of drug shortage information by specialty, so specialists can more easily keep an eye on drugs used in their field. This way non-oncologists wouldn’t have to weed through statistics on cancer drugs they never prescribe and oncologists wouldn’t have to hear about the latest on the amphetamine/dextroamphetamine (Adderall) shortage.”
Ultimately we will not see the end of drug shortages until we open the market for competition and eliminate the Medicare price controls for generic sterile Injectable drugs, but some of the new rules and programs from HHS and FDA are helping reduce the bottlenecks.