Rheumatologists Struggle with Drug Shortages

Advocate groups are pushing for a notification at least six months ahead of time.

The law would give the FDA the ability to impose penalties for not reporting such circumstances, although what those penalties would be is not yet determined.

The bill so far has stalled in committee, but its supporters hope legislation to tackle the shortage problem can eventually be passed.

“Often, the first time pharmacists even learn about something not being available is when they order it and they get a notice back from the drug wholesaler or the company that it’s back-ordered,” says Michael Cohen, the president of the nonprofit Institute for Safe Medication Practices (ISMP).

The FDA’s ability to avoid drug shortages is limited because there is no such advance-warning requirement. The FDA also does not have the ability to force a drug manufacturer to make a drug, although it can intervene in cases where a drug considered medically necessary is facing a shortage. In those cases, the FDA can work with manufacturers to boost production, expedite the approval process, or help with finding alternative sources of raw materials.

Without saying outright that the agency supports the legislation, FDA spokeswoman Yolanda Fultz-Morris said, in an e-mail, “Early notification helps us in many cases to avoid shortages and we continue to encourage manufacturers to notify us when they experience any issue which could lead to a change in supply.”

Dr. Dao says notification should be required when a drugmaker ceases manufacturing of a drug, noting that the FDA reports that 38 shortages were prevented last year because companies voluntarily informed the FDA about circumstances that may have led to shortages. “Makes one wonder,” she says, “how many more could have been prevented if there was mandatory reporting.”