FDA’s Limited Ability

While FDA can control the quality of drugs being sold, it cannot require a firm to make a drug. However, if given enough notice, it can work with manufacturers to prevent or alleviate the impact of a shortage.

If a manufacturer decides to stop making a drug and informs FDA ahead of time, the agency can encourage other firms to ramp up production. FDA also can expedite review of submissions from manufacturers that may include extending expiration dates, increasing capacity or using a new raw material source, if a shortage of raw materials in the root problem.

According to Koh,  FDA was able to prevent 38 drug shortages in 2010. Thus far in 2011, the agency has prevented 99.

In one example, a recent shortage of the drug cytarabine, used to treat certain types of leukemia, resulted from crystal formation in the vials. FDA worked with the manufacturer and found that, if the vials were warmed, the crystals would dissolve and the danger to patients was mitigated. The manufacturer was then able to ship the vials with a letter to healthcare professionals notifying them to inspect for crystal formation and, if present, to warm the vials to dissolve crystals to ensure patient safety.

These types of solutions depend on close communication between manufacturers and FDA, however. At the hearing, Rear Adm. Sandra Kweder, MD, FDA deputy director, explained that the agency always could use earlier warnings.

“[In] the majority of cases of shortages we could have been notified, and in the majority we were not notified,” Kweder said. “It’s getting better, but we still have a large percentage of shortages where we did not know it was coming.”

Currently, manufacturers are not required to inform FDA they are discontinuing a drug unless it is a sole source, medically necessary drug, in which case they must inform FDA six months in advance.

“When they inform us in advance, we work very closely with them to understand the problem and see if this shortage would be something that would be critical for patients,” Kweder explained. “For example, if a company is making a product that 20 other companies make, that’s not exactly a critical public situation. But for these sterile injectables, that’s not the case. So we will work with companies to fix the problem and avoid an interruption in production.

“Now, that is not always possible. When it’s not possible and it looks like a company may have to interrupt production, we go to other manufacturers, and we talk to them about their capacity to increase their production. They usually can’t turn that around on a dime. But we work with them to facilitate ramping up.”

While informing FDA early is imperative, Kweder cautioned that early public notification may not always be in everyone’s best interests. Public notification could result in increased demand as hospitals begin stocking up or hoarding drugs. Also, what looks like a shortage at first may only be a distribution problem upon further examination.

“We think very carefully about when is the right time to make a public announcement about a potential shortage,” Kweder said. “Sometimes you see what looks like a shortage in one part of the country, but there’s plenty of it and more so in another part. We take that potential for making things worse very, very seriously.”

House Energy and Commerce Committee

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