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AHA says penalties as well as incentives are needed to face down 'persistent' drug shortages

BD exiting sterile injectables biz, selling plant and portfolio to Fresenius Kabi
A shortage of sterile injectable opioids tied to problems at a Pfizer plant figures prominently into suggestions by the AHA to the FDA for dealing with drug shortages.

Persistent drug shortages have become dangerous and costly, the American Hospital Association says, forcing staff to use drugs with which they have less experience and that are sometimes more expensive.

Responding to an FDA request for comment, the AHA, which represents 5,000 hospitals and 270,000 physicians, has crafted (PDF) a lengthy list of suggestions for addressing the problems that include both the carrot and the stick.
It calls for some incentives to ensure drugmakers have contingency plans for producing essential drugs and to entice other drugmakers to make products that are often in need. But it also asks Congress to put penalties in place for drug manufacturers that don’t quickly respond to a shortage.
Some of the recommendations seemed pointed at specific producers like Pfizer, where a warning letter for problems at one of its Hospira plants has led to shortages of injected opioids, pain drugs that hospitals turn to every day.

The seven-page letter lauds the FDA for having improved the situation in the last decade but then points to “a troubling increase in the number of persistent shortages” of sterile injectables and intravenous saline.

“Thus, the serious issues underlying drug shortages remain, and may be getting worse. Steps need to be taken to ensure that the right drugs are available to patients at the right time,” the AHA says.
The group wants drugmakers to have to not only notify the FDA of anticipated shortages but also to provide “transparency” into the cause of the problems and be fined if they don’t. It proposes Congress enact incentives for drug manufacturers to establish contingency plans and redundant production lines to be used in the event of a shortage, especially for any essential drugs for which there are fewer than three manufacturers.
For special situations, like with hurricanes that closed down manufacturing in Puerto Rico, the AHA suggests the FDA enforce an allocation list to make sure remaining supplies are distributed fairly, a step it says could help prevent hospitals from hoarding drugs.

It said it should not be just drugmakers’ responsibility to keep the FDA updated in the event of a shortage but also wholesalers and group purchasing organizations. It also suggests the FDA should improve its “interagency communication and cross-agency coordination,” like it did last year in the face of the injectable narcotic shortage. Addressing that shortage involved both the FDA and the DEA, which controls which companies can make narcotics and how much.

When Pfizer’s manufacturing problems left hospitals scrambling for injected pain drugs, the DEA agreed to allocate some of Pfizer’s narcotics quota to competitors, a move that helped only incrementally.
One of those competitors was West-Ward, a division of Hikma Pharmaceuticals. A spokesperson for the company explained the difficulty of trying to face down the shortage once it is already affecting the market.
“We, and the manufacturers who remain in the marketplace, are trying to make up for a nearly 60% drop in supply that is currently affecting patient care,” it explained. “While the DEA recently granted some additional quota for us to purchase the active pharmaceutical ingredient (API), we continue to submit requests for further quota to meet our customer needs.”