Senators to Hamburg: Ongoing Shortages of Pediatric Drugs Call for Regulatory Response

Posted 08 May 2013 | By Alexander Gaffney, RAC 

One of the biggest regulatory news stories of 2011 revolved around the issue of drug shortages, the outcome of a multitude of unfortunate circumstances that had the effect of causing many drugs-and in particular sterile injectables, the likes of which are often used to combat cancer-to be either partially or fully unavailable to patients.

But a curious thing has happened in the last few months: Media attention about drug shortages is itself in short supply.

Senators: Get this Fixed however you can

Now 14 senators are trying to bring the issue back to the forefront, sending a letter to US Food and Drug Administration (FDA) Commissioner Margaret Hamburg asking for her help in resolving ongoing shortages of pediatric medicines, including some used to treat critically ill infants.

The letter, sent 6 May 2013, is signed by a prominent list of 14 bipartisan senators, including lead author Al Franken (D-MN), Sherrod Brown (D-OH), Rob Portman (R-OH), Mark Kirk (R-IL) and Amy Klobuchar (D-MN).

While noting FDA's previous and ongoing efforts to address what they referred to as a "severe shortage of several products that are commonly used at children's hospitals," the senators said the ongoing nature of the shortages is "deeply concerning" and could potentially have a regulatory-based resolution.

"We understand that at least one manufacturer of these products is currently offline and is working with you to get back on the market," the senators wrote. "We ask that [FDA] do everything in [its] power to get these products back on the market quickly and safely."

How do you Solve Shortages?

Manufacturing issues are among the most frequent reasons cited when searching for the root cause of drug shortages. In several cases, FDA investigators have found serious problems at various manufacturing facilities, ordering them to cease production until remediation occurs.

But that approach has backfired on regulators in several ways, causing serious shortages of many types of medicines. In other cases, it has also led to an increase in pharmaceutical compounding, a form of production that has been subject to a litany of problems and complaints in recent months.

What is in FDA's "power" to get these drugs back on the market? Past actions may offer some clues as to how the agency could respond.

FDA has used several tactics in recent months to alleviate drug shortages, including working closely with manufacturers to fix problems, asking industry to alert it to potential problems or planned obsolescence, special regulatory approvals of generic equivalents, and special manufacturing agreements.

The most prominent example of the latter category-special manufacturing agreements-may have been seen in February 2013, when FDA announced that it would permit products manufactured at Ben Venue's Bedford, Ohio facility to reach the market so long as they underwent a special post-production quality assessment at a separate facility. Jannsen, the manufacturer of an oncology drug known as Doxil (doxorubicin, said it anticipated that the changes would result in a full restoration of the drug to the US market.

That approach could be a model for FDA to consider yet again as it looks to correct shortages of parenteral nutrition drugs like sodium phosphate, potassium phosphate, calcium gluconate, calcium chloride, zinc, trace elements and others.

The senators said the urgency of the problem was alarming, with some children being rationed fractions of the necessary drugs, causing some children to show signs of nutritional deficiencies.

"Several hospitals have reported that they are within one or two weeks of running out of these products completely," they added. " It is essential that we do all we can to prevent shortages in products that compose total parenteral nutrition so that children's hospitals can again focus on providing the best care to their patients."

The senators' letter may be found here.

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