Editorial: What Is Your Company's Back Up Plan?

This week Endo Pharmaceuticals reported that several of its products may experience a "constraint" or "disruption" in supply following the temporary shutdown of Novartis Consumer Health Inc.'s Lincoln, NE, manufacturing facility, where these Endo drugs have been manufactured. While this shutdown has not resulted in any known adverse events, such supply troubles embody what Sandra Kweder, FDA's Deputy Director, Office of New Drugs, CDER, called a "growing problem of drug shortages" when speaking before the Senate Committee on Health, Education, Labor and Pensions on December 15. FDA and legislators are being called upon to address drug shortages, but the real work may be up to the pharmaceutical industry.

According to Endo Pharmaceutical's corporate Web site, OPANA ER will see a "short-term supply constraint," and the following drugs may see "short-term supply disruptions": OPANA (oxymorphone hydrochloride) Tablets CII, Oxymorphone Hydrochloride Tablets CII, PERCOCET (oxycodone hydrochloride and acetaminophen USP) Tablets CII, PERCODAN (oxycodone hydrochloride and aspirin, USP) Tablets CII, ENDOCET (oxycodone hydrochloride and acetaminophen USP) Tablets CII, ENDODAN (oxycodone hydrochloride and aspirin, USP) Tablets CII, Morphine Sulfate Extended-Release Tablets CII, and ZYDONE (hydrocodone bitartrate/acetaminophen tablets, USP) CIII.

Endo is working with FDA to minimize "the disruption to patients currently on therapy," reported Julie McHugh, chief operating officer of Endo Pharmaceuticals in the statement on its Web site. It also is expediting production at alternative manufacturing facilities and working to help Novartis restart production at the Lincoln facility.

FDA discusses the importance of such back up manufacturing in its report "A Review of FDA's Approach to Medical Product Shortages.'' While the agency is working to develop guidance and beef up its staff to help mitigate shortages, it has identified as a longer-term action the need to "encourage product manufacturers to develop and maintain a plan for back up manufacturing and sources of Active Pharmaceutical Ingredients and other essential product components."

Proposed legislation may also empower the HHS Secretary to develop plans for manufacturing continuity. The "Preserving Access to Life-Saving Medications Act," which has been proposed in both the Senate and the House of Representatives, proposes that "the Secretary shall collaborate with manufacturers of drugs . . . to establish and improve continuity of operations plans with respect to medically necessary drugs, as defined by the Secretary, so that such plans include a process for addressing drug shortages."

Novation LLC supports the bill. After FDA extended its call for comments on its drug shortages report through December 2011, the hospital supply contract company responded, calling for greater collaboration and communication among manufacturers, wholesalers, distributors, GPOs, and FDA. But it also backs the bill because it "would require FDA to establish criteria to identify drugs vulnerable to shortage and to work with manufacturers to establish continuity of operations for these medications," wrote Novation SVP and general counsel Jill Witter.

The Infectious Diseases Society of America responded, too, emphasizing the need to "ensure diversity in manufacturing plant locations." IDSA stated that "anti-infective drug shortages adversely impact patient care by limiting the availability and choice of antimicrobials," wrote IDSA president James Hughes. "Drug shortages may also exacerbate the serious problem of antimicrobial resistance, as they may limit the practitioner's ability to provide the anti-infective with the narrowest spectrum of activity appropriate for treating a specific infection."

Back in November, when FDA issued its drug shortage report, we wrote that "manufacturers of injectable drugs should also consider redundant or parallel manufacturing processes that can support production should a quality issue occur." This advice rings true again today, and certainly for more than just manufacturers of injectables. All drug manufacturers--and packagers, too--need contingency plans. As we have seen this week, packaging issues can lead to potentially debilitating recalls.

This editorial was published as PMP News's January 12 ePackage Newsletter.

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