Shortages and Sunshine

Apr 01, 2012

There's a great thirst for information on pharma operations, including drug manufacturing problems likely to dry up vital medical supplies, findings from clinical research studies, and company payments to doctors for multiple activities. The rising clamor for more "transparency" in industry operations creates considerable challenges—and costs.

Jill Wechsler
To deal with still-prevalent shortages of critical drugs, Congress is poised to make manufacturers expand reports to FDA about short supply situations and to establish a new track-and-trace monitoring system. At a hearing before the House Energy and Commerce Health subcommittee last month, legislators urged FDA and industry to devise a "robust pedigree system" that would track drugs through the supply chain. Continued shortages, along with the rise in counterfeit drugs such as the cancer therapy Avastin (see sidebar), have kept drug supply chain issues on the front page.

Manufacturers, distributors, and pharmacists told legislators that they have finally agreed on an efficient, affordable national serialization and tracking system dubbed RxTEC, which could replace the current "patchwork" of proliferating state pedigree laws. But Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), said that FDA wants tracking down to the drug-unit level because lot traceability can "only partially" identify the distribution path of contaminated or counterfeit products. As a first step, FDA has established a drug serialization system and continues to work on standards for product authentication and tracking, activities that Congress is likely to authorize through pending user fee renewal legislation.

Meanwhile, FDA is demonstrating it can be very flexible in addressing shortages of necessary therapies. Commissioner Margaret Hamburg announced in February that FDA remedied a serious shortage of the cancer drug Doxil by authorizing Caraco Pharmaceutical Laboratories to temporarily import a replacement drug, Lipodox, produced overseas by India's Sun Pharma. FDA officials emphasized that import of this unapproved foreign drug will be a temporary, limited arrangement and was authorized only after the agency evaluated the quality and safety of the Sun product.

FDA also resolved a critical shortage of methotrexate by expediting approval of a manufacturing supplement from APP Pharmaceuticals and release of thousands of vials produced by Hospira, Inc. FDA said it also is working with Mylan and Novartis' Sandoz Pharmaceuticals to boost their production of preservative-free methotrexate, which is needed to treat children diagnosed with acute lymphoblastic leukemia.

Yet, Hamburg noted in a February speech to the annual meeting of the Generic Pharmaceutical Association (GPhA) that many drug shortages are related to quality compliance issues. On almost the same day that APP announced expanded methotrexate production, FDA issued a warning letter citing the firm for serious manufacturing violations, primarily related to heparin production. And Hospira was able to ship some 65,000 vials of methotrexate in February because it had invested hundreds of millions of dollars in plant remediation efforts to resolve earlier manufacturing problems. Companies making medically necessary drugs "must invest in their manufacturing facilities," Hamburg advised the generics makers, noting that visible shortages involving generic drugs could lead the public "to equate generics with quality concerns."

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