Regulatory Roundup: FDA Issues Warning Letter To Paddock Laboratories; And More.

Regulatory Roundup

FDA issued a Warning Letter to Paddock Laboratories (Minneapolis) on Mar. 1, 2010. The agency alleged that the organization’s marketing of an unapproved new drug-morphine sulfate concentrate oral solution 20 mg/mL-violated the Federal Food, Drug, and Cosmetic Act. The product, manufactured by Paddock, may not be “generally recognized as safe and effective for its labeled uses,” the Warning Letter stated, because it had not yet been approved by the agency. The agency also called the product’s labeling inadequate. If Paddock ceases manufacturing and shipping the product by July 24, 2010, the agency will not take enforcement action.

FDA issued a draft guidance in January 2010 to ensure availability of medically necessary drug products during emergencies such as an influenza pandemic (see back story, “FDA Publishes Guidance for the Production of Medically Necessary Drugs”). Comments on the document were due on March 10, 2010, and only four organizations submitted suggestions: the Biotechnology Industry Organization (BIO), the Parental Drug Association (PDA), GlaxoSmithKline (London), and Genentech (South San Francisco, CA) (see comments docket). Many of the comments from these organizations were critical of the draft guidance. PDA pointed out that the draft document might call for industry to carry out some “overly burdensome” tasks. “While PDA understands and is supportive of FDA’s responsibility to address and alleviate shortages of medically necessary products, we believe that this issue is already managed by companies outside GMP systems,” said PDA in its opening comment letter. Furthermore, commented PDA, “the draft guidance as presently written is open to misinterpretation which could have unanticipated negative impact on GMP compliance of manufacturers if they are required to actually test the implementation of the plan.” BIO added in its comment letter, “BIO agrees there should be some level of 'testing' of the plan, but we do not believe that it is always necessary to actually manufacture a test batch of product as part of the plan testing. For many products including complex biologics, production of test batches will be expensive, could contribute to product shortages, and may inadvertently compromise GMP compliance.” FDA is expected to consider these comments as it finalizes the guidance.