Press Release 1


John Smith, Ph.D.
Smith Consulting Group, LLC
777 Main Street Tulsa, OK 74023
Phone:  918-744-1234 Fax:  918-744-2345

New FDA Amendment Means More Opportunity for Lean Manufacturing

Proposed amendments to the FDA’s Investigational New Drug Safety Reporting Requirements may pose additional reporting burdens for drug makers, but may also provide the impetus for companies to embrace a lean manufacturing implementation in other areas of the drug-production process in order to maintain a competitive edge.

Tulsa, OK – 19 October 2010 – The FDA is amending, effective 28 March 2011, its “regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND)” (Federal Register, vol. 75, no. 188, 29 September 2010). These amended reporting requirements, which contain ambiguous language, are likely to make regulatory compliance more onerous for pharmaceutical firms, which means that lean manufacturing implementation will become even more crucial in other areas of the production process.

The purpose the amendments is, in part, to “improve the utility of IND safely reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite the FDA’s review of the critical safety information . . . subject bioavailability and bioequivalence studies to safety reporting requirements, [and] promote a consistent approach to safety reporting internationally.” A problem arises, though, in the ambiguity or lack of precision in some of the language, specifically, the definition of a “suspected adverse drug reaction (SADR)”: “A noxious and unintended response to any dose of a drug product for which there is a reasonable possibility that the product caused the response.”

Concerns have been raised that the ambiguity of the phrase “reasonable possibility” makes the definition too broad and will lead to “reporting almost every serious, unexpected adverse event because no event could ever be completely ruled out.” In the current climate of increasing global competition, decreasing profit margins, and ever weightier regulatory and compliance burdens, this is exactly what pharmaceutical manufacturers don’t need right now.

Industry analysts and lean manufacturing consultants agree that implementing lean manufacturing solutions could be a way out. Additional reporting will cause delays and waiting in the production process, one of the forms of waste lean manufacturing seeks to reduce. Although this waste may be difficult to reduce when the new reporting requirements take effect in 2011, there are, however, other segments of the manufacturing process that can be improved to compensate. Lean manufacturing’s emphasis on a pull system, waste reduction, sensitivity to customer demand, and continuous quality and production improvement may well prove to be just what is needed now.

Smith Consulting Group has the experience and the qualified personnel to “provide the competitive edge you need to be the market leader in medical products”—even when reporting requirements are expanding.

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