The pharmaceutical industry faces ever higher hurdles in the 21st century. With the recent rash of drug recalls – 2009 is the record year so far – one hurdle that is wreaking havoc with previous profit margins and just keeps growing is that of expanding regulatory compliance burdens and reporting requirements. And now the FDA appears to be raising the bar even higher with its proposed amendments to the Investigational New Drug Safety Reporting Requirements, which take effect 28 March 2011. Lean manufacturing, however, may offer the solution.
According to the Federal Register (vol. 75, no. 188, 29 September 2010), the FDA proposes to amend its “regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND),” allegedly to “improve the utility of IND safety 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, . . . [and] promote a consistent approach to safety reporting internationally.” The potential problem lies in the fact that some of the language is imprecise, ambiguous, and may impose further compliance and reporting burdens on pharmaceutical manufacturers.
For example, a “suspected adverse drug reaction” is defined as 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.” The phrase “reasonable possibility” is too ambiguously broad, potentially leading to “reporting almost every serious, unexpected adverse event because no event could ever be completely ruled out.” The practical result may be expanding reporting requirements to further burden a struggling industry.
Lean manufacturing consultants have proposed the application of lean manufacturing thinking to the compliance-and-reporting aspect of the industry as a means to lighten this burden. They further contend that implementing lean manufacturing solutions in production itself—where processes are more amenable to waste reduction and continuous improvement—will also help.
The dominant principles behind lean manufacturing are ongoing improvement, waste reduction, and responsiveness to customer demand. Within the context of these principles, lean thinking is governed by specifying the value of a product, identifying the value stream for that product, ensuring uninterrupted flow, allowing customer demand to pull the product, and pursuing ongoing improvement. The last two items especially are closely connected with the customer end of the production process, and is where analysts have suggested companies can effectively deal with expanding reporting requirements.
What has been proposed is that pharmaceutical makers view the FDA as the customer and whatever is to be delivered to the FDA as the product. Flow will thus be improved in this area, and what were once viewed as non-value added activities will come to be seen as, and will in a sense become, value-added activities. And so waste is reduced and a process improved.
With lean thinking applied to compliance and reporting, and a lean manufacturing system implemented for actual production, pharmaceutical companies can effectively counteract expanding FDA reporting requirements. The only other ingredient needed is qualified lean manufacturing consultants to guide companies through the process.
To learn more about how lean manufacturing strategies can streamline your business and improve your bottom line, visit Smart Lean Manufacturing .
