Washington Report: Big Production - Pharmaceutical Executive

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Washington Report: Big Production
Manufacturing costs too much and is cumbersome to regulate. FDA's answer: Quality by design.


Pharmaceutical Executive


Team Approach

To deal with more science-based applications, OPS is overhauling its review process to provide more consistent and more timely approval decisions. This will be the case particularly for applications filed electronically and based on the Common Technical Document (CTD), a uniform market application for drugs and biologics that is being adopted by regulatory authorities around the world. The CTD summary provides a format that gives FDA most of the data needed for review, with links to supporting documentation, such as batch records and stability data. The summary includes a pharmaceutical development report in which an applicant can describe how it arrived at its final formulation, specifications, and manufacturing approaches, including failures and false starts.

To assess electronic CTDs efficiently, OPS is making changes in how it reviews chemistry and manufacturing information in applications. Instead of leaving the job to one chemist, NDAs will be handled by teams that can draw on specialists when appropriate. In addition, a separate review office will process manufacturing supplements under a new system that will cull out low-risk submissions that may not require agency evaluation. This effort to reduce the number of manufacturing supplements requiring prior approval will increase reliance on company annual reports to monitor and report quality-related events, such as batch failures and out-of-specification results.

Asking Questions

ANDAs have been experiencing exponential growth at a time when FDA resources have remained static. As a result, there has been talk about instituting user fees for generics makers, according to CDER director Steven Galson. While that debate moves forward, OPS' Office of Generic Drugs (OGD) is proposing a new review system to streamline the review of ANDAs while encouraging manufacturers to implement quality-by-design systems. Part of the plan is a question-based review (QbR) system that will guide reviewers in assessing applications. The questions will also alert manufacturers to issues that OGD considers most critical in documenting drug quality, and provide a format for manufacturers to explain critical process parameters and how drug substance and formulation variables affect product performance.

Although OGD is not requiring companies to use the new system, staffers say that applications based on the old format or submitted on paper will be more difficult to review. Conversely, generic drug makers filing e-applications with complete development reports may move through the process faster. And manufacturers that include QbD information in their applications may receive a lower "risk score" for new products—which means more latitude in making post-market manufacturing changes without prior approval.

Despite promises of regulatory relief, manufacturers have not been jumping on the quality assessment bandwagon. Pharma companies are only beginning to use the CTD, and electronic CTDs are rare. In the end, each manufacturer has to decide whether possible reductions in regulatory burden justify the upfront costs of implementing QbD systems. Such decisions may differ for legacy products compared with new development programs. Worldwide acceptance of quality-based manufacturing systems by regulators may make new quality approaches more attractive, as would evidence that QbD approaches can yield safer and more reliable medicines for everyone.

Jill Wechsler is PharmExec's Washington correspondent. She can be reached at


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