In a press conference earlier this year, Dr. Janet Woodcock, head of the U.S. Food and Drug Administration's (FDA) pharmaceutical division, stated that the FDA has been working on "establish[ing] consistent quality standards for all drugs, whether brand name or generic" over the past 10 years. As part of this effort, the FDA has established the Office of Pharmaceutical Quality (OPQ). The mission of the OPQ is to "assure that quality medicines are available for the American public." Its vision is to "be a global benchmark for regulation of pharmaceutical quality." The OPQ's main focus will be on balancing risk and availability of drugs to the public through a focused and efficient risk-based approach that encourages innovation, as well as emphasizing cross-disciplinary interaction, sharing accountability and joint problem-solving.
The OPQ is intended to "streamline FDA processes that monitor drug quality throughout the product lifecycle." This lifecycle approach by the OPQ will organize review by dosage form to ensure efficiency and consistency and will integrate the review of facilities and manufacturing processes.
The OPQ is also intended to provide greater, more open, honest and direct communication with the FDA. As part of this goal, the OPQ plans to be transparent and engage external stakeholders as it initiates new rules and other changes. For example, the OPQ will be developing written standards and procedures, which will include a set of quality metrics for drug manufacturers. The OPQ will invite the public to comment on these metrics before it produces a final rule. However, it is unknown at this time when these metrics, policies and procedures will be published.
If you have any questions about this Alert, please contact Frederick (Rick) R. Ball, Carolyn A. Alenci, any member of the Pharmaceutical, Medical Device, Pharmacy and Food industry group or the attorney in the firm with whom you are regularly in contact.
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.
