FDA Commissioner: “We’re in Uncharted Territory”

October 28, 2015

Yesterday, FDA Acting Commissioner Stephen Ostroff, M.D. spoke at the RAPS Regulatory Convergence, where he highlighted various events leading to the transformation taking place within the Agency.

During his address, he confessed the Agency is “in uncharted territory,” and advised everyone to “stay tuned”. Currently, a lot is going on within FDA –the transition between commissioners and user fee negotiations, for example. Outside of the Agency there a number of activities that will have a direct impact on FDA – including significant pending legislation.

In the midst of this whirlwind, FDA has continued to introduce and make progress on new initiatives. One that Commissioner Ostroff drew particular attention to is the ‘patient-centric’ approach the Agency launched. He outlined specific actions taken by FDA in order to execute this new approach, highlighting the first-ever Patient Engagement Advisory Committee (PEAC). The PEAC was recently introduced by FDA’s Center for Devices and Radiological Health (CDRH) for the purpose of helping ensure that patient needs and experiences are included, and taken into consideration, during the review of medical devices. He added that “meaningful patient engagement ‘is not without its challenges,’” and provided specific examples, such as patients’ understanding of the regulatory framework and clinical trial design, as well as the exorbitant number of patient perspectives that FDA has had to manage.

Ostroff referenced various conversations in which people “insist that fewer regulations are always conducive to a better business environment.” To this he responded by emphasizing the importance of preserving FDA’s role as “the protector of the American public.”

Finally, he concluded his address stating that “we must not shortchange the standards that have provided safe and effective medical products.”

Do you have an FDA-approved product on the market? Want to ensure you are in compliance with all of FDA’s rules and regulations regarding the marketing of your product? We can help. Contact us today to learn more about our services and how we can help you maintain compliance.



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