Antibiotics, “Cures” Legislation Top Priorities for FDA’s Ostroff


Applied Clinical Trials

Ostroff noted FDA’s expanded international presence, as seen in its expanding overseas offices and in continued efforts to combat infectious disease around the world.


After some three months at the helm of the agency, and likely to remain there for the near future, FDA acting commissioner Stephen Ostroff is engaging agency stakeholders more openly about his goals and objectives for his tenure in the top spot. In a panel discussion at the annual meeting of the Drug Information Association (DIA) in June, Ostroff joined fellow regulatory authorities from the European Union, Japan and Canada in discussing the importance of increased collaboration and cooperation for improving global regulatory processes.

Ostroff noted FDA’s expanded international presence, as seen in its expanding overseas offices and in continued efforts to combat infectious disease around the world. He emphasized the critical importance of fighting anti-microbial resistance by encouraging the development of new antibiotics and diagnostics, combating false and substandard medicines, and discouraging inappropriate prescribing of disease treatments. In an interview, Ostroff expressed optimism that added incentives for developing new anti-infectives provided by recent legislation were beginning to bear fruit. He also is looking for the 21st Century Cures Act before Congress to establish a truncated clinical trials process that would encourage development of anti-infectives for limited, targeted patient populations. But to really make progress in combating antibiotic resistance, he observed, the biomedical research community needs to find ways to prevent the occurrence of resistance-prone infections from occurring in the first place, an area where new vaccines can an important role.

A main goal for Ostroff is to bring “over the finish line” a number of initiatives now in play. At the top of the list is promoting precision medicine through strategies for developing medical products targeted to critical patient needs. The House “Cures” legislation represents an important step in realizing this goal, he said, and also offers FDA added flexibility to hire the scientists and experts it needs to oversee important new technologies and therapies.

One concern Ostroff has about the “Cures” measure, though, is a provision designed to encourage biomarker development. Current language in the bill is fairly broad in allowing any party to call on FDA to evaluate and qualify any proposed biomarker. Such an open-ended program could be “very challenging” for the agency to manage, he observed, as biomarker assessment is an expensive process and involves considerable investment of agency staff time. He expressed hope that Congress will further limit the initiative before it is finalized.

In response to comments by fellow regulators at the DIA session about establishing completely new approaches for generating evidence to support novel therapies, Ostroff emphasized the continued importance of “gold standard” randomized clinical trials. New research designs and methods for precision medicine may lead to more efficient and effective clinical studies, and electronic information systems may identify suitable study participants and collect data more efficiently. But long-established basic research standards remain important to FDA’s leader.



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