FDA seeks expedited approval of high-need medical technologies

The change the agency is considering would create more post-approval studies for products and bring more uncertain devices to the marketplace, Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health in Silver Spring, Md., said in January 2014.  Shuren expressed concern that U.S. patients are increasingly waiting longer to gain access to certain devices because of burdens the FDA places on companies.  He was speaking at an event hosted by the Pew Charitable Trusts, a nonprofit that lists one of its missions as making sure patients have timely access to safe and effective devices.  “We ensure devices are safe and effective, and that’s protecting public health,” Shuren said.  “But we also have to promote public health, ensuring that there’s timely access to those technologies, and facilitating innovation.”

Shuren said makers of cardiac devices are starting to turn to countries outside of the U.S. and Europe to launch their products because of the barriers the FDA and other regulators have placed on approvals.  “A safe and effective technology may take longer to get to U.S. patients, and that’s contrary to what we are about,” he said.  The answer, he continued, is to turn to post-approval studies. While the FDA currently has tools to speed devices to market or require post-approval studies, each has shortcomings, Shuren said.

For example, the FDA can require post-approval studies for devices approved under the pre-market approval application process.  However, the standard for approval is still a high bar to manufacturers and may not be quick for products with a high need.  Post-approval studies are harder for the FDA to require for its de novo classification process, which is an expedited review pathway for devices for unmet needs.

The answer would be to create a new pathway for high-need devices that has both an expedited review pathway and allows the FDA to require post-approval studies. Such pathways exist in the drug-approval process, but not for devices.  The next step for the FDA is to clarify what its thinking is in the form of guidance in order to create a further conversation and receive formal public feedback, Shuren said.

The FDA does not need new authority from Congress to make a new approval pathway possible, said David Nexon, PhD, senior executive vice president of the Advanced Medical Technology Association, a trade group of medical device companies.  He noted that there are a number of changes the agency can make now to its review process and post-marketing requirements.  “Our experience with expedited review in the device center is not generally, our companies feel, terribly good,” Nexon said at the Pew event in January 2014.

But limiting the standard for approval and requiring more post-approval studies also gives providers and patients less data on which to base opinions about treatment, said Diana Zuckerman, PhD, president of the National Research Center for Women & Families.  “What becomes the least burdensome for the device companies may end up being the most burdensome for patients and physicians who are trying to make those judgments based on limited information,” Zuckerman said at the Pew event.

Approving medical devices with more uncertainty opens the door to learning a product is unsafe or ineffective for a population when it’s already being used by those patients.  The possibility raises questions about how the agency would handle those devices.  The FDA experienced the pitfalls of relying on post-marketing studies in 2011, when it revoked bevacizumab’s (Avastin) indication for breast cancer.

REFERENCE:  David Pittman, Washington Correspondent, MedPage Today; 30 JAN 2014

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