Bipartisan thinktank offers FDA fixes

July 28, 2015 in Medical Technology

The Bipartisan Policy Center has issued a set of recommendations to Congress that it says will speed up medical cures and innovation. Central to the recommendations in the report, “Advancing Medical Innovation for a Healthier America,” is the use of healthcare information technology for post-approval studies, new uses for medical devices and an improved approach to clinical studies.

“It’s time to take action to significantly advance medical innovation in the United States,” said former Senate Majority Leader Bill Frist, MD, in a BPC release announcing the report. “Americans cannot afford to rely on 20th century methodologies for treatments when the world is on the cutting edge of new medical technologies. Federal agencies must be equipped to keep the U.S. at the forefront of medical innovation.”

Among the BPC’s health IT-related recommendations: Congress should adopt standards including those “required for accurate identification and matching of patient data, provider identification, transport, terminologies, clinical models, clinical data query language, security, and application interfaces.”

Those standards would then be required for certified electronic health records, providers receiving incentives under meaningful use and any system receiving federal funding for health IT.

However, much of the report focuses on improving the Food and Drug Administration’s ability to work more quickly to evaluate and approve new devices and therapies. Doing so – with more data from health IT applications and patient reported data – would not only improve the health of Americans, the BPC claims, but also reduce costs and make American device manufacturers and drug developers more competitive in the global marketplace.

The BPC set its sights on the FDA in March, when it called on Congress to enable the Food and Drug Administration to use hospital electronic health records and crowd-sourced patient experience data to revolutionize drug and medical device approval.

At that time, Frist noted that the FDA did not have either the resources or the Congressional authority to take full advantage of the data generated by contemporary healthcare IT applications to speed up the approval processes for drugs and devices.

It also expressed concern that the FDA might claim oversight and approval for healthcare IT applications themselves.

The FDA disputes many of the claims the BPC has made about its ability to respond quickly. In a letter to Healthcare IT News last March, Karen Riley, MPH., the FDA’s Deputy Director for Strategy, wrote that the “facts simply don’t support” such assertions.

“Last year FDA approved the most new drugs in almost 20 years,” Riley wrote. “We approved more orphan drugs than ever before. We used the accelerated approval process for more drugs than ever before. FDA is approving drugs faster than all other advanced nations — 40 days faster than Japan, 70 days faster than Canada and 174 days faster than Europe. And our medical device center is on track to meet all performance goals related to device review and approval.”

In the report released Monday, the BPC transformed those concerns into policy recommendations for FDA. Among those specifically related to clinical and patient-generated data:

Improving the medical product development process:

  • Accelerate the generation and use of more relevant evidence—including data from both clinical and patient experience–to support post-approval study requirements, approval of new indications for existing medical products, and ultimately improved clinical trials for regulatory review.
  • Assure greater harmonization of international standards and requirements.
  • Improve the interoperability of health information technology (IT).
  • Improve and expand the qualification and use of new drug development tools, including biomarkers and patient-reported outcomes, and assure that patient perspectives are included in the benefit-risk assessment associated with regulatory decision-making.

Increasing regulatory clarity:

  • Assess the rapidly evolving field of precision medicine and develop a regulatory framework that promotes innovation, protects patient safety, and is flexible enough to accommodate rapid changes in science.
  • Clarify that health IT should not be regulated as a medical device. Recognize independent bodies that can develop and assure compliance with consensus standards and facilitate patient safety reporting to continually improve the development, implementation and use of health IT.

Much of the report’s recommendations dovetail with the 21st Century Cures bill, which passed the House of Representatives earlier this month and next goes before the Senate.

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