Washington, DC—A new bill looks to decrease the time for the development and release of new drugs and medical devices by modernizing clinical trials and removing barriers to collaboration and innovation, according to legislators.
The key provisions of the 21st Century Cures Act—which was recently unanimously approved by the House Energy and Commerce Committee—are intended to speed the marketing approval process of drugs and medical devices.
For drugs, the bill would allow approval of certain drugs based on early-stage clinical trial results, allowing use of surrogate markers in clinical trials, and providing more efficient review of applications for additional indications. The bill would also mandate U.S. Food and Drug Administration (FDA) consideration of patient-experience data in the approval process.
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For medical devices, the bill would allow for priority review for breakthrough medical devices, a pathway for allowing certain modifications to cleared medical devices without supplemental 510(k) submissions, and expansion of the humanitarian device exemption.
“If we want to save more lives—and we do—and keep the leader in medical innovation and the jobs here, we’ve got to make sure that there’s not a major gap between the science of cures and the way that we actually regulate these therapies,” says Chairman Fred Upton (R-MI), co-author of the bill.
Optometry Times Editorial Advisory Board member William Townsend, OD, FAAO, says that changes to the FDA-approval process are needed.
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“Instead of an agency whose goal is to approve products if they’re safe and effective, the FDA has been put into a defensive position in that it doesn’t want anything to go through that isn’t safe,” Dr. Townsend says.
Dr. Townsend uses the example of diquafosol, which was submitted by Inspire, now Merck.
“FDA required 100 percent clearance of staining,” says Dr. Townsend. “Most adult patients walking into our office will show some dgree of staining. In the case of diquafisol, the FDA set the bar at an unreasonably high level. But the drug has been approved and used internationally with great success. The effort to promote safety can become so protective that we deny people some products that really should be approved. The good thing about this bill is that it still allows for follow-up by the FDA, which is important.”