Will 21st Century Cures Act Expose Patients to Defective Medical Devices?

A measure that could impact how drugs and medical devices are approved by the FDA is currently awaiting its future in the U.S. Senate. H.R.6., also known as the 21st Century Cures Act has been approved by both the House of Representatives and the House Energy and Commerce Committee. However, concern has been raised about how some of the changes outlined in the bill could impact patient safety. Changes might also impact the scope of medical device injury lawsuit filings, if more potentially dangerous drugs and devices are introduced to the market.

About the 21st Century Cures Act

The 21st Century Cures Act is a bipartisan bill introduced by Rep. Fred Upton (R-Mich) and co-sponsored by Rep. Diana Degette (D-Colo). The bill establishes new procedures to remove perceived obstacles in the FDA approval process for new drugs and medical devices. Although the bill has been lauded by many special interest groups for the ability to get some drugs and devices on the market sooner, others are concerned that the expedited process could compromise the safety and efficacy of some of those products.

The bill would allow the FDA to approve new drugs and devices based on data like uncontrolled case studies or published medical journal articles alone. Companies would no longer be required to submit larger, later-stage trials as a criteria for FDA approval. The bill would also allow pharmaceutical companies to make changes to medical devices, even devices categorized as high risk, without appropriate clinical documentation of the safety of the change. Companies would also no longer be required to notify the FDA of such changes, leaving patients and even the medical community vulnerable to potential risks associated with such changes.

The bill would also change the reporting requirements under the Physician Payment Sunshine Act. This act was established to create transparency between device manufacturers and physicians to preserve the integrity of the device approval and marketing process. Under the new guidelines, device manufacturers would no longer be required to report speaking fees and other gifts given to doctors that are intended for “medical education” purposes. These relaxed guidelines could compromise the integrity of the devices and ultimately, patient safety in some cases.

Bill amid growing defective device lawsuit number

Even as this bill awaits its fate in the U.S. Senate, the medical device injury lawsuit number continues to climb involving potentially dangerous devices like transvaginal mesh and metal-on-metal hip implants. In some cases, medical devices were approved through an accelerated process known as the 510(k) premarket process. This fast track approval was designed for devices that were similar to other devices that were currently in use at the time the new device was introduced. However, experience has now demonstrated the risks associated with the 510(k) process, as many devices facing legal action were approved in this manner.

Accelerated approval programs have drawn criticism due to claims they put a speedy approval ahead of patient safety. Some are arguing that the 21st Century Cures Act would do the same. Time will tell if this bill can successfully gain approval through the Senate and head to the President’s desk to be signed into law. More time will then be needed to see if concerns about the ramifications of this bill will actually come to fruition.

Resources Resources