Effects on Medical Technology and Research Funding (Part II of IV)
In Part I of this four-part blog series, we provided a general overview of what the 21st Century Cures Act is and some of the different medical fields where funding will be dispersed over the next ten years. In this second segment, we will explore in greater detail one of the primary provisions of the Act: the fast-track development and approval procedures for new medical devices and drugs.
Priority Approval for New Devices
A new priority review process to approve new medical devices that are considered “breakthrough” technologies or are aimed at specific illnesses and diseases, where there is currently no clearly defined or approved treatments, was included in the Act. This new method uses existing procedures but now makes it possible for the medical device manufacturer to request a priority review prior to submitting an application for FDA approval.
Changes to Clinical Trials and Studies
Previously, clinical trials and studies for both new medical devices and drugs were conducted in the region or area where they were developed. Under the new Act, companies could request a sampling of test subjects from a wider range or area outside of the location where the device or drug was originally developed.
“Real World Evidence” and Summary Data
In place of extensive clinical trials, the new Act allows pharmaceuticals and device manufacturers to submit “real world evidence and/or summary data” when being considered for fast approval.
Weighted Risk-Benefit Analysis
For some drugs, like new antibiotics, a risk-benefit analysis is allowed, based upon the risks/benefits the drugs could provide patients when they have untreatable or severe infections, compared to the harms of the illness or disease to obtain approvals.
Concerns About Fast-Track Approvals and FDA Changes
The bill was heavily supported by healthcare lobbying firms and various groups, most notably pharmaceutical companies and medical device companies. As such, some proponents that fought against the passing of the Act have concerns about the impacts it will have on the medical industry as a whole and the relaxed FDA requirements.
Some feel the previous standards set by the FDA were already sufficient for approving new and emerging medical devices and drugs, and the additional reduction further erodes the effectiveness of the FDA.
Other concerns are the long-term impacts approved medical devices and drugs would have on patients. Without detailed clinical trials and studies, there is effectively no way to determine the extent of potential side effects and other issues, current detailed trials and studies provide. Going forward, both medical device manufacturers and pharmaceutical companies will need to keep these concerns in mind when considering which products to submit for fast-track approvals.
In Part III of this four-part blog series, we will further examine how the 21st Century Cures Act will affect current healthcare practices. To learn more about lobbying and how using a lobbying firm can benefit your business, call the lobbying experts at LobbyIt by phoning 202.587.2736 today.