Senators Try to Tackle FDA's "Unnecessary Burdens"

Marie Thibault

Legislators have considered several pieces of legislation related to medical innovation this session, including the "21st Century Cures" proposal, patent reform bills, and an effort to repeal the medical device excise tax. 

The FDA Device Accountability Act of 2015 (S. 1622) is the latest such bill to be introduced. Introduced by Senators Richard Burr (R–NC) and Al Franken (D–MN), the legislators aim to employ a few different ways to make FDA device reviews more efficient. According to a one-page summary of the legislation, there are three main elements to the bill: 

First, the bill would assure consistent application of the "least burdensome" review requirements by:

Second, the legislation would allow medical device sponsors to do what drug companies can already do—secure a central Institutional Review Board (IRB) approval instead of seeking study approvals from several local IRBs. This should make it quicker and cheaper to conduct multi-country and multi-center trials. 

Lastly, the Device Accountability Act asks that FDA publish updated guidance on the criteria for CLIA waivers, espeically for point-of-care and rapid diagnostic tests. According to the bill summary, this guidance should make it clear "that if a test performs the same in the hands of untrained users as it does in the hands of laboratory professionals, then it may be administered in CLIA-waived labs (e.g. a doctor's office)."

"Ensuring that safe medical devices are developed and reviewed quickly will help get them to patients faster, which will improve and save lives. This legislation will also help cut down on the total time it takes for patients to benefit from approved medical devices by permitting more efficient clinical trials," Senator Burr said in a press release from his office. 

Medtech industry group AdvaMed applauded the proposal. In a press release, AdvaMed president and CEO Stephen Ubl said, "Taken together, these reforms will greatly improve the efficiency of FDA's medical technology review process and eliminate redundant regulatory obstacles that impact the timeliness of American patients' access to life-saving and life-enhancing innovations."

Of course, this bill isn't the first piece of legislation attempting to make the FDA regulatory process more efficient. Solutions targeting efficiency are proposed in the 21st Century Cures bill as well. In a post authored for the FDA Law Blog, Jeffrey Shapiro, director at Hyman, Phelps & McNamara, PC, wrote that while trying to ensure consistent application of the "least burdensome" approach is commendable, he is skeptical the legislation will achieve this.

Shapiro wrote, "We do not disagree with Senators Burr and Franken that the "least burdensome" requirement since 1997 has been applied inconsistently, Actually, we would go further and say that it has proven toothless . . . But is the problem really one of "consistency" and "transparency"? The FDAA bill proposes reforms on that premise. In our view, these issues do not get to the root cause, which is that the "least burdensome" requirement is inherently subjective. The fact is, FDA must make safety and effectiveness determinations according to statutory requirements. The "least burdensome" requirement does not lower the safety and effectiveness requirements."

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie. 

[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]