FDA Update – Competing Parties: Stagnant Legislation

By K. Richard Douglas

There is no way around government regulation. Yes, it has its purpose, and many regulations are designed to keep the public safe, but there are others that just seem burdensome. It’s enough to drive a good libertarian crazy.

One federal agency, tasked with keeping the public safe, is the FDA. It is a massive agency with 14,648 (2013 est.) employees and a budget of $5.1 billion. It is a part of the Department of Health and Human Services (DHHS).

According to the FDA’s website, the agency is responsible for “protecting the public health by assuring that foods (except for meat from livestock, poultry and some egg products which are regulated by the U.S. Department of Agriculture) are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective.”

They are also responsible for “protecting the public from electronic product radiation, assuring cosmetics and dietary supplements are safe and properly labeled, regulating tobacco products and advancing the public health by helping to speed product innovations.”

On the points of medical device safety and speeding product innovations, the agency has the role of regulating the companies that design, manufacture, repackage, relabel and import medical devices through its Center for Devices and Radiological Health (CDRH).

The FDA also is one of the watchdogs over the cybersecurity of medical devices along with the Department of Homeland Security (DHS), OEMs, end users and security experts.

In August, Congress passed the Food and Drug Administration Reauthorization Act of 2017. Essentially, the Act reauthorizes several user-fee programs, most notably, the Medical Device User Fee Amendments (MDUFA). It enhances the pre-market review process. President Donald Trump signed the bill into law. The Act will be in force from October 1, 2017 to September 30, 2022.

Among other things, the impact of this legislation will be to speed up and make more transparent the premarket FDA device review process. This should benefit patients by getting new medical devices to market more quickly, while maintaining high standards for patient safety.