The FDA Modernization Act: What it is and Why it’s Significant

In April 2021, Representative Vern Buchanan (R-FL) introduced a bill called the FDA Modernization Act in the U.S. House, as part of a larger piece of legislation regarding amendments to the Federal Food, Drug, and Cosmetic Act. A similar bill was introduced in the U.S. Senate several months later by Senator Rand Paul (R-KY). Also called the FDA Modernization Act, it was authored by Senators Paul and Cory Booker (D-NJ) and co-sponsored by a bipartisan committee including Senators John Kennedy (R-LA), Ben Ray Luján (D-NM), Susan Collins (R-ME) and Bernie Sanders (I-VT). An updated version of the bill, the FDA Modernization Act 2.0, was reintroduced and unanimously passed in the Senate in September 2022.

Background

The FDA Modernization Act is the latest addendum to a comprehensive set of consumer health-related laws that have been in place for over a century, beginning with the Pure Food and Drug Act of 1906. This landmark piece of legislation was designed to protect consumers from mislabeled or dangerous food and medicine, at a time when there was little to no regulation in either industry. Shortly thereafter, the Food and Drug Administration (FDA) was established to help enforce the statutes included in the bill.

The first major amendment to the Pure Food and Drug Act was in 1938, when Congress passed the Federal Food, Drug, and Cosmetic Act (FFDCA) in an effort to better ensure the safety of medication and cosmetics. This amendment required, among other things, that every new drug be tested on animals before being cleared for human use. It’s likely that this requirement was in response to public outcry regarding the deaths of more than 100 people a year prior, after taking medication that contained diethylene glycol and had not been properly tested for toxicity.

What the Bill Includes

The FDA Modernization Act aims to diversify the means by which drug companies can test their products for safety and efficacy before those drugs are brought to market. While animal testing was once considered the gold standard in drug toxicity assessments, recent scientific developments have opened the door to a variety of potentially groundbreaking options. This bill does not ban animal testing, but allows for other validated, scientifically rigorous methods to be used in its place if and when deemed appropriate. These other methods include human microphysiological systems, organ chips and computer modeling - as well as cell-based assays.

Expected Outcomes

The passage of this bill represents a major victory for animal rights activists, who have long decried the use of animals in drug toxicity testing. But there are several other benefits in allowing for alternatives.

Increased efficacy. One of the most compelling arguments against animal testing is that it fails, in many cases, to accurately predict the human response to a particular drug; while they share certain traits, humans and animals are quite different in their physiological composition. Advancements in science allow drug companies to more effectively mimic the human response, thereby enabling more precise and specific results.

Streamlined time to market. Removing the animal drug testing requirement and replacing it with a more modern toxicity screening method may permit drug companies to complete their studies in a shorter time frame - which, in turn, could translate to potentially life-saving medications becoming available to consumers more quickly.

Cost-saving opportunities. Animal testing can be extremely expensive; utilizing less costly methods to ensure a product’s safety and efficacy reduces the overall price of the process for drug companies - freeing those funds for additional research.

Located in San Antonio, TX, StemBioSys develops cell culture technologies licensed from The University of Texas Health Science Center, San Antonio. Our work represents the next evolution in stem cell research. For more information about StemBioSys and our patented technology, please contact us.