Researchers Cut Drug Side Effects in Half with New Tool

Getting life-saving drugs to patients faster sounds perfect, but there's been a hidden cost that two researchers just figured out how to fix.

Professor Hanu Tyagi of the University of Illinois Urbana-Champaign and Rachna Shah of the University of Minnesota discovered that drugs approved through the FDA's fast-track "Breakthrough Therapy Designation" program cause an average of 1,722 more serious health problems per year than regularly approved drugs. But they didn't stop at identifying the problem.

The two researchers dug through records for 300 drugs approved between 2012 and 2019, manually sorting through mountains of FDA data to find patterns. What they uncovered was eye-opening: when the FDA used a specific monitoring tool called Risk Evaluation and Mitigation Strategies (REMS), those serious adverse events dropped to just 875 per year, cutting the risk nearly in half.

"The Breakthrough Therapy Designation is something that's not going away, because it has proven clinical benefits," Tyagi explained. "It's not without risk, but we can optimize it and make it safer."

The breakthrough designation program launched in 2012 to speed innovative treatments to patients who desperately need them. The debate over fast approvals became especially heated during the COVID-19 vaccine rollout, when millions questioned whether speed compromised safety.

The Bright Side

Here's what makes this research so promising: the solution already exists and works. REMS programs put the responsibility on drug companies and healthcare systems to actively manage risks, rather than just slapping warning labels on bottles and hoping doctors and patients read them.

"The term 'breakthrough' can create strong expectations of a benefit," Tyagi noted. "Warnings alone may not be enough when clinicians and patients think of a drug as transformative."

The difference comes down to action versus information. A boxed warning tells you there's a risk. REMS programs actually work to prevent that risk through structured safety protocols, monitoring systems, and required training for healthcare providers.

Their research, published in the Production and Operations Management journal, recommends that the FDA require REMS evaluation for all breakthrough therapy drugs. This simple policy change could protect thousands of patients every year while still delivering innovative treatments quickly to those who need them most.

The findings prove we don't have to choose between speed and safety when it comes to getting crucial medications to patients who are running out of time.