U.S. flag An official website of the United States government
  1. Home
  2. About FDA
  3. FDA Organization
  4. Office of Regulatory Affairs
  5. Regulatory News, Stories, and Features
  6. ORA's Detroit Laboratory and University of Michigan Students Connect for Lab Tour
  1. Regulatory News, Stories, and Features

ORA's Detroit Laboratory and University of Michigan Students Connect for Lab Tour

By Dawn Pyant 

University of Michigan School of Pharmacy students with chemist Michael Truchan at ORA's Detroit Medical Products Laboratory
University of Michigan School of Pharmacy students with chemist Michael
Truchan at ORA's Detroit Medical Products Laboratory

“Science is the universal language,” said Jeanpaul Mivoyel, Acting Director of ORA's Detroit Medical Products Laboratory (DETLMP), a remark that spoke volumes to a visiting group of students from the University of Michigan (U-M), there to participate in a presentation and tour of the laboratory. 

“Nearly every time we saw a machine during our FDA tour, I remembered using it in organic chemistry!” said Zoe Gargiulo, one of the U-M College of Pharmacy students in attendance. “It was very cool to see them used in a real-life context, and it gave me a greater appreciation for my chemistry classes.” 

The Detroit laboratory played host to students from the U-M's Pharmacy Community College Connect, or PC3 Program, on July 24. The program, in its inaugural year, welcomes students from tribal and community colleges across the state of Michigan and offers them various perks and opportunities for engaging in their field of study, including free, on-campus housing, a $6000 stipend, academic advising, peer-to-peer mentoring, job shadowing, and other career exploration support.   

The goal of the program is to increase the number of pharmacists who provide long-term care in underserved communities, helping chip away at the health disparities faced by many communities in the United States. 

U-Michigan believes one way to do this is to cultivate a diverse workforce within the U.S. healthcare system. Its goal is to recruit and graduate students with diverse backgrounds, specifically in the profession of pharmacy. 

They’re making impressive progress: In 2017, the number of students from marginalized and underrepresented communities at the U-M School of Pharmacy was 3.4%. Today, it’s 14%. 

A Lab with Many Crucial Capabilities 

A pharmacist accounting for drugs in a storage room
A pharmacist accounting for drugs in a storage room

The FDA opened its Detroit-based laboratory in 1959 and moved to its current location in 2003. Michael Truchan, a chemist at the lab, who generously helped lead the U-M PC3 Program student visit, provided the budding pharmacists with an overview of the lab’s various program areas, including Shelf-Life Extension, Drug Quality Sampling and Testing, Health Fraud, Bioresearch Monitoring, and Cooperative Research and Development Agreements. 

“Every day I see the importance of our work,” Truchan told the students. “We're here to protect the public.” 

He went on to share real-life examples of how ORA's Detroit lab has advanced public health. 

Chemist Michael Truchan explained how gas chromatography is used to analyze hand sanitizers.
Chemist Michael Truchan explained
how gas chromatography is used
to analyze hand sanitizers

During the COVID-19 pandemic, for instance, the sudden boost in hand sanitizer usage that resulted in shortages of the product led the FDA to formulate a policy for the temporary preparation of certain alcohol-based hand sanitizer products. 

But some of those products proved substandard and even toxic, manufactured with cheaper and unsafe forms of alcohol, like methanol, and other adulterants. 

The Detroit laboratory, among other ORA medical products laboratories, quickly responded, screening incoming suspicious products for harmful adulterants.   

In June and July of 2019, the Detroit lab also worked steadily on the EVALI outbreak among adolescents in the Midwest who had experienced lung injury or harm, including severe pulmonary disease, as a result of using vaping products. 

EVALI, which stands for E-Cigarette, or Vaping Product, Use Associated Lung Injury, is the term used to describe the lung damage or disease that can develop due to vaping.  

Truchan demonstrated how, during the EVALI crisis, field labs used a special vibrational technology to screen for the presence of potentially harmful cutting agents--such as vitamin E acetate, a synthetic form of vitamin E suspected of causing lung injury--in THC-containing vaping products. 
Truchan demonstrated how, during the EVALI crisis, field labs used a special vibrational technology to screen for the presence of potentially harmful cutting agents--such as vitamin E acetate, a synthetic form of vitamin E suspected of causing lung injury

ORA labs, including DETLMP, along with the Forensic Chemistry Center in Cincinnati, Ohio, are dedicated and proud to support the CDC and state and local public health partners in investigations aimed at protecting young people. 

*For more information, including an FDA warning that people NOT use THC-containing vaping products, see Lung Injuries Associated with Use of Vaping Products.

Madison Jeffrey, PC3 Program Manager, spoke highly of the experience at the ORA lab and its impacts on the students. "I think everyone thoroughly enjoyed the visit and the time we spent with FDA."   

 
Back to Top