Lessons from the FDA

On Wednesday, May 1st, 2024, Provita Pharmaceuticals was delighted to welcome members of the Food and Drug Administration (FDA) to the Bergen County Academies for an amazing presentation!

We’ve all definitely heard of the FDA at some point in our lives. The name itself carries weight, as it signifies an organization dedicated to ensuring the safety and efficacy of food, cosmetics, and medicine that we interact with everyday. 

Members of the Food and Drug Administration with Provita CEO, Eesha Oza and Advisor, Dr. Smith at the Bergen County Academies in Hackensack, NJ.

At the Bergen County Academies in Hackensack, New Jersey, students had the wonderful opportunity to gain insights from the experiences and insights of regulatory and compliance officers of this influential agency. The event drew students from various interests, including pharmacy, medicine, entrepreneurship, drug design, computer science, and management. 

What is the FDA?

The Food and Drug Administration (FDA) is an organization dedicated to safeguarding public health. Testing the safety and efficiency is essential to verify human drugs ranging from food products to cosmetics. From its start in 1906, the FDA's responsibilities have expanded over the years. They are now well known for reviewing and approving new drugs and medical devices, conducting inspections of manufacturing facilities, monitoring product safety through surveillance, and enforcing regulations to prevent fraud when marketing products.

Different Roles and Ranks in the FDA

Within the FDA, there are various roles and ranks that contribute to its functioning: 

1. Commissioner: The Commissioner of Food and Drugs is the head of the FDA, appointed by the President of the United States. The Commissioner oversees all activities of the FDA and is responsible for setting its strategic priorities.

2. Center Directors: The FDA is divided into several centers, each focusing on different product types. These include the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), and the Center for Food Safety and Applied Nutrition (CFSAN). Each center is headed by a director responsible for its operations and regulatory activities.

3. Scientists and Researchers: Scientists and researchers at the FDA conduct studies, evaluate data, and provide scientific expertise to support regulatory decision-making. They may specialize in fields such as pharmacology, toxicology, microbiology, chemistry, or epidemiology.

4. Regulatory Reviewers: Regulatory reviewers are responsible for evaluating applications submitted by companies seeking approval for drugs, biologics, medical devices, food additives, or other regulated products. They assess the safety, efficacy, and quality of these products based on scientific data and regulatory standards.

5. Inspection and Compliance Officers: These officers conduct inspections of manufacturing facilities, clinical trial sites, and other establishments to ensure compliance with FDA regulations. They may also investigate complaints, adverse events, or violations of regulatory requirements.

6. Policy Analysts: Policy analysts develop and analyze regulatory policies, guidelines, and standards to support the FDA's mission and objectives. They may assess the impact of proposed regulations, evaluate public comments, and recommend changes to existing policies.

7. Legal and Regulatory Affairs Specialists: Legal and regulatory affairs specialists provide legal advice and support on matters related to regulatory compliance, enforcement actions, product labeling, and intellectual property rights. They may also represent the FDA in legal proceedings or negotiations with industry stakeholders.

How Does the FDA Affect Consumers?

Every day, consumers interact with and use products regulated by the FDA. From the food you eat to the makeup you wear, it’s most likely been FDA-approved. Without FDA regulations, consumers could be consuming and wearing unsafe products and materials. The average civilian doesn’t know what harmful chemicals to look out for in their products, so the FDA takes that stress off the people. 

Medications are also extensively used in the daily lives of many. Every medication goes through years of research and testing before it is released into the market. This is why it takes so long for experimental medications and procedures to be widely distributed and performed, but it keeps all Americans safe. FDA workers travel worldwide to audit numerous medical advances, to see if they are safe for the U.S. No matter where something is from, all consumers can know they are protected.  

Snapshots Into FDA Work Experiences

Many of the speakers shared their highlights and experiences at the FDA throughout their careers, and one of the major points they brought up was the ability to experience different cultural aspects during their inspections in other countries. Their encounters were filled with new destinations, and many shared their appreciation and fascination with the culture of each country they had to visit. 

One speaker talked about his stay in Taiwan, in which he saw a bag of chips taped to each piece of machinery inside of the industry he was performing an inspection on. Curious, he asked one of the workers about this, and they explained that the chips, called Kuai Kuai, were considered signs of good luck that allowed technology to work without a hitch. This speaker also included many photos of himself enjoying the food in various different countries.

Insights from the Audience

As AMST junior Eesha Oza and Provita CEO recounted,

“This year as CEO, I enjoyed planning the event and coordinating with FDA members to give our members the best experience possible! It was a very informative presentation and we were able to give the FDA members a tour of our school’s labs afterwards. I really hope our school is able to work with the FDA for future events because it was such a fulfilling experience.” 

AAST freshman and Provita member Emily Gong mentioned, “I found it really interesting that many different career paths were found within the FDA and how they interacted with each other to perform clinical trials!”

AMST junior Isabella Zelaya Alves and Provita CSO stated,

“I went to the in person trip last year and I thought it was such a cool experience being there but I liked it more this time because we got to open it up to the entire BCA community, and I found it more fun being there this time because they shared many more stories and anecdotes. It made me consider the job as a possible future career because all the people seemed to enjoy their jobs so much.” 

Ultimately, we enjoyed the opportunity to meet and interact with FDA members, and their valuable perspective on the pharmaceutical industry was greatly appreciated. We hope to have similar opportunities and experiences next year with even more FDA members to hear about their engaging stories and inspiring experiences. 

Join us to dive into the world of entrepreneurial science with Provita Pharmaceuticals!