Understanding the FDA (Food & Drug Administration)
Many clients and potential clients have recently been asking me about the state of the pharma/biotech industry given the changes in our political administration.
The ACTUAL questions are:
“Are there still jobs for physicians in pharma?”
“Is it worth me trying to transition to biotech/pharma now?”
“Are all the physicians from government agencies going to be moving to pharma and thus, I have less of a chance to transition?”
I’m writing this blog on March 29th and today, Peter Marks just resigned from the FDA, CBER (Center for Biologics Evaluation and Research) to be exact. This morning, on my way home from the gym I was saddened to read this news. It is, in my opinion, a loss for patients first and foremost.
This news reminded me that many physicians have little exposure to the FDA.
Thus, I asked AI (Perplexity) to help summarize the FDA:
The Food and Drug Administration (FDA) is a cornerstone of public health in the United States, tasked with ensuring the safety, efficacy, and security of a wide range of products. From food and drugs to medical devices and cosmetics, the FDA’s regulatory reach impacts nearly every aspect of daily life. This guide provides an overview of the FDA’s mission, history, regulatory processes, and its role in advancing public health.
What Is the FDA?
The FDA is a federal agency within the Department of Health and Human Services (HHS). Established in 1906 with the passage of the Pure Food and Drugs Act, it was originally formed to combat unsafe food and fraudulent drug claims. Over time, its scope expanded to include medical devices, cosmetics, tobacco products, and more. Today, the FDA employs over 18,000 people across all 50 states and operates under laws such as the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act[1][2][3]
Mission and Responsibilities
The FDA’s mission centers on protecting public health by:
- Ensuring the safety and effectiveness of human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and products emitting radiation.
- Regulating tobacco products to reduce usage among minors.
- Advancing innovation to make medical products safer and more affordable.
- Providing science-based information to help consumers make informed decisions[1][4].
The agency also plays a critical role in counterterrorism by safeguarding the food supply and fostering medical product development to address emerging health threats[4].
How Does the FDA Regulate Products?
The FDA employs a two-phase regulatory approach: pre-market and post-market.
Pre-Market Phase
Before a product can be sold in the U.S., manufacturers must demonstrate its safety and efficacy:
- Drugs: Drug manufacturers conduct clinical trials across three phases. Once sufficient evidence is gathered, they submit a New Drug Application (NDA). FDA experts evaluate trial data to determine if benefits outweigh risks[5][6].
- Medical Devices: Devices are categorized into three risk-based classes. Low-risk devices may only require registration, while high-risk devices need rigorous premarket approvals (PMAs)[7].
- Food Additives & Cosmetics: Products must meet safety standards but typically do not require premarket approval unless they make specific health claims[2].
Post-Market Phase
After approval:
- The FDA monitors products for adverse events reported by consumers or healthcare professionals.
- Manufacturers may be required to update labeling or withdraw products if new risks emerge[5][6].
There are 2 MAJOR divisions of FDA – CBER and CDER:
CBER: Center for Biologics Evaluation and Research
CBER oversees biological products derived from living organisms. Its primary mission is to ensure the safety, purity, potency, and effectiveness of biologics, which include:
- Vaccines for human use.
- Blood products (e.g., plasma derivatives, immunoglobulins).
- Cell and gene therapies.
- Human cells and tissues (e.g., for transplantation).
- Allergenics and live biotherapeutics (probiotics).
- Certain medical devices, such as blood bank equipment.
CBER evaluates Biologics License Applications (BLAs), focusing on manufacturing processes, facilities, and product safety/efficacy. It also oversees post-market surveillance to monitor adverse events related to biologics[1][2][3][4].
CDER: Center for Drug Evaluation and Research
CDER regulates drugs that are chemically synthesized or biologically derived but used as therapeutic drugs (e.g., monoclonal antibodies). Its scope includes:
- Prescription drugs, over-the-counter (OTC) drugs, and generic drugs.
- Therapeutic biologics like monoclonal antibodies.
- Non-medicinal products classified as drugs (e.g., toothpaste, sunscreens).
CDER reviews New Drug Applications (NDAs) to ensure that drugs are safe, effective, and of high quality. It also monitors post-market drug safety through adverse event reporting systems. CDER plays a significant role in drug labeling, advertising oversight, and addressing drug shortages[2][5][6][7].
Key Differences
| Aspect | CBER | CDER |
| Regulated Products | Biologics: vaccines, blood products, cell/gene therapies | Drugs: prescription/OTC drugs, therapeutic biologics |
| Application Type | Biologics License Applications (BLAs) | New Drug Applications (NDAs) |
| Focus | Living organism-derived products | Chemically synthesized or therapeutic drugs |
| Examples | COVID-19 vaccines, blood plasma therapies | Antibiotics, pain relievers, anticancer drugs |
Both centers aim to protect public health by ensuring their respective products are safe and effective for consumers.
Key Achievements in FDA History
The FDA has shaped public health through landmark actions:
- 1938 FD&C Act: Introduced mandatory pre-market review for drugs.
- 1962 Kefauver-Harris Amendment: Required proof of drug efficacy alongside safety.
- Thalidomide Crisis: The FDA prevented widespread harm in the U.S. by refusing approval for thalidomide without sufficient safety data[3].
These milestones highlight the agency’s commitment to rigorous scientific evaluation.
Conclusion
The FDA’s work touches nearly every aspect of life—ensuring that medicines heal rather than harm, food nourishes rather than endangers, and innovations improve rather than compromise safety. By understanding its processes and challenges, educated audiences can appreciate its vital role in maintaining public health while fostering scientific advancement.
Ready to make a career transition to pharma/biotech… want to explore a way to use your medical training and knowledge in a fulfilling way without nights and weekends call or charting. Watch this webinar on Getting Past the Three Major Hurdles to a Career in the Pharma Industry HERE.