FDA 101: What Every American Should Know (and Be Grateful For)

It’s Thanksgiving time–a chance for all of us to reflect on the things for which we are grateful. Given our role as an advocate for a stronger FDA, it is natural for the agency to be part of our thoughts.  It is also part of the Alliance’s mission to deepen public understanding of the FDA's vital mission, expanding responsibilities, and pressing budgetary needs.

With that in mind, Thanksgiving provides a perfect opportunity to refresh policymakers and stakeholders about what FDA does and why it is worthy of our support and gratitude.
 

Responsibilities

The FDA’s primary responsibilities include:

• Ensuring safety and efficacy of prescription, over-the-counter, and generic drugs;

• Regulating medical devices, from simple tools to complex technologies;

• Overseeing the safety of most food products (except meat, poultry, and eggs);

• Regulating tobacco products;

• Ensuring safety of cosmetics and radiation-emitting products;

• Overseeing animal drugs, feeds, and medical devices; and

• Regulating biological products (vaccines, blood products, cellular therapies).

Products Under FDA Jurisdiction

The FDA regulates a broad range of products, including:

• Foods: nearly 80% of the food supply (excluding only meat, poultry, and egg products regulated by USDA), infant formula, dietary supplements, bottled water, and food additives; 

• Drugs: prescription drugs (brand-name and generic) and over-the-counter drugs;

• Biologics: vaccines for humans, blood and blood products, cellular and gene therapy products, tissue and tissue products, and allergenics;

• Medical Devices: from simple items like tongue depressors to complex technologies such as heart pacemakers, dental devices, and surgical implants;

• Electronic Products Emitting Radiation: microwave ovens, X-ray equipment, laser products, ultrasonic therapy equipment, mercury vapor lamps, and sunlamps must all conform to FDA standards for safe use;

• Cosmetics: personal care products, including both cosmetics and OTC products;

• Veterinary Products: livestock feeds, pet foods, and veterinary drugs and devices; and

• Tobacco Products.

Products Not Under FDA Jurisdiction

The FDA does not regulate:

• Meat, poultry, and eggs (regulated by USDA);

• Pesticides (regulated by EPA);

• Vaccines for animal diseases (regulated by USDA);

• Drinking water (regulated by EPA);

• Alcohol (regulated by Treasury); or

• Illegal drugs (enforced by DEA).

FDA Approval Process

The FDA uses a science-based, risk-based approach for product approval:

1. Premarket approval is required for certain high-risk products like new drugs and medical devices.

2. Post-market surveillance involves monitoring products after they enter the market.

For drugs, the FDA employs a twelve-step review process, which includes animal testing, clinical trials, and facility inspections. The agency usually requires: Preclinical testing, Investigational New Drug Application (IND), Phase 1-3 clinical trials, New Drug Application (NDA), FDA review and approval decision, and Post-market safety monitoring.

FDA Enforcement Powers:

• Issue warning letters;

• Order product recalls;

• Seize products;

• Impose fines;

• Pursue criminal charges;

• Block imports;

• Shut down facilities; and

• Require corrective actions.

Altogether, FDA regulates products representing about 20% of annual consumer spending in the United States (more than $2.6 trillion).

Editorial Note:
This week's first Analysis and Commentary column was written by Ben Dash, Policy Advisor at OFW Law