The FDA

The U.S. Food and Drug Administration (FDA) is an agency that is a part of the U.S. Department of Health and Human Services. Specifically, the FDA can be broken down into five primary sections. This includes the Office of the Commissioner, as well as four directorates that oversee the fundamental responsibilities of the FDA. The four directorates are in charge of Foods, Medical Products and Tobacco, Operations, and Global Regulatory Operations and Policy.

The scope of the FDA’s responsibilities extends beyond the immediate 50 United States. Additional territories under FDA regulation include Guam, Puerto Rico, American Samoa, the Virgin Islands, and other areas of jurisdiction within the United States. In addition, the FDA regulates the same products and scientific exploration within the District of Columbia.

According to the U.S. Food and Drug Administration (FDA) website, the FDA is responsible for:

• Regulation of tobacco products.
• Protecting the American public from electronic radiation from approved products.
• Assuring the safety of and proper labeling of cosmetics.
• Assuring the safety and proper labeling of dietary supplements.
• Protecting the public health through regulation and assurance that foods are wholesome, safe, sanitary, and properly labeled.
• Protecting the public health through regulation and assurance that vaccines, human drugs, medical devices, veterinary drugs, and other biological products that are approved for use within the United States are both effective and safe.
• Helping the American public attain access to accurate scientific information that is required to use devices, medicines, and foods to maintain the best possible health.
• Advancing the American public health by aiding with the speed of product innovations.

FDA Medical Review and Development Programs

Due to the last item on the aforementioned list of FDA responsibilities, the FDA agreed to a set list of goals to improve a medical product’s review time. The FDA Fast Track Development Program originated under the Prescription Drug User Act (PDUFA) in 1992. This FDA program evolved into three sub-categories, all with the same goal: to make therapeutically important medical products available to the American public at an earlier time.

FDA Fast Track Program

The FDA’s Fast Track Program is a process that was designed to facilitate medical product development. It was intended to accelerate the review process for prescription drugs and medical devices that treat any serious illnesses. The FDA Fast Track Program also helped to speed-up the review of a medical product that could fulfill a previously unmet need.

To establish that a disease was considered serious, the FDA defined the disease to have effect on a patient’s survival or day-to-day functioning. The FDA also defined a serious illness as a disease that would progress to a significantly more serious health condition if left untreated.

To establish if a new medical product could assist with a currently unfulfilled medical need, the FDA defined that the medical product must offer a new and immediate benefit for the healthcare industry. The medical product must provide a medical therapy, where no other option already existed. The medical product could also be considered for the FDA Fast Track Program if it was scientifically expected to be superior to any existing medical therapy.

FDA Accelerated Approval Program

The FDA’s Accelerated Approval Program focuses on the difference between a clinical trial and a clinical outcome. A clinical outcome is the ultimate end result of using a new medical device or prescription drug. It is considered the “real improvement” from use of the new medical product. It can take many years to discover whether a new medical device or drug offers “real improvement” in a clinical outcome.

As a result, the FDA specified that a medical product may be eligible for their Accelerated Approval Program if it displayed a positive surrogate endpoint during clinical trials. Clinical trials are simply the tests conducted in laboratories, before a product is FDA-approved and released to consumers. A surrogate endpoint is essentially a marker that the FDA identifies as a physical sign or scientific measurement, indicating positive results from use of the new medical product.

The surrogate endpoint must correlate with a clinically significant outcome, such as symptom improvement or increased survival rates. The disease addressed by the new medical product must still be a severe illness or unmet medical need. By using a surrogate endpoint and the FDA Accelerated Approval Program, large medical manufacturers can receive FDA approval for new drugs and devices much faster.

FDA Priority Review Program

The FDA Priority Review Program established a two-tiered system for defining medical product review speeds and times. Standard Review is the suggestion for medical products that only offer minor improvements over preexisting medical therapies. After amendments to the Prescription Drug User Act (PDUFA) in 2002, Standard Review time is supposed to take no longer than 10 months for a new medical product to receive FDA approval.

Priority Review is a distinction given to medical products that offer major medical advances or provide treatment for health conditions that do not already have adequate therapy options. Attaining a Priority Review status results in a decrease of time required for FDA review and approval. With Priority Review, a new medical product is supposed to wait no longer than 6 months before receiving FDA approval.