The FDA Fast Track: Your Key To Expedited Approval Of Drugs Treating Serious Diseases

FDA Fast Track

It takes an average of 15 years from the time a manufacturer with new product idea approaches the Food and Drug Association (FDA) until the time of its final approval for marketing.

• First, the manufacturer submits an Investigational New Drug (IND) application to the FDA.
• Second, the manufacturer completes Phase I, II, and III clinical trials to establish safety and efficacy of the product.
• Third, the manufacturer submits a New Drug Application or a Biologics Licensing Application (NDA or BLA) to the FDA.
• Finally, the FDA reviews the application for safety and efficacy and decides whether to approve the application.

This lengthy approval process is especially a problem for drugs and biologics that treat a serious or life threatening condition. In most cases, people afflicted with this condition do not have 15 years to wait for such a product. To help solve this problem the Food and Drug Administration Modernization Act of 1997 created the designation of the “Fast Track” for certain products. To be eligible for the Fast Track designation a product must:

• Treat a serious or life-threatening condition and
• Must have the potential to address an unmet medical need.

The Fast Track process facilitates the development and expedites the review of eligible drugs. Therefore, the purpose of the Fast Tract designation is to get important drugs to patients earlier.

Determining whether a condition is serious is of course a matter of judgment but is generally based on whether the product will:

• Affect survival,
• Day-to-day functioning or
• The likelihood that the untreated condition will progress from a less serious to a more serious condition.

Some common examples of life threatening diseases are AIDS, Alzheimer’s, heart failure, and cancer.  In addition, diseases like epilepsy, depression and diabetes are considered serious.

A product with the potential to address an unmet medical need must provide either a therapy where none exists or provide a superior therapy to an existing therapy. Some ways to show that a drug has an advantage over another are as follows:

• Shows superior efficacy
• Avoids serious side effects
• Improves the diagnosis where early diagnosis results in improved outcome

A Fast Track applicant must first submit a request with supporting documentation to the FDA for designation for the product and its proposed use. The FDA must then decide within 60 days whether the conditions for Fast Track designation have been met. A drug that receives Fast Tract designation is eligible for some of the following:

• More frequent meetings with the FDA to plan drug development and ensure appropriate data is collected for approval
• More frequent written correspondence about design of clinical trials
• Rolling Review, which means a company can submit sections of the NDA rather than waiting until the entire application is completed to submit to the FDA for review

Frequent communication by the company and the FDA is encouraged throughout the entire drug development and review process to assure that questions and issues are resolved quickly. This will lead to earlier approval and access to the drug by the patients.

Priority Review

In addition, drugs eligible for the fast track designation are likely to be considered to receive Priority Review. A Priority Review designation is also given to drugs that offer major advancements in therapy, or provide superior therapy to an existing therapy.

A Priority Review designation allows for the time of the FDA to review a new drug application to be reduced to a goal of six months. Priority review differs from standard review where the new drug application time has a goal of ten months.

Standard review is applied for a drug that only offers minor improvements over existing therapies. This two-tiered system of review times was created in 1992, under the Prescription Drug User Act (PDUFA), where the FDA agreed to specific goals for improving the drug review process.

The drug company must request priority review. The FDA determines whether a priority review or standard review designation will be assigned within 45 days. But a priority review status does not affect the length of the clinical trial period or the scientific/medical standard for approval.

The distinction between priority review and standard review was created so that the FDA could give additional attention and resources to drugs that have potential to provide significant advances for consumers’ treatment. Some examples of how these advances can be demonstrated are:

• Evidence of increased effectiveness treating, preventing, or diagnosing a disease
• Reduction or elimination of side effects that limit the treatment of a drug
• Documented improvement of the willingness for patient compliance
• Evidence of improved safety and efficacy in a subpopulation, such as children

Accelerated Approval

Another program similar to Fast Track that can speed up the development process before a company submits a marketing application is “Accelerated Approval.” Accelerated Approval involves a surrogate endpoint in clinical trials that is reasonably likely to provide clinical benefits. This surrogate endpoint can save valuable time in the drug approval process. Accelerated Approval can also be used to address drugs whose use could be safe and effective under restrictions and include limited prescribing and dispensing. For this use of Accelerated Approval, the FDA will usually require postmarking studies. If this postmarking study shows the expected clinical results, the FDA will grant traditional approval at that time.

For a company to receive Accelerated Approval for a drug, they must demonstrate that the drug treats a serious or life threatening illness and provides a meaningful therapeutic benefit over existing treatments.

Speeding up the development and availability of drugs that treat serious diseases and have advantages over current therapies is in both the consumers and the company’s best interest. Using the expedited processes of Fast Track, Priority Review, and Accelerated Approval are the best way to get your product to market faster. Having someone who is knowledgeable on these processes can give your company the competitive advantage.

For additional information on these expedited processes, or how we can help you, please contact us here at Regulatory Affairs associates at 248 747 8008. Or email us at info@regaffairs.net

Written by Alexander Cohen

3 17 2010

Edited by: Margaret Stenerson

12 20 2010