U.S. Food and Drug Administration
Performance Plan
2002

1.2 Strategies and Program Overview

1.2.1 Strategies

Desired Outcome

To provide quick and safe access to the medical products of new technology and to enhance consumer access to these new products, as well as to less expensive generic drugs'.

Key Performance Goals

Pioneer Drugs and Biologics

Generic Drugs and Pioneer Medical Devices

Why is FDA's contribution important?

FDA's signature activity and a prime service to the American public is the review of safety and effectiveness of drugs, biologics, and medical devices before they are allowed on the market. FDA is the regulatory gateway through which the medical products resulting from an estimated $50 billion annual biomedical research and development investment must pass and be judged.

A major objective of the human drug review process is to reduce the time required for FDA's review of drugs and biologics applications without sacrificing standards of performance and safety. The Agency emphasizes the review of new drugs that are intended to treat serious or life-threatening diseases, such as AIDS.

Similarly, improving the efficiency and quality of the medical product application review process will assure that safe and effective medical products are available to the American people more quickly. In addition to the obvious health benefits, shortening drug development times also results in significant savings to the pharmaceutical industry.

FDA has approved several thousand generic drugs that are used successfully by millions of patients. Substituting generics for brand name drugs has resulted in savings to consumers of $8 to $10 billion annually.

How are we going to do this?

FDA has adopted a number of strategies to improve its product review processes, including:

• The Prescription Drug User Fee Act (PDUFA) authorizes FDA to collect fees from the prescription drug and biologic drug industries to expedite the review of human drugs and biologics so they can reach the market more quickly.
• Developing standards for new products of emerging technologies, such as novel drugs and biologics, to facilitate product develop- ment, expedite reviews and move products to market faster.
• Strengthening external ties. Expeditious medical product review is dependent upon enhanced collaboration and cooperation with industry, academia, professional societies and health care organizations.
• Implementing a comprehensive quality control system to ensure the Agency's pre- marketing review processes meet its public health responsibilities. FDA is working with stakeholders to implement this in the least burdensome way.
• FDA will continue prioritizing products to increase the efficiency of 'fast track' review processes in order to address the most urgent needs for new medical products first.
• FDA has been working to improve the generic drug review program to reduce review backlogs and achieve the 6-month review goal.

FDA needs to develop knowledge bases that will improve the scientific basis of regulatory guidance and advance science and product development. Formal scientific collaborations and stakeholder interactions are needed as a means to educate and increase the availability of scientific knowledge to consumers, health care providers and academia.

FDA also needs to install and implement current information technology (IT) systems that would ultimately permit the Agency to review drug applications more efficiently (for example, a single Web portal).

Consequences of Not Achieving the Goal

Delays in getting new products to market can postpone critically needed disease prevention and treatment, especially for a growing population of elderly and immune-compromised patients. Failure to achieve the goals for drug and device review will prevent innovative drugs and devices from being made available to patients and doctors in a timely manner. Therapies for treatable conditions would not reach the market in enough time to save lives.

Increased review times impact the amount of time a product is in development which in turn increases the cost of bringing a new product to market. Delays in approving generic drug equivalents result in fewer or no low-cost alternatives and overall higher costs for patients.

How are we doing?

For new drugs and biologics, the story is one of great success. FDA has moved from criticisms of a "drug lag" with other countries a decade ago to the current situation in which new drugs are approved in the U.S. as fast or faster than anywhere in the world, with the same high standards Americans expect. This was accomplished largely by the assurance of sufficient scientific staff funded by industry fees that complement appropriated funds.

Approval times for medical devices are also improving. In FY 2000, although FDA received the highest number of applications in years, the average approval of a new medical device took only 12.0 months, over 25% quicker than in FY 1997. However, in FY 1999, FDA acted upon only 28% of generic drug applications within the goal of 6 months. Reasons included a significant backlog of applications.

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