Research & DevelopmentFDA Modernization

The United States leads the world in the introduction of new medicines thanks in part to the human drug review program by the U.S. Food and Drug Administration (FDA). To ensure the Agency keeps pace with scientific discovery and to enable a more competitive, innovative and sustainable ecosystem, we need to modernize the FDA .

Pro-patient, pro-science, pro-market reforms at the FDA would enhance the competitive market for biopharmaceuticals, drive efficiency in drug development and discovery and help hold down costs. PhRMA suggests policy solutions in three areas for modernizing drug discovery, development and approval: 

Encourage Use of 21st Century Tools for Drug Evaluation, Review and Approval

Scientific advances are re-shaping our understanding of the causes of disease, creating new avenues of research, exploration and discovery. New and powerful tools emphasize individual patient characteristics and include innovative clinical trial design, advanced statistical methods and use of real-world evidence.

Solutions

Ensure FDA Drug Approval Is Scientifically Sound and Efficient

Medical and basic science is advancing at a breathtaking rate. New developments – including those in immunologic and cell therapies, personalized medicine and regenerative medicine – hold the promise of treating debilitating diseases such as Alzheimer’s, cancer, diabetes and many rare disorders.

Solutions

Reduce the Generic Backlog and Incentivize Competition Where Needed

A generic drug enters the market at the end of an innovative medication’s lifecycle. When it does, the FDA allows the manufacturer to submit an Abbreviated New Drug Application (ANDA), which does not require repetition of time consuming and costly clinical trials. As a result, generics can enter the market at a fraction of the price of an innovator medicine. With nearly 90 percent of all U.S. retail prescriptions filled with generics, their timely approval is critical to patient access and the long-term sustainability of our health care system.

Solutions

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