FDA and the New Path to Advance Biomedical Innovation

Epilepsy News From: Wednesday, May 17, 2017

Biomedical innovation is critically important to the 3 million people living with epilepsy who look forward to new drugs and devices because they bring hope of greater seizure control. A third of people living with epilepsy do not have their seizures under control and many more have significant side-effects from available therapies. Despite significant advances in drugs, devices, and surgical options, there is no cure for epilepsy and the number of people living with uncontrolled seizures remains the same. 

The user fee agreements currently before Congress would ensure that the U.S. Food and Drug Administration (FDA) has the resources it needs to review potential treatments in a timely manner, incorporate the patient perspective into the review process, and deliver on the promise of biomedical innovation. 

The History of FDA User Fee Agreements

  • More than 20 years ago, the structure of the FDA changed for the better when pharmaceutical manufacturers and the FDA agreed on a system by which industry would contribute funds to ensure the FDA operated effectively and efficiently.
  • The first user fee program reduced a bottleneck of new drug approvals in the late 1980s and early 1990s that left patients waiting while an under-staffed and under-funded FDA struggled to review applications for new medicines.
  • Over the years, the user fee programs have grown to include generic drugs, biologics, biosimilars, and medical devices.
  • On a basic level, FDA user fee programs establish review timelines and help to accelerate and improve the drug approval process through various initiatives at the agency.

Program Impact 

  • The success of FDA’s user fee programs has resulted in a stronger incentive for individuals and companies to invest in medical research and innovation.
  • Patients and our health care system have benefited from the approval of more than 1,500 new, safe and effective medications and hundreds of approved medical devices.
  • The program helps to protect and promote public health by allowing the agency to keep pace with the rapid increase in the number and complexity of innovative drugs and devices entering the drug development and regulatory review pipeline and eventually entering the market for patient access.

How the FDA User Fee Program Works

  • The specifics of the FDA user fee programs – such as dollar amounts and goals for the FDA – are negotiated every five years through extensive and detailed discussions between all relevant stakeholders, including the FDA, industry, and the patient community.
  • The negotiated agreements are then sent to Congress and the president to be enacted into law.

Reauthorization Needed Now

The user fee programs must be reauthorized this summer or the FDA will not be able to sustain its important work and continue to develop and refine its processes to get valuable therapies to the market in a timely manner.

The Epilepsy Foundation has been supporting the reauthorization of the FDA user fee programs since the negotiations began more than a year ago. 

  • We are especially encouraged by several components in the latest iteration of the user fee programs that will ensure patients are more involved in the drug and device approval processes.
  • The FDA has agreed to strengthen staff capacity to facilitate development and use of patient-focused methods to inform drug review and regulatory decisions.
  • They also will work to explore and further incorporate real world evidence and patient reported outcomes into decisions about drug approvals.

It is crucial that the FDA is responsive to the needs of the patient community and innovations in scientific research and health care delivery.

  • The epilepsy community needs both incremental and major breakthroughs.
  • The policies and goals included in the user fee agreements reflect what the agency, industry, and patient community value.
  • They also will help ensure advancements and improvements within the FDA and ultimately health care more broadly.

We will continue to urge Congress to move judiciously through the process of reauthorizing the user fee programs and to honor the negotiations that led to the agreements. 

Follow the Epilepsy Foundation’s efforts as they relate to the FDA user fee agreements at advocacy.epilepsy.com/FDA.

Authored by

Beatriz Duque Long

Reviewed Date

Wednesday, May 17, 2017

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