Ensuring patients have access to new medicines relies on collaboration from many stakeholders, including policymakers, regulators, researchers, and patients. But, with the plethora of acronyms referring to the approval process, getting up to speed on the regulatory journey of a new medicine can feel like trying to decode a bowl of alphabet soup. Don't let the acronyms confuse you -- let's look behind the letters to learn more about how they help foster future medical innovation. Here are the five most important to patients:
FDA: The U.S. Food and Drug Administration (FDA) is responsible for overseeing the safety, efficacy, and security of numerous consumer products such as food, cosmetics, and pharmaceuticals. With such a wide range of products relying on the FDA's review, ensuring safety and effectiveness can be hefty task. To ensure it covers every angle, the FDA consists of many different branches, each with a specific focus and expertise. The CDER, CBER, and CDRH are just a few of the smaller, specialized branches within the FDA that work to achieve a unified mission of improving public health and safety.
CDER: The important task of determining whether or not a new medicine is safe and effective falls to the FDA's Center for Drug Evaluation and Research (CDER). In addition to reviewing safety, CDER also has the ability to expedite the approval of some innovative medicines through a variety of review processes. For patients, this can mean faster access to new, potentially life-saving treatments. In fact, two-thirds of the 41 new medicines CDER approved in 2014 underwent an expedited review process.
CBER: The Center for Biologics Evaluation and Research (CBER) is a team of experts that work within the FDA charged with reviewing groundbreaking treatments for serious diseases. The CBER focuses specifically on treatments that use biologics, treatments developed from living material, such as vaccines, gene therapy, mono-clonal antibodies, and others. The singular mission of the CBER is to protect and improve public health by ensuring that biological products are safe and effective and available to those who need them.
CDRH: The Center for Devices and Radiological Health (CDRH) determines the safety and efficacy of products ranging from prosthetics and pacemakers to microwaves and cell phones. The CDRH, a component of the FDA, ensures that consumer products and complex medical devices, including those that emit radiation, are safe and effective.
PFDD: Patient-Focused Drug Development (PFDD) is an FDA initiative that gives patients an opportunity to share their experience and participate in the development process of new medicines. Patient stories provide valuable insight into the day-to-day life of someone living with a disease and what patients value in a treatment. The mission of the PFDD initiative is simple: listen to patient experiences and incorporate their perspectives and needs in future medicine development. Since 2013, PFDD meetings have given patients more representation in the development process, helping researchers identify key areas of improvement and further development in order to deliver better, more effective treatments.
While these acronyms may initially sound confusing, they all have one simple goal: ensuring that patients have access to the safe and effective treatments they need. The FDA also aligns its internal reviewers with many external experts from a diverse background of medical and scientific expertise to protect public health and safety while reviewing innovative new treatments. To learn more about the new medicine and medical device approval processes and how these organizations empower patients to participate in the development of effective new therapies, check out the FDA's Overview of Regulatory Review and Research Activities.
What are some other confusing health care acronyms you would like to learn more about? Share your suggestions in the comments section below!