The Food and Drug Administration (FDA), with over 30 different divisions and offices, is responsible for overlooking the safety and efficiency of drugs, medical devices, food and other biological products for the United States public. For people with diabetes, the FDA plays a very important role. They oversee the safety of the drugs that a person with diabetes may have to take, whether it is injectable or oral and the safety of current and newly developed medical devices. (Like blood glucose meters and insulin pumps!)
What are the Important Diabetes Related Divisions within the FDA?
The two divisions of the FDA most important to people living with diabetes are The Center for Drug Evaluation and Research (CDER) and The Center for Devices and Radiological Health (CDRH).
The Center for Drug Evaluation and Research (CDER)
CDER’s primary focus is to ensure that people living within the United States have safe and effective drugs available to them in order to help improve their health. This includes over-the-counter and prescription drugs. For people with diabetes, all insulin, diabetes oral medications, glucagon, and other medications.There are a few initiatives from within the CDER office that are worth nothing:
Critical Path Initiative
The Critical Path Initiative is the FDA’s method of creating a streamlined process of how FDA-regulated products move from a development phase to the consumer more efficiently. You can learn more about the Critical Path Initiative here.
Safe Use Initiative
The Safe Use Initiative from the FDA is a long-term program to help ensure that people are safely and properly taking medications. The goal of the initiative is to decrease the amount of medication misuses and errors by eliminating the wrong doses or medications being prescribed and filled by doctors and pharmacies, as well as educating the public on how to properly take their medications.
Safety First Initiative
The Safety First Initiative was put in place to ensure that an on-going review of a drug is continued throughout its lifecycle.
The Center for Devices and Radiological Health (CDRH)
The CDRH's primary focus is to assure consumers and patients are provided safe and effective medical devices. This includes blood glucose monitoring devices, insulin pumps, continuous glucose monitoring systems, and artificial pancreas device systems. The CDRH includes a Medical Device Advisory Committee which advises the Commissioner about safety related items in regards to medical devices.
Partner with Patients
One of the 2016-2017 Strategic Priorities for the CDRH is to Partner with Patients. The goal is to work with patients to help the development and evaluation of new devices.
We believe that if CDRH is to successfully achieve a mission and vision in the service of patients, we must interact with patients as partners and work together to advance the development and evaluation of innovative devices, and monitor the performance of marketed devices - FDA
The CDRH has created an advisory committee whose sole purpose is patient engagement. This has never been done before in the history of the FDA. Learn more here about the Patient Engagement Advisory Committee.The CDRH has also created the Digital Health Program which focuses on developing and utilizing modern technologies to help create better health outcomes.
How Does the Diabetes Online Community Work With FDA?
#DOCasksFDA
On Monday, November 3, 2014, the Diabetes Online Community (DOC) was involved in a discussion with the FDA. This meeting included nearly 30 people on site just outside of Washington, D.C. and, according to the FDA, more than 1,000 attendees online. During this meeting there were discussions about test strip safety, diabetes related data, patient stories, and more diabetes hot topics.This event showed how a community can come together to advocate for a disease. In fact, so many people showed up at once that is temporarily crashed the FDA's servers!On this day, the DOC made its voice heard and the FDA listened. We can continue to do this by acting now.
StripSafely
StripSafely was created to help the general public understand that there are, unfortunately, inaccurate blood glucose test strips and meters currently on the market. The inaccurate results from these devices can be life threatening. For example, injecting insulin based off of an inaccurate test result can cause a person's blood sugar to drop significantly and quickly. The real work of StripSafely has come from the amazing members of the Diabetes Online Community. StripSafely would love to see the letters or posts you have written about the safety and accuracy of blood glucose monitoring devices.On Wednesday, August 21 2013, StripSafely staged a Tweet-In which asked Congress to send aides to an upcoming Diabetes Technology Meeting. The response from the DOC was enough to start catching the eye of the FDA.
Over the next few weeks, we'll be asking you to take action to help the FDA ensure the safety, quality, and access of diabetes medications and devices.