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Dr. Namandjé Bumpus shares some updates for May in Episode 4 of FDA In Your Day.
0:00 50th Biosimilar Approval
0:38 Anti-choking Devices
1:17 New Initiative
2:21 High Blood Pressure Month
Transcript:
I’m Principal Deputy Commissioner Dr. Namandjé Bumpus with some updates for you from FDA. In exciting news, we recently approved the 50th biosimilar. Biosimilars are made from the same sources, like living cells or microorganisms, as their reference products. You can also expect the same safety and effectiveness from the biosimilar as you would the reference product. Diabetes, arthritis, cancer, and other diseases can be treated with biosimilars so this means the biologic products you may depend on could be available at reduced costs. FDA has some resources you can check out to help understand these treatment options.
Now turning to a recently issued safety communication from FDA. We shared step-by-step guides, approved by the American Red Cross and the American Heart Association, to relieve airway obstruction in choking victims. These protocols include abdominal thrusts, also called the “Heimlich” maneuver, for children and adults. Please know that the safety and effectiveness of over-the-counter anti-choking devices have not been established and they are not FDA approved or cleared. So, if you choose to use them, only use anti-choking devices after the established choking protocols have failed.
FDA is reimagining the home environment as an integral part of the health care system. Our Home as a Health Care Hub initiative advances health equity by aiming to seamlessly integrate medical devices into the home. So, this could allow you to access care in your home rather than having to visit a doctor’s office, clinic or hospital. So let’s here from the Center for Devices and Radiological Health director Jeff Shuren, to tell you more about it. Thanks Namandje, we're actually working with an architectural firm to design a model home using virtual reality that’ll serve as an idea hub. Once completed, this will allow medical device manufacturers to use it as a tool to see how their devices operate in the home to help assure their technologies better meet the needs of consumers and fit more seamlessly into their day to day lives. Or even be used to help demonstrate how clinical trials might be made more accessible to many. Thanks Jeff, this work is critical in bringing more Americans a longer, higher quality life. And before you go, May is High Blood Pressure Education month. More than 119 million American adults have high blood pressure. But only about 1 in 4 of those people have their condition under control. Many people develop high blood pressure when they are in their late 30’s or early 40’s, and it occurs more frequently as people age. Early detection is very important and high blood pressure is often referred to as the “silent killer” because it may show no symptoms. In addition to lifestyle changes, there are several types of medications that treat high blood pressure. Now, each type has benefits and risks that should be carefully weighed by you and your health care professional. So this May, please consider checking your blood pressure, maybe even a few times.
Thanks for watching and see you next time.