Currently, there are around 570 clinics throughout the United States which promise patients they can reduce pain, improve healing, and high all sorts of serious medical conditions including serious illnesses such as Alzheimer’s and muscular dystrophy. These clinics tell consumers they can fix their serious health issues through the use of stem cell therapy. According to Scientific American, around 351 U.S. companies are marketing these stem cell clinics directly to consumers. The problem is, their marketing materials may be dishonest, and the clinics themselves often cannot actually live up to the hype. In a worst-case scenario, the clinics actually cause harm instead of helping.
How can this happen? The issue is the stem cell clinics currently fall into a regulatory grey area and the federal government needs to do more to ensure these clinics are safe. The Food and Drug Administration has already issued draft guidance aimed at improving regulatory efforts, and there has been extensive demand by interested parties to provide comments on the FDA’s proposal. It is not yet clear, though, if the FDA will actually be able to move forward with the new rules which would make reigning in stem cell clinics possible by giving the FDA authority to regulate them in a similar way to the FDA’s regulation of biological drugs.
Regardless of what the FDA does or doesn’t do, anyone who receives treatment at a stem cell clinic should know his or her rights in case a problem occurs. An Atlanta medical malpractice lawyer can provide assistance in pursuing a case to get compensation if something goes wrong and a stem cell therapy clinic causes harm.