Can you explain how the FDA’s new safety requirements might stymie diabetes research?
Tenderich: The FDA is adding additional cardiovascular research requirements to the development of all new oral diabetes drugs. This will have a chilling effect on innovations in diabetes care. As Rebecca has pointed out, it’s pretty unreasonable to require cardiac testing in phase II and phase III drugs that have not given us any reason to believe that they may pose a cardiac risk. The additional expense and time lag caused by testing the drugs for potential cardiac side effects will slow down the whole process and makes some research cost-prohibitive for smaller companies. It takes thousands of additional study subjects to rule out the possibility of cardiac harm, which can add up to tens of millions of dollars. Patients put a lot of faith in the FDA and they just assume that it’s looking out for their best interest – both in terms of mitigating risks and also in regard to encouraging research in the right areas. However, the FDA can be very political – with individual researchers dr
