Wednesday, August 15, 2018

You Must See The Bleeding Edge

Americans value innovation, and we built a health care system that rewards it, but at what cost? Few people understand that medical devices are not regulated as well as pharmaceuticals and patients can have untested objects implanted in their bodies. 

Prescription drugs must be tested in humans, and the FDA reviews the data before they're approved to go to market. The process has its shortcomings, but nothing like what goes on with medical devices. Through a what is essentially a loophole, the 510(k) pathway, medical devices can be approved if the manufacturer demonstrates that their device is "substantially equivalent" to a device that's already on the market. Manufacturers can get approval even if the device they're using for the comparison has been recalled because it caused problems. The new device might be made from entirely different material like using cobalt in a hip replacement or used in a completely different way like mesh that was used for hernia repairs being used for gynecological repairs. Under the current administration, what little control the FDA had is eroding. 





Wednesday, August 1, 2018

Nine Actions to Mitigate Specialty Drug Costs

I was asked to give a presentation at the Employee Health, Benefits, & Well-Being Congress in Boston about what employers can do to manage specialty drug costs. The timing was good, ASHA's PBM contract is out to bid and I've spent the last four months learning what I need to know to evaluate our options. I was happy to share what I've learned and will summarize what I shared here as well with links to some of the things I mentioned.