Senate leaders now say they won’t consider companion legislation to the House-passed 21st Century Cures Act until September, after months of delay. Lawmakers would then have to reconcile the differing House and Senate versions, presumably by year’s end during a lame-duck Congress.
We believe the summer delay is a good thing, and that Congress should actually extend consideration of the complex legislation into 2017 when must-pass FDA funding through industry user-fees will be on the congressional calendar. That way, lawmakers can debate the implications of the proposed bills in the context of the resources FDA needs.
Why further delay? Because the legislation—which makes substantial changes to the way the Food and Drug Administration (FDA) approves drugs and devices—is flawed. As currently crafted, it lowers standards for drug and device approvals and safety, and risks adding to the rising cost of prescription drugs.
The ostensible rationale for the legislation—being pushed by drug and device companies—is that the FDA stifles innovation and advances in treatment by approving drugs and devices too slowly compared with other countries.
In my personal time away from my role at Deloitte, I am a private pilot and passionate volunteer for a charity that facilitates free air transportation for children and adults with medical conditions who need to get to treatment far from home. In my interactions with these patients I hear how important communication is to their well-being. I also hear how outreach from life sciences companies enables improvements in their lives and puts them back at the center of the health ecosystem.
If concepts could get awards, then “risk factor” would surely be a Nobel prize winner. Barely over 50 years of age, it enjoys such an important place in medicine that I suspect most of us doctors could hardly imagine practicing without it. Yet, clearly, the concept is not native to our profession nor is its success entirely justified.
Quality is all the rage in health care these days. It rolls off the presidential tongue and is at the heart of robust targets set by Health and Human Services Secretary Sylvia Burwell. (No less than half of all Medicare payments to be quality based by the end of 2018!)
An expert panel convened by the World Health Organization just declared that there is no scientific basis for canceling, postponing or moving the 28th Summer Olympics in Rio de Janeiro in August or the Paralympics in September because of the Zika outbreak. While many of us experts have expressed concerns about how the WHO handled Ebola and other outbreaks, this time the WHO got it right.
In the United States, we have historically invested far more in treating sickness than we do in maintaining health. The result of this imbalance is not only poorer health, but more money spent in institutions, hospitals, and nursing homes.
Some have suggested that my comments over the past few months about the Meaningful Use program, MACRA/MIPS, and Certification imply that we should just give up – throw out the baby with the bath water.
As a practicing internist, I have followed the gamut of the sturm and drang surrounding interoperability, and have experienced its pros and cons first hand.
