‘21st Century Curse’ in the making?

I haven’t opined in my monthly editorials about the 21^st Century Cures issue at all this year. I did so twice in 2015, in February when it was just an initiative (and my attitude was very “wait and see”) and in May when it was an actual bill in the U.S. Congress (and my attitude was “cautiously optimistic”).

But it’s time to revisit the issue before this year runs out, given that the bill got broad bipartisan support in the House of Representatives and passed, but got bogged down in the Senate, then a revamped version just got passed by the House and, just as we went to the printer with the issue of which this editorial is a part (December), the Senate had just passed it as well.

My current attitude: Confused and uncertain

Not that such a state of mind is odd for me right now, so soon after the recent U.S. presidential election. I tend to avoid getting political in my editorials, but let me just say that the expression “May you live in interesting times”—which, while seemingly a blessing, is actually used ironically as a sort of curse/apocryphal expression—will likely define the United States for at least the next four years.

But as it relates to the 21^st Century Cures situation, I am a bit concerned about how this might impact the U.S. Food and Drug Administration. As chief editor of this magazine, I have an emotional and intellectual relationship with the FDA that would, were it a Facebook status, be “it’s complicated.”

On the one hand, the part of me that deals with pharma and biotech business issues knows that it would be nice to trim the costs of clinical trials and other aspects of the approval process. Unlike most of the American population, I know that high drug prices are often at least as much due to the economic necessity of recouping R&D costs as they are to do with greed.

On the other hand, I also deal with the academic and clinical researcher side of the news and a lot of the people on that side (and me, too) would like to see rigorous scientific study of potential drugs. I was happy in the early talk of 21^st Century Cures to hear about working in “real world” results as part of the review/approval process and possibly streamlining some FDA processes.

Given what seems to be joy from the corporate side and many patient advocacy groups, I have some concern that this bill, should it become law, might actually reduce scientific rigor instead of improving the data, and might undercut FDA’s ability to accurately assess potential drugs. To peruse some of the comments and insights (other than mine) with regard to 21^st Century Cures, see the “Commenting on Cures” article in the Business & Government Policy section of the December 2016 issue of DDNews).

However, despite those reservations, I am—if nothing else—glad to see that, so far, 21^st Century Cures allocates $4.8 billion to the National Institutes of Health that is aimed at funding the Precision Medicine Initiative, the BRAIN Initiative and the Cancer Moonshot initiative.

Let’s hope that, if nothing else, Congress makes sure we have some research funding and doesn’t take away all of FDA’s teeth.