Rep. Billy Long (R-7) is excited about the possibility that Congress will pass the 21st Century Cures Act by the end of this session, and he wants his constituents to know that he cosponsored the bill. Unfortunately, even though Billy seems to think that his support for this bill is a big deal that will will help wipe disease off the map, I’m afraid that, along with some funding for medical research, it contains poison pills in the way of corporate giveaways that may be too big to swallow.
The bill does spend some money on limited types of medical research, and, no matter how inadequate, these days the situation is so dire that more is always good. But not when it comes at the cost of loosening important safety regulations, essentially giving the regulatory store away to pharmaceutical firms and medical device makers in order to solve problems that – guess what? – don’t really exist. Contributors to Health Affairs Blog, a Project Hope affiliated publication which “features posts from noted health policy experts and commentators from a wide variety of perspectives,” summarizes the problems with the bill:
Proponents of the proposed legislation—drug and device companies, and members of both parties in the House and Senate—argue that the FDA stifles innovation and advances in treatment by approving drugs and devices too slowly compared to other countries.
That premise is faulty. Nearly two-thirds of the novel drugs approved in 2015, for example—29 of 45, 64 percent — were approved in the United States before being approved in any other country. The proportion was even higher in 2012 and 2013. The majority of these drugs (60 percent) took advantage of existing FDA expedited review programs—fast track, breakthrough, priority review, and accelerated approval—and nearly half (47 percent) were approved to treat rare or orphan diseases.
As for devices, research shows that “it takes the same amount of time or less for patients to gain access to innovative, high-risk medical devices” in the U.S. as compared to Germany, France, Italy, and Britain.
The House and Senate bills ignore the above facts. They essentially seek to speed-up the approval process by relaxing FDA’s safety and effectiveness standards. And to make that more palatable, sponsors have attached the changes to increases in funding for the National Institutes of Health and the FDA.
Democratic Senator Elizabeth Warren (D-MA) leveled a powerful attack on the paltry and likely ephemeral increase in research funding that is on offer:
For more than two years, Congress has been working on legislation to help advance medical innovation in the United States. Medical innovation is powerfully important, and I have spent as much time working it as any other issue during my time in the Senate.
From the beginning, I have emphasized one obvious fact. Medical breakthroughs come from increasing investments in basic research. Right now, Congress is choking off investments in the NIH. Adjusted for inflation, federal spending on medical research over the past dozen years has been cut by 20%. Those cuts take the legs out from under future medical innovation in America. We can name a piece of legislation the “cures” bill, but if it doesn’t include meaningful funding for the National Institutes of Health and the Food and Drug Administration, it won’t cure anything.
That’s why months ago Senate Democrats said any so-called “cures” legislation must have a significant investment in medical research. And that’s why Senate Republicans publicly committed to doing exactly that. But now they have reneged on that promise and let Big Pharma hijack the Cures bill. This final deal has only a tiny fig leaf of funding, for NIH and for the opioid crisis.
And most of that fig leaf isn’t even real. Most of the money won’t really be there unless future Congresses passes future bills in future years to spend those dollars. …
Just in case, she hadn’t made her position clear, Warren added:
I support most of these proposals. I’ve worked on many of them for years. I even wrote several of them myself. If this bill becomes law, there is no question it will contain some real legislative accomplishments.
But I cannot vote for this bill. I will fight it because I know the difference between compromise and extortion.
Compromise is putting together common-sense health proposals supported by Democrats, by Republicans, and by most of the American people, and passing them into law. Extortion is holding those exact same proposals hostage unless everyone agrees to special favors for campaign donors and giveaways to the richest drug companies in the world.
Somehow, Billy Long neglected to tell us about the real focus of the bill; he wants us to believe that a poorly funded bill based on Big Pharma’s and medical device makers’ wish-list “could save millions of lives.”
When it comes down to it, if the choice is between Ozark Billy and Elizabeth Warren, I know who I believe.