Unpacking the 21st Century Cures Act

Unpacking the 21st Century Cures Act

1
SHARE

President Obama signed the 21st Century Cures Act into law this week.  It’s the largest piece of health legislation since the Affordable Care Act.   No doubt you’ve heard or read that—and it’s true. 

But while the legislation was three years in the making and much hyped, it became the best recent example of that old saying that passing federal laws is akin to sausage making:  You don’t really want to watch what goes into it.

(An aside:  I made venison and bacon sausages from scratch for the first time this year and can attest to the “visceral” nature of that exercise.) 

There’s something for almost everybody in this new law.   That’s one reason it was the most lobbied health bill since the ACA.  In particular, the pharmaceutical and medical device industries were big winners.  Fifty-eight drug companies, 24 device companies and 26 biotech companies lobbied the bill, spending close to $200 million altogether, according to a Kaiser Health News analysis of lobbying data compiled by the Center for Responsive Politics.

What they got:  a big nudge to the FDA to find ways to approve drugs and devices faster.

For example, one change in the law allows FDA to accept as proof of safety and effectiveness less rigorous clinical trials, as well as other types of studies and data—both for the initial approval of drugs and to authorize new uses for drugs already on the market. 

Almost every major medical society, medical school, physician and hospital group, and patient advocacy group (most of which are supported in part by pharma) also supported and lobbied the bill.  In the aggregate, they spent $120 million to push for its passage. 

What they got:  A significant influx of new research dollars, possibly more drugs and devices in the medical armamentarium, and just possibly some innovative new treatments that will save lives and cure diseases. 

The new law pumps $1.8 billion into cancer research under the banner of a “cancer moonshot” (initiated by Vice President Joe Biden); $1.5 billion into research on the brain and neurobiology; and $1.4 billion into matching treatment for cancer and other diseases to people’s genetic make-up (these latter two are also White House initiatives.)  The research components of the law are channeled through the National Institutes of Health. 

The law also provides $1 billion for the Comprehensive Addiction and Recovery Act, a law Congress passed last summer but failed to fully fund at the time.  The money goes primarily to states to ramp up treatment for opioid addiction.

Finally, the law makes reforms to the nation’s mental health system.  Many of those are structural and bureaucratic, and there’s little new money involved.  But, notably, the law reauthorizes suicide prevention programs and it creates new programs to identify kids and young adults at risk for mental illness, and get them into treatment.

All these good things led lawmakers of both parties to vote overwhelmingly for the bill—392 to 26 in the House and 94 to 5 in the Senate. 

The FDA elements

By far the most controversial parts of the law have to do with the changes at FDA.   But here, while both supporters and opponents were vigorous, the end result is not yet discernable.  It could end up being underwhelming, for both sides, in the long run.   

Unless!   And it’s a big unless.  Unless the Trump administration leverages the new law to accelerate the adoption of mechanisms to lower the barriers to drug and device approval—in part by hiring a new FDA commissioner who will do his bidding.  Troubling candidates for the job are already being mentioned, consistent with many of Trump’s appointees so far. 

Here’s the issue:  the actual language of the law gives the FDA broad new latitude to make changes in the direction of less rigorous product approval standards.  But FDA is notoriously slow at changing its rules and regulations.  And it’s an agency that puts a premium on scientific deliberation and procedure.   It would not be easy to change the culture there, or attract new high-level talent if the agency was suddenly seen to be in the industry’s pocket. 

Thus, you could posit a range of scenarios.  In one, Trump’s appointees (at HHS and FDA) wreck havoc at the agency and insist on rapid change.  More likely, however, is that Trump’s appointees (backed by industry) push for big change but are stymied by career staff and external concern in the scientific community.  Or, new FDA leadership would see the importance of deliberative change, with proper vetting and testing of speedier product approvals—recognizing the real downsides of overly quick or major changes. 

Finally, it’s entirely feasible that not much will change at all—just some tweaking that gets a few breakthrough drugs to market a bit sooner.

In short, it’s simply not clear how that critical part of the new law will play out. 

Both industry and consumers would, of course, benefit if effective and safe new drugs and devices reach the market more quickly—the scenario posed by the bill’s supporters.  Alternatively, if critics prove right, lowered standards will push some riskier and/or less effective drugs and devices onto the market.   

Because of the uncertainty, this part of the law warrants vigilance in coming years from Congress, scientists, clinicians, independent consumer groups, media, and the public.

Steven Findlay is an independent healthcare journalist, policy analyst, researcher and consumer advocate.   

Leave a Reply

1 Comment on "Unpacking the 21st Century Cures Act"


Member
Dec 15, 2016

Nice job Steve. I’m not by any means a knowledgeable observer of the FDA, but I am aware of the pressures of the public and politicians to push things through that they anecdotally believe are “cures.” This happens too often in state legislatures with so called mandates, like long term IV therapy for Lyme’s Disease, which most experts believe is bad medicine. Yet trot up three sympathetic patients/parents who have no where else to turn, and voila, a new mandate. FDA is here to protect the public against just such pressures, so I am leery of fast tracks.

I’m sure FDA is over-slow, as are most federal agencies. Yet, to be scientifically oriented in this area ain’t a bad thing. If it’s just a nudge, maybe not so bad.