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21st Century Cures Act

21st Century Cures Act

The enormous medical research bill entitled the 21st Century Cures Act has just been passed and signed into law by President Obama. Like most all government legislation, there was ample push and pull regarding what was included in the final bill. Its proponents will talk about the bill’s “greater good” that will positively impact millions of people. Detractors will point to its shortcomings and the collateral damage left in its wake. Both are correct.

One cannot understate all the good that will come from its passage. There are provisions for Vice President Joe Biden’s cancer moonshot, the BRAIN Initiative, and the Precision Medicine Initiative. It will fund mental health care programs. Grants worth $1 billion will go to states for their drug abuse prevention and treatment programs. Plus, health information technology and software companies should profit indirectly from the bill’s unabashed promotion of electronic health records systems.

Medical universities, hospitals, researchers and physicians also are indirect recipients through the funneling of $4.8 billion to National Institutes of Health, for years criminally underfunded. However, it should be noted that this cash influx is a far cry from the $8.75 billion originally penciled into the budget. Moreover, even that lesser amount is not guaranteed; the money will be appropriated annually. Despite those negatives, new discoveries and scientific breakthroughs are certain to be achieved with this financial boon.

Medical device corporations and the pharmaceutical industry are the biggest beneficiaries—not really surprising considering their massive lobbying effort. Interestingly, none of their bounty involves money. No, their new perks come at the expense of the FDA, best summed up by this curious bit of verbiage from an online article: “…giving the Food and Drug Administration new authority and tools to demand fewer studies from those companies…” The FDA and its supporters are not at all happy with these newfound powers to do less.

The bill’s advocates contend it’s not all bad news for the FDA. Their funding will be increased by $500 million through 2026. But critics contend even that amount is not large enough to offset an anticipated heavier workload. In itself this trade-off between money and workload could be tolerable; it is the weakening of the FDA that many find intolerable. This is the major downside to the bill.

Consumer advocacy groups are angered that the FDA’s stringent drug approval process is now corrupted by the legislation. It’s isn’t just those advocacy groups who consider the FDA’s current drug approval process sacrosanct, either. Scientists, researchers and physicians are extremely wary of outside influences on established protocol. Diana Zuckerman, president of the National Center for Health Research: “The FDA over all these decades has developed a way to know what products work and which ones don’t, but in the last decade they have been pushed to lower those standards… With this bill, they’d lower them even more.”

A small minority of politicians agreed, arguing that politics may be a zero-sum game, but playing politics with the FDA’s procedures and principles shouldn’t be. The softening of standards could very well result in breakthrough treatments and cures; on the other hand, that risk-reward scenario could be disastrous (see: thalidomide and Vioxx). When hard science takes a back seat to eased regulations and anecdotal evidence it is a bitter pill to swallow. Even in light of the greater good.

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Brought to you by Jason Marcewicz, Special Projects Manager

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