On the surface, it looks like every healthcare special interest and their 1,400 lobbyists won an early Christmas present courtesy of the 21st Century Cures Act, which passed the House of Representatives by a whopping 392-26 margin last week and appears headed for Senate passage and enactment.
The deeper ramifications of this behemoth bill will only emerge over time. The final details of the 996-page legislation (that's 600 pages longer than the original bill and 90 pages longer than the Affordable Care Act) weren't known until five days before it passed.
While there's an old saying in politics that you should hold onto your wallets when the legislature is in session, taxpayers needn't be too concerned. The bill's provisions that captured headlines—new funding for the National Institutes of Health and long overdue attention to mental health and the opioid crisis—offered far less than advertised.
The NIH is slated to get $4.8 billion in additional funding over the next decade—assuming Congress actually spends what it appropriated. That's peanuts—half of what was proposed in the original Cures Act and well below the minuscule 2% average annual increase that NIH has lived with since 2004.
Beyond the happy talk about moonshots and cancer cures, the reality is that America, which historically has been the world's main funder of basic scientific research, needs to go well beyond that paltry sum if it wants to make progress in fighting the diseases of aging and rare diseases, which are the major unsolved quandaries in medical science. And it has to make a commitment to do that for a prolonged period of time.
As Eli Lilly & Co.'s failure with its latest Alzheimer's drug showed, there is no easy or quick fix for dementia or cancers or drug-resistant microbes. Only more and better science can give drug developers the validated targets they need to come up with significant breakthroughs—not the ones we're getting now, which too often extend life for a few weeks or months at a prohibitively high price.
Behavioral health advocates celebrated the bill's $1 billion for fighting the opioid abuse epidemic over the next two years. But they, like the research advocates, worry about the Republican Congress actually appropriating what turns out to be a pittance compared to the scope of the problem.
Look at it this way. An estimated one-third of the 300 million opioid prescriptions dispensed annually—a $24 billion market—are abused. Why not slap a 5% tax on the revenue of opioid makers? That would generate over $1 billion a year to combat abuse.
Other stocking stuffers in the bill included $760 million for hospitals over 10 years so some of the outpatient facilities they built and purchased continue to be reimbursed at inpatient rates.
Drug industry and physician offices that deliver infusion drugs got a gift of $660 million, according to the Congressional Budget Office analysis.
All these Christmas tree ornaments succeeded in masking the original intent of the bill. The 21st Century Cures Act was designed to give the drug and medical device industries an easier path to new approvals.
It codifies some clinical trial standards that the Food and Drug Administration already uses for “breakthrough” drugs. And it allows some forms of evidence that would never pass muster under the old rules.
Safety advocates fear this may open the door to unsafe drugs. Insurers, employers and cost control advocates worry the 21st Century Cures Act may speed to market even more overpriced, marginally effective drugs and devices.
The FDA remains the public's only protection against unsafe and ineffective medical products. It will require heightened public vigilance and a strong leader at the agency to ensure this legislation doesn't eviscerate its core mission.