Lawmakers in Washington are gearing up to pass major, far-reaching legislation on drug approval and cancer research. This is a good thing in the main but—no surprise here—Republicans and Democrats differ on approach and details, and things are already getting messy.
This makes the proposed legislation very risky. It could all implode in an election year, but momentum is building fast and both parties have something to gain by passage.
This blog is a primer on what’s happening. Future posts will track the legislation’s progress and delve into some of the issues at stake. Comments are invited.
As you’ve no doubt heard, the White House—with Joe Biden in the lead—has proposed a “moon shot” on cancer research. The administration is expected to propose, in its FY 2017 budget request, $755 million in funding for the initiative, with $195 million of that earmarked for the National Institutes of Health (NIH) and around $75 for the FDA.
Importantly—and you’ll see why below—under the budget deal agreed to in December for FY2016, NIH’s budget was already boosted by $2 billion, with $264 million going to the National Cancer Institute. That was an unprecedented 6% boost after many years of minor or no increases. (A promise of an additional $9 billion for NIH over the next 5 years was also made.)
Among the major goals of the moon shot initiative, according to the White House: launch and complete clinical trials for up to 20 kinds of cancer in as many as 20,000 patients by 2020, with a focus on advancing breakthroughs in immunotherapy—by all accounts the most promising area of cancer research at the moment.
Researchers are already lining up to capitalize. On January 12, a group of leading researchers and drug companies, including Amgen and Celgene, launched “The National Immunotherapy Coalition: Cancer MoonShot 2020.” The stated aim: accelerate the potential of combination immunotherapy as the next generation standard of care in cancer patients.
Meanwhile, lawmakers in Congress are processing a bill dubbed “The 21st Century Cures Act.” (I’ll abbreviate as “Cures.”) It was written by Republicans and emerged from the House Energy and Commerce Committee led by Rep. Fred Upton (R-Mich.). The bill, in a nutshell, gives FDA a batch of new tools to expedite the approval process for new drugs and medical devices. One of those tools would allow the FDA to approve new drugs based on a wider range of research results than is the case now.
The House passed the Cures bill in July, with bipartisan support. Notably, however, support from Democrats came almost entirely from a provision in the bill that increased NIH funding by $2 billion. Most Dems were worried about the FDA provisions but strategized that the Senate would very likely modify those anyway—hence the bill got their vote.
As referenced above, that $2 billion increase for NIH was “borrowed” from the bill in the 2016 federal budget agreement, which became law in December. That served to undermine support for the Cures bill in the Senate, and some thought it might be dead—if not forever at least until after the election.
Then along came moon shot. It appears to have reenergized chances for the Cures bill. Upton and other Republicans are doing everything in their power to leverage moon shot to gain Senate passage. The White House—or more precisely Biden—has signaled a willingness to go along with that. But Republicans in the Senate now say they plan to chop the bill up rather than pass a single piece of comprehensive legislation.
The Republicans move reportedly blindsided Democrats and threw the process into chaos, with Democrats suspicious of Republicans’ motives (again, nothing new about that). Democrats have also stated clearly—led by Patty Murray of Washington state, the ranking Democrat on the Senate Health, Education, Labor, and Pensions (HELP) committee—that they will not support the Cures bill without the additional funding for NIH and FDA that the White House is now calling for, and over multiple years.
Meanwhile, Sen. Lamar Alexander (R-Tenn.), chairman of the HELP committee, has said that breaking the legislation into parts allows the committee to agree on the least controversial parts first and then figure out the rest.
On yet another and separate track is the President’s Precision Medicine Initiative, launched in 2015. It’s been funded to the tune of $200 million so far, with more likely to be proposed in the 2017 White House budget request. In the White House’s words the initiative is “a bold new research effort to revolutionize how we improve health and treat disease….that takes into account individual differences in people’s genes, environments, and lifestyles.”
All these initiatives are related, of course. And it is a positive development that policymakers are focused on increasing the funding of and improving medical research and new ways to treat disease. But buried in the Cures Act, the cancer moon shot, and the precision medicine initiative are some poorly conceived ideas and unrealistic assumptions.
For example, the House version of Cures has been roundly criticized for creating a possible end run around the gold standard for drug approvals: controlled clinical trials. And the cancer moon shot has spurred jeers in some high-level corners of medical research for being overly optimistic about the pace of scientific progress against what is a highly complex constellation of 100 or so different diseases.
Those issues and more will be the subject of future blogs.
Steven Findlay is an independent journalist and editor who covers medicine and healthcare policy and technology.