Politics. Congress has spoken, finally.
The very thin sliver of daylight between traditional Republicans and mainstream Democrats has kept the money printing machines burning the midnight oil for the last 20 years or so.
In the wake of all those U.S. dollars has been lost one of Congress’ few tools for balancing power in Washington – the purse strings. If everyone agrees to spend more money on nearly every cause that makes it to A1 at the New York Times, there become few opportunities for Congress to express its displeasure.
Federal agencies have known, especially as the Chevron Deference doctrine has gotten a workout in the last decade, that they are likely to get their 2-3% increase as long as they keep the White House happy. Even then, some have become quite adept at evading the scrutiny of 1600 Pennsylvania.
The rise of the Republican insurgency is fueled by the will (need?) to change that. They have many complaints but topping the list are border security, foreign aid and management of the Public Health Emergency.
The last of these has some bipartisan support which gave the rebels a win. The FY 2024 appropriations was signed by President Joe Biden yesterday. It provides a mere 0.80% increase in funding for the National Institutes of Health.
In a nod to President Biden’s long-standing interest in cancer research, the National Cancer Institute will see a 1.6% increase, the rest will see flat funding and small declines. The Centers for Disease Control will receive no increase in funding.
Scientific research funding has been the bipartisan darling of Congress and the White House since the Human Genome Project, with an interregnum for the Affordable Care Act pay-fors in 2008-12. Will the reversal be enough for the agencies to start appearing at hearings and responding to FOIA requests?
We will have to see.
Policy. Even though it is quite clear the FDA may have let slip its standards on COVID vaccine efficacy and possibly safety, especially as it relates the booster roll-out in 2021, they are escaping the worst of the budget offense thus far.
Part of the reason stems from the industry-derived support of the agency through user fees. Another factor is Congress’ role as a secular Lourdes for those with rare or incurable diseases seeking support for treatment approval.
True to form Congress has taken CMS to task for its limited coverage of the very expensive Alzheimer’s drugs in the appropriation narrative. It is funny. Congress passed the Inflation Reduction Act to limit the growth of drug prices, something CMS must establish as fact at some point. Well, as long as it doesn’t interfere with constituents’ therapies.
It is a conundrum. Accelerated approvals like that for the first wave of the amyloid-centric drugs combined with a high price invite gatekeeping. On the other hand, novel therapies for very sick people needed regulatory approval yesterday.
The most likely result of Congress stamping its foot is probably nothing but they are illustrating the difficulty of navigating the shoals of high prices, limited clinical evidence and patient advocacy.
Power. It is almost imperceptible but the regulatory paradigm at the FDA has shifted. Efficacy seems to be getting offloaded to insurers – including CMS – in the name of Real World Evidence.
In terms of efficacy, the FDA’s recent label expansion for Wegovy is based on an industry study that is good enough but still challenges other research that suggests weight loss does not seem to have a great effect on avoiding major adverse cardiovascular events.
But what the hell, right? Insurers are more than equipped to limit use, collect data and determine efficacy.
The government does not want to be seen as greenlighting a drug or device that might kill people. They are also ill equipped to standup to the patient advocacy that operates at scale in the internet age. The problem gets more acute as the big R & D machinery at NIH slows.
In classic bureaucratic style, they are pitching the problem to someone else.
It is one way to get out to the price-efficacy-advocacy trap especially when Congress has renewed interest in appropriations.
Have a great rest of your weekend.