HARI SREENIVASAN: While most attention has been focused on the action at Trump Tower in Manhattan, lawmakers at the U.S. Capitol are close to passing a major bill that would lead to big changes for drug approval, medical research and much more.
Lisa Desjardins kicks off our coverage with this report.
LISA DESJARDINS: Weeks from the end of its term, Congress is on the verge of passing a whopper of a bipartisan bill.
SEN. MITCH MCCONNELL, Majority Leader: This legislation promotes critical investments in research.
SEN. HARRY REID, Minority Leader: We’re going to pass the Cures Act.
LISA DESJARDINS: A godsend to supporters, a spending spree or corporate giveaway to critics, here’s a look at the 21st century medical cures bill. It is a mammoth $6 billion measure, now four major pieces of legislation packed in one, starting with a giant nearly $5 billion shot of funding to the National Institutes of Health for research.
That includes almost $2 billion for the Moonshot effort led by Vice President Joe Biden to find a cure for cancer praised in a White House Web video today.
VICE PRESIDENT JOSEPH BIDEN: A lot of lives will be affected by this bill, God willing.
LISA DESJARDINS: That’s one reason many Democrats are on board. Another? The bill now includes $1 billion to address the opioid epidemic. It’s a national crisis that’s been in funding limbo for months.
A third major piece? Mental health reform, including a new assistant secretary position for mental health and substance use.
Republican Tim Murphy, a psychologist, has pushed for this for years.
REP. TIM MURPHY (R-Pa.): This doesn’t end the scourge of mental illness, but this puts us on a path to really make some substantial change and give people help.
LISA DESJARDINS: Now for what Republican leaders love, the bill’s core, reforming and speeding up the Food and Drug Administration’s drug approval process.
To some, that’s modernization that cuts red tape, but to others it’s a safety risk. And some lawmakers see it as a gift to drug companies.
Those voices are led by Massachusetts Senator Elizabeth Warren.
SEN. ELIZABETH WARREN (D-Mass.): I cannot vote for this bill. I will fight it, because I know the difference between compromise and extortion.
LISA DESJARDINS: But she is in the minority. The bill has received bipartisan support in Congress so far, and the president plans to sign it into law.
For the “PBS NewsHour,” I’m Lisa Desjardins.
HARI SREENIVASAN: Let’s dive a little deeper now into this bill, what would change, and some of the criticisms around it.
For that, we’re joined by two reporters who have covered this field extensively, Sydney Lupkin of Kaiser Health News, and Ed Silverman, senior writer with STAT News, a site covering medicine and health care.
So, Sydney Lupkin, let’s start with what does or doesn’t happen to the FDA. There’s been a lot about that. What’s the biggest potential change?
SYDNEY LUPKIN, Kaiser Health News: Sure.
So, one of the things that happens for the FDA is, it gets another $500 million over 10 years. It also has more hiring power to fill the hundreds of vacancies that it has as a result of new initiatives, new laws other over the years. So, that’s one thing that does happen to it.
But the big thing is that it really sort of makes the approval standards a bit more flexible for drug and device manufacturers.
HARI SREENIVASAN: OK.
Ed Silverman, if this flexibility increases, is the FDA stick on the hook if something goes wrong?
ED SILVERMAN, STAT News: Yes, it’s a double-edged sword for the agency, because on the one hand there will be a new process that could be in place.
The agency will have to come up with a guidance, as it’s called, a program that will determine whether or not it can use different data to evaluate the approval process for new indications or new uses for existing medicines.
The catch with that could be that, if something goes awry, the agency is still on the hook. Let’s say there’s patient harm, for instance. So that’s the downside, because, at the end of the day, it’s the regulator who is typically blamed when something goes wrong.
HARI SREENIVASAN: And, Ed, this has already gotten pushback from the likes of Bernie Sanders and Elizabeth Warren.
ED SILVERMAN: Right.
Well, the concern is that, in making the approval process more flexible for new uses for existing medicines, it’s actually lowering the standards, because of instead of using what is considered the gold standard, randomized control trial, the new approach would allow the agency possibly to look at other sorts of data, something like safety surveillance data, patient-reported outcomes, these observational studies.
These are the sorts of things that are legitimately useful and tell us real things, but they’re not the same as having a full-blown trial. And that’s the sort of tool that is used to determine the safety and effectiveness of any medicine. So, that’s a big potential difference.
HARI SREENIVASAN: And, Sydney Lupkin, that also affects the bottom line of pharmaceutical companies, because while the clinically approved double blind is the gold standard, it’s also pretty time- money-expensive.
SYDNEY LUPKIN: It’s more expensive.
So, this does stand to save them a lot of money, which is why they lobbied for it. There was a lot of lobbying activity on this bill, more than 1,400 registered lobbyists on it representing 400 different organizations, many of them pharma. Yes, it stands to save them a lot of money.
HARI SREENIVASAN: So, a lot of people, whether it’s people who are dealing with the impacts of opioid abuse or hospitals that are focused on research, they have been for it. They stand to benefit from this.
SYDNEY LUPKIN: Right, because of the NIH funding in the bill.
The NIH is the National Institutes of Health, and, basically, a lot of that money will wind up going into grants that go to hospitals, that go to universities, that go to different labs to do research. Mostly — you have all heard of Joe Biden’s Cancer Moonshot. There’s also a — something called the brain initiative to sort of study the brain more, Alzheimer’s, understand more about how it works, that you can prevent things, and precision medicine, which is, to very much simplify it, a lot of genetics research.
HARI SREENIVASAN: Ed Silverman, how about the appropriations of this? If it’s not the Cancer Moonshot or brain research, and if it’s not one of those marquee things that people care about, what happens to the rest of these huge amounts of dollars, and is it a guarantee that it will happen year after year?
ED SILVERMAN: Well, it all sounds wonderful, but the money has to be appropriated.
So, from day one, we have that question hanging over the entire effort. Will that money actually go as intended to the right agencies, so it can do the work? Presumably, the FDA will get funds, so they can have more resources to take on things like different approval processes.
But the money’s got to be there. So, if it’s not appropriated, well, then where are we? The agency will end up having more work without the added resources. And I think that’s one of the struggles that has made the process over the past few weeks and months difficult to sort out and really feel comfortable that Congress is going to do what it says it will do.
HARI SREENIVASAN: So, Sydney Lupkin, there seems to be a shift away from preventative measures in parts of the bill.
SYDNEY LUPKIN: What the bill does is, is takes away, I believe, $3.5 billion in funding for preventative medicine, funds set up under Obamacare to study things like Alzheimer’s, chronic conditions, hospital-acquired infection.
And, of course, the goal of that fund is to study these things so that then it ultimately saves the health care system money. If you can prevent something, you don’t have to spend as much money treating it. And that had been mandatory funding.
So now it will get about 30 percent less than it had.
HARI SREENIVASAN: Ed Silverman, when it comes to big pharma companies, drug prices are something that consumers care about, something that even hospitals and different insurance companies are trying to figure out a way to decrease. Does this tackle that at all?
ED SILVERMAN: No, not really.
And I think that that’s one problem that Congress is going to have to face up to, whether it likes it or not. It may not be in this legislation, given that the Senate vote appears to be near, at this point anyway. So the bill doesn’t really address some of the fundamental challenges and issues that are inherently problematic right now in the pricing system in this country.
HARI SREENIVASAN: Is this just the general nature of such a large omnibus bill?
ED SILVERMAN: Yes. It’s almost the kitchen sink approach, but not quite, because Congress is trying to pick and choose a little bit of what’s easiest and what it’s most ideologically comfortable pursuing.
For all the detail — and there are close to 1,000 pages in this bill — it really doesn’t address everything. And, unfortunately, we discuss pricing. That’s not really mentioned here in a way that’s going to be meaningful for Americans. And while there may be portions that are helpful, there are portions that are also problematic, as I mentioned before, with concerns about the FDA approval process and what that means down the road for patient safety.
HARI SREENIVASAN: All right, Ed Silverman of STAT News and Sydney Lupkin of Kaiser Health News, thanks so much.
SYDNEY LUPKIN: Thank you.
ED SILVERMAN: Thank you.
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