Last week, the Senate passed the 21st Century Cures Act, a controversial bill that provides funding for NIH in exchange for the rolling back of a slew of regulations for drugs and medical devices
SENATOR: I just want to say to all those legislators here, “Fantastic.” THOMAS HEDGES: On Wednesday, the Senate passed a sweeping health bill that aims to increase funding for disease and mental health research, as well as streamline the approval process for drugs and medical devices. The 21st Century Cures Act calls on the FDA to, among many things, take the “least burdensome approach to proving the safety of a number of medical products.” SARAH SORSCHER: Naturally, industry supports this bill. It provides them with research funding. It lowers the bar that they have to jump over to get approved. So, all around it’s a huge gift for PhRMA. THOMAS HEDGES: Proponents of the bill say it restores funding to the broadly-supported National Institutes of Health but Sarah Sorscher of Public Citizen says that, in fact, The Cure Act only raised funding for NIH as a bargaining chip in exchange for lower FDA approval standards. SARAH SORSCHER: And our big concern there is that you really want to be improving the quality of products that are coming down the pipeline. But you don’t necessarily want to be attacking the gatekeeper at the end of the pipeline because if these products aren’t good enough to be getting approved, then they’re not necessarily going to help patients. And what you might end up with is a lot of innovative, expensive products that are largely untested. THOMAS HEDGES: While the bill flew through both Houses of Congress with only 5 dissenting voices in the Senate and 26 in the House, leading Senate progressives Bernie Sanders and Elizabeth Warren strongly oppose The Cures Act, arguing that the bill’s good provisions serve mostly as a distraction from the rest of its contents. ELIZABETH WARREN: But I cannot vote for this bill. I will fight it because I know the difference between compromise and extortion. SARAH SORSCHER: Warren had a brilliant speech speaking out against this bill. She acknowledged that there was some good things in it. But she said, overall, this bill has really been hijacked by the pharmaceutical industry. And she said that when American voters say that Congress is owned by big companies, this is what they’re talking about. And she’s absolutely right about that. This is the most lobbied bill involving healthcare in recent history. There were over 1,300 lobbyists working on this bill and it is a goody bag of giveaways to the pharmaceutical industry. THOMAS HEDGES: Sorscher and Warren both lobbied against some of what they say were the most destructive provisions in the original bill pushed by the industry’s main lobbying group, the Pharmaceutical Research and Manufacturers of America, or PhRMA, which is composed of over 400 companies and universities, including AbbVie, the maker of Humira, as well as Johns Hopkins University here in Baltimore. They succeeded in rolling back some of those provisions. But the ones that remain in the bill, Sorscher says, are harmful still. They include weakened approvals of what are known as “new indications”. SARAH SORSCHER: So, if you get a drug and it’s approved for two different conditions and yours was the second condition, it may not be supported by high-quality evidence, whereas, the first one was. THOMAS HEDGES: The bill also has a provision boosting regenerative medicine, a fairly new and highly untested industry. SARAH SORSCHER: A lot of potential there but also very untested and there’s a lot of quack medicine in this area where clinics are offering to give you the moon for very untested therapies. THOMAS HEDGES: The bill would also further streamline the already slim approval process for new medical devices and antibiotics, allowing products to hit the market quicker — but with a risk of injuring patients for lack of rigorous testing. That provision might increase the number of cases like the Essure scandal, for example, where thousands of women have been injured by a birth control device many say didn’t receive a proper assessment. More broadly, Sorscher worries that negotiations for The Cures Act will become the new model for legislative business in Washington. SARAH SORSCHER: I think what Cures does is it sets a new precedent for an agency, NIH, that has had its funding cut in real dollars dramatically over the past 12 years — we’re going to see future negotiations like this playing out, where they’re looking for temporary, small, incremental funding, in exchange for permanent public health concessions. And that’s not a recipe that we want to be looking for moving forward. THOMAS HEDGES: The bill, which Obama’s expected to sign, may not have included some of the worst provisions policy experts like Warren and Sorscher succeeded in fending off, but that doesn’t mean that big pharma won’t continue to push for those concessions in the future. SARAH SORSCHER: We’re coming into a new round of negotiations because the FDA is funded by industry through user fees, and that agreement is renegotiated every four years. So, coming into the fall, we’re going to be again fighting for funding for a public agency, this time FDA, in return for concessions. And a lot of those bad provisions that were proposed for Cures are going to be back on the table — and we’re going to continue to be one of the strongest voices opposing the weakening of regulation in that area.