The White House gave the final compromise its strong support, saying the legislation “offers advances in health that far outweigh” its concerns about the funding of the bill, which came partly from selling off oil from the Strategic Petroleum Reserve.
Yet the changes were not enough to satisfy either the far right or consumer advocacy organizations like Public Citizen, which said the bill still went too far in relaxing approval standards for drugs and devices. The conservative group Heritage Action noted that the legislation had ballooned from 300 pages last year into “an almost 1,000-page omnibus health care spending bill.” Although its specific objections focused on spending, its core critique was nearly the same as Warren’s: “In Washington terms, back-room negotiators have turned the Cures bill into a Christmas Tree, loaded with handouts for special interests, all at the expense of the taxpayer,” Heritage wrote.
On the left, Public Citizen argued that even before the bill’s relaxed regulations, Congress had already made it too easy to get drugs and particularly new medical devices to market without sufficient study. “We’ve already reached a point, we believe, where we’ve gone too far,” said Michael Carome, director of the organization’s health research group. “The existing regulations already provide a pathway for quick review for bringing drugs to market. And any further weakening would undermine where we are.”
In particular, Carome cited a provision in the Cures Act that would allow a company to win approval for a second use of an FDA-approved drug without conducting a randomized clinical trial and instead using what’s known as “real world evidence.”
He explained: “Suppose a drug is approved for rheumatoid arthritis and you have to do the randomized clinical trials to prove it was safe and effective, and now you want to have marketed for multiple sclerosis, you can rely upon real world evidence, which is a much lower standard of evidence. It’s more subject to bias and manipulation and can be very misleading. If you’re a patient, such a double standard should be very disconcerting.”
Warren seized on that same provision, arguing that it amounted to “legalized fraud.”
“Pushing treatments without scientific evidence that they work is fraud—fraud that can hurt people,” she said in her floor speech. “It also undercuts the development of real cures.”
In an unusual alliance with Republican Senator Charles Grassley of Iowa, Warren also criticized a provision that would exempted companies from having to disclose certain payments to hospitals and doctors encouraging them to prescribe their drugs. With opposition mounting, the legislation’s sponsors removed that language at the last minute, but Warren said its removal was not enough to win her support.
Her attack on the bill this week blindsided supporters like DeGette, who insisted the measure’s benefits clearly outweighed its flaws and said Warren either misunderstood or was misrepresenting the Cures Act. “There’s absolutely no weakening of any kinds of review,” DeGette told me. “We have the gold standard for safety and efficacy in the world, and we preserve those.”