Senator Bernie Sanders Statement on the 21st Century Cures Act

He has not commented specifically on 21st Century Cures.

Senate Majority Leader Mitch McConnell, Kentucky Republican, said he is eager to send the legislation to Mr. Obama’s desk, as GOP leaders eye a bipartisan win to cap a whirlwind election year in which a legacy-defining trade deal and criminal justice reforms fell by the wayside.

Legalizes fraud: It’s against the law for drug companies to market drugs for uses not approved by the FDA.

“Millions of Americans are desperately waiting for effective treatments and cures for their chronic disease or disability”. He also urged lawmakers to leave intact funding that has already been allocated for the prevention fund “for the explicit and intended goal to refocus our health-care system on preventive health”.

“If you exclude the generic price from the average, that raises the rebates that pharma has to pay to Medicaid”, Rye told Bloomberg BNA Nov. 28.

If Cures stalls in the Senate, where critics have argued it gives too much leeway to the drug industry, backers fear it could be a lengthy wait for another chance to lock in NIH funding and tweak FDA rules. Ellen Sigal, chair and founder of Friends of Cancer Research, says, “It fosters innovation and doesn’t lower safety standards”.

“This is particularly important for us at the National Organization for Rare Disorders because we represent about 30 million Americans with rare diseases, and over 95 percent of rare diseases do not have a FDA indicated treatment”, he said. The latest version was rolled out this past weekend by Rep. Fred Upton R-Mich. and Senator Lamar Alexander R-Tenn. with an eye towards passing the bill before the end of the year. “Without rectifying this, the bill gives more power and discretion to the agency managers responsible for the risky products”. Democrats would not approve the accelerated approval provisions unless funding for the National Institutes of Health and the FDA was included. Pierce said it’s an effort to reconcile various government financial relationship reporting requirements, which now vary among the different funding agencies.

While the earlier version would have provided $8.75 billion in mandatory funding for the NIH, the new text would instead create several “innovation” funds.

Both concerns could have severe implications, she explained, by saturating the market with ineffective FDA-approved drugs and increasing overall medical costs.

Senator Grassley was critical (again) in helping remove a loophole that would have meant less transparency for patients and consumers and less accountability for doctors, drug companies, and medical device manufacturers. While it is expected to pass with strong bipartisan support – the previous version passed 344-77 – some barriers remain. Rep. Upton garnered broad support from device makers, drug manufacturers, researchers, and patient advocacy groups. The group called on Congress not to rush the bill through, issuing a statement of potentially harmful provisions. To speed up this process, one provision would allow the use of “real-world evidence” instead of the more time-consuming clinical trials now required to demonstrate efficacy.

“The package includes a number of important improvements to [the Food and Drug Administration’s] medical device premarket program created to increase the efficiency, predictability and transparency of the agency’s review process”, said Scott Whitaker, the CEO of the Advanced Medical Technology Association, the device industry trade group whose members include Medtronic, St. Jude Medical and many other medical technology companies with major Minnesota ties.

“It doesn’t mandate that FDA use it”, she said about the Cures language on real-world evidence.

“They just know that despite the promise of scientific breakthroughs, they can’t get the therapy that might save their life”.

On Monday, Senate Judiciary Chairman Charles E. Grassley blasted a plan to reduce public disclosure of companies’ gifts to doctors that was tucked into the package, potentially complicating efforts to quickly clear the measure.