(Editor’s Note: The 21st Century Cures Act also includes the little noticed Small Business Health Care Relief Act of 2016 which would allow groups with 50 or fewer employees to provide tax-free HRAs to employees to purchase individual coverage. The impact would be to provide similar tax free status to employer HRA contributions for individual coverage as is currently enjoyed by employer premium contributions for group coverage.)
Senator Elizabeth Warren on Monday railed against legislation that would ease standards for new drugs and medical devices, saying the bill had been “hijacked” by the pharmaceutical industry.
Senator Elizabeth Warren on Monday railed against legislation that would ease standards for new drugs and medical devices, saying the bill had been “hijacked” by the pharmaceutical industry.
With the legislation headed for a possible vote in the House this week, the Massachusetts senator accused Republican lawmakers of trying to extort Democrats by tying additional funds for medical research to the bill, known as the 21st Century Cures Act.
“I cannot vote for this bill,’’ Warren said on the Senate floor, speaking to a largely empty chamber. “I will fight it because I know the difference between compromise and extortion.”
Republicans say the legislation will help spark innovation in health care and deliver faster cures for Americans. Scores of patient advocacy groups have campaigned hard for the Cures Act, while the more consumer-oriented public health groups have raised questions about whether it was designed to help patients or drug and device companies, which have long complained about red tape and burdensome requirements for Food and Drug Administration approval. More than 1,300 lobbyists have pushed for passage.
On Friday, House and Senate leaders announced that they had finally hammered out a deal on the legislation. It would give states $1 billion to fight the opioid crisis, in addition to providing $4.8 billion for continuing three signature Obama administration research programs over the next 10 years: Vice President Joe Biden’s cancer moonshot, the BRAIN Initiative, and the Precision Medicine Initiative.
An earlier House version of the Cures Act, passed last year, called for $8.75 billion for the National Institutes of Health over five years.
The current legislation also includes $500 million for the FDA, well below the amount Democrats had sought.
In the Senate, Warren and Washington Senator Patty Murray, the ranking Democrat on the Senate Health, Education, Labor and Pensions Committee, have long argued that they would only support Cures legislation that included significant investment in basic medical research.
On Monday, Warren said the NIH funding for medical research in the current legislation amounted to only a fig leaf.
“And most of that fig leaf isn’t even real,” Warren said. “Most of the money won’t really be there unless future Congresses pass future bills in future years to spend those dollars.”
While Warren said she supported many of the provisions, she called others “huge giveaways” to the drug industry.
Warren cited several measures she viewed as especially outrageous, although she said she had countless more.
One, she said, would roll back requirements for doctors to report some “Sunshine Act” payments from drug companies. The provision would exempt companies from disclosing fees given doctors for receiving continuing medical education sessions, medical journals, or textbooks. Earlier Monday, Senator Charles Grassley (R-Iowa) said he would consider placing a hold on the legislation “unless this provision is removed.”
Warren described another measure that would permit drug companies to market drugs for unapproved uses as legalized fraud.
And finally, Warren criticized provisions designed to speed approval for stem cell therapies. Referring to a major Republican donor who would stand to benefit from the provisions, “This megadonor has poured millions of dollars into Mitch McConnell’s personal campaign coffers and into his Republican super PAC, and now he wants his reward. So the Cures act offers to sell government favors.”
After Warren ended her speech, a stunned-looking Senator John Cornyn (R-Texas) rose and protested the senator’s language and tone. Cornyn called for more civility.