Legislation to speed up the federal approval of new drugs and medical devices and to increase funding of medical research passed the U.S. House of Representatives 392-96 on Wednesday, Nov. 30 and is likely to get a Senate vote soon, though it faces opposition from some Democratic senators.
"This medical innovation bill is one that can have a
substantial impact for families across the country," said Senate Majority Leader Mitch McConnell, R-Ky., a strong supporter of the legislation. He has pushed for a provision in the bill to allow the U.S. Food and Drug Administration to accelerate approval of stem cell therapies, formally called "regenerative advanced therapies," Sheila Kaplan reports for Stat, the health-and-medicine supplement to The Boston Globe.
The provision "call(s) for devices used with a stem cell product to be considered moderate risk, unless the secretary of Health and Human Services determines that the device or use requires a higher risk classification," Kaplan reports.
Opponents of the provision believe stem-cell therapies should be more closely regulated and subject to clinical trials.
Sen. Elizabeth Warren, D-Mass., in a Monday floor speech, said a big contributor to McConnell's campaign would benefit from this stem-cell therapy provision, Kaplan reports in a separate article. “This mega-donor 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," she said.
The $6.3 billion legislation would give states $1 billion to fight the opioid crisis; provide $4.8 billion for continuing three "signature Obama administration research programs" over the next 10 years, including: Vice President Joe Biden’s cancer moonshot, the BRAIN Initiative, and the Precision Medicine Initiative; a $500 million increase to the FDA and a number of programs to improve mental health care, Kaplan reports.
A "major sticking point" for the bill, Kaplan reports, is that House Democrats required it to have funding for medical research, but Republicans on the Senate Health, Education, Labor and Pensions Committee would not approve funding without determining where the money would come from.
But now that the Patient Protection and Affordable Care Act is likely to be repealed, with the election of Donald Trump, Democrats have agreed "to underwrite the Cures Act with some money from the ACA, and some to be generated by sales of part of the Strategic Petroleum Reserve," Kaplan writes. NPR adds that it will also be paid for through reduced payments to Medicare and Medicaid.
"Leaders from both parties have called passage of the Cures bill the most important thing Congress could do this year," Kaplan writes.
Opposition to the bill
Warren said she also opposed the Cures Act because she said it had been "hijacked" by the pharmaceutical industry.
The bill has been debated at length over the past three years, Kaplan notes, with "a parade of celebrities" and more than 1,300 lobbyists representing pharmaceutical companies, medical device firms and patient advocacy groups pushing for its passage.
The Society for Public Health Education opposes the bill because it takes money away from the Public Health and Prevention Fund, which pays for programs that address obesity, diabetes, smoking cessation, cancer screenings, access to vaccinations and access to healthy foods, to pay for the Cures Act.
"Taking $100 million from the Prevention & Public Health Fund will have disastrous consequences for the future of public health," the group said.
Many consumer groups continue to oppose the bill, agreeing with Warren, who has said that many Democrats are agreeing to the bill in order to get the additional funds for medical research, which isn't guaranteed and will have to be approved in future legislation.
“While there are positive aspects of this legislation, many provisions would severely weaken the FDA’s drug and medical device approval standards and seriously harm rather than help patients,” Jack Mitchell, director of government relations for the National Center for Health Research, which advocates for patient safety, told Kaplan. “Congress shouldn’t sacrifice the safety and effectiveness of medical products in order to increase research monies.”
Kaplan also reports that many public health advocates have called the bill's provisions a "weaker alternative to the current gold standard of randomized clinical trials."
Sen. Chuck Grassley, R-Iowa, has voiced his opposition to the bill because it "exempts companies from reporting payments made to doctors for receiving continuing medical education sessions, medical journals or textbooks, " Ed Silverman writes for Stat. Consumer groups have also called for the removal of this provision.
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| Senate Majority Leader Mitch McConnell |
The provision "call(s) for devices used with a stem cell product to be considered moderate risk, unless the secretary of Health and Human Services determines that the device or use requires a higher risk classification," Kaplan reports.
Opponents of the provision believe stem-cell therapies should be more closely regulated and subject to clinical trials.
Sen. Elizabeth Warren, D-Mass., in a Monday floor speech, said a big contributor to McConnell's campaign would benefit from this stem-cell therapy provision, Kaplan reports in a separate article. “This mega-donor 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," she said.
The $6.3 billion legislation would give states $1 billion to fight the opioid crisis; provide $4.8 billion for continuing three "signature Obama administration research programs" over the next 10 years, including: Vice President Joe Biden’s cancer moonshot, the BRAIN Initiative, and the Precision Medicine Initiative; a $500 million increase to the FDA and a number of programs to improve mental health care, Kaplan reports.
A "major sticking point" for the bill, Kaplan reports, is that House Democrats required it to have funding for medical research, but Republicans on the Senate Health, Education, Labor and Pensions Committee would not approve funding without determining where the money would come from.
But now that the Patient Protection and Affordable Care Act is likely to be repealed, with the election of Donald Trump, Democrats have agreed "to underwrite the Cures Act with some money from the ACA, and some to be generated by sales of part of the Strategic Petroleum Reserve," Kaplan writes. NPR adds that it will also be paid for through reduced payments to Medicare and Medicaid.
"Leaders from both parties have called passage of the Cures bill the most important thing Congress could do this year," Kaplan writes.
Opposition to the bill
Warren said she also opposed the Cures Act because she said it had been "hijacked" by the pharmaceutical industry.
The bill has been debated at length over the past three years, Kaplan notes, with "a parade of celebrities" and more than 1,300 lobbyists representing pharmaceutical companies, medical device firms and patient advocacy groups pushing for its passage.
The Society for Public Health Education opposes the bill because it takes money away from the Public Health and Prevention Fund, which pays for programs that address obesity, diabetes, smoking cessation, cancer screenings, access to vaccinations and access to healthy foods, to pay for the Cures Act.
"Taking $100 million from the Prevention & Public Health Fund will have disastrous consequences for the future of public health," the group said.
Many consumer groups continue to oppose the bill, agreeing with Warren, who has said that many Democrats are agreeing to the bill in order to get the additional funds for medical research, which isn't guaranteed and will have to be approved in future legislation.
“While there are positive aspects of this legislation, many provisions would severely weaken the FDA’s drug and medical device approval standards and seriously harm rather than help patients,” Jack Mitchell, director of government relations for the National Center for Health Research, which advocates for patient safety, told Kaplan. “Congress shouldn’t sacrifice the safety and effectiveness of medical products in order to increase research monies.”
Kaplan also reports that many public health advocates have called the bill's provisions a "weaker alternative to the current gold standard of randomized clinical trials."
Sen. Chuck Grassley, R-Iowa, has voiced his opposition to the bill because it "exempts companies from reporting payments made to doctors for receiving continuing medical education sessions, medical journals or textbooks, " Ed Silverman writes for Stat. Consumer groups have also called for the removal of this provision.
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