Nov 30 (Reuters) - The U.S. House of Representatives is poised to pass a sweeping, $6.3 billion bill that supporters say will spur medical innovation, speed access to new drugs, expand access to mental health treatment and battle the opioid epidemic.
The bill, known as the 21st Century Cures Act, has widespread bipartisan support, including the backing of the Obama administration. But critics say it will give massive handouts to the pharmaceutical industry while making cuts to public health programs and Medicare.
Two years in the making, the 21st Century Cures Act contains 19 core bills, including measures to advance personalized medicine, shorten drug approval review times and boost Alzheimer’s and cancer research. The House will vote on the bill on Wednesday. The Senate is expected to vote on it next week.
The Act, sponsored by Republican representative Fred Upton from Michigan, provides $4.8 billion to the National Institutes of Health and $500 million to the Food and Drug Administration to streamline the clinical trial process and hire new staff.
It provides $1 billion over two years to battle opioid and heroin abuse and includes $1.8 billion to support Vice President Joseph Biden’s Cancer Moonshot initiative, designed to speed research into new cancer therapies.
Still, critics of the legislation, including Democratic Senator Elizabeth Warren of Massachusetts, say the legislation will lower standards for drug approvals and jeopardize patient safety. They also say the Act will make it easier for companies to make claims that a drug works for conditions that have not been approved by the FDA.
“This is just what Big Pharma wants,” Democratic Senator Jeff Merkley said in a speech on the Senate floor on Wednesday, saying the bill consists of “big favors for Big Pharma and big favors for Big Tobacco.”
Money to pay for the bill will be offset by reductions in other spending, including Medicaid payments for some medical equipment and through the sale of oil from the Strategic Petroleum Reserve, something the administration said “continues a bad precedent of selling off longer term energy security assets to satisfy near term budget scoring needs.”
House Speaker Paul Ryan said he expected “very good bipartisan support” for the legislation. “This is going to be a game-changer,” he said. “It will fundamentally transform the way that we treat and cure diseases in this country.”
A controversial provision that would have made it easier for companies to conceal payments to doctors under the guise of continuing education was dropped at the last minute. Republican Senator Charles Grassley from Iowa, had opposed the provision.
“This is good news for transparency and the public,” Grassley said in a statement on Tuesday. “With drug prices through the roof, the way drug and device makers spend money is of more public interest than ever.”
Patient advocates support the bill, which requires that their voices be brought more formally into the drug approval process. Patients have increasingly put pressure on the FDA to approve drugs even if evidence that they work is slim.
The bill expands access to mental health treatment and services. Vern Buchanan, Republican representative from Florida, called the provision “a breath of fresh air after decades of flawed policies.”
Reporting by Toni Clarke in Washington; Editing by Tom Brown