�鶹Ů��

With an atypical burst of bipartisanship, the Senate shipped legislation to President Barack Obama on Wednesday lowering hurdles for government drug approvals as the 114th Congress bumped toward the end of a two-year run highlighted by upheaval and stalemate. A week after the House easily approved the biomedical bill, senators passed it by a similarly overwhelming 94-5 margin. (Fram and Taylor, 12/7)

In many ways the bill, known as the 21st Century Cures Act, is a return to a more classic approach to legislation, with policy victories and some disappointments for both parties, and potential benefits for nearly every American whose life has been touched by illness, drug addiction and mental health issues. Years in the making, the measure passed 94 to 5 after being overwhelmingly approved by the House last week. (Steinhauer and Pear, 12/7)

The bill provides for $4.8 billion in new funding for the National Institutes of Health; of that, $1.8 billion is reserved for the “cancer moonshot” launched by Vice President Biden to accelerate research in that field. Another $1.6 billion is earmarked for brain diseases including Alzheimer’s. Also included are $500 million in new funding for the Food and Drug Administration and $1 billion in grants to help states deal with opioid abuse. (DeBonis, 12/7)

Sen. Lamar Alexander, R-Tenn., who leads the committee involved in writing the bill, on Wednesday said it would “help us take advantage of the breathtaking advances in biomedical research and bring those innovations to doctors’ offices and patients’ medicine cabinets around the country.” (Siddons, 12/7)

The new legislation places a strong emphasis on science, pushing federal agencies to fund only programs that are backed by solid research and to collect data on whether patients are actually helped. The bill strengthens laws mandating parity for mental and physical health care and includes grants to increase the number of psychologists and psychiatrists, who are in short supply across the country. (Szabo, 12/7)

But the Cures Act, nearly 1,000 pages long, does not lay out many deadlines. “The dirty secret is it’s going to take many years to implement these things,” said Bethany J. Hills, who runs the FDA practice at Mintz Levin Cohn Ferris Glovsky and Popeo. “There are many provisions requiring guidances, and whenever Congress has mandated that FDA provide guidance on something, FDA historically is perpetually late.”(Kaplan, 12/7)

But the wins come at the expense of funding for public health prevention programs. The bill cuts $3.5 billion over 10 years from President Barack Obama's Prevention and Public Health Fund, which was established under the Affordable Care Act and sets aside money for prevention programs that help battle Alzheimer's disease, smoking, lead poisoning, heart disease, diabetes, stroke and falls among elderly adults. (Johnson, 12/7)

A sprawling health bill that passed the Senate Wednesday and is expected to become law before the end of the year is a grab bag for industries that spent plenty of money lobbying to make sure it happened that way. Here are some of the winners and losers in the 21st Century Cures Act. (Lupkin and Findlay, 12/7)

Republicans have been pushing for the changes for the past few years, arguing that the FDA takes too long to study scientific evidence and sometimes wrongly insists on large, multiyear clinical studies that delay important treatments to patients. The bill’s mechanisms allow the FDA to use shorter and simpler studies more widely. Under the measure, certain new antibiotics could see shorter trials, and a fairly wide range of drugs could get additional approvals for new uses based on relatively low amounts of evidence, such as data summaries and data from company registries. (Burton, 12/7)

The bill had a long and difficult path to final passage, with input from every corner of the healthcare sector. A total of 1,455 lobbyists representing 400 companies, universities and other groups gave input on the bill, according to the Center for Responsive Politics. (Ferris, 12/7)

The legislation has generated concerns among many consumer advocates, who have warned that provisions that would speed federal regulatory review of new drugs and medical devices could expose patients to new risks. “The bill has been sold erroneously as a common sense, bipartisan compromise that enables scientific innovation and medical breakthroughs for America,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “But in reality, the legislation includes a grab bag of goodies for Big Pharma and medical device companies that would undermine requirements for ensuring safe and effective drugs and medical devices.” (Levey, 12/7)

President Barack Obama is expected to quickly sign the legislation — one of the final bills of his administration, cementing a health care legacy that extends beyond the Affordable Care Act. (Norman, 12/7)

“We are now one step closer to ending cancer as we know it, unlocking cures for diseases like Alzheimer’s, and helping people seeking treatment for opioid addiction finally get the help they need,” said President Obama, who is expected to soon sign the bill into law. (Radelat, 12/7)

Two months after the Obama administration promised a “moonshot” to accelerate the fight against cancer, Vice President Joe Biden summoned top health care lawmakers to a meeting in the Old Executive Office building. Biden, whose son, Beau, died from brain cancer less than a year earlier, saw a path to fund the initiative in Energy and Commerce Chairman Fred Upton’s 21st Century Cures bill — a measure designed to boost funding for research on cancer and other diseases while making sweeping regulatory changes at the FDA that easily passed the House but was struggling to gain momentum in the upper chamber. (Karlin-Smith, Norman and Haberkorn, 12/7)