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December 8, 2016

News Roundup: Congress Passes the 21st Century Cures Act

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Associated Press – Congress Approves Biomedical Bill as Leaders Eye Adjournment

"This is a reminder of what we can do when we look out for one another," Obama said in a written statement that promised his signature. Referring to families that have endured losses to cancer, Alzheimer's and drug abuse, he added, "Their heartbreak is real, and so we have a responsibility to respond with real solutions. This bill will make a big difference."

EurekAlert – ASHG supports Genetic Privacy Provisions in 21st Century Cures Act

The American Society of Human Genetics (ASHG) commends Congress for strengthening privacy protections for genetics research participants as part of the 21st Century Cures Act (H.R.34) passed on December 7. These provisions, Section 2012 and Section 2013 of H.R.34, were originally introduced in the Senate by Senator Warren (D-MA) and Senator Enzi (R-WY) as the Genetic Research Privacy Protection Act (S.2744), legislation endorsed by ASHG.

Fortune – Everything You Need to Know About the Massive Health Reform Law That Just Passed Congress

Still, the law has its share of critics who aren’t quite so thrilled as the across-the-aisle victory may imply. For instance, legislators like Sens. Elizabeth Warren of Massachusetts, Bernie Sanders of Vermont, and Jeff Merkley of Oregon recently warned that Cures amounts to a big pharma giveaway which will weaken regulatory standards on drugs, provide a mere pittance to the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), and do nothing to confront the rising tide of high drug prices. They point to the fact that the $4.8 billion in NIH funding included in Cures must be re-authorized every year, and that drug approvals which can be based on “real-world” patient outcomes (rather than rigorous clinical trials) could actually endanger patients.

The Hill – Senate sends far-ranging medical cures bill to Obama's desk

Sen. Lamar Alexander (R-Tenn.), who has shepherded the bill through the upper chamber over the last year, called it a “Christmas miracle.” He said the broad scope of the bill reflected a rare moment of compromise within Congress and in the White House to tackle some of the nation’s top concerns — difficult-to-treat diseases, opioid addiction and mental health. Alexander, who leads the Senate Health Committee, pointed to the “unusual” work across the aisles. Biden made personal phone calls urging senators to pass the bill, while Speaker Paul Ryan (R-Wis.) did a “triple somersault” to find a way to fund the bill, he said.

International Business Times – Eating Disorder Treatment, Research Gets National Recognition In 21st Century Cures Act

With the passage of the 21st Century Cures Act Wednesday, Congress enacted legislation dealing directly with eating disorders for the first time. Along with a number of health provisions and an allocation of $4.8 billion in funding for the National Institutes of Health, the bill calls for better education and training for eating disorders, appropriate treatment and reformed health insurance coverage.

Kaiser Health News – Senate Approves Landmark Mental Health Bill As Part Of 21st Century Cures Act

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. … But Rep. Frank Pallone, D-N.J., said he’s concerned that proposed Republican changes to the health care system could undercut any progress made by the bill. Millions of Americans with mental illness could lose coverage if Congress repeals the Affordable Care Act or cuts spending on Medicaid, which pays for about 25 percent of all mental health care, he said.

The Los Angeles Times – Senate passes $6.3-billion medical research bill and sends to Obama

The White House acknowledged that it has issues with parts of the legislation, but Obama noted that the trade-offs were worth it. “Like all good legislation, it reflects compromise,” the president said during his weekly radio address Saturday.  

NBC News – Senate Passes Sweeping 21st Century Cures Act Funding Medicine

The bill provides especially detailed instructions to states for boosting mental health care, which most advocates agree is badly neglected across the country. … [But n]ot everyone loves the act. For one thing, it takes cash from a public health initiative meant to help people prevent America's biggest killers: chronic diseases such as heart disease, cancer, obesity and diabetes.

Medscape – Congress Passes 21st Century Cures Bill

A broad swath of the healthcare industry supported the Cures bill. Medical societies on board included the American Psychiatric Association, the American Society of Clinical Oncology, and the American Gastroenterological Association. The bill also enjoyed the backing of the American Heart Association, the Arthritis Foundation, the Association of American Medical Colleges, and, not surprisingly, the Pharmaceutical Research and Manufacturers of America, the trade group for drug makers.

The New York Times – Sweeping Health Measure, Backed by Obama, Passes Senate

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. … “I doubt that there is a family in America who will not be touched by this important legislation,” said Senator Susan Collins, Republican of Maine.

NPR Shots – Mental Health Care Gets A Boost From 21st Century Cures Act

The bill includes provisions aimed at fighting the opioid epidemic, 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. It also would push states to provide early intervention for psychosis, a treatment program that has been hailed as one of the most promising mental health developments in decades.

POLITICO – Biden’s farewell gift: Cancer moonshot helps pass $6.3 billion research bill

The bill provides significant amounts of money for various programs: $1.8 billion for Biden’s cancer moonshot, $1.5 billion for Obama’s Precision Medicine Initiative aimed at tailoring treatments to people based on their genes and lifestyles, $1.5 billion for the BRAIN initiative, to advance scientists' understanding of the human brain to solve diseases like Alzheimer’s and $1 billion for anti-opioid efforts. The catch was that while the regulatory rollback that so rankled some Democrats is guaranteed, the research funding is not. It will have to be appropriated each year. 

POLITICO – Major FDA reform bill heads to Obama’s desk

The $6.3 billion 21st Century Cures Act, which funds some of the outgoing Obama administration's top research priorities, has been relentlessly driven by House Energy and Commerce Chairman Fred Upton for nearly three years. The bill, approved in a 94-5 vote, also includes a host of industry friendly reforms to FDA’s drug and medical device review process — some controversial — in addition to the research and opioid funding that drew a majority of Democrats to support it. It also provides a major update to mental health care policy, but provides no new funding for those programs.

STAT – Senate passes landmark 21st Century Cures Act — but it will take years to implement

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.” FDA officials have already lamented that the agency is stretched thin. Because the Cures Act calls on the agency to take on new responsibilities, some argue that it’s time for the agency to hire more staff — something the FDA has wanted to do for years.

The Washington Post –  Congress passes 21st Century Cures Act, boosting research and easing drug approval

“The bipartisan passage of the 21st Century Cures Act is an example of the progress we can make when people from both parties work together to improve the health of our families, friends and neighbors. . . . This bill will make a big difference, and I look forward to signing it as soon as it reaches my desk.”

Yahoo! Finance – Biocom Applauds Passage of Landmark Biomedical Innovation Legislation

While Biocom had supported additional funding for the NIH, we applaud this large-scale, bipartisan, and collaborative effort that will change the future of innovation in the United States. We look forward to working with the new Administration and Congress over the coming years on the implementation of the bill and on issues that were not addressed in the bill, including the reimbursement of telemedicine, remote patient monitoring services, and other emerging technologies, that together represent the future of modern medicine.