HH.R. 6 – 21st Century Cures Act
Sponsor: Rep. Fred Upton (R-MI)
Co-sponsors: 230, including Rep. Joe Heck (R-NV) and Rep. Cresent Hardy (R-NV)
Synopsis: As explained on Rep. Joe Heck’s website, this act “modernizes the health-care innovation infrastructure, incorporates patient perspective into the drug and device approval process, supports advances in personalize medicine, streamlines clinical trials, and provides more resources to support cutting-edge research to ensure the United States maintains its role as the premier medical innovator in the world.”
Action: Introduced in House on 5/20/2015, and referred to several House committees. On 5/22/2015, referred to the Subcommittee on Health. The House Energy and Commerce Committee unanimously approved it in May 2015. It went on to pass the House on 7/10/2015 with a vote of 344-77. On 7/13/2015, it was received in the Senate, read twice, and referred to the Committee on Health, Education, Labor, and Pensions.
Sponsor Comments: “Our 21st Century Cures effort seeks to capture just a sliver of hope and optimism that countless patients exude despite sometimes insurmountable odds. They need the next generation of treatments and cures, but they do not have until the next generation to wait,” said Congressman Fred Upton (R) from St. Joseph, Michigan, who also chairs the House Committee on Energy and Commerce. “While the history of health innovation is remarkable, we’ve now got our sights set on the future, on 21st Century Cures. This bill is about making sure our laws, regulations, and resources keep pace with scientific advances. In this, the greatest country in the world, Americans deserve a system second to none. We can and must do better. The time for 21st Century Cures is now.”
Co-sponsor Joe Heck (R-NV) said, “Improving healthcare innovation will allow us to better treat patients and save lives. As a physician, I understand the important role medical research, clinical trials, and collaboration play in developing treatments and finding cures to rare diseases. If we want to keep pace with the scientific advances of recent years, we must update federal rules for drug and device approval to deliver cures and therapies more quickly to patients who desperately need them. The United States has more Nobel Prize winners in medicine than any other country, and the 21st Century Cures Act will ensure we maintain our nation’s leadership role in discovering the cutting-edge, novel therapies and treatments of the future. I was pleased to cosponsor this legislation and support its passage on the floor and urge the Senate to quickly consider this bill.”
Jessica’s Take: The act was drawn from information gathered over a year or more of listening to experts in the health-care field—doctors, researchers, innovators, job creators, educators. Dozens of bipartisan roundtables were held across the country, and feedback was solicited from white papers and social media. Committee hearings were held to gather comments.
The enormous amount of information gathered and viewpoints considered led it to gain approval from the House. However, in October 2015, debates over drug prices and complaints from consumer advocates about safety concerns caused the bill to stumble in the Senate. The bill is being rewritten as the Innovations for Healthier Americans Act, which is expected to look much leaner than the Cures act, as it will not include the pharmaceutical industry perks and FDA reforms that have been the subject of controversy over rushed approval processes. Little evidence suggests that the FDA is a bottleneck to innovation.
The Senate will vote on this bill in 2016, but considerable work is left to do. The bill is supported by numerous patient-advocacy organizations, but the American Hospital Association opposes provisions that it says interfere with hospitals’ ability to gather and retain patient information. Additionally, it includes a seemingly unrelated provision for the government to sell millions of barrels of oil from the strategic petroleum reserve rather than tapping financial resources currently dedicated elsewhere. This alone is likely to meet with considerable resistance.
In short, the Senate bill is nowhere near being a shoo-in for passing in 2016.
H.R. 1583 – Small Business Contractor’s Clarification Act of 2015
Sponsor: Rep. Cresent Hardy (R-NV)
Synopsis: This bill amends the Small Business Act to revise the federal procurement requirements of the Administrator of the Small Business Administration (SBA) with respect to small business contracts for articles, equipment, supplies, services or materials, or to perform construction work for the government.
The permission to submit an offer for a procurement contract, even though the offeror is not the actual manufacturer or processor of the product in question, is extended to additional kinds of small businesses, including: women-owned small businesses; HUBZone small businesses, and small businesses owned and controlled by service-disabled veterans. Contracts whose principal purpose is acquisition of services or construction are exempt from this Act.
Limitations on SBA subcontracting are revised to require contracts that are principally for supplies from a regular dealer in such supplies, and that are not contracts principally for services or construction, to supply the product of a domestic small business manufacturer or processor, unless a waiver is granted by the Administrator under specified conditions.
Action: Introduced in House on 3/24/2015, and referred to the House Committee on Small Business.
Sponsor Comments: “Small businesses need more clarity on federal government contract rules,” said Hardy. “My bill solidifies the ‘non-manufacturer’s rule’ in order to clarify that service contracts do not have to meet the same small business requirements as manufactured goods contracts, a move which will pave the way for better opportunities for the businesses in the 4th Congressional District and all across the nation.”
Jessica’s Take: House Small Business Chairman Steve Chabot spoke in support of this reform, which is aimed at improving small business participation. Chabot said that when America’s small businesses are given greater opportunity to compete for federal contracts, “it improves quality, reduces costs, and ensures we have a robust industrial base supporting our military.”
The bill was introduced soon after it was reported that in 2014, federal agencies successfully hit their annual goal of delivering 23 percent of contracting dollars to small businesses—the first time it had happened since 2005. However, some evidence suggests that this figure may misrepresent the facts—that companies are simply getting larger rewards and that many contracts categorized as going to small businesses actually are going to large ones. This legislation attempts to address that issue. It’s impossible to predict the future, but The Washington Post suggests that chances are good on this one passing, as similar reforms in favor of small businesses have traditionally done well in Congress.
H. Amdt. 374 to H.R. 2577
Sponsor: Rep. Dina Titus (D-NV)
Synopsis: This amendment redirects $1 million in funding within the Operating Grants to the National Railroad Passenger Corporation for the purpose of developing passenger rail service in the Las Vegas area.
Action: Introduced for consideration on 6/3/2015. The amendment was adopted by voice vote and was included in the Transportation, Housing and Urban Development and Related Agencies Appropriations Act for FY 2016. Congress went on to pass the bill in December, 359-65 in the House and 83-16 in the Senate. President Obama signed the bill to which this amendment is tied into law on Dec. 4, 2015.
Sponsor Comments: On the House floor, Titus commented, “I rise today with a simple amendment; it’s one that is meant to shed light on the inadequate investments that are being made in our nation’s passenger rail service.
“The bill before us appropriates nearly $16 billion for aviation, over $40 billion for our roads, over $10 billion for public transit, but just $1.1 billion for our nation’s passenger rail service.
“I represent Las Vegas, where we import everything from tourists to lobsters, so we certainly understand the importance of transportation mobility.
“Many international and domestic travelers alike are shocked to learn when they’re coming to Las Vegas that a major metropolitan city, home to more than 2 million residents and playground and boardroom to over 42 million visitors a year, does not have access to passenger rail service.
“Visitors from Europe or Asia are accustomed to taking trains from one city to another, and they face a sad reality when traveling to Las Vegas from other Southwestern tourist destinations…
“Now a lot of attention has been paid to the Northeast Corridor, where travelers frequent Amtrak service along the East Coast, but we should not forget that it was the railroad that built the West, and still today, remains a critical piece of our transportation network.
“China is investing $128 billion in rail in 2015 alone; India $137 billion over the next 5 years, and yet we’re investing only $1.1 billion.”
“So Mr. Chairman, since this amendment really has no monetary impact, I would respectfully ask that you accept it; and it’s my hope that we recognize this mode of transportation that is so tied to our nation’s history, and that we can continue to work together to see that it gets attention and support that it deserves.”
Jessica’s Take: Rail service in Southern Nevada, where the population has grown by a million new residents and 10 million visitors annually over the last two decades, ought to have rail service, and emphasizing its development makes sense. But like most well-intentioned measures, cost becomes a major factor. The bill to which this amendment is tied provides for $10 billion over five years to go to Amtrak and other rail programs, along with other transportation changes, yet includes no means to pay for them. There’s little interest being expressed in raising the gas tax. Until Congress can hash out a plan to pay for it, and until Americans can come around to see the value of rail service (a far-off prospect), it seems unlikely that much will be done to revitalize rail travel in Southern Nevada. But only time will tell.