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Updates from Utah Gov - Organizations

Friday, June 24, 2016 - 11:00am

Marco's Statement on Running for Reelection

U.S. Senator Marco Rubio issued the following statement today announcing he will run for reelection in the United States Senate:

In politics, admitting you’ve changed your mind is not something most people like to do. But here it goes.

I have decided to seek reelection to the United States Senate.

I understand my opponents will try to use this decision to score political
points against me. Have at it. Because I have never claimed to be perfect, or to have all the answers.

Still, the people of Florida deserve to know why I’ve changed my mind.

I have often said that the U.S. Senate can be a frustrating place. And it’s true. After witnessing the gridlock that grips Washington, I think just about every American – Democrat or Republican – would agree.

But the Senate is also a place from which you can perform great services for the people you have the honor of representing. And I am proud of the work we have done to help thousands of Floridians over the last six years. 

The Senate can also be a place from which great policy advances can be made. I am proud that we have done that too.

But as we begin the next chapter in the history of our nation, there’s another role for the Senate that could end up being its most important in the years to come: The Constitutional power to act as a check and balance on the excesses of a president.

Control of the Senate may very well come down to the race in Florida. That means the future of the Supreme Court will be determined by the Florida Senate seat. It means the future of the disastrous Iran nuclear deal will be determined by the Florida Senate seat. It means the direction of our country’s fiscal and economic policies will be determined by this Senate seat. The stakes for our nation could not be higher.

There’s also something else. No matter who is elected president, there is reason for worry.

With Hillary Clinton, we would have four more years of the same failed economic policies that have left us with a stagnant economy. We would have four more years of the same failed foreign policy that has allowed radical Islam to spread, and terrorists to be released from Guantanamo. And even worse, if Clinton were president and her party took control of Congress, she would govern without Congressional oversight or limit. It would be a repeat of the early years of the current administration, when we got Obamacare, the failed stimulus and a record debt.

The prospect of a Trump presidency is also worrisome to me. It is no secret that I have significant disagreements with Donald Trump. His positions on many key issues are still unknown. And some of his statements, especially about women and minorities, I find not just offensive but unacceptable. If he is elected, we will need Senators willing to encourage him in the right direction, and if necessary, stand up to him. I’ve proven a willingness to do both.

In the days ahead, America will continue to face serious challenges – the possibility of terrorist attacks at home and abroad, a declining military, anemic economic growth and low wages, assaults on our rights and values, outdated health care, education and pension programs in desperate need of reform – that face backward or uncertain responses from either Clinton or Trump.

No matter who wins the White House, we need a strong group of principled, persuasive leaders in Congress who will not only advance limited government, free enterprise and a strong national defense, but also explain to Americans how it makes life better for them and their families. I ultimately changed my mind about this race because on that front, and in that fight, I believe I have something to offer.

In the end, this was a decision made not in Washington, but back home in West Miami over Father’s Day weekend, with my wife and our four children.

There were two paths before us. There was one path that was more personally comfortable and probably smarter politically. But after much thought and prayer, together we chose to continue with public service; to continue down the path that provides the opportunity to make a positive difference at this critical and uncertain time for our nation.

In the end, there was simply too much at stake for any other choice.

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Nearly 10 Million Adults Found to Be Severely Nearsighted in the United States

Largest U.S. study of its kind using American Academy of Ophthalmology’s national ophthalmic database also finds women at higher risk of potentially blinding complication

SAN FRANCISCO – June 21, 2016 – A new study estimates that 9.6 million adults in the United States are highly myopic, or severely nearsighted. Of those, nearly 820,000 have a degenerative form of the disease and more than 41,000 suffer a complication called myopic choroidal neovascularization that could cause long-term vision loss, with women at higher risk. The findings are being published online today in Ophthalmology, the journal of the American Academy of Ophthalmology. This is the first large-scale study ever done to calculate the real-world prevalence of myopic choroidal neovascularization in the United States.

Myopia has become increasingly common over the past several decades. In the United States, the number of nearsighted people rose from about 25 percent in the early 1970s to 40 percent around the turn of millennium.[1] While nearsightedness often can be corrected with eyewear or surgery, severe nearsightedness in which the eye continues to elongate can result in complications as the eye stretches.

Progressive high myopia, also called pathologic myopia, is a degenerative form of the disease. It can cause atrophy of the retina that lines the back of the eye. People with high myopia and the degenerative form are at higher risk of myopic choroidal neovascularization. This condition is characterized by the growth of new, unstable blood vessels beneath the retina. If untreated, it can cause vision loss that may then become permanent. As the prevalence of myopia continues rising, researchers are looking to better understand myopic choroidal neovascularization.

This study was conducted jointly by investigators from the American Academy of Ophthalmology, Genentech, the National Institutes of Health and UC Davis. Among the findings:

  • Nearly 4 percent of adults in the United States have high myopia, defined as -6.0 D or worse in their right eye. That is equivalent to 9.6 million people.
  • The prevalence of progressive high myopia is 0.33 percent. That is equivalent to 817,829 adults.
  • The prevalence of myopic choroidal neovascularization is 0.017 percent. While the disease appears rare, it affects 41,111 people in the United States.
  • Women appear to be at greater risk for complications of high myopia. The prevalence rate for progressive high myopia was 0.42 percent in women compared to 0.25 percent in men. An estimated 527,000 women have that condition compared to 292,000 men. Similarly, for myopic choroidal neovascularization, the prevalence rate for women is double that of men.

“Prior to this study, we really had no idea how many people had myopic choroidal neovascularization, which can be devastating,” said lead author Jeffrey Willis, M.D., Ph.D., a retina fellow at the UC Davis Eye Center and a clinical research fellow at Genentech. “I think the findings emphasize the growing issue of nearsightedness and the burden it creates in terms of medical complications that cannot be fixed with just glasses or contacts.”

To calculate the prevalence of high myopia, the team took diagnosis data from 8,865 participants in the National Health and Nutrition Examination Survey (NHANES) from 2005 through 2008. They applied the prevalence to 2014 U.S. Census Bureau population numbers to estimate the number of people affected. On its own, NHANES does not have a large enough sample size or the right type of ophthalmic data to accurately calculate the prevalence of myopic choroidal neovascularization. To do that, and to find the prevalence of progressive high myopia, researchers turned to 2014 data on 2.6 million individuals in the Academy’s IRIS Registry®, the nation’s only comprehensive database of ophthalmic patient outcomes. The rate was then applied to the high myopia population numbers to come up with real-world estimates.

The IRIS Registry is the only source of real-time data on ophthalmic care nationwide. It currently holds clinical information from 88 million office visits to 13,739 ophthalmologists and eye care professionals. Without this volume of clinical information, the prevalence of these diseases among a real-world population could not have been calculated, researchers said.  

"The sheer size of the IRIS Registry gives us tremendous research capabilities we did not possess before in ophthalmology,” said retina specialist David W. Parke, II, M.D., CEO of the American Academy of Ophthalmology and a co-author of the study. “We believe using IRIS Registry data to more accurately establish eye disease prevalence, find new risk factors and evaluate treatments for many types of eye conditions will become more common, to the benefit of the public.”

The Prevalence of Myopic Choroidal Neovascularization in the United States,” Willis et al. Ophthalmology, article in press, June 2016. DOI: 10.1016/j.ophtha.2016.04.021. For a full copy of the study or more information, please contact the Academy’s Public Relations Department at media@aao.org.

For more information on myopia or other eye conditions and diseases, visit the American Academy of Ophthalmology’s EyeSmart® website.

About the American Academy of Ophthalmology
The American Academy of Ophthalmology is the world’s largest membership association of eye physicians and surgeons. A global community of 32,000 ophthalmologists, we are passionate about protecting sight and fighting preventable blindness. For more than 120 years, we have been educators, innovators and advocates for the public and our profession to ensure the highest-quality medical and surgical eye care. Our EyeSmart® program is a preeminent source of eye health information for the public and empowers people to preserve their vision. For more information, visit www.aao.org.

About Ophthalmology
Ophthalmology, the official journal of the American Academy of Ophthalmology, publishes original, peer-reviewed, clinically-applicable research. Topics include the results of clinical trials, new diagnostic and surgical techniques, treatment methods, technology assessments, translational science reviews and editorials. For more information, visit www.aaojournal.org

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Lee CREATES Act Hearing Opening Statement 

 

WASHINGTON—Today, Senator Mike Lee (R-UT) delivered an opening statement in the Senate Judiciary Hearing titled The CREATES Act: Ending Regulatory Abuse, Protecting Consumers, and Ensuring Drug Price Competition. Remarks as prepared for delivery are available below and online.

 

Good afternoon and welcome to this hearing of the Subcommittee on Antitrust, Competition Policy, and Consumer Rights. Today’s hearing is entitled, “The CREATES Act: Ending Regulatory Abuse, Protecting Consumers, and Ensuring Drug Price Competition.”

 

Before I begin, I would like to thank Senators Grassley, Leahy, and Klobuchar, for their support and work on this bill and today’s hearing, as well as their staff, who have worked tirelessly to bring it all together.

 

The subject of discussion today, the CREATES Act and our attempt to end anticompetitive abuse of FDA safety regulations, is an important one. Nine months ago, when this subcommittee held a hearing on two major health insurance mergers, I noted that, “[w]hile vibrant competition in every industry is important to our economy, consumers and policy makers pay special attention when healthcare is involved.”

 

This is because consumers in this market are not just consumers; they are patients, caregivers, mothers and fathers, making life-changing decisions that impact their personal as well as economic well-being.

 

Undoubtedly, the most frequent example of rising costs in healthcare is prescription drugs. Nearly everyone has a story about sticker shock at the pharmacy counter, or anger at learning the drug they need isn’t covered by their health insurance, or frustration that no generic version of a drug they depend on has come to market. In response to these concerns Congress in 1984, led by the senior senator from my state, Senator Hatch, passed the Drug Price Competition and Patent Term Restoration Act, known as the Hatch-Waxman Act, to facilitate and encourage increased entry of lower-cost generic pharmaceuticals. The result has been a drastic increase in generic entry and billions of dollars in savings to consumers and tax-payers.

 

Yet increased competition doesn’t always sit well with incumbents. And unfortunately, complex regulatory environments are often rife with opportunities for manipulation and abuse to avoid competition. This is exactly what has happened with certain prescription drugs.

 

When Congress passed the FDA Amendments Act in 2007, one of the things it intended to do was to provide the FDA authority to ensure certain dangerous drugs were handled safely and responsibly in order to protect patients and prevent misuse. To do so, it created the Risk Evaluation and Mitigation Strategy program, or REMS. A REMS program can take many forms, but one element it may include is restricted distribution. In these situations, a drug is not sold through the normal supply chain, going to third-party wholesalers who sell it to pharmacies and hospitals. Instead, the drug is distributed directly by the manufacturer or through a specialty pharmacy that only sells to patients with a prescription.

 

Some companies realized they could take advantage of this situation. When they have a drug subject to a REMS with restricted distribution, they can use it as an excuse to deny samples of the drug to potential generic competitors--samples that are necessary for the generic to conduct the testing required by the FDA under the Hatch-Waxman Act, the Act whose entire purpose was to increase generic entry.

 

The CREATES Act, which stands for Creating and Restoring Equal Access to Equivalent Samples, aims to end this abuse by providing two causes of actions by which generic competitors can get access to samples and ensure they are not excluded from a REMS program. While some parties have attempted to use the antitrust laws to address this conduct, I believe it is better characterized as a competition policy problem stemming from a regulatory misuse of government regulation. In these situations, the answer is not to pile antitrust enforcement on top of regulation, but to fix the underlying problem: the law itself. I believe the CREATES Act does just that and am hopeful that it will become law and lead to increased competition and lower prices for consumers.

 

Again, I thank Senators Grassley, Leahy, and Klobuchar for their leadership on this issue and support for this bill, and I look forward to hearing from our esteemed panel of witnesses.

 

http://www.lee.senate.gov/public/index.cfm?p=speeches&id=D038B585-B5F0-47F9-BF8B-59B2600BCCB5