WASHINGTON – U.S. Senator Roger Wicker, R-Miss., today issued the following statement after voting to override President Obama’s veto of the “Justice Against Sponsors of Terrorism Act”:

“Victims of the 9/11 attacks and their families deserve to have their day in court. President Obama’s misguided veto of this legislation would have robbed them of that opportunity. I am pleased that the Senate has acted decisively to override that veto and help clear the way for these families to find justice.”

Specifically, the “Justice Against Sponsors of Terrorism Act” would allow victims, including the families of those lost on September 11, 2001, to hold foreign sponsors of terrorism in the United States accountable for their actions.

WASHINGTON – Following efforts from U.S. Senators Roger Wicker, R-Miss., and Amy Klobuchar, D-Minn., the Food and Drug Administration (FDA) has announced that it has accelerated approval for the first drug to treat Duchenne muscular dystrophy (DMD). In April, Wicker and Klobuchar led a bipartisan letter urging the FDA to use all available resources and authorities to accelerate the process of getting safe and effective treatments to patients diagnosed with DMD. The Senators also highlighted the Food and Drug Administration Safety and Innovation Act (FDASIA), legislation that provides the agency with improved flexibility to grant approval to rare disease treatments that have proven to be beneficial and allows the FDA to impose post-approval studies to confirm the clinical benefit. The Patient Focused Drug Development initiative, also included in the law, asks that the agency consider the views and experiences of patients as part of the drug review process.

“In the 15 years since I introduced the MD-CARE Act, this ranks as one of the most important milestones in our fight to cure Duchenne,” Sen. Wicker said. “I am thrilled that the FDA has acted within its authority to allow young men and their families to have access to this drug. We should take every opportunity to help improve the quality of life for those living with the disease.”

“Today’s announcement will make a tremendous difference for people living with Duchenne muscular dystrophy. I am proud that through our bipartisan efforts, the Food and Drug Administration was able to use all available tools at their disposal to approve this groundbreaking drug,” said Sen. Klobuchar, a Senate co-chair of the Rare Disease Congressional Caucus. “We are now one step closer to improving the quality of life for those living with this disease.”

In 2014, Wicker and Klobuchar’s legislation to help improve the lives of patients with muscular dystrophy was signed into law by the President. The Muscular Dystrophy Community, Assistance, Research & Education (MD CARE) Act supports medical research and policies to improve treatments and quality of life for muscular dystrophy patients.

In addition to Sens. Wicker and Klobuchar, cosigners of the April letter to the FDA included Kelly Ayotte (R-NH), John Barrasso (R-WY), Michael Bennet (D-CO), Richard Blumenthal (D-CT), Barbara Boxer (D-CA), Sherrod Brown (D-OH), Maria Cantwell (D-WA), Shelley Moore Capito (R-WV), Bill Cassidy (R-LA), Susan Collins (R-ME), Chris Coons (D-DL), Tom Cotton (R-AK), Angus King (I-ME), James Lankford (R-OK), Edward Markey (D-MA), Robert Menendez (D-NJ), Lisa Murkowski (R-AK), Chris Murphy (D-CT), Marco Rubio (R-FL), Jeff Sessions (R-AL), Charles Schumer (D-NY), and Elizabeth Warren (D-MA).

The full text of the letter is below:

Dear Dr. Woodcock,

Thank you for your ongoing commitment to the expeditious review of candidate therapies for Duchenne Muscular Dystrophy (DMD). In recent years, advancements in science have resulted in progress toward advancing the first-ever disease-modifying treatments for DMD, a goal we hope will be achieved soon.

As the FDA continues its review of potential new therapies for DMD, we urge the agency to utilize all available resources and authorities to accelerate the process of getting safe and effective treatments to patients diagnosed with this 100 percent fatal disease. The Food and Drug Administration Safety and Innovation Act (FDASIA) had a strong focus on accelerating the approval of drugs that treat unmet medical needs, prioritizing the patient perspective in evaluating new drugs and treatments and providing reviewers with flexibility when evaluating drugs for a life-threatening illness. We request you fully employ the tools Congress included in FDASIA and the broad regulatory flexibility the agency is granted through federal regulation[1] to help advance new DMD therapies.

The accelerated approval pathway outlined in Section 901(b) of FDASIA gives the agency the flexibility to grant approval to rare disease treatments that “have an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit,” and allows the FDA to impose post-approval studies to confirm the clinical benefit. In FDA’s draft Guidance, Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment Guidance for Industry, the Agency expanded on this concept specifically in the context of DMD. We request that the agency consider surrogate endpoints and intermediate clinical endpoints to reduce the time and difficulty of performing clinical studies on treatments for rare diseases like DMD and help new therapies become accessible to patients who otherwise have no option as the agency has done with other deadly diseases such as HIV and cancer.

FDASIA includes multiple provisions focused on addressing the challenges of the rare disease patient community. The patient population of a rare disease is by definition small, meaning clinical trials will be conducted with fewer participants than trials for more prevalent conditions. We encourage the agency to utilize advances in regulatory science that can allow clinical trials in a small population able to provide the evidence necessary for accelerated approval of products that treat life-threatening, rare diseases.

FDASIA launched the Patient Focused Drug Development (PFDD) initiative and charged the agency to take into account the views and experiences of patients as part of the review process. As you know, the DMD community worked collaboratively with regulators and benefit-risk experts to ascertain patient-preference data, collect narratives from the community, and produce draft guidance that informed FDA’s development of the draft Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment Guidance for Industry. In addition, the experiences of patient representatives on the advisory committee and testimony of patients at the advisory committee meetings offer important perspectives and information. We urge the FDA to ensure that all of these perspectives are considered in regulatory review.

Patient perspectives are also important in conducting risk-benefit analyses. The FDA notes “that physicians and patients are generally willing to accept greater risks or side effects from products that treat life-threatening and severely debilitating illnesses, than they would accept from products that treat less serious illnesses” and “that the benefits of the drug need to be evaluated in light of the severity of the disease being treated.” Under Title 21 regulations, it is appropriate for the FDA to exercise broad flexibility when reviewing drugs for certain disease types while ensuring safety and efficacy. We urge the FDA to ensure this flexibility is considered in the review of candidate therapies that meet regulatory requirements, while maintaining the rigor necessary to uphold safety and efficacy standards for new drugs.

The risk of doing nothing for a patient with DMD is their certain death. Treatments that are safe and reasonably likely to produce clinical benefit for DMD patients could meaningfully alter their lives.

Members of Congress remain committed to ensuring the FDA has the tools, authorities, and latitude necessary to review and approve safe and effective treatments for rare diseases as quickly as possible. We hope and expect that the agency will fully utilize these tools and authorities when appropriate to provide patients and physicians with new options to treat rare and deadly diseases like DMD.

Former first lady Laura Bush was wise to say that "the most valuable thing in my wallet is my library card." Our public libraries offer our communities more than shelves of books. They provide access to print and digital resources that can help patrons with a variety of projects, from working on a school assignment to searching for a new job.

In an effort to keep Mississippi's 235 public libraries vibrant places for research and learning, I am working to donate a portion of my book collection as well as raise awareness about the Library of Congress Surplus Books Program. The Library of Congress receives more than 20,000 items every day but retains only about half of the items for its permanent collection.

Through the Surplus Books Program, educational institutions, nonprofit organizations, and state and local public agencies can apply to receive these materials for their own collections. The materials – which include paperback and hardback books, audio and video recordings, and maps – cover a number of subjects and interests. To learn more about this program and how to participate, please e-mail my office at wicker_books@wicker.senate.gov.

Mississippi Hosts Second-Annual Book Festival

We are lucky to live in a state with such a world-renowned literary tradition. Last year, nearly 4,000 people gathered at the State Capitol in Jackson for the first Mississippi Book Festival. This year's festival on August 20 brought in even more visitors and authors, including Pulitzer Prize winners Richard Ford and Jon Meacham. As a participant, I was honored to interview author Anne L. Webster, whose book "Mississippians in the Great War: Selected Letters" offers an emotional portrait of war through the eyes of the soldiers, nurses, and relief workers from our state who traveled far to defend freedom.

Millions of Children Have Received Free Books

We all have a role to play when it comes to promoting literacy. Anyone who takes the time to read to a child is making a difference in these young lives. In addition to our public libraries, public-private organizations like Reading Is Fundamental (RIF), which distributes free books to children in need, are working to change troubling statistics. One such statistic reveals that two-thirds of low-income families do not own any books for their children.

Reading skills can lead to success in school and later in life, making the work of RIF vital to creating opportunities for our children. Over the past 50 years, the nonprofit literacy organization has distributed hundreds of millions of books to more than 40 million children. My wife, Gayle, and I remain very involved with RIF, serving as guest readers to children across the state. Just this week, I joined 50 fourth graders at West Lowndes Elementary School near Columbus in reading an excerpt from Mark Twain’s "Huckleberry Finn.” Gayle has also co-chaired the leadership committee for RIF’s annual event in Washington. I was honored to receive the Book Champion Award last year.

I will continue to support federal investments in literacy, successful public-private partnerships like RIF, and better collections for our public libraries. Access to books is one of the greatest gifts we can give to our children, to our communities, and to our state.

WASHINGTON – U.S. Senator Roger Wicker, R-Miss., authored the “Ensuring Useful Research Expenditures is Key for Alzheimer’s (EUREKA) Act,” S. 2067, last September to create prize-based incentives to encourage more public-private collaboration in the fight against Alzheimer’s disease and related dementia. As of July 14, the bipartisan bill has reached a total of 61 Senate cosponsors.

“My EUREKA bill is an answer to a devastating disease that impacts more than five million Americans today,” Wicker said. “It would not take money away from taxpayers or current research initiatives. It would require funding only when pioneering advancements are made toward a cure for Alzheimer’s, truly making a difference in people’s lives. I am grateful that three-fifths of my Senate colleagues are ready to put the best minds together to achieve breakthroughs in treatments, prevention, and ultimately a cure. This is our charge for the 21st century, and we cannot rest until we achieve success.”

The legislation would not replace other funding and research initiatives for Alzheimer’s but add another route for breakthroughs. Further, the bill would authorize the Director of the NIH to work with other federal agencies to establish prize challenges informed by the research milestones contained in the National Plan to Address Alzheimer’s Disease. Challenges could focus on a number of areas:

• Identification and validation of Alzheimer’s biomarkers; 
• Development of non-invasive and cost-effective early detection and diagnostic tools;
• Repurposing of existing drugs to address Alzheimer’s disease; and 
• Development of new tools and approaches to care for persons with Alzheimer’s disease and improve their quality of life.

Prize challenges enable government sponsors to pay only when a prize team achieves specified goals or milestones. Although funds will be authorized and reserved for awards, prizes will only be granted when teams achieve clearly defined objectives, making the EUREKA Act a cost-effective tool to spur leading-edge research. Additionally, EUREKA would permit the receipt of donations from the private and philanthropic sectors to fund the competition and build the award fund.

The National Institute of Health (NIH) has set a goal of curing Alzheimer’s by 2025. Today, Alzheimer’s is the most expensive disease in America and has a 100 percent fatality rate. According to a report released earlier this year, caring for people with Alzheimer’s disease and other dementias is estimated to cost the United States $226 billion in 2015, with one in five Medicare dollars spent on an Alzheimer’s victim. Unless a cure is found, treatment costs are expected to grow to an estimated $1.1 trillion by 2050. In Mississippi, 12 percent of senior citizens have Alzheimer’s. The number of victims is expected to rise 27.5 percent by 2025, increasing from 51,000 to 65,000.

Original cosponsors include: Sens. Shelley Moore Capito, R-W.Va.; Angus King, I-Maine; Brian Schatz, D-Hawaii; Kelly Ayotte, R-N.H.; Susan Collins, R-Maine; and John Barrasso, R-Wyo. In addition to the original cosponsors, the following senators have backed the bill: Johnny Isakson, R-Ga.; Thom Tillis, R-S.C.; Mark Warner, D-Va.; John Boozman, R-Ark.; Pat Toomey, R-Penn.; Thad Cochran, R-Miss.; Bill Cassidy, R-La.; John Hoeven, R-N.D.; Jim Risch, R-Idaho, Amy Klobuchar, D-Minn.; Lisa Murkowski, R-Alaska; Richard Burr, R-N.C.; Sherrod Brown, D-Ohio; Ben Cardin, D-Md.; Kirsten Gillibrand, D-N.Y.; Tom Carper, D-Del.; Tom Udall, D-N.M.; Ed Markey, D-Mass.; Jeff Merkley, D-Ore.; Dan Sullivan, R-Alaska; Mazie Hirono, D-Hawaii; Mike Rounds, S.D.; Orrin Hatch, R-Utah; Ted Cruz, R-Texas; Mike Leahy, D-Vt.; Chris Coons, D-Del.; Tim Kaine, D-Va.; Al Franken, D-Minn.; Bill Nelson, D-Fla.; Mark Kirk, R-Ill.; Debbie Stabenow, D-Mich.; Cory Gardner, R-Colo.; Marco Rubio, R-Fla.; Dan Coats, R-Ind.; Joe Donnelly, D-Ind.; Bob Menendez, D-N.J.; Jeanne Shaheen, D-N.H.; Tom Cotton, R-Ark.; Cory Booker, D-N.J.; Gary Peters, D-Mich.; Roy Blunt, R-Mo.; Tim Scott, R-S.C.; Mike Crapo, R-Idaho; Jim Inhofe, R-Okla.; Ron Johnson, R-Kan.; Chris Murphy, D-Conn.; Heidi Heitkamp, D-N.D.; John McCain, R-Ariz.; Jack Reed, D-R.I.; Chuck Schumer, D-N.Y.; Jon Tester, R-Mont.; Chuck Grassley, R-Iowa; Joni Ernst, R-Iowa; Lindsey Graham, R-S.C.; and David Vitter, R-La.

Wicker’s legislation is supported by more than 70 organizations, including the XPRIZE Foundation, Alzheimer’s Foundation of America, UsAgainstAlzheimer’s, Alzheimer's Association, Eli Lilly and Company, BrightFocus Foundation, and the MIND Center at the University of Mississippi Medical Center.