Federal Focus - July 2012

Senate to Hold Hearing on International Disability Rights Treaty The Senate Foreign Relations Committee recently announced that it will hold a hearing on July 12th on the Convention on the Rights of Persons with Disabilities (CRPD), an international treaty which essentially takes the Americans with Disabilities Act international. The President signed the treaty in 2009, but in order for it to have the force of law—the United States Senate must ratify it by a two thirds majority. The Society has been working in close collaboration with other organizations like the U.S. International Council on Disabilities to increase support in the Senate and the Committee hearing is exciting progress towards ratification. Senate Committee Approves Funding for MS Priorities In mid-June, the Senate Appropriations Committee approved a bill that contains funding for many priorities for people affected by MS. MS activists have been weighing in with their members of Congress about these funding priorities since the spring. The Senate Committee-approved bill includes $30.72 billion for the National Institutes of Health (NIH), a small increase over the previous year. The NIH is the country’s premier institution for medical research and each year, dedicates around $120 million toward MS-related research. As part of the NIH funding, the Committee would provide $40 million for the Cures Acceleration Network, a new program that aims to advance the development of effective treatments and reduce significant barriers between research discovery and clinical trials. The Committee also provided $4.99 million for the Lifespan Respite Care Program that supports our nation’s 65 million+ family caregivers, $3.47 billion for the Low-Income Home Energy Assistance Program (LIHEAP), and $11.7 Billion for the Social Security Administration (SSA) to fund SSA’s day-to-day operational responsibilities and help speed the process of receiving disability benefits. There are several more steps before this bill becomes law, but its contents are promising and show that members of Congress are hearing MS activists’ messages that even with the continued difficult budget climate, investing in issues like MS research is important. U.S. Supreme Court Health Care Ruling After much anticipation, the U.S. Supreme Court ruled on June 28th to uphold most of the Patient Protection and Affordable Care Act (ACA). The ruling was a 5-4 decision, with Chief Justice Roberts as the swing vote. The Court decided that the cornerstone of the law—the individual mandate requiring people to have health insurance or face a financial penalty—is valid as a tax, even though the court simultaneously said the mandate is not permissible under the Constitution’s commerce clause. Because it has been deemed constitutional, the law’s individual mandate will require most people to have health insurance or face a fine, starting in 2014. There are exceptions to the mandate for people who cannot afford coverage even with a subsidy, and those with religious objections. The individual mandate is critical because it expands the pool of people paying for insurance--spreading the cost more widely and allowing other important provisions to continue like banning lifetime limits and ending discrimination based on pre-existing conditions. While the individual mandate was upheld, the high Court also ruled that the part of the law expanding Medicaid must change. As enacted, the law required states to expand their Medicaid programs or face losing the federal government’s entire contribution to the program. By a 7 to 2 vote, the court found this too coercive on states and struck it down. Now, rather than demanding that states expand their Medicaid programs, each state has the option of doing so. With this historic decision behind us, the Society will continue its work on the law’s implementation in the interests of people affected by MS and it will work with members of both political parties to further refine and improve public policies relating to this and other health-related laws. Bill to Support Drug and Device Approval Enacted Over the past two weeks, the House and Senate approved an important piece of legislation that expedites the review of drugs and devices by authorizing “user fees” – the Food and Drug Administration Safety and Innovation Act (S. 3187). After both chambers came to a compromise, the House quickly moved to pass the bill at the end of June with the Senate passing it shortly thereafter. This bill reauthorizes the Food and Drug Administration’s (FDA) ability to collect user fees for five years to provide funding for the prescription drug and device approval process. In addition to branded drugs, this bill incorporates user fees for generic and biosimilar applications for the first time. This bill also codifies some other important policies at the FDA. The user fee program essentially allows the FDA to charge drug and device firms a fee for every application they submit for review to the FDA. In return, there is an explicit expectation that the FDA will hire more staff and review these treatments faster, in order to get them on the market more quickly. In addition to determining the fee amount, this agreement incorporated a number of new policies. Two of the policies were supported by the Society: 1) to better incorporate patients’ views on benefits and risks of drugs and devices as they are being evaluated and 2) to improve the FDA’s ability to evaluate drugs using biomarkers and patient reported outcomes as clinical endpoints. The Society applauds Congress’ bipartisan work to get this legislation to the President so quickly and is happy that the FDA will continue to have resources to quickly and effectively evaluate drugs and devices for patients.