Biogen Idec participates in public policy discussions that we believe benefit patients and foster innovation and growth in the industry.
We have positions on a number of key issues, including:
Biogen Idec believes all Americans should have access to affordable, high-quality healthcare. We support healthcare reform that strikes the right balance between providing the best care for patients, controlling costs, expanding access to more Americans, and providing continued incentives for the research and development of new medicines. The Affordable Care Act, which was signed into law in March 2010, accomplished several of these goals. Our ActiveSource™ Coordinators are helping patients understand and leverage the provisions of the federal law to gain access to health insurance coverage that enables them to afford not only our therapies but other services necessary for them to manage their diseases. At the same time, there are some provisions in the law that may limit access to care for patients, such as decisions made by the Independent Payment Advisory Board. We continue to advocate for changes to this and other issues to ensure that patients are able to access and afford the care they need.
We believe biosimilars, which are approved subsequent versions of innovative biological products, have an important role to play in providing high-quality drugs to patients at a lower cost. While innovation continues to be a key driver of healthcare, access to high-quality therapies at a lower cost is becoming increasingly important. As an industry, we have a responsibility to address both innovation and access because it is what patients need. To that end, we support provisions in the Affordable Care Act that will allow for the approval of biosimilars while protecting patient safety, ensuring product efficacy and promoting the continued innovation of the biotech industry.
Reauthorization of the Prescription Drug User Fee Act
The Prescription Drug User Fee Act (PDUFA), enacted in 1992, authorizes the U.S. Food and Drug Administration (FDA) to collect user fees from companies that develop prescription drugs. These fees are then used to fund the review and approval process at the FDA. PDUFA, which has received a renewal every five years since it was first enacted, is up for reauthorization in 2012.
PDUFA has played an important role in expediting the approval of safe and effective medicines, and we believe that reauthorization will help make important improvements, enabling the FDA to meet the drug review timelines. Specifically, we believe a more transparent and predictable regulatory environment is in the interest of the industry and patients. Policies that help the FDA address existing drug review challenges and make new, safe and effective therapies available to patients more quickly should be considered this year as part of the reauthorization of PDUFA.
The corporate tax rate in the United States, which is among the highest in the developed world, positions the country at a competitive imbalance. Biogen Idec supports reforming the U.S. corporate tax system in a way that will attract, retain and support innovative industries and high-tech manufacturing jobs in the United States. We believe public policies, such as a well-designed innovation box regime that incentivizes companies to locate their intellectual property and corresponding economic activities in the United States, should be part of a reformed corporate tax system.
Biogen Idec also maintains an employee- and board-funded federal political action committee (PAC). The Biogen Idec PAC supports federal candidates working to advance public policy goals important to our company. By law, these contributions are publicly disclosed on the Federal Election Commission’s website at www.fec.gov. In addition, we are a member of several industry trade associations, including organizations that may engage in lobbying.