Biogen is committed to advancing public policies that facilitate a robust research environment and ensure patient access to new and improved treatments.

Biogen’s ability to discover, develop, and deliver life-altering therapies to patients is significantly impacted by public policies. In order to remain a leader in the biopharmaceutical industry, and one with a demonstrated commitment to patients, we believe it is incumbent upon Biogen to maintain active engagement in the development and improvement of such policies..

Developing sound public policy is a complex and collaborative process that requires coordination with public and private organizations.

In support of our policy goals, we routinely engage with patient advocacy organizations, federal and state government agencies, and industry associations.

Biogen focuses on policy issue areas that advance medical science and impact discovery, development and delivery of innovative biopharmaceutical products to improve the lives of patients.

We have positions on a number of public policy issues, including:

Ensuring patient access
Sufficient protections should be in place to establish healthcare systems that ensure timely patient access to the most appropriate healthcare providers, services and treatments. Provider networks, within both private and public health plans, should allow patients to receive coordinated care not only from their primary providers, but also from specialists and subspecialists who may be necessary to best treat their condition. Patients should be able to choose the healthcare providers with whom they have the most confidence and trust. Additionally, comprehensive formulary coverage will ensure that the decision as to which medicine to use is best made by the patient and their physician. As scientific progress leads us down the path toward more innovative, effective and personalized treatments, it is increasingly important that patients gain the most value from these advancements.

Intellectual property
Intellectual property (IP), including patents and regulatory data protection, is the lifeblood of the biotechnology industry. Lengthy and high-risk product development periods require strong IP protections to attract the investment the industry needs to fund research and development of lifesaving therapies. 

A stable and secure patent system is necessary for continued biomedical innovation and ongoing investment in research to fund new treatments and cures for patients facing the most challenging diseases. In 2015, Biogen worked with universities, venture capitalists, patient groups and select technology manufacturing companies to support a predictable legal framework that ensures strong IP protections.

Corporate Tax Reform in the U.S.  To help the United States attract and retain innovative companies, as well as the jobs and societal benefits that go with them, we must build a competitive corporate tax system that provides incentives for companies to invest in research, development and advanced manufacturing in the United States.

21st Century Cures Initiative
In 2015, Biogen actively engaged in the success of the 21st Century Cures Initiative to help develop a regulatory framework in the United States that accelerates the pace of treatments and cures for patients without compromising patient safety or product efficacy.

Newborn Screening
Biogen continues to work with stakeholders, including patient groups, public health agencies, and policymakers to advance newborn screening for SMA. The primary focus in 2015 was on establishing pilots to generate data necessary for the addition of SMA on the federal recommended uniform screening panel.

The importance of early SMA detection through newborn screening

Women on Boards
Biogen leadership testified in front of the Joint Committee on Labor and Workforce Development at the Massachusetts State Senate, supporting non-binding Resolution S-1007, a mandate for more companies to add women on their boards, which is now approved.

Biogen leadership submitted testimony before the Commonwealth of Massachusetts Senate in support of the “Freedom MA” bill in support of extending

anti-discrimination protections in public services and accommodations to transgender people, which was successfully passed in May 2016.

In addition to our areas of emphasis in 2015, Biogen has an ongoing focus on:

Clinical trials data transparency
Biogen is committed to advancing public health through responsible sharing of clinical trial data in a manner that is consistent with the following imperatives:

  • Safeguarding the privacy of patients,
  • Preserving scientific rigor and trust in regulatory systems, and
  • Maintaining incentives for investments in biomedical research.

Biogen publishes its clinical research, collaborates with academic researchers and shares clinical trial information on public websites, such as, at the time of patient recruitment, after marketing authorization and when investigational research programs have been discontinued. Biogen adheres to the Principles for Responsible Clinical Trial Data Sharing, jointly adopted by our trade associations, Pharmaceutical Research and Manufacturers of America (PhRMA) and European Federation of Pharmaceutical Industries and Associations (EFPIA). In line with the principles, Biogen is committed to:

  • Enhancing data sharing with researchers,
  • Enhancing public access to clinical study information,
  • Sharing results with patients who participate in clinical trials,
  • Certifying procedures for sharing clinical trial information, and
  • Reaffirming commitments to publish clinical trial results.

Learn more about our clinical data transparency.

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 of new drugs by the FDA. PDUFA, which has been renewed every five years since it was first enacted, is up for reauthorization in 2017.

PDUFA has played an important role in expediting the approval of safe and effective medicines. As PDUFA comes up for reauthorization, we support regulatory reforms, including those that target clinical trials and regulatory science, to reduce development and approval timelines and accelerate the availability of treatments for patients with unmet medical needs.  

Biosimilars, which are follow-on similar versions of innovative biological products, have an important role to play in providing high-quality therapies to patients at a lower cost. While innovation continues to be a key driver of health care, access to high-quality therapies at lower costs is also important. As an industry, we have a responsibility to address both innovation and access. To that end, we support the creation of a well-functioning market for biosimilars while protecting patient safety, ensuring product efficacy and promoting the continued innovation of the biotech industry.  

Biogen recognizes that traditional pharmacy compounding can play a useful role in personalizing a treatment for an individual patient or patient subpopulations. As such, pharmacy compounding operations should be small-scale in nature and limited to those cases in which the pharmacy receives valid prescriptions for the individual patient(s) in question. Large-scale compounders of prescription drugs should be required to comply with good manufacturing practices outlined by regulators in order to ensure that products meet all necessary quality and safety standards. When an approved compliant version of a drug is available, patient safety should not be placed in jeopardy by allowing compounding pharmacies to produce an unauthorized version of the drug that may present safety, efficacy and manufacturing risks.