Giving People a Reason to Care about Biotechnology
By James C. Mullen
President & CEO
Biogen Idec, Inc
Today, the 15th BIO International Convention kicks off here in Boston, just a few miles from one of the original hubs of biotechnology in Cambridge, Massachusetts. During the next three days, more than 20,000 people from across the globe will attend our annual convention to discuss the future of this innovative and still-emerging industry.
We have come a long way from our first meeting held in Washington, D.C. in 1987 when only 155 people attended. Our industry has come to represent a global success story. We have created more than 4,200 companies across the globe and have developed entirely new industries such as bioagriculture and industrial biotechnology. We have developed biotherapeutics and technologies that are extending and improving the quality of life of patients suffering from debilitating diseases, reducing the global environmental footprint and helping feed the world.
During my tenure as chairman of the Board of Directors of the Biotechnology Industry Organization (BIO), I have regularly discussed the policy priorities of the organization. In the past two years, BIO has had many accomplishments and prepared for the challenges ahead, but the overriding priority remains the same as when I began in this role - we must give people a reason to care about the success of biotechnology.
Heal the World
The U.S. biotechnology industry has developed more than 250 new therapies for patients in its 30-year history, extending or improving the lives of millions of patients. And the industry has supported programs that have helped more patients gain access to the latest, most innovative therapies.
BIO fully supports the Medicare prescription drug benefit that has provided affordable medications, including biotechnology therapies, to more than 38 million Americans. The overwhelmingly majority of Medicare recipients are saving more than $1,200 per year under this program. And premiums are lower than expected - as is the cost to the federal government - due to the program's negotiations between drug benefit plan providers and drug manufacturers.
BIO and its members must continually remind policymakers that our novel therapies and medical advances are built on profits and - perhaps more accurately - the promise of profits. We must not let short-sighted Medicare reform schemes close the open-market system that encourages innovation and delivers important medicines to patients. But increasing patient access to new medicines requires more than this. While many of our patients have benefited from recent medical breakthroughs, many others are waiting for new and better drugs to emerge from our labs.
The recommended improvements to the Prescription Drug User Fee Act (PDUFA) announced this year come as a result of extensive input from the industry, as well as patient organizations, consumer groups, and other stakeholders. The recommendations will allow continued enhancement of the Food and Drug Administration's (FDA) post-market safety capacity and help ensure careful, timely, and transparent review of new drugs and biologics. Since its inception in 1992, PDUFA has enabled the FDA to approve more than 1,100 new medicines and reduce review times for innovative drugs and biologics, providing patients and doctors with earlier access to breakthrough treatments.
We must also ensure that any effort to develop a pathway for follow-on biologics adheres to two core principles: protect patient safety and promote biomedical innovation. Earlier this year, BIO adopted a core set of principles to guide this important debate. We must all work diligently to ensure that these principles are incorporated into any effort to establish a pathway to follow-on biologics.
Feed the World
Biotechnology continues to help feed the world. And as the world's population increases, the demand for food will only grow. Biotechnology offers solutions to these challenges, but we must work to increase adoption of agricultural and industrial biotechnology throughout the world.
In 2006, a record 22 countries planted biotech crops, including six countries in the European Union (EU). Worldwide, as the farming industry has adopted the new technologies and science offered by biotechnology, there has been continued recognition of the safety and benefits of biotech plants.
Over the past decade that biotech crops have been commercialized, there has never been a single reported human health incident or harm to the environment. In fact, under strict government regulations and strong industry oversight, biotechnology has improved food crops with significant benefits to farmers, consumers, and the environment.
Fuel the World
Biotechnology also has a role to play in fueling the world. In February, Energy Secretary Samuel Bodman announced six Department of Energy grants that will support the construction of biorefineries. These projects will help bring more ethanol motor fuel to the pump within the next few years, potentially reducing reliance on imported oil and emissions of greenhouse gases.
These new, modern biorefineries may significantly speed the commercialization of ethanol from cellulose and many other biotechnology-based products, including new plastics, chemicals, and pharmaceuticals. By any definition, we have only begun to tap biotechnology's potential for creating cleaner, more efficient technologies to fuel our engines - and economic growth.
The Future
We must continue to educate policymakers and the general public about the benefits of biotechnology, the process of innovation, and the impact their decisions have on our ability to create the products that can improve and save lives, feed people, reduce pollution, and lessen our dependence on oil.
Biotechnology's ability to benefit the world is our industry's shared vision. It reflects the hard work being done by our employees every day when they arrive at our companies or research labs. Their efforts are noble and filled with hope. But it is up to all of us to honor the work they do by giving people a reason to care about the success of biotechnology.
