Jim Greenwood Gives the Keynote Address to Annual Meeting of the Massachusetts Biotechnology Council

Thanks to Speaker Tom Finneran and to Massachusetts Biotechnology Council for the opportunity to be with you today.

Mr. Speaker, I seek unanimous consent to address the house.

I'm from Bucks County, Pennsylvania - just outside of Philadelphia. I understand that for Bostonians Philadelphia is considered the Midwest.

The American Revolution that was ignited here in Boston was propelled forward in Philadelphia with the writing and signing of the Declaration of Independence.

For 16 years on Christmas Day I donned my Captain Morris uniform and joined George Washington and other re-enactors in crossing the Delaware River to capture Trenton.

But I've spent much of the past 13 or 14 years in Washington, DC - the epicenter of power and politics.

Last night I traveled 450 miles north and now here I stand in Boston - the epicenter of academia and science.

This is the place that ignited America's most recent revolution - the biotechnology revolution - which I believe will enhance human life on earth every bit as much as democracy itself.

I believe biotechnology is the path through which human beings will fundamentally transform ourselves.

Today we are a species destined, like every other species, to inhabit this planet precariously.

We are subject to the brutality of random genetic mutations within ourselves and to the ravages of the viruses and bacteria that reside in and around us.

Through biotechnology we are bending those evolutionary mechanisms to reach inside ourselves and rewrite our destiny. To profoundly advance our individual and collective survivability and to improve the quality of our lives as individuals and as a global civilization.

This revolution not only began in Massachusetts, but it continues here every day in its universities and its commercial enterprises.

Harvard University just announced that it will begin to use somatic cell nuclear transfer to clone embryonic stem cells with specific genetic traits so its researchers can find cures for diseases like Lou Gehrig's -- a tragically debilitating malady that afflicts 30,000 Americans.

And Massachusetts companies continue to lead the revolution.

Drug-resistant infections kill more Americans every year than AIDS and breast cancer combined. It is a huge problem. Massachusetts-based Cubist Pharmaceuticals is producing one of the few new antibiotics in the world.

Rotavirus kills 440,000 children a year - a child a minute. Massachusetts-based Avant Immunotherapeutics has produced a vaccine.

18 million Americans suffer from alcohol dependence and abuse, and their families and communities suffer because of them. Massachusetts-based Alkermes produced Vivitrol, an extended-release injectible approved just this April that enables these individuals to make their decisions about sobriety once a month, instead of one day at a time.

HIV - the most vicious pandemic in modern history - has claimed 25 million lives and is expected to infect 90 million men, women and children in sub-Saharan Africa alone. Massachusetts-based Vertex has produced protease inhibitor Lexiva and continues its battles against cystic fibrosis, chronic pain, hepatitis C and cancer.

400,000 Americans suffer the terribly debilitating, agonizing and depressing ravages of multiple sclerosis. Massachusetts-based Biogen-IDEC invented Tysabri, a monoclonal antibody that reduces relapse by two-thirds.

Pompe disease is fatal in newborns and in later onset causes muscle deterioration that results in the inability of its victims to breathe. Massachusetts-based Genzyme, a world leader in treatments for orphan diseases, recently won approval for Myozyme, another of its life-saving and life-enhancing therapies.

Pancreatic cancer strikes 30,000 people in America every year and another 60,000 in Europe. Most of these patients die in less than a year. Therion Biologics is awaiting review of what could be a breakthrough in treating one of the most deadly diseases known to mankind.

Alnylam's work on RNA interference ... Novartis' prodigious and broad production of therapeutics ... Elixir's work on aging ... GTC's development of therapeutic proteins in transgenic animals - all are leading edges in the biotechnology health care revolution.

And, of course, the biotechnology revolution is not limited to health care.

It is the gene revolution that holds the only real hope to end hunger. And here in Massachusetts companies like Aqua Bounty, with its genetically enhanced salmon, are leading the way to enhance our productivity.

It is through biotechnology that humanity will learn to thrive on earth with sustainable solutions that meet our present needs without compromising the ability of future generations to meet their own needs.

Massachusetts-based Metabolix is pioneering the production of plant-made plastics that are not just recyclable, but biodegradable.

It will be biotechnology - engineering enzymes that can break cellulose into distillable sugars - that will provide the world with a motor vehicle fuel that can be sustainably produced and consumed.

And that will reduce our burning of petrochemicals that contribute to the volume of greenhouse gases in the atmosphere.

And, of course, not only in Massachusetts, but across the country and around the world, biotechnology is transforming the balance of power between disease and hope.

Just last week, the FDA approved Merck's Gardasil, a vaccine against cervical cancer that strikes a half million women every year in the U.S. alone. This revolutionary product may end cervical cancer in a generation.

Massachusetts biotech companies will continue to lead the world in biotech discovery, research and development.

But I want to return to the 450-mile distance between Boston and Washington.

Most of you recall the days when every application for a new drug or biological was loaded into a truck and driven to the FDA. It's about an eight-hour trip. If you're lucky.

Thankfully, a growing percentage of applications are transmitted electronically today.

But whether it arrives at FDA in an instant or after a long day's drive, an application then begins, on average, a year of waiting for the review to be completed. Plus whatever additional time is added to the approval time by requests for additional data.

Review times have certainly been shortened by PDUFA and the extra staff it has enabled the FDA to hire.

Harvard's Daniel Carpenter and others studied review times and concluded in their 2003 paper that for each additional CDER employee FDA brought on, review times were reduced by 3.3 months.

But while PDUFA fees have nearly doubled - from about $125 million in 1998 to $250 million last year - review times have been flat at about the one year average for all of those seven years.

How can this be?

Part of the problem is that while PDUFA fees have gone up, the dollars appropriated by Congress available for drug review have gone down.

Very simply, FDA is drowning under the weight of its added responsibilities and budget woes and it sees PDUFA as its life-line.

In 1993 PDUFA fees covered 7% of the costs of drug reviews. Today, PDUFA fees account for 53% of the cost. The user fees were intended to supplement - not replace - federal funds.

The Congress has doubled the NIH budget, but flatlined the FDA.

On top of that, earmarking of FDA funds for counterterrorism, bio-defense, pandemic preparedness, food safety, the president's emergency plan for AIDS relief, SARS and West Nile virus have further eroded the appropriations available for drug reviews.

We support all of these programs. But FDA has been forced to fund them with resources originally intended for core activities, including human drug review.

Additionally, the actual cost of hiring and retaining FDA staff has consistently outpaced the funding that the agency receives.

Consequently, FDA has not been able to hire the staff needed to address this additional workload.

Not only has this prevented us from gaining more ground on review times, but our growing share of the overall costs have only fanned the flames of our critics who claim that CDER is the servant of our industry - whether it's serving us well or not.

In fact, separate studies published last year by Nature and the Brookings Institute demonstrated that there is no correlation at all between PDUFA fees and safety.

The probability that a drug would be withdrawn from the market by the FDA has been unchanged by the advent of the drug user fees.

Nonetheless, the work that we do to reduce suffering around the world is too important for our industry to be unnecessarily exposed to the criticism that we are "buying approvals" regardless of how absurd the charge.

If the balance of fees to appropriations continues to trend upward to 60/40, 70/30 and 80/20, the perception becomes unseemly.

When the BIO board of directors hired me, I was directed to create a world class advocacy organization. I am pleased to report to you today that in the past 17 months I have done exactly that. Our team is the best in Washington.

We are working around the clock to make sure that when biotech companies here in Massachusetts or anywhere else around the country combine the talents of the best scientists, the best investors and the best business managers to develop new, life-enhancing products, that the public policy environment in Congress, in the administration, the states, the localities and around the world is conducive to your success.

Last year, for example, BIO worked successfully for the passage of critical liability protections for manufacturers of vaccines, therapies, and diagnostics for pandemic influenza and bioterrorist threats.

Today, our bright, able and committed staff are working hard and effectively to make sure that the government advances, rather than impedes, biotechnology.

The issues we are working hard on include Sarbanes-Oxley compliance, SBIR eligibility, intellectual property protection, follow-on biologics, PDUFA, Critical Path, agricultural biotechnology, funding for cellulosic ethanol and a variety of state and local initiatives.

But nowhere is our work more important than in making certain that the FDA is an accelerator, and not a bottle-neck, for innovation.

The facts are that the FDA is not transparent enough and is too unpredictable.

We intend to work with Secretary Leavitt and Dr. Von Eschenbach to make the agency work better for all Americans - patients, health care providers and biotech innovators.

Our success will depend upon our ability to clearly articulate how we believe improvements can be made.

But it will also require more money from Congress. We at BIO intend to lead a bipartisan coalition to press and press hard for adequate appropriations for FDA.

I believe that patient groups, health care professionals, pharmaceutical and biotech companies, Republicans and Democrats should join together to demand that Congress provide sufficient funding to FDA so that the FDA can efficiently, and in a timely manner, ensure the safety and efficacy of medicines that save and improve the lives of every man, women and child in our nation.

Biotechnology is leading us to a way of life barely imaginable just a few short years ago. The convergence of genomics, proteomics, informatics and nanotechnology is creating a new paradigm of health care.

One in which we will examine our children's individual genomes at birth and apply technology to predict and prevent diseases that have plagued mankind forever.

In the age of personalized medicine, designer drugs will be custom made for each individual long before symptoms can even appear.

During BIO's international conference in Chicago in April I escorted Illinois Governor Blagojevich through our exhibit hall.

He was quite impressed by all he saw. But after a bit he turned and asked me, "So what is biotechnology?" I started to give him some of the limited microbiology I've picked up in the past year and a half.

I didn't feel like he was getting it, so I said, "Governor, you see all these people? We envision a world free of disease, free of hunger and free of pollution. And we believe that biotechnology will get us there."

He looked at me and said, "Boy, you guys are optimists!"

And he's right. To be in this business you have to be an optimist. The odds against getting a new biotech product from an idea, to the bench, through clinical trials and the FDA and ultimately to the patients are pretty long.

The scientists and the biotech companies in Massachusetts are among the best in the world. And I have great confidence in you.

What I'd like you to know is that 450 miles from here in Washington, DC, BIO has the best and the brightest and most committed staff in the nation's capital.

Our mission is to be the world class advocacy organization that your efforts and innovations deserve. We are committed to doing all we can to propel forward the new revolution that you began here in Boston.

And we are working day and night to help you succeed, because succeed you must. Thank you.