This year the Biotechnology Innovation Organization (BIO) celebrates our 25th anniversary. It’s impossible to review BIO’s interactive historical timeline without reflecting with pride on the role we’ve played in shaping policy to save lives and promote the health of our planet.
So much of our work comes down to educating folks – policy makers, the public and each other – about the work we’re doing and its value to humanity. For 25 years, BIO has convened the biotechnology community in impressive fashion. And we’ve communicated the needs and aspirations of our scientists to Capitol Hill, state capitols and policymakers worldwide to make sure government leaders embrace thoughtful policy that helps science march forward.
I know this, because I was one of those lawmakers inspired by my BIO education. Through this organization, I came to see the miracles our industry makes possible.
I was an eighth-year U.S. Congressman representing suburban Philadelphia in March 2001, doing woodwork painting at home and watching 60 Minutes on my television. Correspondent Steve Kroft was interviewing an American fertility doctor named Dr. Panayiotis Zavos, who claimed he could clone a human being – and planned to do so within the next 24 months.
I recoiled at the thought. As a former child welfare caseworker, I felt that no child should be brought into the world as a “copy” of someone else and that every human deserved to be the unique offspring of two parents. I chaired the U.S. House Committee on Energy and Commerce Subcommittee on Oversight and Investigation and was confident that my colleagues on both sides of the aisle would share my deep ethical and existential objections to human cloning. So I convened a hearing with the goal of outlawing the practice.
As I prepared for that hearing, I was visited at my office by then-BIO CEO Carl Feldbaum. He told me that BIO shared my concerns about reproductive cloning. But he also explained to me the enormous promise of therapeutic cloning. This is a process that entails the removal of a nucleus of a somatic cell – and its transfer by injection into a denucleated, unfertilized human ovum. This process enables researchers to understand how pluripotent stem cells become blood, eye, heart, skin, and brain cells, as well as every other specialized cell in the human body. This work is the basis for regenerative medicine that holds the potential to cure everything from Parkinson’s to Alzheimer’s disease.
Not only did BIO’s advocacy convince me, it made me a champion for the science. When the issue of therapeutic cloning came before the House for a vote, I gave one of the most passionate floor speeches of my political career in defense of “the most promising opportunity to cure the diseases that have plagued humanity for centuries.”
Three years later, I received a call from a headhunter asking if I was interested in interviewing for the job of BIO President and CEO. My first reaction was “thanks but no thanks.” My approval ratings were high, and who gives up a perfectly good seat in Congress anyway? But as I reflected on the opportunity, I thought about the fact that I had served as a legislator at the state and federal levels for nearly a quarter-century. Rather than be a politician for life, perhaps I could use my knowledge of Washington to help this remarkable, young industry realize its vast potential.
I decided to go for it. In my BIO job interview, I was asked if I had a passion for biotechnology. This is what I said:
“Four and a half billion years ago, when the first cell divided, life began on our planet. Since then, Darwinian evolution has led to the birth of human beings – the crown of creation – with these huge brains and opposable thumbs and amazing perceptions and abilities that allow us to literally reach into our bodies, extract our DNA, look at it under a microscope, and create something that will one day prevent a parent from burying a child. Or one day, prevent a man from looking at his wife in their twilight years and say, ‘Who are you?’
Darwinism teaches us about the survival of the fittest, but the truth is, we don’t want just the fittest to survive. So if you’ll give me this opportunity, I’d like to help you outrun Darwin.”
I got the job.
BIO is an industry organization, but I’ve always tried to put my values and the needs of patients first in our work here. Shortly after taking the helm at BIO, Congress debated the issue of biosimilars. These are medicines with no clinically meaningful differences from existing FDA-approved products – essentially a generics industry for biologic medicine. When the biosimilars debate began, it became clear to me that the heads of many Washington pharma offices didn’t want a biosimilars industry. The companies they represented had monopolies on existing biologics and raised questions as to whether biologics could be safely replicated.
I told the BIO Board that opposition to biosimilars would be a mistake. I shared my belief that the pharmaceutical industry’s initial opposition to the creation of a generics industry had cost the drug industry credibility on Capitol Hill, and I argued that we should not repeat the error.
I convinced the BIO Board that we should become the primary advocates for the creation of a safe, well-regulated biosimilars industry. In so doing, we would educate lawmakers about the science and the law. Rather than eventually having biosimilars legislation forced on us, I argued, we could instead lead the way by embracing competition – and this would put us in a strong position to advocate for the necessity of a 12-year period of data exclusivity on innovative biologics.
Biosimilars would give patients access to more affordable treatments when biologic patents expire. Adequate data exclusivity would offer biotech investors confidence that the intellectual property underlying their investment would be protected.
In the end, the Affordable Care Act created a biosimilars pathway and granted 12 years of data exclusivity for innovative biologic drugs. We even won over Democrats on the House Energy and Commerce Committee over the objections of Chairman Henry Waxman. The committee approved BIO’s position by a 47-11 vote.
As our timeline shows, we’ve won many important battles over the last 25 years. As we look forward to the next 25, there will be plenty of thorny ethical issues to debate and critical policy choices to make. The human genome has been mapped and hundreds of new treatments are in the pipeline as a result. The first gene therapies are starting to be approved by the FDA. The CRISPR gene-editing breakthrough holds transformative potential to treat and cure disease. Advanced biofuels, industrial biotech processes and genetically enhanced crops are helping reduce pollution and feed our rapidly growing global population.
Genetics today stands where chemistry did just a few decades ago: People sometimes fear that which they don’t understand. As Americans have learned more about the unintended consequences of putting chemicals in the air, we have discovered ways to utilize science without polluting our environment. When people hear about genetically modified plants, some still worry about unintended consequences. But as President Obama said of GMOs, “We must follow the science.”
Today, I spend a great deal of my time on Capitol Hill helping lawmakers understand the policy choices before them and helping them understand how manipulating genetics – ethically and responsibly – offers us our greatest hope to live longer and sustain our planet. But like all other areas of science, genetics must be appropriately regulated.
And every day BIO’s public affairs team and I work to persuade policy makers and the public that short-sighted attempts at government-imposed price controls would undermine our work to innovate life-changing and life-saving medicines for which patients and their loved ones pray.
It has been an honor to lead this organization for 13 years and counting. I’ve interviewed former U.S. Presidents on the BIO Convention stage and overseen the growth of this organization to a staff of 173 committed advocates who serve a global membership of more than 1,000 companies strong. I’ve racked up uncountable frequent flier miles visiting every corner of this country – and the world – to promote an industry that truly fuels, feeds and heals the world. But my most memorable moments have been the everyday interactions I’ve had with brilliant researchers and whip-smart entrepreneurs, knowing their hard work adds up to beating disease and bringing hope.
Congratulations to everyone who has been part of this indispensable industry for the last quarter-century. There’s no telling what the next 25 years of biotech innovation hold in store for us.