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With the 118th Congress wrapping up in a few months, the Biotechnology Innovation Organization (BIO) continues its work to improve policy that impacts the biotechnology industry and to foster an ecosystem where biotech innovation can heal, fuel, and feed our world.
BIO’s efforts are guided by BIO’s Seven Core Strategic Priorities. Below we describe those strategies and look at how they shape our actions.
1. Advance and Enlarge the “Virtuous Circle” of Biotech-Driven Innovation
Biotech innovation takes a full ecosystem – from idea to investment to product development. BIO’s role is to protect, advance, and enlarge this ecosystem.
“This is an entire virtuous circle of innovation,” according to BIO President & CEO John F. Crowley. “Oftentimes that begins with a patient or a family in need with the four words ‘we have a problem.’ And oftentimes it’s one of our great academic research centers and a researcher, an individual, a team, that answers with four words: ‘we have an idea.’ The role of BIO is going to be to make sure that that entire innovation ecosystem, that virtuous circle, is protected and advanced.”
What BIO’s doing: BIO’s work in this area includes opposing the disincentives for innovation in the Inflation Reduction Act (IRA) price controls. BIO has repeatedly noted the way IRA price controls negatively impact innovation and access to treatments, most recently in an amicus brief for a case challenging the constitutionality of the price controls.
BIO is also supporting bills to correct specific anti-innovation measures in the IRA, including the ORPHAN Cures Act, to encourage further research to see if new cures can address a secondary indication; and the EPIC Act, to give small molecule drugs the same 13 years of exemption from price controls that biologic drugs receive.
2. Identify and Break down Barriers to Access to Medicines
All patients must have access to the latest innovations in medicine, and BIO is working to make this a reality.
“Innovation without universal access is insufficient and is an incomplete mission. Nobody should ever go one day without the medicines that they need,” says Crowley. “BIO can be very uniquely positioned as a convener, bringing attention to this issue, but also bringing solutions and bringing people to the table to ensure universal access.”
What BIO’s doing: Promoting innovative payment arrangements, which can increase patient access while helping states manage their Medicare funds. Legislation to support these innovative arrangements include the proposed Medicaid VBPs for Patients (MVP) Act, which BIO supports.
BIO is also supporting legislation that prevents pharmacy benefit managers (PBMs) from trying to profit by restricting patient access through “step therapy,” limits on the formulary of covered drugs, and practices that put independent pharmacies out of business. BIO is promoting passage of several proposed reforms, designed to improve transparency of PBM operations and increase their accountability.
3. Powerful Story Telling: Who we are & Who we serve, What we do, Why we do it, Where we work
BIO seeks to share the stories of lives transformed by medical miracles and the assurance of food and agricultural security through biotechnology advancements.
“We need to tell the stories of people whose lives have been transformed by the miracles of medicine. We need to tell the story of how food and agricultural security has been ensured by advancements in the broad field of biotechnologies,” says Crowley. “We need to also tell the stories of people in need. People who need hope.”
What BIO’s doing: Crowley often shares his own story of the challenges and successes of both his family and the biotech companies he led in fighting the Pompe disease that affects his daughter and one of his sons.
BIO’s events help biotech firms to tell their stories, in company presentations and through personal meetings.
BIO puts new ideas before the public with a constant stream of stories about innovators and their innovations. Some examples include big ideas from Ginkgo Bioworks, Eli Lilly, Simplot, LanzaTech and LanzaJet, Moderna and Merck—as well as startups like Talus Bio, Immuto Scientific, Concerto Biosciences—and so many more.
BIO also amplifies stories from patients and their families, furthering discussion of conditions such as Parkinson’s, ALS, arthritis, women’s healthcare, ultra-rare disease, and others.
4. Extraordinary Focus on Patients, Caregivers & Families
Every decision we make in the biotechnology industry should be geared toward patients and guided by empathy.
“Think if you had this disease, whatever it may be, or you’re the mom or the dad of a child with this disease, what decision would you make?” Crowley says. “When we look at some of these therapeutic areas, we’re going to change very small parts of the world, but for people living with many of these conditions, and their families, that’s the entire world for them.”
What BIO’s doing: BIO frequently partners with patient organizations for advocacy efforts, sharing information, discussion of patient group concerns, and organizing webinars, like the one on long COVID.
The annual BIO Patient & Health Advocacy Summit is dedicated to highlighting patient issues and enabling networking that empowers patient groups.
Almost all of the legislative and policy advocacy that BIO undertakes regarding medicine and biopharma ultimately benefits patients. Just some examples:
- Seeking PBM reforms that improve patient access.
- Telling lawmakers how to reform the 340B program so it helps patients.
- Opposing prescription drug affordability boards (PDABs), which reduce access to medicines but don’t appear to cut costs.
- Supporting legislation that would end so-called “Quality Adjusted Life Year (QALY)” measurements, which can actually devalue patients’ lives.
- Supporting legislation to fight antimicrobial resistance, which kills millions.
As described above, BIO also seeks to share patient stories.
5. Biotechnology as a National Security Imperative
Biotechnology makes essential contributions to our national security by ensuring public health and a secure food supply.
“Our biotechnology industry is a national security asset,“ says Crowley. “We think about what we need to do to prepare for the next pandemic. How would we respond to a bio terror attack. We need that resiliency. We need the ability to provide for the public health in those very extraordinary circumstances. I can’t think of anything more important to our national security than ensuring a vibrant public health.”
What BIO’s doing: Working hard to support renewal of the Pandemic All Hazards Preparedness Act (PAHPA), which is essential to ensure our preparation for public health threats like a pandemic or bio terrorism. BIO also supports initiatives like President Biden’s Biodefense Strategy.
BIO also provides support and involvement in the National Security Commission on Emerging Biotechnology (NSCEB), a body of experts and lawmakers established by Congress to guide biotech and national security and provide the federal government with recommendations. And bio hosts discussions and panels on biosecurity, like the one that launched the 2024 BIO International Convention.
Another essential piece of national security is food security. BIO’s Agriculture and Environment Center of Excellence parallels the work of the National Security Commission as it seeks to align agricultural policy and processes across the U.S. Department of Agriculture (USDA), Food and Drug Administration, and Environmental Protection Agency to increase reliability of our food supply.
BIO supports national security focused legislation proposed for the next Farm Bill, including the Agriculture and National Security Act, Agricultural Biotechnology Coordination Act, Biotechnology Oversight Coordination Act, and Synthetic Biology Advancement Act.
6. Expand & Engage Our Membership & Stakeholders
BIO’s stakeholders include anyone who understands how they benefit from the success of biotechnology.
“I think we need to think more broadly about membership in BIO,” said Crowley, to open up to “people who see they have a vested interest in the success of the biotechnology industry.”
He added that it’s important to explain new biotechnology innovations, like medicines, vaccines, agricultural technology or climate tech, so people can understand “why it’s important for them, and their children and grandchildren.”
What BIO’s doing: BIO attracts members with a robust offering that includes opportunities to network and receive focused training all year round. During BIO’s conferences and events, BIO and its members can deepen engagement. The networking achieved at gatherings like the BIO International Convention, the Investor Forum, and others often lead to the kinds of partnerships that make biotech possible.
7. Food Security & Climate Impact: Biotech’s Unique Role
We must work to ensure that biotechnology innovation can protect our environment and food security.
“We’re coming into this new age of biotechnology,” says Crowley. “I’m a firm believer that our economy ahead is going to a bioeconomy broadly and I think that’s our responsibility to advance that world but also to make sure that we’re doing it in a way that’s most fitting to the overall mission of biotechnology to heal, feed and fuel the world.”
What BIO’s doing: BIO has been supporting a robust Farm Bill with policy that supports bio-based fuels, ensures federal procurement of biobased products, and enables biostimulants that support crop health, among other priorities.
BIO also supports legislation and policy that encourages production of sustainable aviation fuel (SAF). To that end, BIO joined the recently formed SAF Coalition.
Along with these actions, BIO supports biotechnology developments through efforts to protect intellectual property, support startups, encourage investment and generally ensure that we can all benefit from biotech innovation.
