America Cures
A Defining Moment in America's Biopharmaceutical Leadership
America’s leadership in medicine research and development powers global innovation and domestic economic growth. As we celebrate 250 years of American ingenuity, let's continue to embrace innovation and discovery for a healthier and more prosperous future – and we must prioritize and protect our uniquely American ecosystem.
America Cures: We get new medicines 3 years faster than other countries
America's leadership in medicine research, development and manufacturing depends on policies that create the strongest innovation ecosystem and ensure people can access and afford the medicines they need.
America's blueprint to win in medicines
- Strengthen the ecosystem that enables innovation
- Protect strong intellectual property rights
- Maintain a predictable regulatory environment
- Build a collaborative research infrastructure that can compete globally
- Preserve a competitive market free from government price controls
- Fix the system to make medicines more accessible and affordable
- Address harmful system incentives that increase costs
- Ensure patients get the medicines their doctors prescribe
Price controls and other anti-innovation policies undermine America's ability to compete globally and risk access to cures.
When America Leads in Medicines, Every American Benefits
Innovative treatments are transforming patient care and reducing long-term health care costs. Because of this ecosystem, American patients access breakthrough medicines years ahead of the rest of the world.
The biopharmaceutical industry is expanding its U.S. footprint and investing in America’s future, fueling jobs, investment and economic growth in every state.
Explore our industry's investment in America
Medicines available here first
Fueling economic growth
Ensuring a more secure America
Leadership is a Choice; Smart Policies Make It Possible
Smart policy has created America’s innovation ecosystem and powered decades of breakthroughs in medicine.
While Europe adopted price controls and strict regulations, the United States rewarded risk-taking and innovation through smart federal policies, public-private partnerships and strong intellectual property protections.
The result: Europe gave up its leadership in medical innovation while the U.S. built a robust ecosystem of medical discovery.
America’s Biopharma Leadership is at Risk
For the first time in decades, America’s leadership is on the line, and we risk losing our competitive edge.
China is delivering on its plan to dominate the future of medicine development and now has the world’s fastest growing pipeline. At the same time, U.S. policymakers are advancing policies that would undermine America’s world-leading ecosystem.
China's Coordinated Strategy
U.S. Policy Uncertainty
Smart Policy Timeline
Smart Policy Has Powered America's Innovation Ecosystem
For over 40 years, the U.S. has led global biopharmaceutical innovation. This success is driven by a robust ecosystem of smart federal policies, public-private partnerships and strong intellectual property protections. These incentives ensure that R&D investments continue to turn scientific discoveries into life-changing treatments for patients in the United States and around the world.
1980: Turning Discovery into Medicine
Bayh-Dole Act
The framework that enables the private sector to turn federally funded research discoveries into life-saving medicines for patients.
- Then: Many promising ideas for new medicines were left undeveloped.
- Policy Impact: Universities can license early-stage discoveries to biopharmaceutical companies who invest further to turn those discoveries into lifesaving medicines.
- Today: Because of additional investment from biopharma, 200+ new medicines have been developed through public-private partnerships.
1983: Hope for Rare Diseases
Orphan Drug Act
Proof that smart incentives can unlock innovation where markets alone cannot.
- Then: Only 38 drugs were available for rare diseases.
- Policy Impact: Incentives encourage R&D for treatments for small patient populations.
- Today: 750+ treatments have been approved for 1,300+ rare disease uses.
1984: Innovation and Competition
Hatch-Waxman Act
A system that balances innovation and affordability, giving U.S. patients more choice than anywhere else in the world.
- Then: Generics comprised just 19% of prescriptions dispensed at the pharmacy counter.
- Policy Impact: Clear pathway for generics while incentivizing innovation.
- Today: 90% of prescriptions are filled with generics with an average copay under $7.
1992: Predictable Regulatory Review for Groundbreaking New Treatments
Prescription Drug User Fee Act (PDUFA)
A pathway that shows efficiency, certainty and rigor are essential for investment and innovation.
- Then: FDA regulatory reviews for new drugs took more than two years on average.
- Policy Impact: Faster, science-driven regulatory review of new medicine while maintaining high standards for scientific rigor and patient safety.
- Today: 10 months review time for standard applications | 6 months for priority applications.
1997: Treatment Options for Children
Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA) were permanently reauthorized in 2012.
Recognition of the unique considerations and challenges of developing medicines for children.
- Then: Few labeled indications and clinical trials for pediatric populations.
- Policy Impact: Established authorities and incentives to encourage manufacturers to conduct pediatric studies of medicines.
- Today: 700 studies so far with more than 300 drugs approved for pediatric populations.
2006: Coverage for Seniors
Medicare Part D
A predictable market that supported innovation for aging populations.
- Then: Nearly 1 in 3 seniors lacked drug coverage.
- Policy Impact: Prescription coverage for Americans on Medicare – at costs far below original projections.
- Today: All seniors have drug coverage options which may be put at risk by government price setting.
2010: More Competition for Biologics
Biologics Price Competition and Innovation Act
An approach to lowering costs while fostering the innovation pipeline.
- Then: No pathway for biosimilars.
- Policy Impact: Additional competition while encouraging innovation.
- Today: 60 biosimilars competing with 16 biologic brands and $20.2 billion in annual health system savings.