Breakthroughs
America’s biopharmaceutical companies are transforming patient care.
From harnessing immune systems to fight cancer to delivering gene therapies for rare diseases, our industry is innovating for a healthier America.
Progress for Patient Care
Over the last 25 years, biopharmaceutical innovations have transformed how we fight disease, changing the lives of millions of patients, their families and their communities.
Cancer Care Progress
New cancer medicines contributed to 1.3 million fewer cancer deaths between 2000 and 2016.
Cardiovascular Outcomes Improved
A new generation of cardiovascular therapies have drastically cut hospitalization and mortality for patients over the last decade.
Mental Health Breakthroughs
New mental health treatments, including the first novel schizophrenia medication in decades, are offering hope to patients.
Chronic Disease Prevention
GLP-1 therapies are transforming care for chronic conditions like diabetes and obesity, while also helping to prevent serious diseases affecting the heart, liver and kidney, as well as sleep apnea and even some cancers.
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.
Smart Policy Built the U.S. Innovation Engine
While many promising medicinal ideas once sat undeveloped, biopharma investment now transforms publicly funded research into lifesaving, real-world innovations.
Turning Discovery Into Medicine
The Bayh-Dole Act 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 that invest further to turn those discoveries into life-saving medicines.
Today
Because of additional investment from biopharma, 200+ new medicines have been developed through public-private partnerships.
Hope for Rare Diseases
The Orphan Drug Act is 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.
Predictable Regulatory Review for Groundbreaking New Treatments
The Prescription Drug User Fee Act is 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 and six months for priority applications
Treatment Options for Children
The Pediatric Research Equity Act and Best Pharmaceuticals for Children Act are a 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.
Smart Policy Helped Scale Innovation and Affordability
Limited generic competition, high costs and uneven access has given way to a balanced system that enables innovation while delivering lower costs.
Innovation and Competition
The Hatch-Waxman Act gave us 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.
Coverage for Seniors
Medicare Part D serves as a predictable market that supports 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.
More Competition for Biologics
The Biologics Price Competition and Innovation Act is 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.
Medicines Are a Vital Tool for Healthier Lives
In the last two and a half decades, medicines have demonstrated their unmatched value to the health system by preventing more costly interventions.
"Thanks to our nation’s incredible biopharmaceutical researchers who work tirelessly to develop treatment options for patients like me, I am able to have a second chance at life. I am blessed to say that now over 25 years later, I am still cancer-free."
Terry
Cancer Survivor
The Promise of Artificial Intelligence in Medicine
Used as a tool, artificial intelligence (AI) in medical research has the potential to identify promising ideas, improve research and development and clinical trials and safely deliver medicines faster.
Breakthroughs are Possible Through Smart Policy
Smart policies that foster innovation are the key to ensuring U.S. biopharmaceutical leadership. Drug price-setting policies and proposals to allow government seizure of patent rights risk undermining the innovation ecosystem that drives breakthroughs.
Sustaining American biopharmaceutical leadership and access to groundbreaking medicines requires a supportive and predictable policy and regulatory environment that encourages collaboration and risk-taking.
Our Work in Action
To maintain America’s global leadership, we need to support the next generation of innovation in medicine.
