Global Leadership in Medical Innovation
Global Leadership in Medical Innovation Frequently Asked Questions
- What does CAMI mean by a national medical innovation agenda?
- Why do we need one?
- What is the benefit of private-public partnerships?
- When people have lost jobs with biopharmaceutical companies, how can the report claim there is a lack of talent?
- Why do we want the FDA to have more resources? Doesn't that just mean more oversight?
- Do I need to worry about my job being sent overseas?
- If most states have programs in place to support biopharmaceutical companies, why do we need federal programs?
What does CAMI mean by a national medical innovation agenda?
We are at a national crossroads on several fronts. America is looking forward to economic recovery after a lengthy downfall that threatened to reach catastrophic proportions. We also are at the beginning stages of implementing the new health care reform law, which that has the potential to significantly improve our health system and extend access to care for millions of Americans, just as our population reaches record levels of obesity and chronic disease.
The biopharmaceutical sector is uniquely positioned to ensure that America's economic recovery and health care system improvements are meaningful. The billions of dollars that our companies spend on innovative research and development play a large role in our economy, and the groundbreaking new medicines that are developed as a result of this investment hold the potential to change the way we fight diseases in the future.
However, our country needs to renew its commitment to medical innovation. Our companies' work is ongoing, but it is in the face of many evolving challenges. CAMI's recommendation for a national medical innovation agenda is their call to arms for programs and policies that will support, rather than stymie, our sector's potential impact on the economy and on America's patients.
Why do we need one?
Biopharmaceutical companies have long been committed to R&D in America, investing roughly 70% of their annual R&D spend domestically. The effect has been remarkable, from growing life expectancy to groundbreaking treatments for diseases that previously were seen as death sentences, like AIDS, or rare diseases that previously had no dedicated treatment, like lupus. Last year alone, 34 new medicines were approved by the FDA.
However, recent years have brought in heightened regulatory challenges, changes in the global marketplace, and record competition from abroad. Now is the time to address these issues in a meaningful way to encourage growth in our sector and throughout the health care field in general.
What is the benefit of private-public partnerships?
Biopharmaceutical research requires many layers of expertise, and no one entity can fulfill every function. Fortunately, research in America takes advantage of these layers of expertise by operating within a collaborative system. The sharing of knowledge is what allows us to best move from discovery to development to, hopefully, eventual delivery of innovative new medicines to patients who need them.
For example, working with a coalition of scientists from FDA, industry and academia, a group of pharmaceutical research companies recently agreed to share pooled data from failed Alzheimer's disease clinical trials. The shared goals of the project are to help shed light on how the disease progresses, potentially improve the drug development process and ultimately bring new treatments to patients.
When people have lost jobs with biopharmaceutical companies, how can the report claim there is a lack of talent?
We recognize that much of the strength of America's biopharmaceutical sector is based on the experience and skills of the people who work for our companies. Many companies have had to make difficult business decisions, but our underlying concern is that changes in the education system in America could lead to a future generation of workers who don't have the backgrounds in the sciences that our current workers offer. That's why we want to see a renewed emphasis on STEM education - so that today's students can be tomorrow's innovator.
We also recognize that many companies have suffered job losses. The report does show reasons for optimism, though. First, it found that from 2007 to 2008, the biomedical sector saw a 1.5% growth in jobs, compared to 0.7% in the rest of the economy. In addition, this is a sector that has enjoyed historical growth that far surpasses the rest of the economy. With programs and policies that support innovation, we're confident that the sector can lead America's economic recovery.
Why do we want the FDA to have more resources? Doesn't that just mean more oversight?
Sound review and fair oversight by the FDA are important parts of our core mission, which is the discovery, development and delivery of safe and effective new medicines. We view the FDA as a partner who helps us to ensure that the review process is fair and predictable and that the medicines we bring to patients are as safe and effective as possible.
However, insufficient resources have meant that in recent years, we've seen some inconsistencies and delayed reviews of potential new medicines. The CAMI report suggests that providing the agency with the funding and resources it deserves and requires will help achieve the fluid, reliable process that is best for patients.
Do I need to worry about my job being sent overseas?
We don't know what the future holds for each individual company. What we do know is that the biopharmaceutical sector is one that has historically been committed to having a strong U.S. presence, with roughly 70% of annual R&D spending invested domestically. We also know that many states across the country are making significant efforts and investments to support, and grow, the sector's presence.
Now, we hope that CAMI's call to action for an innovation agenda will help lead to federal policies and programs that will further support sector growth.
If most states have programs in place to support biopharmaceutical companies, why do we need federal programs?
State programs have proven to be very effective. For example, North Carolina and Maryland have both invested significant resources to attract the sector, ultimately leading to the creation of successful biopharmaceutical clusters that have provided jobs and led to medical advances.
However, increasing competition is coming from outside the U.S. Because of this, state programs are competing with programs sponsored by foreign national governments. That's why CAMI's report says that it is time for our federal government to help supplement state efforts to ensure that biopharmaceutical innovation remains an American strength.