As published in the Roanoke Times on 12/15/2014 by Jeff Gallagher, CEO Virginia Bio
Rep. Morgan Griffith, R-Salem, recently invited a round table of leaders of the biomedical community in Southwest Virginia to gather ideas to support the work of the Energy and Commerce Committee, which he serves on, and the bipartisan 21st Century Cures Initiative.
Along with his colleague Rep. Phil Roe, M.D., (R-Tennessee) Griffith led, questioned and discussed ideas with academics, researchers, health care experts and biomedical company executives on how to revamp the federal laws and regulations that impact the discovery, development and delivery of cures and treatments to patients. This roundtable, hosted by Dr. Dixie Tooke-Rawlins, provost of the Edward Via College of Osteopathic Medicine, was one of many similar discussions conducted across the nation by members of the committee. Representatives from local companies Revivicor, BioTherapeutics, Teva and Health Diagnostic Laboratory participated, along with experts form Virginia Tech, Carilion and UVa.
The 21st Century Cures initiative deserves our applause. It’s a bipartisan effort to take a coherent look at the whole system, from drug discovery, to development to delivery, and the impact of the Food and Drug Administration, National Institutes of Health and other federal agencies. As a nation, we created and for the last 75 years have enjoyed the world’s greatest system for turning biomedical innovation into practice. To remain globally competitive and retain that leading position, we can and must improve to bring health and relief to more people more quickly and efficiently.
Industry experts here and around the nation have provided specific suggestions: greater involvement of patients, modernizing clinical trials and drug development, phaseless drug development, use of real world and post-approval data to support regulatory decision making, focusing special resources on key unmet medical needs, and preparing the FDA for the future.
I suggest in this long and intricate process keeping four points in mind.
The system is complex, robust but delicate. The system includes not only FDA and NIH, but also taxes, intellectual property rights, reimbursement systems and tort liability. Faster regulatory agencies in Europe have U.S. medical device firms taking their innovations to Europe first, and at rates accelerated by the new Medical Device Tax on revenues. Without strong intellectual property protection and affordable enforcement, no new drugs will be developed privately. Nor will innovative products be developed if the payor bureaucracy, private and public, has no codes to reimburse it.
Private investment and small business is essential. The private sector has a significant role in taking innovation through development to market. Smaller, more nimble companies are a key link in the chain, being closer to needs and closer to university sources of technology. Policymakers should support and extend the Small Business Innovation and Research program, which allocates a small percentage of federal research dollars to small companies, giving birth to great innovation, companies and jobs across the commonwealth. Before creating any new regulatory or paperwork burden, consider the impact on entrepreneurs and small companies.
One size need not fit all. Three decades ago, the Orphan Drug Act carved out rare diseases for special regulation, special path through FDA, and special market exclusivity. This policy has been a roaring success in development and marketing of drugs for unserved populations. Innovative approaches are required to address major needs such as antibiotic resistance, vaccines, and long-onset diseases such as Alzheimer’s. The breakthrough therapy designation is a recent example. Permitting and promoting collaboration among businesses and institutions would address challenges too big for any one entity.
Reinvigorate the system with fresh shared values. The system is set up to reward treatment for specific acute diseases, not for prevention or overall health, as evidenced by no federal payor reimbursement codes for prevention or early detection within the thousands for illness treatment. It’s set up to avoid risk at all cost, even if that means withholding promising experimental therapies from informed patients in need. FDA has discretion under current law to undertake many changes on its own; let’s get alignment to value innovation, prevention, wellness, flexibility and patient choice.
It is an important and timely endeavor that Griffith and his colleagues on both sides of the aisle are taking on. I am honored to serve as CEO of VirginiaBio, the statewide association of businesses, researchers and research institutions that invent, develop and commercialize biomedical innovation in Virginia. We pledge our support and wish them the best of success, for how they fare will impact the health, wellness and economic well-being of generations of Virginians to come.
12st century cure