The U.S. Food and Drug Administration (FDA) has multiple mandates. One of the agency’s primary responsibilities, according to their website, is to advance “the public health by helping to speed innovations that make medicines more effective, safer, and more affordable.” How does the FDA attempt to accelerate innovation?
Recently, I heard Dr. Vicki Seyfert-Margolis, Ph.D., Senior Advisor for Science Innovation and Policy for the FDA Commissioner’s Office, present a talk at Harvard Medical School in which she provided an overview of the FDA’s reinvigorated innovation initiatives.
Here are the areas needing additional focus, according to Seyfert-Margolis:
- Need for practical innovation. There is no shortage of innovation at the bench. The FDA and other stakeholders in the pharmaceutical industry need to focus more attention on foundational process innovations that would help accelerate review and approval of the wide array of novel formulations and devices submitted to the FDA. For example, how could a surrogate market be created for Alzheimer’s? How could subjects for studies be recruited more quickly?
- Need for more patient and public engagement. Researchers should continually be asking what is important to patients and how research can make patients’ lives better. People need accurate information, as well as information that is easy to understand and use, to inform daily decisions related to health and wellness.
- Need to engage payors more often and address their interests. More attention needs to be given to payors’ perspectives in terms of how they perceive products and formulate pricing protocols. Stakeholders in the drug development ecosystem should work to ensure enhanced levels of efficiency by harnessing healthcare IT and post-market surveillance tools and processes.
- Need for more innovation in food and nutrition regulation. Food security, regulation and oversight don’t get as much attention as they should. National security may be gravely threatened by a disruption in food supply chains, or the contamination of strategic food stores. Additionally, the troubling upward trend in obesity rates among adults and children signals an urgent need for nutritional tactics and knowledge to be deployed more widely and with greater impact to the public.
- Need to focus more on prevention. Our system is really a “sickcare” system, rather than a healthcare system. Typically, patients become engaged or take action only after they’ve become sick. As a result, emotional, physical and monetary resources are consumed at unnecessary levels. Prevention is often less costly than treatment. More research into prevention therapeutics would help address this trend.
- Need to explore how early stage development can be “de-risked.” Given the massive investment required to bring a drug from discovery to market, industry, regulators and providers of capital must work together to implement ways to “de-risk” early stage research. This includes developing shared language and understanding about what “de-risking” means.
What is the FDA doing to propel innovation?
FDA Commissioner Dr. Margaret Hamburg, M.D. has renewed the agency’s focus on the topic of innovation. In a November 2011 report, Driving Biomedical Innovation, the FDA articulated strategic focus areas for innovation efforts:
- Rebuilding FDA’s small business outreach services.
- Building the infrastructure to drive and support personalized medicine.
- Creating a rapid drug development pathway for targeted therapies.
- Harnessing the potential of data mining and information sharing, while maintaining strong privacy protections.
- Increasing consistency and transparency in the medical device review process.
- Training the next generation of innovators.
- Streamlining and reforming FDA regulations.
An innovation page on the FDA’s website was launched in February 2012 and provides a gateway to understanding innovation efforts across the agency. Seyfert-Margolis highlighted two initiatives:
- Entrepreneur-in-residence (EIR) program associated with Innovation Pathway 2.0. The EIR program seeks to bring private sector innovators to the FDA to collaborate with agency personnel leading innovation efforts. The Pathway program is designed to facilitate earlier collaboration between innovators and the agency. Such collaboration seeks to permit rapid prototyping and product revisions before key questions and hurdles become too expensive or time intensive to address.
- Data sharing. The agency is working to unlock and share its rich data stores with researchers and innovators. For a trove of healthcare related data, visit: www.healthdata.gov
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