The FDA's 7 Steps To Biomedical Innovation
By Lori Clapper, Editor
After months of internal analysis and outside meetings with stakeholders, the FDA developed a new plan titled "Driving Biomedical Innovation: Initiatives for Improving Products for Patients." This blueprint breaks down the immediate steps the agency can take to sustain product pipelines and to keep the industry growing.
- Help small businesses
- Drive and support personalized medicine
- Create a rapid drug development pathway for important targeted therapies
- Harness the potential of data mining and information sharing, while protecting patient privacy
- Improve consistency and clarity in the medical device review process
- Train the next generation of innovators
- Streamline and reform FDA regulations
This year, the FDA says it has seen an improved quality of new drug submissions, having approved several scientific breakthroughs, including the first new treatment for Lupus in 50 years, two new therapies for Hepatitis C, and the first drug shown to be an effective treatment for Melanoma. However, the agency is concerned with the low quantity of submissions. Investors spent nearly $95 billion for R&D in 2010 alone, and this money has not translated into a parallel increase in submissions. In fact, last year the agency received the lowest number of applications for novel drugs in nearly two decades. No single cause can be blamed for this slump in innovation, but the global economy, more complex science and products, and product safety and efficacy are all contributing factors.
FDA Commissioner Margaret Hamburg has recognized that the FDA, as a whole, needs a makeover if it plans to keep up with the ever-changing scientific landscape. She said, "America is at an important crossroads, where the science before us presents unprecedented opportunities to create new and better medical products and to promote better health for the public."
In her blog, Vicki Seyfert-Margolis, senior advisor for science innovation and policy at the FDA, also explained that this document is not a total solution, but "represents a productive and important first step toward smart innovation-focused reform at FDA."