Innovation is not the first word that comes to most people’s minds when they think of the U.S. Food and Drug Administration. Dr. Frank Torti can offer perspectives from both outside and inside the agency.
Torti said that as director of Wake Forest University’s Comprehensive Cancer Center, he saw the university’s technology transfer office trying to figure out how to get small molecule drugs through the FDA’s regulatory process. But in his own stint as the FDA’s chief scientist, Torti saw firsthand the challenges of regulating industries that have grown in complexity and global reach — growth that stretches the agency’s resources across international borders.
Torti was appointed the FDA’s first chief scientist in 2008. In 2009, he was appointed acting commissioner, a post he held briefly before returning to Wake Forest. But Torti’s time at the agency gave him perspective on the challenges that it faces. The FDA regulates products whose value tops $3 trillion, Torti said today in a keynote speech at the Nanotech Commercialization Conference in Durham, North Carolina. More and more of those products come from overseas. And the products are becoming increasingly complex as technology’s rate of change accelerates.
“The lesson, I think, for the FDA is that the agency, as large as it is, cannot do it alone,” Torti said.
Torti said that he does not intend to discredit the efforts of those who work at the FDA. But he said the agency must change. Some of that change will come from working with partners. Small biotechs, for example, can help regulators understand the new technologies that are coming their way. While FDA regulatory decisions must be independent of industry, Torti listed working with partners among his 10 commandments for FDA reform. Here’s his list.
1. Innovation. Innovation must become part of the mindset of the FDA. FDA strategy must be preemptive, not reactive. That means looking for where the next generation of products will come from.
2. Speed approvals of drugs and devices. It’s just too slow, Torti said. One example where the FDA can speed the process is to require some clinical trials post-market, meaning a company would need to do less up front. While such decisions must be done carefully, they can be done.
3. Clarify the path to decisions. Companies often say they don’t know what they need for FDA approval. The FDA could give better guidance.
4. Make the approval process consistent. Torti said that he often heard that a regulatory recommendation depends on the reviewer. Consistency, Torti said, is necessary for the FDA to be an effective agency.
5. Implement a review of FDA performance. A review can help the FDA find out where it needs to improve.
6. Update infrastructure systems.
7. Collaboration. Mandate collaboration, not competition between the FDA and other federal agencies. Several federal agencies touch on healthcare and there needs to be greater clarity on who does what. For example, during recent salmonella outbreaks, it was unclear whether the FDA or the Centers for Disease Control and Prevention held the lead role.
8. Overhaul the medical devices approval process. Which devices go through the 510(k) pathway? Which ones need premarket approval? It’s unclear and the system needs to be rethought, Torti said.
9. Direct congressional funding to the agency. Right now, the seven centers that comprise the FDA each get their own funding. Funding separate centers makes it difficult for the FDA to communicate and act as a single agency. Torti said that Congress should fund the FDA as one agency.
10. Partner. Encourage the FDA to partner with anyone who can help it. That includes big pharmas, small biotechs, academia and consumer groups. Torti said that partnering can also include working with European regulators. The FDA must make the regulatory decisions. But Torti said pharma and medical device companies should be more engaged in the process.
[Photo from Flickr user jbtaylor]