Former FDA Head Calls for More Integration in Medtech Community

On April 8, Andrew von Eschenbach, M.D., former head of the U.S. Food and Drug Administration (FDA), said that medical device and diagnostic companies must improve their collaborative efforts to overcome the new, complex problems facing the industry.

Eschenbach, who served as FDA director from 2005 to 2009, described several broad changes needed in the regulatory and financial sectors of the medical device industry during a keynote address at an event at the Lahey Hospital and Medical Center in Burlington, Mass. He noted that because of the rapid pace in recent innovation on understanding how cells and cell nuclei work, the medical industry as a whole is at a turning point. As the types of medical conditions and diseases targeted become more complex, the solutions need to follow suit, going beyond a basic drug or device treatment. What that means, Eschenbach said, is that companies need to work together much more than current intellectual property (IP) law allows.

“You need to be collaborating and sharing intellectual property at the very outset,” he said. “Today, there are huge barriers to doing that.”

Among the needed changes, he said, are modifications to the funding model that would support teams of scientists and companies, not just individuals.

“There is no company that can ever get as big as it needs to be to do everything on this,” he said.
He also said that massive changes are needed in the FDA to allow more of what he called market-driven regulation instead of government-mandated regulation.

“We need the ability for people to hold each other accountable,” he said. “It makes the whole system better.”

While von Eschenbach acknowledged that for small biotechnology startups, IP often is the most valuable asset, he pointed out that the need to protect it must be balanced. He said that both Europe and China already are working together to create regulatory and financing systems that are more favorable to the changes in medical innovation.

“Do we have the right legal framework that allows for sharing of IP? I don’t know,” he said. “There’s going to be winners and losers here. Those countries that create the right legal systems to encourage that are going to be the winners. The game has begun.”

Eschenbach’s tenure at the FDA was peppered with controversy. He was criticized for overruling his staff recommendations, the most well-known example of which was him giving ReGen Biologics Inc.’s Menaflex device fast-track approval. He stepped down from his role as FDA commissioner in January 2009 with the arrival of the Obama administration.