Medical Device Daily Washington Writer

Biomedicine's future is dependent on the new reality in healthcare of integrating the parts and pieces of product discovery, development and delivery, said former FDA Commissioner Andrew von Eschenbach, who recently joined Greenleaf Health as a senior adviser.

In an environment where science and medicine have moved rapidly from simply observations of the manifestations of disease to understanding of the mechanisms of disease, the FDA, industry and Congress all need to make adjustments if healthcare is going to be reformed and transformed, said von Eschenbach, who spent 25 years at the University of Texas M.D. Anderson Cancer Center (Houston) before becoming director of the National Cancer Institute in 2002 and later moving to the FDA in 2005.

Von Eschenbach noted that when he joined the FDA, his challenge was one of resuscitating the agency.

"It was like encountering a patient who was on life support," he told Medical Device Daily's sister publication, BioWorld Today, calling the agency one that had antiquated information technology systems and a shrinking work force, with 30% of its personnel set to soon retire.

"My first and foremost challenge and responsibility as commissioner was along the lines of resuscitation, developing the justification and rationale for additional resources, acquiring those resources and beginning to transform the infrastructure," von Eschenbach said.

However, the agency has recently received more funds to increase its staff and improve its technology and the FDA's move to its new White Oak headquarters in Silver Spring, Maryland, which began in 2003, has progressed smoothly, said von Eschenbach.

He left the FDA in January, and his new position for Greenleaf Health does not involve lobbying. Rather, he is advising organizations about long-term strategies involving product discovery, development and delivery.

The medical product industry, too, is now facing its own challenges, he noted. As with the computer industry, where the success of a laptop or hard drive is dependent on the microprocessor and other components and vice-versa, healthcare has become an industry in which the success of a therapeutic intervention is increasingly becoming reliant on the use of diagnostic tests, von Eschenbach said.

What used to define market share is no longer the case, he said, noting that drugs and devices in the future will not always be made for large populations, given the progress of personalized medicine and the knowledge of mechanisms of diseases.

"Industry has to rethink market share based on what are commonalities as it relates to fundamental mechanisms for which you are developing an intervention," von Eschenbach said.

Firms should be developing their interventions against a mechanism rather than against the outcome of the disease, he said.

For instance, von Eschenbach said, when angiogenesis inhibitors were being developed as cancer treatments, no one had considered at that time that they also could be successful treatments for macular degeneration of the eye, as is now the case, with many doctors substituting Genentech's (South San Francisco, California) cancer drug Avastin (bevacizumab) for its much more expensive, but basically similar, drug Lucentis (ranibizumab).

From a mechanistic perspective, he explained, both cancer and macular degeneration "are diseases with abnormalities of angiogenesis operative."

Novartis's (Basel, Switzerland) Gleevec (imatinib mesylate), which is approved to treat chronic myeloid leukemia and gastrointestinal stromal tumors, is another example, von Eschenbach noted.

"Who in oncology would have ever said those diseases are the same," he said. "But from a mechanistic point of view, they can be thought of as the same."

While the medical products industry and the FDA currently are transforming their models for developing and regulating therapies, Congress also must transform its mindset, said von Eschenbach.

Lawmakers, he said, must understand that the FDA needs the ability to engage with device and drug makers. "You can't do this in a vacuum," von Eschenbach contended. "There is going to have to be consultation, corroboration and cooperation," he said.

However, he added, "That doesn't mean the FDA is going to stop being a strong regulatory agency and it doesn't mean the industry doesn't have to remain economically viable. The FDA should be and ought to be the strongest, most effective regulatory agency on the planet protecting and promoting public health of the people it serves. But that doesn't mean it doesn't do it in collaboration and cooperation with industry."

If the FDA and industry are forced to work in separate silos, new therapies will be delayed, von Eschenbach said.

"The more you isolate the FDA from the industry and isolate the industry from the FDA, the greater problems you are going to have," he said.

If personalized medicine is going to move forward, von Eschenbach said, "Why would we not want to do that in dialogue with each other so that we are aligning discovery and development with the regulatory pathway that is going to bring those things rapidly and efficiently to patients? Why are we going to create barriers or partitions between those rather than create this in a way that is much more seamless?"

The FDA, he said, must make a better case to Congress and reassure lawmakers about the necessity of communication between the agency and industry if regulation is going to be able to keep up with the scientific advances that lie ahead.

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