SAN JOSE, Calif. The Food and Drug Administration wants a few good scientists—quite a few actually.
The FDA is bolstering its scientific capabilities in the face of accelerating technology change and market globalization, said the agency's newly appointed chief scientist in a keynote address at the Biomed Device conference here Thursday (Sept 11).
"We just hired 1,300 new people, about 900 of whom have significant scientific training and expertise," said Frank Torti, who joined the FDA in May. "This is just the beginning," he said citing a recent $150 million increase in the FDA's budget and more expected in federal budgets still in the approval process.
The move represents the first incremental hiring for the 11,000-person agency in "many, many years," said Torti. "The regulatory agenda for the FDA has grown substantially in the last 20 years while its work force has remained largely flat," he added.
The FDA regulates an estimated $1 trillion in products, nearly 25 percent of gross domestic product, ranging from cosmetics, hamburger and microwave ovens to the latest advances in nanotechnology for medical devices.
"I want to develop a young, questioning work force familiar with the new science," said Torti, former director of a cancer center at Wake Forest University and an oncologist for 30 years
Torti is developing a science plan for the agency at a time when "the job of the FDA has changed dramatically and permanently," he said.
This year foreign manufacturing sites will exceed domestic ones for FDA regulated products for the first time. Today medical devices generate more than 4.5 million regulatory events a year related to imports, second only to food at 6 million a year. China and India are by far the top producers of drugs imported into the U.S, he added.
To create a smarter inspection process, the FDA is testing in the Los Angeles area a new risk-assessment algorithm called Predict. "You can't look in every box anymore, and we also have to shift to testing through a product's life cycle at manufacturing and other critical points," he said.
Technologies are shifting as fast as markets with a broadening array of converged devices, drugs and techniques coming on line as well as advances in nanotechnology. Torti showed several advances in carbon nanotubes that could have application to new disease treatments.
"Deciding whether some of these treatments should be classed as devices or drugs is a relevant challenge," he said.
Torti said the FDA's science advisory board is evolving and may develop some special interest subgroups. It has already defined nanotech and medical imaging as two of the areas in which the FDA needs to bolster its expertise. Torti added to that list the emerging field of systems biology as well as wireless technology and software.
The new chief scientist aims to set up FDA centers of excellence in collaboration with universities to act as consultants on specific questions. He also wants to strike up partnerships with industry, especially in biotech issues.
"I believe there are many dialogues we can have with regulated industry because there are many issues of mutual scientific interest," Torti said."We need to be able to tackle the controversial science issues."
Whether the bolstered science capabilities speed approvals at the FDA remains to be seen.
"Everything we do is about speeding the critical path," Torti told one questioner. "My cancer patients never wanted to go off and study new techniques for months. They wanted new things to help them get better."
Separately, the FDA is internally reviewing new rules covering the quality manufacturing processes for devices that include both hardware and drugs.
"We are internally reviewing a draft," said John Barlow Weiner, an associate chief counsel for policy in the FDA's combination products office, speaking on a panel here. "I would hope it comes out this year, but it could arrive next year," he said referring to uncertainties due to the November election.
One of the chief challenges for the rising number and variety of so-called combination products such as diagnostic testers and implanted devices is that vendors use separate quality procedures for making the hardware and making the drugs.
"The essence of this issue is you are talking about two separate cultures," said Geoffrey Levitt, a chief counsel for drug maker Wyeth (Madison, N.J.). "The two worlds need to come together."
Device designers also face big hurdles crafting clinic trials needed for FDA approval. Deciding what sorts of systems or drugs to use as comparisons and picking the test parameters is a top challenge, said Suzanne Kiani, a senior scientist at Genentech Inc. (South San Francisco).
"If you have to repeat a clinical trial it is laborious, time consuming and can even kill a company," she said.