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Reality Check On Science At FDA

Facing huge challenges, agency wields meager resources

by Britt E. Erickson
September 6, 2010 | A version of this story appeared in Volume 88, Issue 36

Credit: Eugene Hoshiko/AP
FDA Commissioner Hamburg (center) visited the Shanghai Institute for Food & Drug Control as part of an effort to improve the safety of products imported into the U.S.
Credit: Eugene Hoshiko/AP
FDA Commissioner Hamburg (center) visited the Shanghai Institute for Food & Drug Control as part of an effort to improve the safety of products imported into the U.S.

To restore public trust and confidence in the U.S.’s food and drug supply, the Food & Drug Administration plans to strengthen its regulatory science and to take a lead in harmonizing international regulations for food and drug safety.

But with a limited budget, the agency needs creative ways to bridge the gap between the resources it has and what it needs to stay on top of the latest science. As a first step, FDA has begun collaborating more than it has in the past with other federal agencies. It is also undertaking comprehensive reviews of its centers to see where improvements can be made and to help set priorities.

At an Aug. 16 meeting, FDA’s science board, a group of external experts who advise the agency on emerging science, discussed FDA’s current challenges, as well as initiatives the agency is undertaking to bolster its science and credibility. The board provided several recommendations for improving FDA’s food center, examined FDA’s nanotechnology research priorities, and heard about FDA’s efforts to build a database of clinical trials data.

Having just returned from a trip to China hours before addressing the science board’s meeting, FDA Commissioner Margaret A. Hamburg had globalization on her mind. It is impossible to screen every product that comes across the border, she acknowledged. “The impact of globalization is so enormous now in terms of our ability to oversee the products that we regulate that we have to have a new engagement, a new way of thinking,” she said.

Hamburg stressed the importance of sharing information with regulatory agencies and scientists in other countries such as China, and she asked the board to begin thinking about ways to harmonize international standards for regulating foods and drugs. She also emphasized the need to strengthen regulatory science—research that involves assessing the risks and benefits associated with a new drug or product—throughout FDA.

With respect to food safety, FDA should strive to be “the best in class,” a model by which international food regulatory agencies benchmark themselves, suggested board member Rhona Applebaum, vice president and chief scientific and regulatory officer at Coca-Cola. “Because if that is done, we’ll be able to harmonize regulations globally,” she said.

Applebaum was speaking on behalf of a science board subcommittee that began a comprehensive review of FDA’s Center for Food Safety & Applied Nutrition (CFSAN) in late 2009. She presented several findings from that review at the August meeting.

The number of ingredients in foods and cosmetics is growing, and imports are on the rise, Applebaum reported. “It’s not going to get any better. It’s going to continue to get more complex,” she warned. Yet despite the growing responsibilities of CFSAN, the number of research staff at the center hasn’t changed in the past decade, she pointed out.

“You are expected to mitigate today’s problems and know ahead of time through your crystal ball what the issues are going to be tomorrow,” Applebaum stressed. When FDA fails to do that, she said, the public’s “confidence goes down the tubes.”

In its final report to FDA, the board recommended that CFSAN give laboratory and nonlaboratory research, including regulatory science and communications, equal treatment. The report also suggested that the center beef up its extramural research program.

Absent from the report, however, was a review of FDA’s Office of Cosmetics, which is part of CFSAN. Most of the subcommittee members were food experts who didn’t have the expertise to assess cosmetics regulations, Applebaum explained. FDA should do a separate review of that office, the group suggested, particularly in light of concerns raised by the Campaign for Safe Cosmetics, a nonprofit advocacy group that claims many personal care products, including baby shampoo, are laden with carcinogens and other toxic chemicals.

Credit: FDA
Credit: FDA

Unfortunately, many science board members acknowledged, CFSAN does not have the money to implement the recommendations. Insufficient resources At FDA was a recurrent theme throughout the meeting.

For instance, after a presentation by FDA’s nanotechnology task force, it became apparent to some board members thAt FDA does not have the resources it needs to assess the risks of nanotechnology in FDA-regulated products. “Food and nanotech are underfunded by huge amounts,” pointed out the chairwoman of the science board, Barbara J. McNeil of Harvard Medical School. “The agency has great plans, but no resources.”

FDA currently invests $7.3 million in nanotechnology, an amount that required “a heroic effort” to obtain, according to Jesse Goodman, FDA’s chief scientist and deputy commissioner for science and public health. But some members of the advisory board said it was a minimal amount of money and urged the agency to do more.

Much of the discussion on nanotechnology centered on the unpredictability of nanomaterials. Science board member Martin Philbert, a toxicologist and professor at the University of Michigan School of Public Health, stressed that “size doesn’t matter.” He urged FDA to focus on the chemical and physical properties of nanomaterials and not their size when defining a regulatory approach in this area.

But the science isn’t there yet to know how nanomaterials behave in biological systems, Goodman claimed. He emphasized the need to obtain enough data to predict the effects of making various changes to nanomaterials.

FDA plans to use part of its $7.3 million nanotech budget to fund the Collaborative Opportunities for Research Excellence in Science (CORES) program—an effort to promote external research and cross-center activities. Research priorities for CORES include characterization of nanomaterials, such as defining the chemical and physical properties that affect potency and determining the characteristics that affect safety; assessing how nanomaterials interact with biological processes in fluids and tissues; and developing in vitro and in vivo toxicity tests for nanomaterials. Some of the money will also go to enhance laboratory research facilities and to pay for staff training and professional development.

Another initiative that got the board’s attention was FDA’s plan to build a database to store all the information FDA has from clinical trials. Unlike the situation with food and nanotech, in this case, FDA found a creative way to fund the project. The database will be built with money from the American Recovery & Reinvestment Act of 2009. Although FDA did not directly receive the stimulus money, it applied for a small fraction of the $300 million in stimulus funds given to its sister agency, the Agency for Healthcare Research & Quality, for comparative effectiveness research.

When C&EN went to press, AHRQ had awarded a little more than $700,000 of that money to an FDA contractor to purchase computer equipment for the database. Other grants related to the database project are expected to be awarded by the end of this month. They would provide money for quality-assurance support, conversion of legacy data into a standardized format, FDA-hosted workshops on comparative effectiveness research, and partnership-building efforts.

“We have the world’s richest source of clinical data, and it’s generally extremely high-quality data,” Goodman told the science board. “There are incredible possibilities if we can bring that data together.”

One of the challenges of building such a database is thAt FDA receives massive amounts of information in many different formats, noted Vicki L. Seyfert-Margolis, senior adviser for science in FDA’s Office of the Commissioner. “We’ve been working toward a standardized approach to acquire, receive, and analyze study data,” she said. “The standardization of study data is vital to integrate premarket and postmarket data to improve our ability to protect the public and ensure patient safety.”

Some members of the science board were shocked to hear thAt FDA still accepts clinical trial data in paper format. When asked whether the agency has the authority to require electronic submissions, agency officials replied that it does. “We are moving in that direction,” Goodman added. But FDA is still deciding what standardized format to require.

The number of ways to use such a database is endless. For example, one could compare selective serotonin reuptake inhibitors or other antidepressants across different age groups to see whether there is an increase in suicidality, Seyfert-Margolis suggested. Or one could compare “stents or surgical interventions in cardiovascular disease versus therapeutic interventions.” In that case the data would come from two different FDA centers, she pointed out. Another example is looking at multiple drugs across a class for renal toxicity.

In terms of drug safety, FDA is also beefing up its toxicology activities. The agency recently joined a collaboration called Tox21 to improve its ability to predict drug toxicity (C&EN, July 26, page 24). As part of the collaboration, FDA is giving researchers at the Environmental Protection Agency, the National Toxicology Program, and the National Institutes of Health’s Chemical Genomics Center access to its drug data to help validate high-throughput molecular assays and computational methods for predicting toxicity.

“This is an extremely important area,” Goodman stressed, referring to the Tox21 collaboration. “We want to develop a strategy for moving toxicology forward to change how new products are regulated.”

To get all FDA centers on the same page, FDA has formed a senior council on chemical and environmental science. “Most of these issues cut across the centers and more typically multiple departments and agencies,” Goodman noted. The council will likely interact with multiple agencies, including EPA, NIH, and the Departments of Agriculture and Defense, he said. “As we modernize toxicology and risk assessment, we need to build across our agency a consensus on what we are doing and how we are doing it.


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