Lack of Resources Compromises Product Safety

NEWS TRENDS

Unless substantial resources are provided to improve FDA's workforce, the safety of products regulated by the agency could be in jeopardy. A yearlong evaluation of the scientific and technological capacities at FDA found deficiencies in the regulatory systems that oversee medical devices, drugs, cosmetics, and food.

The work was initiated at the request of FDA commissioner Andrew von Eschenbach. He asked FDA's Science Board to form a subcommittee to review whether science and technology at FDA could support current and future regulatory requirements. What they found might not have been a surprise to those who work at the agency. However, the findings alarmed the members of the Science and Technology Subcommittee, which released a 300-page report in December.

“I don't think it's news to FDA that [it] needs more resources,” says Thomas Novelli, director of federal affairs at the Medical Device Manufacturers Association (MDMA). “I think internally they're always saying ‘we need more resources and more appropriation.' The administration isn't necessarily meeting those demands, at least in its budget proposals. Congress, for its part, hasn't been meeting those demands either.”

The report states that FDA has “serious scientific deficiencies” that render the agency unable to meet regulatory responsibilities. According to the report, the deficit comes from high demand on FDA resources and the lack of increased capital to meet the need. Products are becoming more innovative and complex. There is pressure from the public and Congress to do more about safety issues. Yet, the resources the agency is getting aren't proportional to those expectations. “Today, not only can the agency not lead, it cannot even keep up with the advances in science,” the report says.

The subcommittee wants to see significant changes within FDA, including the establishment of a chief scientific officer, the development of incubators for innovation, which would increase networking between universities and industry, and the improvement of information technology (IT) and data analysis.

The subcommittee consists of three members of the Science Board and 30 additional experts in regulatory science, including leaders from industry, academia, and other government agencies. Some of them said during a media conference call that Congress has the power to correct the lack of resources within FDA. They documented that, in the last 20 years, Congress has enacted more than 125 separate statutes requiring FDA to carry out various actions and programs, while providing the agency with just 817 new employees.

“Only Congress can provide the money and people needed to restore FDA science to the level necessary to implement its statutory obligations to protect the public health,” says Peter Barton Hutt, senior counsel at Covington and Burling LLP (Washington, DC). “Unless Congress appropriates additional money and personnel, none of the recommendations of our subcommittee can possibly be implemented.” Hutt is a former chief counsel for FDA.

The main problem areas cited in the report are a weak scientific organizational structure, major gaps in scientific expertise, and an inadequate IT infrastructure, which the subcommittee called disturbing. In addition to recruitment challenges, the turnover rate of the science staff is double that of other government agencies.

“We have insufficient IT expertise to support emerging sciences such as genomics, nanotechnology, and wireless devices,” says Dale Nordenberg, MD, managing director of healthcare industry advisory at PriceWaterhouse­Coopers LLC (Atlanta). “This means that FDA can't effectively support innovation in the industries that it regulates.” The shortcomings could also affect the nation's global competitiveness, he says.

Nordenberg adds that clinical trial data are trapped in piles of warehouse paper, which prevents valuable analysis from helping people. According to the report, there are no backups of such records either. FDA's computer systems and networks are also out-of-date and cannot keep up with evolving science. “We've seen an IT infrastructure [that] can't support the growing regulatory burden caused by globalization, including the need to monitor 300,000 sites globally,” Nordenberg explains.

The report asserts that increased funding is critical for FDA to get the resources it needs. However, the question remains whether such funding would be sufficient.

MDMA and AdvaMed are working with two advocacy organizations, the FDA Alliance and the Coalition for a Stronger FDA, to push for an increase in agency resources.

“AdvaMed believes FDA must be given adequate resources so that it can continue its vital work of protecting and promoting the public health,” says Janet Trunzo, executive vice president of technology and regulatory affairs at AdvaMed. “The Coalition [for a Stronger FDA] is committed to working with the administration and Congress to ensure that FDA has the resources it needs to meet its mission.”

Unfortunately, there is also a disparity between FDA's budget and that of other government agencies. For example, FDA's annual IT budget is about $200 million, whereas the yearly IT budget at the Centers for Disease Control is $500 million. “When you consider the regulatory mandate of FDA, and the impact on industry as well as on medical products and consumer safety, it seems reasonable that the IT budget for FDA needs to be increased substantially.” Nordenberg estimates that the IT budget needs to be increased by 100–150%.

External subcommittee adviser Roy Vagelos suggests a yearly plan to bring in new leadership, build statistics, and develop an extension of resources, which he thinks should be doubled over a five-year period.

Steven Grossman, executive director of the FDA Alliance, says the coalition discussed a 15% budget increase, which probably won't be enough. “We believe the size and magnitude of the needs range from $250 million to $450 million a year, and you're looking at four to six years to accomplish all that needs to be done at that level.”

The subcommittee's report, FDA Science and Mission at Risk, is available on FDA's Web site.

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