On December 3, 2007, the Food and Drug Administration’s Science Board, an advisory committee
to the FDA, adopted the findings and recommendations of its subcommittee’s report: “A Mission at Risk.”
The report concludes that FDA is an agency at risk of failing to carry out its mandate, leaving our citizens at risk of grievous
harm if the FDA scientific infrastructure is not strengthened and if the agency is not given the means to ensure the safety
of our foods, drugs, medical devices and other consumer products.
The report was requested in 2006 by FDA Commissioner Andrew Von Eschenbach
to assess whether FDA’s current science and technology was sufficient to protect the nation’s food and drug supply.
The FDA Science Board formed a subcommittee to undertake this review and included outside experts from industry, academia,
and other government agencies. The final report, more than a year in the making, is one of the most comprehensive examinations
of the FDA in its history. Some key points
from the report:
1) The protection of
basic commodities of American life, such as our foods and drugs, is an essential government function.
The need for an effective FDA has never been greater. In addition to its critical role in the safety of our food supply,
drugs, vaccines, and medical devices, the agency is responsible for a vast array of other products, from cell phones and television
sets to cosmetics, blood, and pet food. Further, FDA is a critical component
in combating emerging threats such as bioterrorism and virulent new diseases (e.g., avian influenza, SARS).
2) FDA has been recognized
as one of the Federal government’s most trusted entities for more than 100 years, but it is being allowed to wither
away. FDA’s scientists and regulators have characteristically been
recognized worldwide for their skill and dedication. This tradition of excellence is being seriously eroded by lack of support,
notably among decision makers in the White House and Congress. Without strengthening
the scientific base of the agency and without more resources, the agency cannot meet its public health mission and protect
the safety of our citizens, despite responsibility for regulating a quarter of consumer expenditures.
3) The demands upon
the FDA have soared in recent years. Congress has passed 125 statutes in the past two decades, adding significantly to FDA workload. There are 375,000
establishments making FDA-regulated products. R&D investment in drugs and medical devices has tripled in a decade. There
has been an exponential increase in drug adverse reaction reports. The emergence of extraordinary new health threats (such
as SARS, E coli 0157H:7, AIDS, BSE) have placed increasing demands on the agency. In
just a decade, there has been a ten fold increase in imports, coming from more than 100 other countries. Over 50% of drugs are imported, along with 15% of our food supply. Yet, FDA has not been given the
resources to address a dramatic change in the sourcing (and associated risk) from products made overseas.
4) FDA resources have
not kept pace with its responsibilities. The agency’s core programs
have lost a thousand people in the past decade; FDA’s food headquarters staff
has lost 20% of its scientists in just the past three years. Similarly, FDA has
lost several hundred inspectors since 2003, leaving the agency incapable of inspecting domestic manufacturers and meaning
that few of the nation’s ports have FDA inspectors.
5) Innovations and
advancements in science are outstripping FDA’s capacity to regulate them, threatening the safe introduction of new technologies
and American leadership in pharmaceuticals, vaccines, biotechnology, and medical devices.
The United States is on the cusp of a “revolution”
in therapeutics that holds great promise for treatment of cancer, Alzheimer’s, Parkinson’s, and other serious
conditions. Breakthroughs in human genome research, molecular biology, nanotechnology,
food processing technology, computational mathematics, in vivo imaging are likely to change the face of medicine and
food production. FDA does not have the scientific expertise, infrastructure, nor has capacity to prepare for those breakthroughs. As U.S. competitiveness
in science and medicine are under increasing challenge, a weak FDA is a brake on the very technologies that we are relying
upon for our medical, technological and economic future.
6) FDA cannot ensure
the safety of our food supply. The report’s authors saw a food safety
system in which basic inspection and enforcement functions have been severely eroded, along with the agency’s ability
to respond rapidly to food-borne disease outbreaks. The FDA did 35,000 domestic food inspections in 1973, but will do only 8000 this year. On
average, FDA inspects most facilities only once every ten years. Despite the thousands of overseas producers sending
food to our shores, the foreign inspection rate is far worse. The agency may have the resources to inspect a dozen foreign
food manufacturers in 2008, Moreover, as FDA’s leadership in food
safety erodes, other countries are presenting themselves as the appropriate model for food safety standard setting, to the
detriment of principles of sound science and to market access for American food exports.
7) FDA’s Information
Technology systems are woefully outdated and inadequate, posing a concrete threat to the agency’s public health mission. The report’s authors were extremely disturbed by the state of FDA’s IT
infrastructure. They found a situation problematic at best, at worst dangerous. Many of FDA’s systems are far beyond their expected life span, and systems fail
frequently (even email systems are unstable). Reports of product dangers are
not rapidly compared and analyzed, inspectors’ reports are still laboriously hand written, and the system for managing
imported products cannot communicate with Customs and other government systems.
Conclusion The findings
of the FDA Science Board report echo study after study by the Institute of Medicine, the National Academy of Sciences, Congressional
committees, the Government Accountability Office and other expert bodies that have documented FDA’s resource shortfalls
and the resulting public health threat.
In sum, FDA’s resource constraints cannot be reversed without
a determined effort by Washington decision makers to rebuild this bulwark of our
system of consumer protection. Nor can any management or leadership changes
be expected to have a significant impact, in the absence of very significant increases in resources. Without action, the costs to our society will be far greater than the costs of rebuilding the FDA.