Scathing Report on FDA Calls for Radical Effort to Fix Ailing Agency
The U.S. Food and Drug Administration is so underfunded and understaffed that it is putting consumers at risk to unsafe foods and drugs, according to a report, “FDA Science and Mission at Risk,” released by an advisory panel to the government agency on November 30th. The report—developed over the past year by experts in academic, industry and other government agencies—presents a biting assessment of the current state of FDA, which regulates the nation’s food, drugs, vaccines and medical devices.
The report highlights a number of severe problems plaguing the government agency, an organization that regulates over $1 trillion in consumer products annually. Among many others, the report highlights the following problems plaguing the FDA and hindering the fulfillment of its mission:
- A lack of a coherent vision and structure for the organization.
- A depleted staff, which despite a huge growth in agency responsibilities, is about the same size as it was 15 years ago.
- A workforce with far too few scientists who understand emerging biotechnology
- An “inadequate” and “obsolete” information-technology system.
The report found that most of the problems in the agency stemmed from the interplay of two main factors: the rapidly increasingly demand put on the FDA and the fact that the agency’s resources, financial and intellectual, have not risen to meet the increasing demand. If the discrepancy between the responsibilities placed on the FDA and the resources the FDA has to successfully uphold these responsibilities is not rectified, then the organization will stand in an increasingly precarious position that is dangerous for the American consumer and the American economy.
Fixing the problems afflicting the FDA is essential to the health of this country. As a nation, we must realize that if America is to continue to be a player on the world stage and an example for other countries, our important government agencies must be brought up to par. The experts that wrote this report should be commended for their effort, but their dedication will mean nothing if their recommendations are not taken seriously and if policy makers do not act on them. It is the right time for the FDA to catch up to the science that it purports to evaluate in a sophisticated and impartial fashion.
The report summarizes its plea to the FDA:
We recognize that adequate resources — human and financial — alone will not be sufficient to repair the deteriorating state of science at FDA, which is why we also recommend significant restructuring. But without a substantial increase in resources, the Agency is powerless to improve its performance, will fall further behind, and will be unable to meet either the mandates of Congress or the expectations of the American public. This will damage not only the health of the population of the US, but also the health of our economy. Currently each American pays about a penny and a half a day for the FDA; an increase to three cents daily would not, in our view, be a great price to pay for the assurance that our food and drug supply is, indeed, the best and safest in the world.
In its National Innovation Agenda, the Center for American Progress calls for increased funding for the FDA and other governmental scientific groups.
UPDATE: The Senate Health, Education, Labor and Pensions Committee will hold a hearing on food safety at 10:30 a.m. this morning. Webcast available here.
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