U.S. Food and Drug Administration: Agency at risk

Any company with a medical device, novel therapeutic technique or diagnostic product knows too well that a key hurdle to getting that product to market is approval by the U.S. Food and Drug Administration (FDA). Because no new drug or medical technology can be used in the U.S. without FDA first assessing its safety and efficacy, it’s one hurdle that cannot be avoided and must not be mismanaged.

But the agency, which for over a century has safeguarded food, drugs, medical devices, cosmetics, and animal feed, is under stress. Meetings with FDA representatives are getting pushed, in some cases, beyond the 30 or 75 days required by law because of inadequate staffing. In emerging areas such as nanotechnology, no one person at the agency is designated as an expert. Only two people are responsible for pet food. As commerce and other daily transactions move into the electronic realm, FDA is smothering under literally thousands of volumes of paper drug and device submissions.

FDA’s own commissioner, Andrew von Eschenbach, has noted that the agency “is not adequate to regulate the food and drugs of the 21st century.” During a speech before the National Press Club, he pointed to the pace of change as the driver in the need for FDA’s transformation. “This is a time in which the winds of change in health care in terms of power and pace are not a gentle breeze but a jet stream. And FDA must respond to these changes if it is to continue to fulfill its mission of protecting and promoting health.”

In December 2006 von Eschenbach asked FDA’s science board, the advisory committee to the commissioner, to look at the health of science and technology at the agency and determine whether it was sufficient to support current and future regulatory needs. The board’s report, published in November 2007, found a number of areas in serious need of upgrading. Among them: inadequate scientific expertise within the agency; a turnover rate among scientific staff that is twice that of other government agencies; limited collaboration with external scientists; and insufficient or outdated information technology resources.

The report found that the agency was operating with roughly the same number of people in 2007 as in 1992. Over roughly the same time period, Congress added to FDA’s oversight responsibilities by passing 125 new statutes, or unfunded mandates, the agency was required to implement.

Two options

As Peter Barton Hutt, a Washington, DC, attorney specializing in food and drug law wrote in the report, “We can limp along with a badly crippled FDA and continue to take serious risks with the safety of our food and drug supply, or we can fix the agency and restore it to its former strength and stature. If Congress decides to fix FDA, however, this cannot be done cheaply. It will be necessary to appropriate substantial personnel and funds to reverse the damage done to FDA in the past two decades.

FDA’s current budget is just over $2 billion. The report calls for doubling the budget and increasing personnel by 50% in the next two years. “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,” suggest the authors.

The administration asked for $2.4 billion for FY2009, a 5.7% increase over the current year. As with other health-related agencies the needs of FDA are overshadowed by the war and the everpresent macropolitical tensions generated by the Republicans and Democrats. Rosa DeLauro (D-CT) chairman of the appropriations subcommittee responsible for FDA has been highly critical of the administration’s handling of the agency’s needs. In remarks at an Institute of Medicine forum DeLauro castigated the White House for “taking the bargain basement approach then using it as an excuse for its poor performance.”

To his credit Von Eschenbach finally asked Congress for more money this spring, a move that supporters say was desperately needed. “He’s under incredible pressure,” says Steven Grossman, deputy executive director of the Alliance for a Stronger FDA. “He reached a point where he recognized the right thing to do was in conflict with his [political] loyalty.” The request resulted in an additional $275 million added to a supplemental war spending bill for the current year. In June, Health and Human Services Secretary Mike Leavitt announced the Bush Administration was amending FDA’s FY2009 budget request and asking for an additional $275 million. Of the new money, $50 million would be earmarked to strengthen FDA’s core science and emerging technology expertise.

Tracking emerging technologies

The Science Board report notes that some of the most challenging areas for FDA to keep up with are wireless healthcare devices, nanotechnology, medical imaging, robotics, cell- and tissue-based products, regenerative medicine, and combination products.

While the report praised the Center for Devices and Radiological Health (CDRH) for its work to identify important future technologies, it noted that at current staffing levels CDRH will fall behind in these fast-moving fields. The center’s technology forecasts have a 10-year horizon, but the report suggests shortening that time frame to three to five years. Among the key areas CDRH is tracking for the future are photonic technologies, imaging systems, sensors, and early diagnosis/detection technologies.

In addition to 76,682 establishments in the United States, the FDA regulates a large number of establishments around the world. (Source: USFDA 2006)

CDRH is making good progress to prepare for future technologies, but could lighten the workload of senior science staff through the use of post-doctoral fellows. For example, three to four post-docs would be involved in emerging areas of optics research, including ultra-high-resolution optical imaging systems (confocal microscopy and optical coherence tomography) to study the fundamental principles, critical parameters, advantages, and limitations for applications to minimally invasive techniques. Three to five post-docs would be involved in high-priority areas of MEMS and nanotechnology, including the development of physical, chemical, and biological characterization of nanomaterials, and understanding bioeffects of these materials.

To bolster FDA’s core science knowledge, the report also recommended creating an agency-wide, cross-disciplinary entity whose sole responsibility would be to identify the tools and techniques needed to manage the emerging science and technology issues presented to FDA. The group would assist in developing FDA’s science strategy and would help set budget priorities based on the scientific portfolios.

In an effort to modernize medical product-development cycles, FDA established the Critical Path Initiative in 2004. This ambitious program attempts to apply new scientific tools to medical product development and was started as the agency experienced a decline in new drug and biologics applications. By engaging novel design and product development strategies, FDA expects to reduce the number of products that fail during the later stages of development. They anticipate the use of new techniques and tools will identify early on in the development cycle which products are likely to fail. This early identification will enable resources to move to products with a better chance of success, thus saving money and time.

But as the Science Board report noted, the program is being sustained by a few dedicated senior staff and is seriously underfunded. This year the program was allocated $5 million. Of the 76 high-priority areas, which include medical imaging, only a handful of the areas are being addressed.

Developing the most innovative programs to grab the best emerging science has to offer will mean little if the agency’s information technology (IT) infrastructure can’t keep pace. For IT staff, that means upgrading the majority of network servers, all of which are more than five years old. The average IT expenditure per FDA staff member is $16,000 compared to $35,000 at the Center for Disease Control, an agency comparable in size. A stronger IT backbone would also allow drug and device reviewers, as well as FDA science staff, to manage large datasets and data models.

Moving forward

Fixing 20 years of neglect will take time. The stress cracks go all the way to the foundation of the agency. A new initiative to hire 700 employees by year’s end is ambitious. The recommendations by the Science Board are far ranging and will require time and money to implement. As the agency continues to meet the most pressing public health needs industry must do its part to respond when asked for comments on guidance documents the agency drafts that set policy for how device development proceeds. A recent CDRH request received only two responses.

What began as a small effort to halt the misbranding and adulteration of food and drugs in the late 1800s has turned into a major scientific, regulatory, and public health agency that regulates more than $1 trillion in consumer products annually. FDA has aptly been labeled the “gold standard” for regulatory organizations. Keeping this agency at the top requires support from all sectors.