Illustration by Roger Schillerstrom
Federal government agencies typically navigate through the intersection of politics and funding. For the much-maligned US Food and Drug Administration (FDA), that intersection is likely to become particularly busy this election year as politicians, government officials, and special interest groups draw attention to the agency’s weaknesses and needs, both real and perceived, to advance their particular agendas.
This year will also be one of transition for FDA, as officials begin implementing the more than 200 new provisions included in the Food and Drug Administration Amendments Act of 2007. That measure gives the agency new and far-reaching powers for drug safety oversight, including requiring manufacturers to conduct additional post-market clinical studies and change labels and prescribing literature if safety problems are detected. Implementing many of these new provisions will require issuing additional guidances and promulgating policies and procedures, says FDA Deputy Commissioner Janet Woodcock. But the regulatory procedures for doing so are complicated and time-consuming, and no one can tell how long the process will take.
What does seem certain is that the FDA will continue being cast as a poster child for all that is wrong with regulatory agencies. Depending on one’s perspective, FDA is: inefficient and bungling, chronically under funded and understaffed, rife with conflicts of interest, and prone to politicization. Then there is the issue of new drug approvals. For many patient advocacy groups, the FDA has been too slow in approving life-saving and other medications.
Three congressmen in December called for an investigation into why the agency refused to approve Provenge, an experimental prostate cancer vaccine developed by Dendreon Corp., Seattle, Wash., after an FDA advisory board had backed the treatment. Activists and lawmakers suggest conflicts of interest may have been involved. At the other end of the spectrum, during the four years since the Vioxx and Celebrex debacles, other lawmakers and consumer groups have castigated the agency for having approved medications too quickly and ignored emerging safety concerns.
As a result, the FDA’s reputation has deteriorated from being the world’s “gold standard” for drug approval to being a demon that endangers the lives of consumers. “Inadequately trained [FDA] scientists are generally risk-averse, and tend to give no decision, a slow decision or, even worse, the wrong decision on regulatory approval or disapproval,” concluded a report in November by the FDA Science Board Subcommittee on Science and Technology. “FDA’s inability to keep up with scientific advances means that American lives are at risk. Today, not only can the agency not lead, it cannot even keep up with advances in science,” stated the report, “FDA Science and Mission at Risk.”
Science at the FDA is in a “precarious” position, the report found, due to “extraordinary” advances in scientific discoveries, the growing complexity of new products and claims submitted for agency approval, and emerging safety problems combined with a chronic deficiency in funding that has kept the number of agency personnel unchanged over the past two decades. “The agency will flounder and ultimately fail without a strong scientific foundation,” the report warned, noting that insufficient funding is largely responsible for FDA’s failure to retain and motivate its workforce and for its abysmal information technology infrastructure.
The report recommends giving the FDA “substantial and sustained additional appropriations,” to correct these problems. Similar recommendations have been made by the Institute of Medicine (IOM), the Government Accountability Office (GAO), and various congressional committees. An IOM report last year suggested that FDA needed at least $350 million more to address urgent needs in drug safety. Other groups, including the Coalition for a Stronger FDA (co-chaired by three previous secretaries of FDA’s parent Department of Health and Human Services) have urged a 15% increase in federal appropriations annually for the next five years. But those increases, even if awarded, would still be insufficient, the Science Board report says.
President Bush in December signed a congressionally-approved 9.1% increase of $142.6 million over the FDA’s Fiscal 2007 appropriation, bringing the agency’s Fiscal 2008 budget to $1.73 billion. On top of that, the agency will receive another $459 million from prescription drug user fees. “There is unanimity within the FDA stakeholder community that FDA has been chronically under funded and is at risk of losing its position as the world’s leading consumer protection agency,” said Wayne Pines, a former associate FDA commissioner and former board member of the FDA Alliance, a nonprofit public interest group formed last year to support the FDA.
The FDA Alliance and a similar group, the Coalition for a Stronger FDA, merged in January, 2008 and formed the Alliance for a Stronger FDA to focus on securing greater levels of funding from Congress and the Administration. “More voices calling for additional federal appropriations for an abandoned agency cannot be ignored,” said Diane Dorman, a vice president at the National Organization for Rare Disorders (NORD).
With election politics already at center stage, drug safety issues are likely to become a significant part of the presidential candidates’ proposals for re-engineering the nation’s health care system. Congressional committees have explored the FDA’s handling of safety concerns surrounding GlaxoSmithKline’s diabetes drug Avandia and Sanofi Aventis‘ antibiotic Ketek, suggesting some advisors may have had financial conflicts. Some congressional Democrats last year supported legislation that would have barred the FDA from granting any financial conflict of interest waivers. While those measures did not pass, members of Congress made it clear they want the agency to do more to clamp down on the waiver-granting process.
For instance, nestled in the final congressional appropriations legislation for Fiscal 2008 is language encouraging FDA to limit granting conflict of interest waivers “to the greatest extent possible.” This was evidently in response to FDA rules proposed in November that would require outside experts to disclose all actual and potential financial ties with relevant companies and industry and explain why they should still be allowed to advise the agency. If a waiver was approved, the disclosure form—and its details—would also be posted on the FDA’s Web site prior to the advisory meeting. Currently, the fact that waivers had been granted are disclosed by the FDA but the details are not.
About the Author
Contributing editor Ted Agres, MBA, is a veteran science writer in Washington, DC. He writes frequently about the policy, politics, and business aspects of life sciences.
This article was published in Drug Discovery & Development magazine: Vol. 11, No. 2, February, 2008, pp. 10-12.
Filed Under: Drug Discovery