Boston Globe - America Needs a Strong FDA

December 06, 2008
As President-Elect Barack Obama focuses on selecting leaders for his administration, a top priority should be to rebuild the Food and Drug Administration

 

under the leadership of a strong, science-based commissioner who will ensure discipline and order to the regulatory process.No regulatory body is more important than the FDA in protecting the health of Americans. The FDA has the responsibility to regulate $1 trillion worth of products in the economy - $1 out of every $4 of consumer spending, including vital drugs, medical devices, and food. The last thing any of us desires is a lax regulatory process that permits unsafe products to reach the market. But American consumers cannot afford to be denied access to products required to save their lives because of inadequate funding and challenges facing the FDA.

The FDA's professional staff, which has a deep dedication to sound scientific decisions, is doing a remarkable job under difficult circumstances. However, the agency will immediately need expert leadership to expand its scientific capacity and meet its vital mandate to the American public. It has suffered from a chronic underfunding and inadequate staffing, and a lack of leadership continuity.

During his campaign for the presidency, Obama said that the FDA is "underfunded" and "needs new technology," and is not adequately resourced to address the increasing complexities of the healthcare marketplace.

The gap between growing FDA mandates, evolving science, and available resources must be closed if Americans are to have access to these vital products and assurance of their safety. This will require a strong commissioner who can make the case to Congress as well as provide confidence to the American consumer.

For its part, Congress needs to make a long-term commitment to increase the FDA's funding for scientifically rigorous regulation, as appropriation shortfalls during the Bush years have led to a persistent and dramatic staff shortage. Congress has taken steps to address the chronic underfunding, but a multi-year effort will be required.

During the past decade, the FDA was without a confirmed commissioner more than half of the time. The lack of stable leadership has exacerbated the FDA's problems during critically challenging times. This is something that the new president and Congress must fix immediately.

The job of FDA commissioner is not just about setting policy and being a spokesperson to the American people on health issues. It is also a huge management challenge, and requires a talented and decisive leader, experienced in managing a large, complex organization.

Topping the list of requirements for the next FDA commissioner are the temperament, judgment, and relevant experience to manage a diverse science-based agency of 10,000 professionals. This leader should be a scientist or physician with impeccable credentials to strengthen the FDA's scientific capabilities and infrastructure.

The nominee must understand how to ensure the agency keeps pace with rapidly developing science and is committed to making decisions that are grounded in science and law. The FDA leader must ensure informed healthcare decisions that evaluate both the benefits and the risks of products, and appropriately communicate them to medical providers and patients.

The new commissioner must also assure the public that the agency can meet its expanded global mandate. The FDA's new charter includes protecting Americans from bioterrorism and cross-border disease transmission, as well as assuring the safety of foreign imports. As Congress expands the FDA's mandate, it must be matched with resources to fulfill its global responsibilities.

The American public has the right to expect that the president-elect will choose an authentic leader who is fully qualified and dedicated to realizing the FDA's mission. In short, the FDA must become the global standard bearer in regulating the approval of innovative, life-saving medicines and therapies while safeguarding the public health.

Kevin Sharer is chairman, CEO, and president of Amgen Inc. Bill George is professor of management practice at Harvard Business School and the former chairman and CEO of Medtronic Inc.

Ellen Sigal, chairwoman and founder of Friends of Cancer Research, also contributed to this article.