FDA Snubbed in Stimulus

October 07, 2009

By Andrew C. von Eschenbach and Wayne Oliver Original Publication: The Hill

During his visit to the National Institutes of Health (NIH) this week, President Barack Obama announced his plan to spend $5 billion of the $787 billion economic stimulus package in government grants to increase medical research for cancer, autism and heart disease. We applaud this investment in biomedical research, which will create tens of thousands of new jobs and create significant medical breakthroughs. But not one life will be saved, not one disease will be cured, and not one illness will be prevented until those medical breakthroughs are translated into treatments that can be delivered to patients. That cannot occur until those treatments are approved by the Food and Drug Administration (FDA).

This is the fatal flaw in the president’s plan because not one dollar of stimulus money will be used to enhance the capacity and capability of the FDA — the federal agency that is responsible for approving every new drug, vaccine and medical device. Taxpayers who believe their money will be used for their direct benefit will be distressed if we simply enhance the discovery, but not the delivery, of medical miracles.

Increasing our investment in the FDA is not inflating but enabling the federal agency that is responsible for regulating almost 24 percent of all consumer goods. No other agency on a daily basis has as much of an impact on our economy and our public health. The omission of the FDA from the economic stimulus package is exacerbated by the fact that no attention is being paid to the FDA in current proposals to reform healthcare. This is a mistake. In 2006, the late Sen. Edward Kennedy said during a senate FDA commissioner’s confirmation hearing, “The Food and Drug Administration is perhaps the most important health agency that we have in the United States of America, and probably in the world. The Centers for Disease Control may be a close-to-second.

Obviously, NIH has an extraordinary role to play. But the Food and Drug Administration … has such influence and responsibility to the American families, in terms of its leadership.” Over the past century, the FDA has been charged with the responsibility to regulate every drug and medical product that we depend on to protect and promote our health. The FDA is the bridge that must be crossed by every innovative drug or medical device before it can be used in practice.

And past results have been astounding.

During the 20th century, we witnessed more progress in the diagnosis and treatment of disease than in all previous centuries of medical practice. Causes of unremitting suffering and death like cancer, heart disease, polio, influenza and other maladies have either been conquered or are in decline. Patients like Lance Armstrong, diagnosed with a cancer that was previously certain to be fatal, have lived to achieve their greatest accomplishments. And thus far the 21st century has not disappointed. Exponential progress in science and technology now make real the promise of healthcare that enables those blinded by macular degeneration to see and those who are lame from stroke or spinal cord trauma to be able to walk. New medical disciplines like nanomedicine, regenerative medicine, and genomic and molecular medicine are producing medical products that make miracles previously prayed for now achievable.

The problem is that the decades of fostering discovery and development of miraculous breakthroughs was accompanied by decades of neglect of the agency that controls their delivery. We are confronted by a wide chasm between what we are able to create and what we are able to deliver.

As the world of medical science and technology has changed, the FDA has struggled valiantly but in vain to keep pace. Decades of increasing regulatory burden accompanied by shrinking support and resources left the FDA with a diminished capacity to embrace new scientific technologies and meet the demands needed to protect the public health.

Providing resources that many in government and the private sector now realize are desperately needed is only the first step. Those resources used to enhance the capacity and capability of the FDA must be accompanied by the design and implementation of a 21st century regulatory framework. This is not a task that can be left to the agency alone, but one that will require the sustained and sophisticated expertise of all sectors engaged in the discovery, development and delivery of modern healthcare.

As we attempt to stimulate our economy and reform our nation’s health system, this is the time to build a 21st century FDA that will help drive innovation, dramatically shorten the time between discovery and delivery, and allow Americans everywhere to have access to safe, effective and miraculous discoveries that can save their lives and the lives of their children and grandchildren.

Von Eschenbach, M.D., is a former commissioner of the FDA and a senior adviser at the Center for Health Transformation (CHT), which was founded by former House Speaker Newt Gingrich. Oliver is a CHT vice president.