By Arthur A. Levin, MPH
(November & December 2002)

The FDA, Politics and Public Protection

It would seem rational, given the host of reports detailing the poor quality of American health care, the record number of newly approved drugs withdrawn because of safety concerns and the evidence that hormone replacement therapy does more harm than good, that there is an argument to be made for more government oversight in order to better assure the safety and efficacy of medical products.

But, in fact, rather than looking to maintain or even enhance, the Food and Drug Administration’s (FDA) authority, the current, unabashedly industry friendly Congress and the Bush administration appear to be busily looking for ways to diminish it. The timing seems to be ripe. The New York Times recently reported that drug makers “spent more than $30 million to help elect their allies to Congress” and are discussing ways “to turn that influence into legislative victories.” And according to the Wall Street Journal, “Venture capitalists, long wary of the tortuous approval process for medical devices, say they hope they have found their white knight in the new U.S. Food and Drug Administration Commissioner, Mark McClellan.”

What’s being done to erode the FDA’s integrity and authority? First, Congress re-authorized the agency to charge the drug companies user fees that will help pay for review of the approval applications for new drugs and biologics. In the ten years since user fees were first authorized, the FDA has become inextricably dependent on industry to the tune of $162 million dollars. The obvious conflict of interest will soon be extended to medical devices.

Medical device user fees are estimated to bring in $150 million over the next five years. Even worse, the device industry has been given the OK in certain instances to hire private contractors to carry out factory inspections in lieu of FDA inspectors. I find it alarming that Congress has opened the door to privatizing some traditional governmental regulatory responsibilities, especially when the Bush administration has said it would like to eventually turn 850,000 federal jobs over to the private sector.

User fees also have provided Congress with cover for their historic underfunding of the FDA. The result is that the agency cannot adequately carry out many of the public protection duties that Congress has assigned it. The advent of device user fees can only exacerbate this problem. Since fees began, staff devoted exclusively to new drug and biologics pre-approval has doubled, while staff for all other oversight activities has shrunk by 15%. So, for example, there are too few inspectors to regularly visit drug manufacturing plants in the U.S. and abroad to make sure good manufacturing standards are maintained and to regularly inspect the safety of the thousands of food products that come under FDA authority. Before the introduction of user fees, the FDA was free to allocate its resources as its scientists felt necessary.

After years of complaining about the slow pace of approval of new biologics, such as gene therapies, the industry trade association called BIO has finally convinced the FDA to shift the process away from its division with the most scientific expertise to another department. While the FDA claims that this shift will achieve greater efficiency and review consistency, insiders have told me that politics is the real reason for the shift. BIO has had the approval process moved to more “industry friendly” division of the FDA. The intent, of course, is to speed up the approval process for biologics, which may not be in the best interest of the public. A Congressional report showed that, though the approval times for biologics has been longer than for regular drugs, the complexity of “cutting-edge technology involved in developing and manufacturing biologics” may be part of the reason for longer review times.

The Bush administration will not be content to stop here. And the stakes for the drug industry are higher than ever. While topping the Fortune 500 list of most profitable industries in 2001, many drug makers report sagging earnings in 2002. They oppose attempts by some in Congress to limit or discourage drug advertising to consumers on the basis of its effect on rising drug costs. In my next column I’ll talk about efforts underway to restrain FDA’s authority to regulate drug advertising to the detriment of public safety.

Science Under Attack

Science and politics have always been intwined, but I cannot remember a time when federal health policy has been so dominated by a President’s political agenda. The attack on scientific integrity in government has been sweeping in scope – and it has not gone unnoticed by some in Congress.

In a recent letter to Secretary of Health and Human Services (HHS) Tommy Thompson, a dozen members of Congress expressed concern that “scientific decision-making is being subverted by ideology and that scientific information that does not fit the Administration’s agenda is being suppressed.” Cited as an example of ideological censorship is the removal of scientific information posted on HHS web sites, including a fact sheet on latex condom effectiveness in reducing the risk of sexually transmitted diseases and the National Cancer Institute’s finding that abortions do not increase the risk of breast cancer.

The House Members charge that federal scientific decision-making is being subverted by Administration ideology stems from reports of the termination of government scientific advisory committees whose recommendations are at odds with the President’s political agenda. One such shuttered committee, the Secretary’s Advisory Committee on Genetic Testing, had previously recommended that the FDA exercise its authority to regulate the increasingly profitable gene testing market. The FDA will not do so, however, in part because of resource constraints. Increasingly promoted by doctors and companies that advertise directly to the public, these genetic tests purportedly assess a person’s future disease risk based on specific genetic mutations. But industry has not had to prove that the genetic tests can actually predict specific disease risks or have any medical usefulness at all.

According to the Washington Post, the Advisory Committee had convinced the FDA to exercise its authority to oversee the burgeoning genetic testing industry. Subsequent to the Bush administration taking office, the FDA has reportedly reversed course and is even rethinking whether it has the legal authority to regulate genetic testing.

The National Human Research Protections Advisory Committee has also been axed. It was created in response to reports of major deficiencies in federal protections afforded people enrolling in clinical trials. The Committee’s recommendations included, among other “industry unfriendly” improvements, a tightening of conflict-of-interest rules and new restrictions governing research involving the mentally ill.
Committee member Paul Gelsinger, whose son Jessie died in a gene therapy experiment later found to have broken basic safety rules, told the Post the he was not surprised by the HHS action. “It’s always been my view that money is running the research show,” he said, “so with this Administration’s ties to industry I’m not surprised.”

In a separate letter to Secretary Thompson, Congressman Edward J. Markey expressed concern that highly qualified scientific members of the Center for Disease Control (CDC) Advisory Committee on Childhood Lead Poisoning Prevention were being replaced with “individuals who are affiliated or openly sympathetic with the views of the lead industry.” Markey singles out one Administration candidate, William Banner, MD, PhD, as a particularly offending example.

In my opinion, Banner’s nomination seriously threatens the health of children. Consider this: in his deposition during a lead paint lawsuit brought by Rhode Island against paint maker Sherman Williams, Dr. Banner opined that lead levels ten times current CDC guidelines were safe in children. Never mind that considerable scientific evidence and the overwhelming majority of experts in the field support the CDC guidelines.

Finally, the Administration reportedly wants W. David Hager MD, appointed chair of FDA’s important Reproductive Health Drugs Advisory Committee. Dr Hager not only recommends that women read biblical scripture to treat their gynecological conditions, but he reportedly doesn’t prescribe contraceptives to unmarried women and wants the FDA to ban the abortion pill RU-486. At the same time, a highly qualified candidate for consumer representative on the Committee, Cindy Pearson, Director of the National Women’s Health Network, has apparently been rejected.