The Politics of FDA Approval

In October of 2010, the United States Food and Drug Administration made a stunning admission of wrongdoing. Two years prior, the FDA succumbed to outside pressure and cleared a knee implant that never should have been approved. The “Menaflex” had already twice been rejected by the FDA on grounds of causing increased risk of injury and little to no benefit to patients. But despite vocal opposition by medical experts, four congressmen from New Jersey convinced the commissioner of the FDA to overrule his own agency’s scientists and approve the Menaflex on its third approval attempt. The scientists insisted the device should at least be tested for safety, but the congressmen asserted safety trials were not even necessary. Public campaign finance records revealed that each of the New Jersey congressmen received substantial campaign donations from ReGen Biologics, the maker of the device. All four claimed that their pressure on the FDA was not influenced by the money ReGen gave them, but this connection is difficult to deny.

Perfect objectivity may be an impossible goal; even the commissioner of the FDA is not immune to external pressure. But the Menaflex could never have been wrongfully approved were it not for one particular FDA program that allowed a single, influenceable person to overrule the collective scientific opinion of a federal agency and circumvent essential safety review. This was allowed because of the FDA’s perpetual pursuit of efficiency.

The Menaflex was green-lit through an FDA program called 510(k) or Premarket Notification. Designed to increase the efficiency of the approval process, 510(k) allows a medical device to forgo rigorous clinical safety trials if it is deemed similar enough to an already-approved device. In many cases, the 510(k) program has proven to be a substantial cost saver. It has allowed thousands of rough equivalents to bypass expensive safety trials. But to the 210 patients who received the erroneously approved knee implant, the 510(k) program represents the FDA at its worst: failing to protect American citizens under the guise of increased efficiency.

Admittedly, for the Menaflex, unethical congressional pressure could arguably share blame with the FDA’s quest for efficiency. But a 2011 study by Dr. Diana Zuckerman, a former Yale professor and the current president of the National Research Center for Women & Families, showed that wrongful approvals stemming from 510(k) may be more the rule than the exception. Zuckerman found that of all medical devices ever recalled by the FDA because they could seriously harm patients or result in death, more than two-thirds had been approved through the 510(k) program.

Though Congress is currently reevaluating the merits of 510(k), the Menaflex controversy raises important questions about the cost of efficiency itself. Does a more efficient Food and Drug Administration actually yield better results for consumers? Many say yes. If products are approved more quickly, they can be brought to market sooner and begin helping patients earlier. Biomedical companies often use this argument to justify their demand for faster approval times. Moreover, in light of budget realities, some argue that it is prohibitively expensive to rigorously test every new drug and medical device.

Of all medical devices ever recalled by the FDA because they could seriously harm patients or result in death, more than two-thirds had been allowed to forgo safety trials in the name of efficiency. Courtesy of RRY Publications.

But a loud and clear opposition disagrees. They claim that a more efficient FDA does not yield better results for the consumer. For an agency that regulates over 25 percent of all consumer spending in the United States and is tasked with ensuring the safety of every person who purchases food or uses medicine, it is reasonable to allocate more than the eight dollars per American that Congress budgeted for the agency in 2012.

A reasonable compromise might be to charge the companies who seek FDA approval and use that money to pay for clinical trials. This is precisely the approach taken by the FDA since 1992 for novel drugs whose safety have never been tested. However, the roughly $2 billion per year the FDA currently receives from drug companies as “user fees” raises the potential for conflicts of interest between sound science and financial motives. Perhaps the only way to prevent conflicts of interest while ensuring the highest safety standards would be to rigorously test every drug or medical device, regardless of similarity to previous approved products and, furthermore, for the federal government to be the sole source of FDA funding. On the other hand, such an approach is the antithesis of efficiency and cost effectiveness.

Dr. Joseph Ross, Assistant Professor of General Medicine at the Yale School of Medicine, is an expert on federal medical policy and its impact on quality of medical care. He recently published a study in The New England Journal of Medicine comparing the average approval time of the FDA to those of its peer agencies, the European Medicines Agency and Health Canada. Despite a long-standing industry claim that the FDA does not approve products quickly enough (for lack of funding or otherwise), Dr. Ross found that the FDA’s approval time is, on average, roughly a month and a half faster than its peers. Speaking about the 2012 renewal of the FDA’s authorizing legislation, Dr. Ross says, “As the new bill in Congress was being discussed, what was coming from the industry side was ‘FDA is still not fast enough.’ When I hear that, I think, knowing that faster is probably sloppier, is speed really such a concern?” He continues, “For me, the principle responsibility of the FDA is to make sure that only safe medications are out there on the market. But there are still unsafe drugs getting approved. If Europe were moving faster, but their safety records were the same, maybe you could argue that the FDA should go faster. But if the FDA is moving faster, what the industry is doing is likely to push the FDA into making sloppy decisions.”

Many aspects of the FDA’s charter are updated only once every five years, and just last July, the 2012 legislation was passed by Congress and signed by President Obama. As such, a serious overhaul would likely have to wait until 2017. But in light of recent findings, Congress may want to do two things: (1) de-emphasize the pursuit of efficiency by either tightening or discarding programs like 510(k) that only ostensibly increase efficiency at the cost of safety and, (2) if ever the FDA is found slower than its peers, reinforce the FDA overall by increasing the agency’s budget rather than cutting corners and skipping steps of regulatory review. The FDA may not be the hottest topic in Washington, but the regulation of food and drugs, especially when it goes wrong, should deserve the utmost attention of American politics.