The True Goal of the FDA Should Be Drug Innovation
Last week, the Senate Committee on Health, Education, Labor, and Pensions met to consider legislation that would reauthorize the Food and Drug Administration’s (FDA) user fee programs. These programs make up a large part of the agency’s budget. This process will continue over the next several weeks.
Earlier this month, the House Committee on Energy and Commerce also held a hearing to consider improvements to the regulation of medical technologies. This will most likely become a part of the reauthorization legislation. While an admirable goal, the true goal that policy makers should pursue is to create an environment in which innovation and entrepreneurship can thrive with as few barriers as possible.
Some of the bipartisan proposals, like allowing certain hearing aids to be sold over the counter in pharmacies, are steps toward that goal. At the same time, there were also proposals in the House advocating more bureaucracy and controls that will ultimately hurt consumers.
The default attitude toward innovation should be to allow it to proceed unencumbered by prohibitive regulation unless it poses an imminent, catastrophic, and irreversible harm to society. While medical technology can sometimes pose higher risks to society, it can also produce massive benefits in the form of lives saved and extended.
Many people have heard the story of Ron Woodroof, brought to life in the movie Dallas Buyers Club. In the mid 1980s, Woodroof contracted HIV and doctors told him he would die shortly. Unwilling to accept this prediction, he found drugs to treat his condition in other countries that the FDA had not approved for use in the United States. These drugs worked and Woodroof lived well past what the doctors had first believed possible. When he began to tell his friends about his life-saving discovery and give them the same medication in order to save their lives, the FDA opened an investigation and tried to stop Woodroof from helping them. Too often, the agency interferes with patients making legitimate –– and often informed –– choices about their health.
Since health is such a private matter, it’s crucial that patients, with consultation from their doctor, ultimately make the cost-benefit decisions. No bureaucratic official in Washington is equipped with the proper knowledge to determine what each patient would consider an acceptable risk. For example, Steve Holl, a biologist living in California, was diagnosed with a particularly deadly form of brain tumor in 2010. He decided that he wanted to try a potentially dangerous, custom-made vaccine to treat his condition. Holl judged the risk of the unapproved treatment as worth it if he could live for even a couple months more, all so that he could dance with his daughter at her wedding. No government agency should be able to preempt this kind of deeply personal choice.
In light of these principles, proposals seeking to make technology like hearing aids available to more consumers should be encouraged since they place power in the hands of patients. Increased access and less regulation will benefit many patients who, in this case, are losing their hearing, and encourage greater development of medical technology.
It currently costs $2.6 billion on average to develop a drug and gain the proper approvals needed to market it. Few companies can foot this kind of a bill and bear the risk that the government will veto their application in the end. Proposals that lessen the number of steps needed to bring new drugs to market will lower the cost and allow more firms to participate in the process.
On the other hand, proposals that erect more barriers and regulatory checkpoints generally increase costs, stall innovation, and reduce patient access. Another proposal discussed at the House hearing would require third party companies that service and repair medical technology to register with the FDA, maintain a system to process complaints, and report adverse events. While these steps may be helpful and encourage accountability in the industry, it would be more efficient and useful to allow the industry to self-regulate through some sort of certification process or rating process. This particular proposal will likely double the equipment repair costs for hospitals and practices using third party service providers, negatively affecting rural hospitals.
Ultimately, Congress is not considering policies that go far enough toward encouraging innovation in medicine. The FDA has more foundational problems that need to be addressed. The agency has become too risk averse and prone to extremely restrictive rules. Changing the focus of the FDA from drug and device approval to risk education will arm patients with information and allow them to make their own judgments about risk-reward tradeoffs.
Keeping the patient as the focus of FDA policy will ensure that the agency encourages new medical developments to reach patients who will benefit from them. We are in the middle of incredible developments in genetics and artificial intelligence that can save the lives of many patients. Continuing business as usual will only slow down life-saving treatments. Meanwhile, patients are needlessly dying.
Jordan Reimschisel is a research assistant focusing on emerging technology in the medical field. He is a Young Voices Advocate.