Why FDA regulation is a boon — not a barrier — to innovation
By Dr. Margaret Hamburg, former commissioner of the U.S. Food and Drug Administration
Adapted from remarks given at the Center for International Security and Cooperation, a research center of the Freeman Spogli Institute for International Studies, on April 18, 2017.
In our current political moment, more and more Americans have begun to question the role of government and the regulations it enforces. After six years as commissioner of the Food and Drug Administration (FDA), I must urge that we proceed with caution down these avenues of thought. While regulation has a reputation for slowing growth and innovation, this need not be so. Regulation that is smart, transparent, and science-driven can bolster industry, improve consumer confidence, and help coordinate the increasingly labyrinthine global supply chains through which the goods Americans consume every day travel.
Fundamentally, the FDA is a public health agency that makes science-based regulatory decisions to promote and protect the health of the American people. It is an agency buffeted by different stakeholder groups with competing priorities, ideologies, and financial pressures. At the center must always be the needs of Americans and their families, who seek health, well-being, and treatments for devastating illness. The stakes for the FDA, therefore, are high indeed.
These high stakes are reflected across the staggering scope of FDA operations. The FDA is responsible for regulating between 20 and 25 cents of every dollar that consumers spend on products.
The FDA oversees the:
- Safety and efficacy of medical products, biologics, and vaccines
- Safety of the blood supply
- Safety of cosmetics and dietary supplements
The FDA also shares a responsibility to oversee the food supply with the Department of Agriculture. We used to joke that the FDA oversees 80 percent of the food supply and gets 20 percent of the money, while for the Department of Agriculture it’s the reverse! While I was commissioner, the FDA also took on the historic new responsibility to regulate tobacco products. This has huge public health importance, as smoking remains the leading cause of preventable death in this country.
In an era of globalization, products that Americans consume here at home are often coming in whole or in part from places outside our borders, often following complex supply chains. For foods, some 50 percent of fresh fruit and nuts, 20 percent of vegetables, and over 85 percent of seafood consumed in the United States are imported. For medical products, 40 percent of finished drugs and 80 percent of the active pharmaceutical ingredients in the drugs we use coming from overseas as well. About 35 percent of the medical devices that we use here come from other countries.
The possibility for contamination, adulteration, quality lapses or other public health risks is substantial. The number of different handlers — from the producer, to the distributer, to the packager, to the re-packager, to the exporter, to the importer — is immense. Collaboration with companies and with other regulatory agencies worldwide is essential to ensure Americans’ safety.
Going forward, the renewed political emphasis on nationalism could be quite harmful to public health protection. One must only look at a series of fairly recent public health crises to understand the risks. Adulterated heparin (a blood thinning drug) and dairy products coming from China took lives and caused disease in their country and in ours. Foodborne outbreaks here in the United States quite frequently are linked to contaminated products coming from beyond our borders. We cannot step away from a strong global and collaborative approach to regulatory oversight of food and medical products.
Similarly, the current devaluation of expertise and science is very worrisome, especially when combined with a reflexive anti-regulatory ideology. During my tenure as commissioner, we modernized and streamlined the FDA’s drug approval system and sought to build stronger, more effective partnerships with stakeholders, importantly including patients and industry.
Furthermore, when done right, the regulation that the FDA implements is a boon to innovation, not a barrier. Not only does it enhance the quality of the products that end up in the market, but it improves consumer confidence in those products. Moreover, it levels the playing field for companies, allowing the best products to rise the top rather than those with the most aggressive marketing. If a company has a legitimate, effective product to sell, there is nothing worse than having so-called snake oil salesmen eroding public trust and creating pressures on other companies to lower quality to compete. When an inevitable problem arises — a health scandal or a product recall — it’s devastating not merely to the one company involved, but to an entire industry. Industry, then, benefits from a strong, well-supported FDA, as do patients and consumers.
The FDA also plays a critical role in responding to emergencies. It is right at the center of the development and availability of new medical countermeasures for naturally occurring or deliberately caused biological threats, including drugs, vaccines and diagnostics for dangerous diseases. This came into full force with the outbreak of Ebola, which former President Obama declared one of the most challenging episodes of his presidency. The question of how to make potentially useful products available as rapidly as possible to people, while protecting already vulnerable people from something not fully tested that might cause more harm, is never an easy one to answer.
Each and every day, the FDA makes an essential difference in the lives of Americans and people around the world. This is a critical time to make sure that the agency has the resources — both dollar and human — to do its important job. In my view, the FDA represents a key role of government and it may be one of the best bargains around.
Looking at the federal budget that supports FDA, it works out to about $8 per American per year. The irony is that almost certainly most Americans spend more than eight dollars on FDA-regulated products on any given day. The responsibilities of the FDA have long outstripped the available resources. In recent years, progress has been made, but the possibility that funding may be constricted under President Trump’s administration is deeply alarming. Now, more than ever, the FDA needs the requisite funds required to continue to advance strong, smart regulatory oversight and global engagement.
The FDA remains a pillar of the American regulatory system. There are no doubt reforms to be made and better ways that it could operate. But this administration should tread cautiously when attempting wholesale reform or funding reductions.
