FDA Needs a Fresh Approach, and Fast

Due to these concerns, the FDA should shift its mission toward risk education. New medical technology will bring potential safety concerns, and these ought to be considered seriously — but always alongside the potential benefits.

We stand on the cusp of a potential revolution in the field of medical technology, as new data-driven and internet-enabled technologies are poised to expand significantly the range of life-enriching, and potentially even life-saving, treatments and technologies.

But it can’t happen unless we get serious about reforming public policies that limit these opportunities by making innovation difficult if not impossible.

Luckily, change might be on the way. In his first address to Congress, President Donald Trump touched on several signature issues like immigration, infrastructure and health care. But in the middle of his speech, Trump slipped in several paragraphs on a topic that had not received much of his attention previously: the Food and Drug Administration.

Trump proposed “slashing” the restraints that lead to the “slow and burdensome approval process” keeping lifesaving drugs from reaching patients like Megan Crowley, a survivor of a rare disease.

Amid contentious debates over President Trump’s other policy priorities, this is one issue where more widespread, non-partisan agreement should be possible. First and foremost, lives are on the line, and everyone should agree that counter-productive rules and unnecessary red tape should be reformed to avoid more needless suffering or death.

The old system is broken and can’t keep pace with new technological realities. As medical care grows more personalized and decentralized, the FDA will find it increasingly difficult to control medicine and medical devices using the decades-old approval regime. If the FDA doesn’t adapt, not only will we miss out on innovation but our safety may be compromised as well.

The FDA currently requires the vast majority of new drugs and devices to receive a pre-market stamp of approval. This was easier to do in an age when the medical profession was limited to a small number of huge pharmaceutical companies and medical labs. But in an age of 3-D printed prosthetics, mail-order genetic testing, wearable fitness devices, countless smartphone health apps, and even “biohacking” (or medical self-experimentation using new, unapproved technologies), the FDA is slowly losing control.

As one of us (Thierer) pointed out in a recent Mercatus Center paper on this topic, the cost of enforcing the old approval regime grows constantly. Forcing every teen 3-D printing their own braces or every group of fathers making improvements to their children’s insulin pumps to seek the FDA’s blessing before proceeding requires an immense amount of time and money.

Not only is enforcing the old regime increasingly impractical, it also hinders the United States’ potential for greater innovation. Cracking down on new and experimental developments in medicine forces entrepreneurs to go overseas to countries like the United Kingdom. The U.K. offered the genetics company 23andMe a favorable regulatory environment to sell its genetic tests after the FDA sent the company a letter ordering it to cease selling customers any information on diseases for which they may be at risk based on their genome.

The FDA’s drastic action stonewalled American consumers who could have otherwise reaped the benefits — both economic and medical — of the company’s presence. In a world where global innovation arbitrage is becoming a reality, with innovators able to relocate to countries with far more hospitable regulatory regimes, it is essential that U.S. policymakers move quickly to keep cutting-edge innovation here, in the historic epicenter of medical breakthroughs.

Due to these concerns, the FDA should shift its mission toward risk education. New medical technology will bring potential safety concerns, and these ought to be considered seriously — but always alongside the potential benefits.

In an age of decentralized and personalized medicine, the most valuable contribution the FDA can make is ensuring that individuals are empowered with more and better information about the risk trade-offs associated with new medicines and devices. Additional structural changes like global regulatory reciprocity are needed to encourage speedier approval of medical innovation.

Each passing day without reform means lives could be needlessly lost. So far, Congress has failed to consider meaningful reform. Perhaps the president can spur them to greater action. If not, the increasing pace of discovery in medicine will give consumers the ability to acquire the life-saving drugs and devices they need whether those drugs are approved or not. The FDA needs reform soon, or technological growth may render it obsolete.