March 26, 2018 Reading Time: 3 minutes
Ever since its creation in 1906, the FDA has played the role of gatekeeper in the provision of pharmaceuticals, ultimately deciding which medications and treatments will be legally available to consumers. (Michael J. Ermarth)

In a twisted display of devotion to state bureaucracy, a significant bloc of US congressmen recently sided with the Federal Drug Administration (FDA) by scuttling right-to-try legislation for terminally ill patients.

Right-to-try laws give patients the opportunity to try medications that have successfully gone through phase one of the FDA approval process but are not officially on the market yet. They expedite access to potentially life-saving treatments that would normally take years to be available on store shelves.

This policy is active in 38 states, and now some legislators want a federal version of this law to make sure that the FDA does not override states. Right-to-try advocates can count on support from President Donald Trump, who has recently stated that terminally ill patients “should have access to experimental treatment immediately that could potentially save their lives.”

Unfortunately, the political class in Washington, DC, would rather maintain the status quo of leaving patients clinging to their very lives and at the mercy of bureaucratic delays.

These delays are not merely a coincidence, but rather the result of the FDA’s bureaucratized nature. Ever since its creation in 1906, the FDA has played the role of gatekeeper in the provision of pharmaceuticals, ultimately deciding which drugs and treatments will be legally available to consumers.

They must all go through a three-step approval process:

  • Phase 1: The medication is administered to a small number of healthy individuals—20-80 volunteers—or people who share the same condition. This can last several months.
  • Phase 2: The population of patients is expanded to include several hundred people with the condition that the medication intends to treat. This can span several months to two years.
  • Phase 3: Last but not least, the FDA employs potentially thousands of volunteers to determine the efficacy and potential adverse side effects. All in all, this final phase takes one to four years to complete.

Drugs that fail to pass through all these phases do not end up on the market, irrespective of their potential benefits. While this process seems straightforward, it simply does not deliver in meeting the needs of the chronically or terminally ill.

In fact, the FDA’s standard operating procedure is a cruel endeavor toward languishing patients who do not have the luxury of waiting. For many, their very survival is hanging in the balance by a matter of weeks or months, not years.

Sadly, soulless bureaucracies tend to overlook this. The infamous Charlie Gard case serves as a lurid reminder of the kind of cruelty health bureaucracies are capable of. Instead of allowing the terminally ill infant to undergo an experimental treatment in the United States, bureaucrats at the United Kingdom’s National Health Service (NHS) rejected Gard’s parents request to travel.

Thanks to the heavy-handed NHS bureaucracy, Gard tragically succumbed to his illness.

Examples of this type are hardly confined to the United Kingdom. Many patients find themselves in similar positions, left writhing in agony due to the FDA’s mandates. These are the system’s forgotten victims—the thousands of terminally ill patients whose very lives are in jeopardy due to petty bureaucracy.

Reason writer Ronald Bailey illustrated some of the unseen consequences of the FDA’s overreach: “If it takes the FDA 10 years to approve a drug that saves 20,000 lives per year, that means that 200,000 people died in the meantime.”

There is simply no telling how many people die on a yearly basis as the result of the FDA’s restrictions. Furthermore, the agency’s obsession with safety could be preventing us from enjoying a higher quality of life.

Columbia University economist Frank Lichtenbeg contends that the increase in life expectancy from 1960 to 1997—69.7 to 76.5 years—is largely attributed to “increased drug approvals.” One could only imagine the wonders that an unfettered drug market would do for overall living standards, especially for the terminally ill that need it most.

Critics argue that right-to-try is too risky. But let’s face it, a country like the United States did not become as prosperous as she is by being risk-free. Audacity and risk-taking are necessary for a society to move forward.

For the sake of progress and common decency, it’s high time that policymakers start reconsidering the FDA’s role in the approval process for medical treatments. Thanks to this bureaucratic status quo, countless loved ones and friends must undergo needless suffering. How about we give right-to-try laws a chance.

José Niño

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