We Need FDA Reform—Just Ask Peyton

We Need FDA Reform—Just Ask Peyton
November 2, 2011

The American medical community consistently creates new drugs and procedures to advance health care. Unfortunately, those advancements face heavy resistance from the Food and Drug Administration (FDA) and often are not accessible to many patients in need. Recently, Indianapolis Colts quarterback Peyton Manning had to fly overseas to receive a stem cell treatment currently unavailable in the United States solely due to federal regulation.

Traveling abroad for treatment is a luxury beyond the reach of most Americans, yet according to the Deloitte Center for Health Solutions, the percentage of Americans who will travel outside of the country for medical care is expected to increase by 35 percent annually, reaching more than one million patients by 2012.

Federal regulation--especially the arduous FDA drug approval process--is stifling health care innovation in the United States. The process now takes up to ten years and costs more than $1 billion for a single drug. Not ten years to develop it, but ten years just to get the federal government to decide whether to approve it. In the meantime, millions of patients wait in unnecessary pain for new drugs to become available, and thousands die in the process.

This system cries out for reforms that will allow patients and doctors to employ new medical treatments without having to leave the country, empty their bank accounts, or wait for care any longer than they absolutely must.

Past attempts at reforming the approval process have been short-lived and of limited success. The FDA has strong incentives to place absolute certainty of safety above cost and, most importantly, above timely access. The press prominently report on deaths and injuries potentially caused by the FDA approving an unsafe drug. But suffering and death from having no suitable treatment because of an overly extensive approval process go unrecognized. Therefore, the FDA always errs on the side of caution, testing more than necessary. Yet, a solution exists that could increase consumer choice, lower prescription drug costs, and lessen the wait for American patients.

It is called Free To Choose Medicine.

Free To Choose Medicine is a dual-track system that would allow patients to make their own informed decisions regarding their personal use of drugs that have passed safety trials but have not yet been approved by the FDA. On one track, the FDA approval process would continue as it does now, and patients who choose to wait for FDA approval before using a drug could do so.

The other track would allow drugs not yet approved by the FDA to be on the market up to five years sooner than they otherwise would be. Patients, after being informed by doctors and aided by information on a pubic database listing potential drug reactions, could then make their own drug use decisions.

New liability rules would protect doctors and drug developers from lawsuits for negative effects of drugs chosen from the Free To Choose Medicine track unless fraud or negligence is found. Patients who select the Free To Choose Medicine track would be more than adequately informed of the greater risk in taking a drug that is not yet FDA-approved, and by making that choice they would waive their right to sue if adverse side effects arise.

Free To Choose Medicine would not affect anyone who doesn’t want to participate, but it would allow people who need drugs already tested for safety to get them. This system would bring more choice to consumers while allowing patients to receive treatment sooner, reducing suffering and saving lives.

Very few of us have the financial resources of a Peyton Manning. That is why the health care industry needs more reforms like Free To Choose Medicine that empower patients, lower health care costs, and increase quality of care.


Kendall Antekeier (kantekeier@heartland.org) is the health care legislative specialist for The Heartland Institute.