Free to Choose Medicine Parallel Track Will Reduce Costs and Save Lives

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By: Sarah Lee

Voters routinely cite rising health care costs near the top of their list of concerns. Finally, Congress has proposed legislation that would address the exorbitant cost of prescription drugs. Another major health care issue Americans want the government to fix is lack of access to potentially lifesaving medications and treatments for patients with terminal illnesses. Fortunately, The Heartland Institute has a solution to this problem: Free To Choose Medicine (FTCM).

FTCM allows patients with debilitating illnesses to work directly with their doctors to access medications that have already passed the Food and Drug Administration’s (FDA) Phase I safety trials. It typically takes 12 years (and billions of dollars) for drugs to be deemed safe by the FDA. Unfortunately, thousands of patients suffer and die each year while waiting for FDA bureaucrats to approve a drug or treatment that could save their lives and relieve their relentless pain and suffering.

Under FTCM, these patients could decide, in consultation with their doctors, to take potentially lifesaving medications placed on a “parallel track.” To help gather real-time data and improve treatment, their experiences would be tracked in a tradeoff evaluation drug database (TEDD).

In theory, FTCM would lower treatment costs by bringing more drugs to the market—a process which typically takes more than a decade and $3 billion—and allow quicker access to medications desperately needed by those suffering from serious illnesses.

Here’s how it works: the “parallel track” offers an alternative to the FDA’s leviathan drug approval process. Certain drugs could be chosen by manufacturers for the FTCM track allowing patients to work with doctors to assess the risk and reward of trying groundbreaking drugs and treatments that have not been fully approved by the FDA. TEDD would provide a pool of  data available to the FDA as well as pharmacists, physicians, and drug makers based upon real-time results.

Although it has not been used recently, the parallel track was vital in combating the AIDS epidemic in the late 1980s. In fact, the FDA implemented a parallel track in 1992 to treat AIDS patients who didn’t have time to wait for experimental drugs to be approved.

Calls to expand the parallel track used during the AIDS crisis have gained momentum. In fact, Senators Ted Cruz (R-TX), Mike Braun (R-IN), Rand Paul (R-KY), and Mike Lee (R-UT) recently wrote a letter requesting FDA consider expanding the parallel track.

“In recent years the FDA has sought to streamline its drug approval process … [h]owever, significant barriers to ready access remain,” the senators wrote. “Despite FDA’s efforts, it still takes on average 10 to 12 years and as much as $2.8 billion to bring a new treatment from lab to patients. Many patients with critical illnesses cannot wait that long. One unused solution that the FDA already has at its disposal is to expand the already existing Parallel Track to other diseases.”

In essence, the senators are calling for a process that would allow patients to work directly with their doctors to decide which drugs they want to try, which is exactly what FTCM would do. The senators note:

Today, millions of Americans are similarly afflicted by or dying from debilitating diseases such as Alzheimer’s disease, cancer, and amyotrophic lateral sclerosis (ALS). Similar to the HIV/AIDS crisis, promising, potentially life-saving drugs for these diseases are mired in Phases II and III of the drug-approval process. Although demonstrating amazing results for the few Americans allowed to participate in clinical trials, these much-needed drugs and therapies remain years and billions of dollars of investment away from FDA approval and full access by patients.

In order to bring these drugs and therapies more quickly and at a lower cost to Americans, we strongly urge the FDA to expand the Parallel Track to target these devastating diseases. Under an expanded Parallel Track, the sponsors of any drug or therapy that has successfully passed safety criteria would have the option to allow patients with critical illnesses—not already enrolled in controlled clinical trials—to access these drugs and therapies after consulting with their doctor.

FTCM would expand this concept even more, while providing a wealth of data to doctors, pharmacists, and the FDA via TEDD.

The FDA should expand the parallel track. Doing so will save lives and relieve needless suffering for thousands of Americans. Even better, FTCM could supplement legislation intended to lower the overall cost of health care. If Congress genuinely cares about the health and desires of the American people, they ought to embrace FTCM, which will reduce costs and put patients and their doctors (not FDA bureaucrats) in charge of life altering health care decisions.

Sarah Lee ([email protected]) is a health care policy advisor for The Heartland Institute.

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