As the 2020 election creeps closer, candidates are focusing increasingly more on solving one of the most vexing problems Americans regularly encounter: the incredibly high cost of prescription drugs.
Politicians on both sides of the aisle have recommended policies aimed at bringing down the cost of prescription drugs. However, their so-called “solutions” rarely address the root problem: the U.S. Food and Drug Administration’s antiquated drug approval process.
Fortunately, The Heartland Institute has a plan that will bring new drugs to market faster and at a reduced cost to the consumer. The plan would reform FDA’s approval process and offer an option for patients to try new drugs deemed safe by FDA after those drugs pass their initial trials.
Aptly named Free to Choose Medicine (FTCM), the program — which was developed by independent researcher Bartley Madden — would offer a parallel drug approval track that would reduce the 10-12 years and $3 billion it currently takes to bring a new drug to market. Unfortunately, these costs are borne by patients in exorbitant drug prices, needless suffering or even death.
Under FTCM, new drugs would have to pass initial safety tests and at least one efficacy trial. Then drug sponsors could choose to offer them on the FTCM track. Patients who wish to access those potentially life-saving medications would have the option, in consultation with their physician, to use the FTCM track drugs. Patient information would then be logged in a “Tradeoff Evaluation Drug Database,” which would include significant patient privacy protections. This key element would allow patients and their doctors to make informed choices about treatments, and the information could be used by FDA to supplement or even supplant clinical trials for certification.
Simply put, FTCM can bring drugs to market in a more efficient and safer manner than the FDA status quo. And, perhaps most important, patients would have the opportunity to make their own individual choices about what’s best for them as they fight serious illnesses.
Some FTCM detractors might attempt to argue that this is a completely untried approach, but that’s not accurate. A similar, albeit limited, version of the plan successfully helped to deal with the onslaught of the AIDS/HIV epidemic in the early 1990s. At its peak, the AIDS/HIV epidemic killed 50,000 Americans per year. To address the crisis, the U.S. Department of Health and Human Services created a parallel track program in 1992 that allowed 12,000 patients to access a life-saving medication that was still in FDA-mandated clinical trials three years ahead of final approval.
More recently, Japan adopted a system similar to FTCM. In 2014, that country’s government, concerned about its aging population, recognized it needed to reform its approval process for new drugs and therapies. Later that year, Japan adopted something similar to the FTCM regime for regenerative medicine products that could be reimbursed under the country’s health insurance system.
Edward Hudgins, research director at The Heartland Institute, wrote about Japan’s version of FTCM based on Madden’s vision, calling it “the right idea at the right time.”Although FTCM is a groundbreaking approach, it is neither radical nor irresponsible. FTCM would authorize access to treatments already certified as safe and that have passed at least one efficacy trial. FTCM would allow individuals to choose whether to participate in the program. No longer would Americans be forced to suffer or die while waiting for years for FDA’s slow-moving, broken regulatory system to deliver potentially life-saving treatments.
In early 2019, The Heartland Institute presented FTCM to members of the Trump administration and lawmakers on Capitol Hill. Fortunately, Trump administration officials and members of Congress were very receptive to the idea of FTCM legislation. FTCM could be adopted if the executive branch offers it as a regulatory change — the way the parallel track for AIDS drugs was created — or through legislation.
In the run-up to the 2020 election, Americans should press policymakers to recognize the value of not only reducing the cost of prescription drugs to consumers but also in putting health care choices back where they belong: in the hands of the individual. Fortunately, FTCM can achieve both these goals.