Aug 17, 2016
Patients Need the Right to Try
Post by Freedom Partners
Last week, Indiana Governor and potential vice president Mike Pence shared a moving and emotional moment with an 11-year old boy whose father has Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s disease.
The young man has asked Governor Pence about enacting a federal right-to-try law similar to what he signed into law in Indiana. Such a law would allow terminally ill patients who have exhausted all other avenues to take potentially life-saving drugs that have not received federal approval.
Such a law is long overdue: The FDA’s approval process for drugs is downright inhumane. It inhibits patients in dire situations from taking appropriate risks to save their lives.
The FDA’s process is absurdly complicated and costly. The full process of bringing a potential new drug to market can take as long as 19 years – a staggering amount of time. As for cost, Tufts University recently estimated it costs an average of $2.6 billion to get a drug approved. Shockingly, only 19 percent of drugs actually make it past all three stages of clinical trials.
Many research companies can’t afford to make it through this process, which is more about checking bureaucratic boxes than saving lives. The result is a loss of countless drugs and potentially even cures that could have given patients with terminal illnesses a new lease on life.
Tellingly, the FDA itself realizes that non-approved drugs can save lives, which is why there is a “compassionate use” exemption process. But these exemptions are themselves tremendously onerous. In fact, 99 percent of the applications are never finished because they can take up to 100 hours to complete. Not to mention, drug companies are usually hesitant to participate in “compassionate use” exemptions because a drug failure or complication could jeopardize a drug’s approval.
Clearly, the current system is a loser for patients. We can do much better to restore hope to patients that so desperately need it. By passing right-to-try legislation, the federal government can restore to patients the hope that they so desperately need.