Earlier this year, President Trump signed legislation a “right-to-try” bill, which allows those with life-threatening illnesses to bypass FDA regulations and take experimental treatments. At the time, CNBC reported that, “Critics say the legislation undermines the FDA’s authority to regulate drugs and could leave patients vulnerable to medicines that might not work or may even be harmful.” The critics are correct. So?
Many medicines don’t work and almost all have some harmful side effects. So? If someone has a life-threatening disease, a side effect is likely the least of their concerns. And if the drug doesn’t work, they are no worse off than they were. But these are relatively minor issues.
The real issue is who should be deciding an individual’s treatment. Should it be the individual in consultation with his doctor? Or should it be a faceless bureaucrats?
Undermining the FDA’s authority is a good thing, and it is long overdue. The regulatory process delays approval of many drugs, resulting in needless suffering and death. It also adds billions of dollars to the cost of developing new drugs, and those costs must eventually be passed on to consumers.
While it is impossible to calculate the precise number of deaths resulting from the delays imposed by the FDA, the Cato Institute estimated that more than 200,000 Americans died between 1967 and 1997 because they were denied access to drugs used elsewhere in the world. As one example, Dr. Louis Lasagna, director of Tufts University’s Center for the Study of Drug Development, estimated that 119,000 Americans died because of the FDA’s seven year delay in approving beta blocker heart medicines. A four year delay in approving a clot-busting drug called tissue plasminogen activator cost an estimated 30,000 lives. How do these delays protect patients? What good is promoted by denying patients access to drugs and leaving them to die.
To read more about the FDA’s policies, click here to download a free chapter from Individual Rights and Government Wrongs.