Patients are dying because of Food and Drug Administration (FDA) delays. On average, it takes ten years to approve a new drug. USA Today reports on two brothers with muscular dystrophy. One is taking an experimental medication and doing well. The other brother is unable to get the medication and deteriorating. The Huffington Post reports on a malignant melanoma patient who died while seeking an experimental treatment that he felt might save him.
States are beginning to fight back by giving their citizens the “right to try” experimental drugs. On May 17th, Colorado Democratic governor, John Hickenlooper, signed into law HOUSE BILL 14-1281, the “RIGHT TO TRY ACT.” It declares that, “ (c) PATIENTS WHO HAVE A TERMINAL ILLNESS HAVE A FUNDAMENTAL RIGHT TO ATTEMPT TO PURSUE THE PRESERVATION OF THEIR OWN LIVES BY ACCESSING AVAILABLE INVESTIGATIONAL DRUGS, BIOLOGICAL PRODUCTS, AND DEVICES.
There are naysayers such as bioethicist Ph.D. who wrote a NBCNEWS.com article titled, Bioethicist: ‘Right to Try’ Law More Cruel Than Compassionate. In it, he calls the Act “Flat out cruel” because it gives patients a false sense of hope because the drug companies are under no obligation to supply the medications and the Act makes no provisions for payment. In other words, he would deny lifesaving drugs from those who can pay because some cannot pay.
A www.Forbes.com article, “The False Hope Of Colorado’s ‘Right To Try’ Investigational Drug Law. The author, David Kroll says, “States cannot trump federal drug regulatory authority” but gives no basis for this statement.
If asked, the Kroll would probably refer us to the 1942 Wickard v. Filburn Supreme Court decision. In this decision, the nine lawyers used the Commerce Clause, Article I, Section 8, Clause 3 of the U.S. Constitution. It reads, “ To regulate Commerce with foreign Nations and among the several States.” They reasoned that they could regulate how much wheat a farmer grew to feed his chickens because if he had not grown his own wheat, he would have bought it on the open market. This would have affected commerce among the states.
What the federal government should do is stay within the intent of the Constitution. They can constitutionally regulate or prevent the sale of drugs that cross state or international borders. However, they cannot constitutionally regulate or ban the sale of drugs within a state or another nation.
Georgia also has citizens who are denied possible life saving drugs by the FDA. This should be a non partisan issue. During the next session, our lawmakers, both Democrat and Republican, should consider drafting “Right to Try” legislation. They should also add a section that say if the drug is made and sold in Georgia, the FDA has no regulatory authority.