President Trump on Wednesday signed legislation into law that gives patients the “right to try” experimental drugs, cementing a major policy priority for the White House.
“For many years patients, advocates and lawmakers have fought for this fundamental freedom and incredibly they couldn’t get it,” Trump said just before signing the bill. “And there were reasons. A lot of it was business, pharmaceuticals, a lot of it was insurance, a lot of it was liability and so I said you take care of that stuff. And that’s what we did.”
The bill gives a terminally ill patient an avenue to try an experimental drug that has gone through the first of three clinical trials required for Food and Drug Administration approval. The first clinical trial reviews whether or not a new drug is safe, but not if it is effective.
Proponents say the bill gives terminally ill patients a chance to improve their condition if they have exhausted all FDA-approved treatments. Critics say that the bill instills false hope in those patients because the drugs haven’t been fully vetted to be effective yet and may be safe.
The FDA already has a program called compassionate use that approves 99 percent of requests from patients for access to experimental products. Right-to-try would bypass that program and not require a patient to apply with the FDA to get approval to seek access to an experimental drug.
But neither compassionate use nor the new law requires the drug company to provide the experimental product.
Drug companies are often reticent to provide their product outside of a clinical trial, since terminally ill patients that seek a product through compassionate use are traditionally sicker than those who are in a clinical trial.
Drug companies are worried that any deaths from taking the drug outside the clinical trial could imperil FDA approval.
The new bill doesn’t mandate that drug companies provide the products, but it does let the FDA ignore deaths outside a clinical trial. Proponents hope that may be enough to get drug makers to provide the products.
So far, 40 states have passed their own right to try laws, among them was Indiana signed by Vice President Pence while he served as governor.
