Report: Trump to sign controversial law granting patients access to experimental drugs

President Donald Trump is slated to approve legislation this week that will give terminally-ill patients access to experimental drugs that haven’t yet been cleared by the FDA.

The “right-to-try” bill has sparked a great deal of controversy among policymakers and patient groups. While some, including the president, describe the effort as offering hope to patients with limited options, others argue that it undermines the FDA’s authority as the regulatory body charged with protecting patients.

Opponents of the legislation have specifically noted that the FDA already has an option for terminally-ill patients seeking investigational therapies: “expanded access” or “compassionate use.” Generally, the FDA advises that people looking to access an experimental drug or device enroll in a clinical trial. But if the patient isn’t eligible for an ongoing trial or there aren’t any ongoing trials, they can request access to the product via expanded access.

The FDA grants 99% of these requests, according to The Hill.

Right-to-try critics also caution that this legislation, which is designed to help patients, could ultimately allow room for companies to take advantage of sick patients.

“The legislation would roll back essential patient safeguards and could result in patients being harmed by unproven, and potentially unsafe, therapies,” a group of patient groups wrote in a letter to lawmakers, according to STAT. “Furthermore, the legislation would significantly restrict FDA’s ability to stop access to an experimental therapy and would remove expert consulting requirements on dosing and other important safety measures currently provided by FDA.”

But right-to-try supporters counter that patients who have limited time should not have to wait for the FDA to move through its own internal processes before deciding if a patient can receive an experimental treatment.

“The Administration believes that treatment decisions for those facing terminal illnesses are best made by the patients with the support and guidance of their treating physicians,” the White House said in a statement last week.

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Theranos whistleblower Tyler Shultz to participate in keynote interview at DeviceTalks Boston At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos. Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston. REGISTER NOW