ASCO Does Not Support 'Right-to-Try' Laws

Pam Harrison

April 06, 2017

The American Society of Clinical Oncology (ASCO) is all in favor of helping cancer patients have greater access to new treatment options outside of clinical trials when all other options have failed, but "right-to-try" (RTT) legislation is the wrong way of doing it, a new position paper states.

"We don't support right-to-try legislation because these laws ignore key patient protections without actually improving patient access to investigational drugs outside of clinical trials," ASCO Chief Medical Officer Richard Schilsky, MD, said in the statement, which was issued online April 5.

"Most RTT laws, while well intentioned, are not an effective mechanism for improving access to investigational drugs for terminally ill patients and may cause unintended harms," he concludes.

To date, 33 states have passed RTT laws, which allow patients to seek access to investigational drugs directly from drug manufacturers without any oversight from the US Food and Drug Administration (FDA) and without the FDA's necessary safeguards.

"ASCO is concerned that existing and proposed RTT laws do not adequately protect patients, do little to facilitate patient access to such therapies, and potentially interfere with recent reforms that are already streamlining patients' access to investigational agents," according to the statement.

The main flaw in the RTT legislation is that it does not compel drug manufacturers to provide the requested investigational drug, ASCO notes. In other words, these laws do not remove a fundamental barrier to access investigational drugs.

 
Sometimes I call these 'right-to-beg' laws. Dr Art Caplan
 

"Sometimes I call these 'right-to-beg' laws," Art Caplan, PhD, NYU Langone Medical Center, New York City, commented in a recent Medscape video, in which he argued against the RTT laws.

"You have a right to request something from a company, but it does not mean that they will give you the drug," he adds. "The laws feel good and sound good...but they don't achieve much in terms of getting people access."

Indeed, Dr Caplan suggests that none of these laws that have been enacted so far have facilitated a single person's gaining access to an experimental drug.

"These drugs are trying to go around the FDA, but the FDA doesn't control access to experimental drugs...and there is nowhere in these laws that says that the company must supply the drug if a patient asks for it," Dr Caplan told Medscape Medical News in a report on RTT laws.

ASCO agrees with this viewpoint, adding that RTT laws place no legal obligation on insurers to pay costs for routine care associated with the delivery of an experimental treatment or for treatment of complications caused by it.

Thus, RTT laws establish no new rights or protections for patients, ASCO emphasizes.

Furthermore, RTT laws bypass reviews that are currently mandated by the FDA to ensure patient safety.

A new bill that was introduced in the Senate, the Trickett Wendler Right to Try Act of 2016, would prohibit the FDA from preventing or restricting access to unapproved products when a patient has a terminal illness and lives in a state where an RTT law is in place.

But in their position paper, ASCO argues that the Trickett Wendler Right to Try Act of 2016 may jeopardize patient safety.

ASCO also suggests that the proposed law is largely unnecessary, given that the FDA has recently done much to streamline their expanded-access program, the sole purpose of which is to grant patients access to experimental drugs outside of clinical trials in as little time as possible.

This streamlining process seems to work well: In 2016, the FDA approved virtually all of the expanded access requests it received with a median approval time of 4 days for nonemergency cases, according to ASCO.

Another potential harm associated with RRT laws is that terminally ill patients stand to lose their right to access hospice care when in need.

"Once in hospice, you have to give up medical treatment," Dr Caplan pointed out. "So if a dying patient starts using an experimental drug, it may mean leaving hospice. That is something that also needs to be addressed," he added.

Provisions in the 21st Century Cures Act aim at improving the current FDA expanded access policy, which ASCO fully endorses.

These provisions would require drug manufacturers to make their expanded access policies publically available, along with contact information. They would also mandate that manufacturers specify the length of time they anticipate would be necessary to acknowledge receipt of the patient's request.

"As the leading medical society for physicians involved in cancer treatment and research, ASCO supports access to investigational drugs outside of clinical trials when there are adequate patient protections in place," the society points out in its statement.

The society has taken a stance against the RRT legislation because "these laws as currently envisioned and enacted will interfere with already-streamlined and effective protocols, potentially putting patients at high risk for unclear benefit."

ASCO. Position statement on access to investigational drugs. Published online April 5, 2017. Full text

Follow Medscape Oncology on Twitter for more cancer news: @MedscapeOnc

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....