Concerns Over Newly-Passed Right-to-Try Legislation Were Front and Center During BIO
Published: Jun 14, 2018 By Alex Keown
Days after President Donald Trump signed the Right-to-Try legislation there are still many uncertainties about the law – key among those concerns is who will pay for the treatments should a terminally ill patient be given access to an experimental drug and who will administer the treatments.
Some of those concerns were on display at BIO in Boston last week. Forbes noted that the chief executive officers of some biotech companies were “overheard fretting about the new law—and the resources they would have to pour into handling a potential flood of requests from desperate patients.” Forbes did not note which executives of companies expressed concern about the law, nor did it elaborate on the additional resources that companies could have to use to handle requests under the law.
Requests are already coming into multiple companies. Israel-based BrainStorm issued a press release last month noting that it has received numerous Right-to-Try requests from patients for its Phase III experimental amyotrophic lateral sclerosis therapy NurOwn.
During a question and answer session with U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, Jim Greenwood, president of Biotechnology Innovation Organization (BIO) the CEO of a privately-held oncology company said he had received a threatening telephone call over the right-to-try. The unnamed CEO said the daughter of a pancreatic cancer patient demanded the right to try the unnamed company’s experimental treatment. The woman obtained the CEO’s cellular telephone number from the company’s website, MedCity News reported. The CEO said the woman became “obnoxious” and angry when he told her that her mother’s physician would have to fill out a compassionate use request form on his company’s website.
Additionally, the CEO told Gottlieb that since the legislation was passed May 30, the company has received 10 requests for the right-to-try its experimental drugs. While the one phone call was the only concerning one that was reported, the unnamed CEO expressed concern that the Right-to-Try law could hurt recruitment for future clinical trials. He said it would “obviate the need for patients to join the trials,” MedCity News said.
Forbes also noted that a BIO panel discussion was led by Takeda Pharmaceutical’s chief counsel, Liz Lewis “on the legal implications of giving patients early access to drugs outside the strictly monitored confines of clinical trials.” The legislation allows terminally ill patients to appeal for access to those medications that could save their lives, as long as they have cleared Phase I of clinical testing.
The appealing patients would not be considered part of the clinical trial and any adverse reactions to the experimental medications taken by the terminally ill patients will not affect clinical review.
While the patients have a right to seek out the medications, the law does not require companies to provide the medications to those patients. There is also nothing in the legislation about who will pay for the medications. The legislation does not compel drug companies to give those experimental drugs to patients. Insurance companies may also not be required to cover the treatments, which could leave the patients on the hook for medications that could run well over $100,000.
Forbes spoke with Gregory Pence, a professor of bioethics at the University of Alabama at Birmingham, who also raised several other concerns about the Right-to-Try legislation. Who will supervise the administration of the drugs to patients outside of clinical trials? If a personal physician is required to do so, will their malpractice insurance rates have to be revised due to the risks? How will the medications be delivered to patients granted access to the drugs under Right-to-Try?