The Right to Try Act of 2017, S. 204 was passed by the Senate in August 2017. In the months following, the House Energy and Commerce Committee held a hearing on Right To Try, taking testimony from several patient groups and others.
Among concerns was that the legislation, which would permit certain unapproved, investigational drugs to be given to terminally ill patients, did not explicitly include key safety provisions, according to the Association of Clinical Research Organization (ACRO). In an attempt to address these issues, the House passed a revised version of the bill (H.R. 5247) in March of this year.
However, with ensuing pressure, the House took the Senate-passed bill (S. 204) to a vote this week – passing the bill 250 to 169.
The decision sends the hotly-debated bill to the desk of President Trump, who has this morning tweeted that he will sign the “big legislation.”
“Today’s vote is a beacon of hope for the patients who are desperately seeking the ‘right to try’ investigational treatments and therapies. While some Senate Democrats want to block vulnerable patients from accessing investigative drugs, we refuse to let them delay any longer,” said Energy and Commerce Committee Chairman Greg Walden (R-OR) and Health Subcommittee Chairman Michael C. Burgess, M.D. (R-TX) in a press release.
“We look forward to working with the Trump Administration, who have been staunch advocates for this important policy, and the Food and Drug Administration to ensure this soon-to-be law is carried out effectively," the statement continued.
Scott Gottlieb, MD, head of the US Food and Drug Administration (FDA) yesterday tweeted that he is ready to implement the legislation “in a way that achieves Congress’ intent to promote access and protect patients.”
Leading up to the vote, opponents of the bill – including ACRO – continued to express concerns, calling on leadership to “remain committed to making absolutely essential improvements to the Senate bill, as they did with H.R. 5247.”
“Without oversight by the FDA and required reporting of serious adverse events, access to experimental therapies which have not fully demonstrated safety, let alone efficacy, is not only bad science, it is bad clinical practice,” Doug Peddicord, executive director, ACRO, told Outsourcing-Pharma.com.
Additionally, more than 100 advocacy groups sent a letter Monday to Paul Ryan and Nancy Pelosi expressing their “strong opposition” to the bill.
The National Organization for Rare Disorders (NORD) also has issued a statement following today’s passage of the Right to Try Act:
“Today, the House of Representatives passed the Right to Try Act (S.204). We at the National Organization for Rare Disorders (NORD) are sorely disappointed that the House of Representatives has voted to send this legislation to the President’s desk.
We have strongly opposed all Right to Try legislation, as we do not believe that it will safely and genuinely increase access to investigational therapies outside of clinical trials. Unfortunately, this version of Right to Try, S.204, is particularly concerning.”
NORD described S.204 as “devoid of all patient protections” and lacking a standard for informed consent. According to the organization, the legislation also has “a much broader definition of eligibility, and contains vastly weaker reporting requirements.”
“Thus, not only will this legislation be ineffective, as all Right to Try laws are, it will also present a danger to the many patients we represent,” NORD said in the statement.