Healthcare on the Hill - House Defeats Right to Try Act

March 14, 2018

The “Right to Try” bill failed a vote in the House on Tuesday. After being unveiled over the weekend, the bill was rushed to a vote using a procedure normally reserved for uncontroversial bills. However opposition, primarily from Democrats, lead to the bills defeat.

Fast-track procedures require two-thirds majority for passage and the bill fell short. Two hundred fifty House Members supported the bill and 140 opposed it. Only two Republicans joined 138 Democrats who opposed the bill. Thirty-two Democrats supported the bill along with 227 Republicans.

Opposition to the bill was based on concern for patient safety and the fact that the FDA already has a system in place (Expanded Access) to grant patients access to experimental therapies. The top Democrat on the House Energy and Commerce Committee, Frank Pallone Jr. D-NJ voiced his strong opposition to the bill on Monday.

He said in a statement,

“Rather than rush to pass a bill that was hastily unveiled over the weekend without careful consideration or bipartisan consensus, we should work together to find a sensible path forward that protects patients and upholds FDA’s approval process while ensuring patients, with no other recourse, have access to investigational therapies.”

More than 75 patient advocacy groups also opposed the bill. The group, which included the American Cancer Society and the American Lung Association,  sent a letter to House leaders that expressed “... concern with creating a secondary pathway for accessing investigational therapies outside of clinical trials that would remove Food and Drug Administration (FDA) approval and consultation, and would not increase access to promising therapies for our patients because it does not address the primary barriers to such access.”

FDA Commissioner, Scott Gottlieb said at a congressional hearing in October that the FDA approves 99% of the requests it receives under its Expanded Access program.

“Emergency requests for individual patients are usually granted immediately over the phone and non-emergency requests are generally processed within a few days," he said.”

The barrier to receiving experimental treatment is usually pharmaceutical companies, not the FDA. Companies have a number of reasons why they deny patient requests for experimental drugs.

Often the companies only make enough of the drugs for clinical trials. So they do not have an extra supply of unapproved drugs. Companies claim that making additional amounts of complex new drugs can be expensive and time consuming and may distract the team from the work of getting the drug approved for wide use as quickly as possible.

Additionally, patients requesting access to experimental drugs outside of clinical trials are often among the sickest patients. If these patients have a bad reaction to the drug of if the drug is not able to help them, companies fear that the FDA's and the public's opinion of the drug may be harmed.

The Right to Try bill only granted the right to request experimental drugs. It did not force companies to provide the drugs. However, the bill did shield pharmaceutical companies, doctors, and hospitals from some of the legal jeopardy associated with providing experimental drugs to critically ill patients.

Despite the bill's failure on Tuesday, Republicans will apparently attempt to pass the bill or similar legislation again. House Majority Leader, Kevin McCarthy R-CA, said in a statement, “We will not let this be the end.”

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