Right to Try Act of 2018 - H.R.5247
Right to Try Act of 2018 - H.R.5247

Right to Try Act of 2018 - H.R.5247

Published Friday, March 23, 2018

The House passed H.R.5247 that would allow eligible patients to seek access to drugs, through drug manufacturers, that have not yet been cleared by the Food and Drug Administration (FDA). The measure specifies that, in order to be eligible, a patient must be diagnosed with a disease or condition from which they are likely to die within a matter of months, or one that causes significant irreversible morbidity likely to lead to a severely premature death. The bill specifies that any such drugs that patients could try would need to have completed phase-one clinical trials, not have been approved or licensed for any use, and would need to currently be under an active FDA application or undergoing clinical trials.

The Senate passed a version of the "right-to-try" proposal S. 204 in August, but it stalled in the House over concerns about patient safety and whether the bill would provide any new benefit for patients. President Donald Trump called for swift passage in his State of the Union address in January.

House Energy and Commerce Republicans introduced an updated version early Saturday morning that they said sought to balance patient access and protections. The bill was a result of compromise between the committee leadership and right-to-try champions Sen. Ron Johnson and Reps. Andy Biggs and Brian Fitzpatrick.

Changes, like requiring swifter reporting to FDA of adverse events, received praise from those who have opposed the legislation. But most said flaws in the bill still outweighed the added protections.

"Regardless of the specifics of this bill, like all federal and state right-to-try efforts, this bill addresses a problem that doesn't exist," said Patti Zettler a professor at Georgia State University and former associate chief counsel at FDA. "I worry that this bill both sells false hope to patients and misleads the public about the importance of FDA oversight of medical products."

The new House bill was endorsed by the Goldwater Institute, the libertarian think tank that spearheaded the right-to-try movement.

"We are a resilient and resourceful nation, and when faced with long odds, Americans should be given the opportunity to harness our country’s vast medical innovation by accessing experimental treatments," House Majority Leader Kevin McCarthy said in a statement. He urged the Senate to act swiftly on the updated bill following presumed House passage.

The Senate right-to-try bill passed with unanimous consent, but it may face more opposition from Democrats in the House. Energy and Commerce ranking member Frank Pallone said he will not vote for the bill.

Floor Situation

On Tuesday, March 13, 2018, the House will consider H.R. _____, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018, under suspension of the rules. The bill was introduced on March 9, 2018, by Rep. Brian Fitzpatrick (R-PA).

Summary

H.R. ____ authorizes the use of eligible investigational drugs by patients who have been diagnosed with a certain illnesses, exhausted approved treatment options and is not eligible to participate in a clinical trial.

The bill defines an eligible patient as those with “a stage of a disease or condition in which there is reasonable likelihood that death will occur within a matter of months, or a disease or condition that would result in significant irreversible morbidity that is likely to lead to severely premature death.”

The legislation allows for investigational drugs to be used if they have completed phase 1 of clinical trials, they have not been approved or licensed for any use under the Public Health Service Act, and an application has been filed that is active under the Public Health Service Act. The legislation removes liability on the manufacturer, sponsor, physician, hospital, or clinical investigator if the above conditions are met and there are not additional factors such as willful, criminal, or reckless misconduct or gross negligence, and removes liability if such an entity makes the determination not to provide the investigational drug.The bill requires doctors for such patients to report “serious adverse events” from the drug to the manufacturer. The legislation also strengthens patients protections with clearer informed consent and real-time adverse event reporting as well as a standard to notify the Food and Drug Administration (FDA) when a patient receives an unapproved drug through the new alternative pathway. The liability protections apply to both the existing expanded access program as well as the new alternative pathway, leveling the playing field by removing a perverse incentive to choose on program over the other.

Background

The Food and Drug Administration (FDA) regulates the U.S. sale of drugs and biological products, basing approval or licensure on evidence of the safety and effectiveness for a product's intended uses. Without that approval or licensure, a manufacturer may not distribute the product except for use in the clinical trials that will provide evidence to determine that product's safety and effectiveness.

Under certain circumstances, however, FDA may permit the sponsor to provide an unapproved or unlicensed product to patients outside that standard regulatory framework. Two such mechanisms are expanded access to investigational drugs, commonly referred to as compassionate use, and emergency use authorization. Although FDA granted over 99% of the expanded access requests it has received since 2010, patients and others point to what they see as FDA-created obstacles to access. In February 2015, FDA released draft guidance and a new form that, when finalized, would reduce the amount of information required from the physician. Since 2014, 38 states have passed so-called right to try laws to bypass FDA permission for access to an investigational drug.

The Senate passed similar legislation in August. The Senate bill has broader language that states a patient “with a life-threatening disease or condition […] who has exhausted approved treatment options” may receive access to a untested drug if a doctor certifies it is necessary.

Cost

A Congressional Budget Office (CBO) estimate is not currently available.

H.R.5247 - Right to Try

The House and Senate have passed S. 204, thus clearing it for the president, a bill that would have given terminally ill patients the right to seek drugs that remain in a clinical trial phase and are not yet fully approved by the Food and Drug Administration. 

Suggested Text

Thank You:

Thank you for passing the "Right to Try" bill, giving terminally ill patients the right to seek drugs that remain in a clinical trial phase and are not yet fully approved by the Food and Drug Administration. 

Opposition:

I oppose S.204 the "Right to Try" bill, and would like to know why you voted for it?

Additional Information:

Would allow patients with life-threatening diseases or conditions who are not participating in clinical trials to seek access to experimental and investigational drugs directly from a drug manufacturer, without approval by the Food and Drug Administration. It would require that in order for the patient to be eligible, the patient must first try all approved treatment options and be unable to participate in a clinical trial. Only drugs that have completed phase 1 clinical trials, that have not been approved or licensed for any use, and that are currently under an active FDA application or are undergoing clinical trials would be eligible for use under the bill's provisions.

Do you support this bill? If so, tell your Member of Congress thank you for voting for passage.

Right to Try Act

The House passed (267-149) the "Right to Try" Act (H.R. 5247), a bill that would give very sick patients the ability to request access to experimental medicines without going through the FDA. The bill now moves to the Senate.

Do you think the Senate should pass H.R. 5247 the "Right to Try" Act?


Bill Summary

H.R. 5247 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018



S. 204 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017



Related Votes

Right to Try Act (H.R.5247) - House Passage



Experimental Drugs for Terminal Illness (H.R.5247) - House Passage (Failed)



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