Lawmakers Call for Federal Right to Try Expansion
“The goal should not be maintaining an exceedingly expensive—in time and money—status quo, clinical trial process.”
A dozen members of Congress signed a letter to acting U.S. Food and Drug Administration (FDA) Commissioner Ned Sharpless urging the agency to broaden its discretion on the federal Right to Try track beyond HIV and AIDs, focusing renewed public attention on the Free to Choose Medicine (FTCM) movement.
Right to Try was signed into law in 2018 and allows patients with life-threating diseases access to investigational drugs meeting certain criteria. FTCM promotes the idea of allowing patients and their doctors to decide whether to use experimental drugs that have passed Phase 1 safety and one or more Phase II efficacy trials in the lengthy FDA approval process.
A debate has emerged over whether drug companies should be able to profit from drugs at the experimental stage. Without a profit incentive, drug companies may be reluctant to release their experimental products to the public. If they can market early, there is concern drug companies would have less interest in conducting additional trials.
University of Richmond medical ethicist Jessica Flanigan told Bloomberg Lawthe concern about marketing drugs before they are known to be effective is no different from the current situation.
“People can already access drugs that have not been tested for efficacy when they use drugs off-label,” Flanigan said.
Drugs to Patients Sooner
The debate over marketing has shed light on the drug regulatory system in general, says Bart Madden, author of Free to Choose Medicine: Better Drugs Sooner at Lower Costand a policy advisor to The Heartland Institute, which publishes Health Care News.
“The goal should not be maintaining an exceedingly expensive—in time and money—status quo, clinical trial process,” said Madden. “Rather, the goal should be to deliver better drugs, sooner, at lower cost. The comprehensive FTCM plan has multiple parts designed to work together to optimize the entire drugs-to-patients system and deliver better drugs, sooner, at lower cost.”
A Real-Life Database
Real-life data from early release of investigational drugs is one of the key features of FTCM, says Christina Herrin, FTCM campaign director for The Heartland Institute.
Herrin says part of the FTCM plan is a tradeoff evaluation drug database (TEDD) in which doctors provide a patient’s drug treatment results, plus genetic and biomarker information, as a condition of participation in the program.
“This would help patients and doctors make better-informed decisions if they choose an FTCM track,” said Herrin. “They could match their potential for improvement based on the experience of others. This is more than the current tracking system provides.”
TEDD would make for a better decision-making process all around, says Madden.
“TEDD can enable patients, advised by their doctors, to make informed decisions,” said Madden. “It can identify subsets of patients who respond especially well or poorly to the FTCM drugs and would improve the research and development decisions of biopharmaceutical companies.”
FTCM would also make drug development more competitive, says Madden.
“Drug companies would be motivated to charge lower prices in order to obtain higher usage and more-comprehensive TEDD data,” said Madden.
AnneMarie Schieber (firstname.lastname@example.org) is managing editor ofHealth Care News.
Free to Choose Medicine: https://www.heartland.org/Center-Health-Care/free-to-choose-medicine/index.html