Swordsmyth
12-24-2019, 06:56 PM
Four Republican lawmakers have authored new legislation to permit drugs for critically ill patients to enter the market before completing late-stage trials, saying the bill was necessary because the U.S. Food and Drug Administration's regulatory process was too slow and burdensome.
The bill would create a time-limited conditional approval pathway in the U.S. similar to a system that has long been used by European regulators.
The House bill is sponsored by Republican Reps. Bruce Westerman of Arkansas, Mike Gallagher of Wisconsin and Tim Burchett of Tennessee. Sen. Mike Braun, R-Ind., authored the Senate legislation.
The conditional approval would be valid for one year and could be renewed annually for up to five years. The pathway is intended for new products to treat, prevent or medically diagnose seriously debilitating or life-threatening diseases or chronic conditions that lack meaningful treatments.
The therapy's expected benefits must also outweigh its potential risks. Companies would be required to meet certain obligations, like completing clinical investigations to provide full demonstration of safety and effectiveness and other studies.
Manufacturers would also have to demonstrate that necessary postmarket surveillance and risk management tools were in place.
The products would be required to state in their labeling and promotional materials that they are conditionally approved by the FDA pending a full demonstration of effectiveness.
Companies could seek full U.S. approval at any time. The FDA would be required to let manufacturers include in their applications the real-world evidence they collected during the conditional approval period.
Even though the FDA has had an accelerated approval process in place since 1992, the four Republicans said that regulatory pathway is not sufficient to speed promising therapies to patients with life-threatening and debilitating diseases that lack effective treatments and cures, such as amyotrophic lateral sclerosis.
"Sometimes these medicines are backlogged in a bureaucratic, expensive FDA process that delays them from coming to market faster," Burchett said in a Dec. 19 statement.
"Patients with fatal diseases are fighting for their lives every day while real, meaningful, life-extending treatments sit on the shelf just beyond their reach," Braun added.
The lawmakers want the FDA to be able to grant the limited marketing authorization to new drugs that have successfully completed phase 1 and 2 trials, with the idea that companies could generate revenue to help fund their phase 3 studies.
They emphasized their legislation is targeted especially at small biopharmaceutical companies that may struggle to cover the costs of late-stage trials.
More at: https://www.spglobal.com/marketintelligence/en/news-insights/trending/r7auraq5UKsQT1xqJUZdhw2
The bill would create a time-limited conditional approval pathway in the U.S. similar to a system that has long been used by European regulators.
The House bill is sponsored by Republican Reps. Bruce Westerman of Arkansas, Mike Gallagher of Wisconsin and Tim Burchett of Tennessee. Sen. Mike Braun, R-Ind., authored the Senate legislation.
The conditional approval would be valid for one year and could be renewed annually for up to five years. The pathway is intended for new products to treat, prevent or medically diagnose seriously debilitating or life-threatening diseases or chronic conditions that lack meaningful treatments.
The therapy's expected benefits must also outweigh its potential risks. Companies would be required to meet certain obligations, like completing clinical investigations to provide full demonstration of safety and effectiveness and other studies.
Manufacturers would also have to demonstrate that necessary postmarket surveillance and risk management tools were in place.
The products would be required to state in their labeling and promotional materials that they are conditionally approved by the FDA pending a full demonstration of effectiveness.
Companies could seek full U.S. approval at any time. The FDA would be required to let manufacturers include in their applications the real-world evidence they collected during the conditional approval period.
Even though the FDA has had an accelerated approval process in place since 1992, the four Republicans said that regulatory pathway is not sufficient to speed promising therapies to patients with life-threatening and debilitating diseases that lack effective treatments and cures, such as amyotrophic lateral sclerosis.
"Sometimes these medicines are backlogged in a bureaucratic, expensive FDA process that delays them from coming to market faster," Burchett said in a Dec. 19 statement.
"Patients with fatal diseases are fighting for their lives every day while real, meaningful, life-extending treatments sit on the shelf just beyond their reach," Braun added.
The lawmakers want the FDA to be able to grant the limited marketing authorization to new drugs that have successfully completed phase 1 and 2 trials, with the idea that companies could generate revenue to help fund their phase 3 studies.
They emphasized their legislation is targeted especially at small biopharmaceutical companies that may struggle to cover the costs of late-stage trials.
More at: https://www.spglobal.com/marketintelligence/en/news-insights/trending/r7auraq5UKsQT1xqJUZdhw2