Bioscience companies along the Denver-Fort Collins corridor could bring "breakthrough" drugs to market sooner under legislation President Barack Obama has signed into law.
The bipartisan measure, which renews the Food and Drug Administration, includes a provision co-authored by Sen. Michael Bennet, D-Colo., cutting the FDA's approval timetable for new drugs.
Supporters say the bill would benefit hundreds of Colorado startups that are developing novel medicines and therapies.
They say the provision could also help severely ill patients who are willing to take experimental drugs that haven't undergone the full battery of tests for all possible side effects and complications.
Wait times for new drugs can last 10 years from the idea stage to the product-delivery stage. Reducing that time would help patients who don't have long to live receive potentially life-saving medicines and therapies quickly, proponents say.
Most drugs would not be covered under the provision. Only the few that the FDA classifies as "breakthrough" would qualify. The FDA also wouldn't be able to cut corners on safety under the proposal.
The agency would have the authority to decide on a case-by-case basis if some aspects of the approval process can be waived for some of the most promising drugs and therapies being developed.
About 600 bioscience companies, research institutions and venture capital groups in Colorado employ about 20,000 people, and the industry continues to grow despite the sluggish economy, according to the Colorado Bioscience Association.
The breakthrough drug provision -- which the FDA supported -- was co-sponsored by Bennet and Republican Sens. Orrin Hatch of Utah and Richard Burr of North Carolina.
The overall FDA bill won overwhelming bipartisan support, a rarity in the sharply partisan Congress. The Senate approved the initial measure 96-1 and the House approved it 387-5. Obama signed the bill on Monday.
"This new law makes much-needed changes to outdated regulations and allows the FDA to focus on the safety and quality of drugs and therapies," Bennet said in a statement.
The leaner regulatory process "will spur innovation, allowing bioscience companies and entrepreneurs in Colorado . . . to more quickly advance life-saving breakthrough drugs and medical devices to patients," he said.
Under the provision, the FDA would have the power to stop a drug from reaching the market and could yank it once it hits the shelves if safety issues arise.