What lame duck? What gridlock? Legislation in Washington too often crawls, stalls, or dies, but the 21st Century Cures Act rushed through Congress to President Obama’s desk, where he signed it yesterday. Almost everybody likes this law, the Washington Post reports, except for patient advocacy groups who worry that it speeds up FDA approval for new drugs at the expense of safety and efficacy. Detractors also point out that the United States already has one of the fastest drug approval processes in the world.
The pharmaceutical industry argues that allowing the FDA to include real-world evidence in its approval process will break the bottleneck to keeps drugs and medical devices from the patients who need them. The act defines real-world evidence as data coming from sources other than randomized trials. A draft guidance is due in five years. The bill also creates a smoother path for the approval of regenerative medicine and lets the makers of antibiotics test their products on small groups of patients.
Source: Washington Post