Congress Wrestles With Medical Research Funding, FDA Approval Processes
Medical research advocates warn Congress about the dire impact that automatic spending cuts scheduled to take effect in January would have on efforts to control disease and develop life-saving treatments. Also in the news, how the concept of "fast-track" Food and Drug Administration approvals is playing on Capitol Hill.
The Hill: Advocates Warn Automatic Cuts Would Hit Medical Research
Automatic federal spending cuts set to take effect in January would threaten U.S. leadership in the field of medical research, risk the spread of disease and delay treatments for patients, a report out Friday warned. Advocates with Research!America argued that sacrificing research investments for deficit reduction would also be a bad economic move (Viebeck, 5/11).
The Fiscal Times: FDA Cuts A Deal To Fast Track Drugs And Devices
In sections of the bill that deal with regulations at the agency, Congress plans to give companies working on drugs for life-threatening conditions an easier pathway to accelerated approval, a classification created in the early 1990s during the AIDS crisis. Accelerated approval, which is based on so-called surrogate markers that are likely to lead to better outcomes, postpones definitive clinical trials proving effectiveness until after the drug hits the market. ... The device industry achieves its major goals in the bill through subtraction (Goozner, 5/11).