The 21st Century Cures Act: More Homework To Do

In July, the US House of Representatives approved the 21st Century Cures Act, which heads to the Senate for a vote this fall. While no one can complain about the Act’s purported goal of “bring[ing] our health care innovation infrastructure into the 21st Century,” or increasing funding for the National Institutes of Health, the optimism surrounding the legislation obscures measures buried within that many agree will make newly approved drugs and medical devices less safe and effective, increase the cost of medical products, and discourage innovation in biomedical research. Long-term value to the public’s health is being sacrificed to the short-term goals of faster Food and Drug Administration (FDA) approvals for drugs and medical devices. Many of the provisions appear to be favorable to the pharmaceutical, biotechnology, and medical device industries, while not providing benefits to patients. We address some of our concerns with the bill below. FDA Is Not The Bottleneck The idea that FDA regulatory processes are a bottleneck to new drug development and approvals is not supported by evidence. An increasing number of people have voiced concern about the quality of biomedical research being produced, including about the lack of reproducibility in research, and the setting of research agendas by those with interests other than public health. This year, the FDA has approved 89 percent of applications for new drug uses, according to Forbes. If this data is any indication, t...
Source: Health Affairs Blog - Category: Health Management Authors: Tags: Costs and Spending Drugs and Medical Technology Featured Health Professionals Hospitals Public Health Quality 21st Century Cures Act Big Pharma Drug approval Fred Upton Research funding Thurgood Marshall Source Type: blogs