The 21st Century Cures Act Gets A Mixed Reception

Last week, the House Energy and Commerce Committee unanimously passed the 21st Century Cures Act, a new bill that will help fund medical research and relax regulations related to the discovery, development and delivery of new drugs. While some consider the new bill as a major step forward for the industry, where the cost of developing new drugs has skyrocketed; others say the bill puts the public in danger as it doesn't require the meticulous testing that has been necessary in the past. Funding Change The bill offers incentives for scientists working on drugs that are important to the industry as a whole. The act dedicates government dollars to researchers working to develop precision medicine drugs and antibiotics that combat resistant strains. The legislation also supports the creation of a massive genomic database that will use large volumes of genetic data in order to help in the push toward developing precision drugs that target a specific gene. Safety Questions Public safety groups have questioned the safety of such a bill, saying that allowing drugs to be approved by the Food and Drug Administration without full clinical testing creates a risk for patients. If passed, the bill would allow high-risk medical devices like pacemakers to gain approval without a full clinical study, something many say could create a dangerous precedent. Biotechs On Board? While biotech companies initially saw the bill as good for the industry as an initial draft extended market exclusivity rules for new drugs. However, those offers were dropped in the final version of the bill, leaving the biotech industry with little reason to back the bill. The Energy and Commerce Committee recently requested financial support for the bill from the Biotechnology Industry Organization, something the group is unlikely to offer without any benefits.