As always, actions speak louder than words. The administration has succeeded in speeding up the drug approval process and has brought additional transparency to both the FDA review process and the drug supply chain. These moves will result in broader access to less expensive medicines for patients.
FDA Commissioner Scott Gottlieb has cut red tape and bureaucratic inefficiencies at the agency. As a result, the FDA approved a record number of generic drugs in 2017. New drug approvals also hit a two-decade high.
Dr. Gottlieb has also supported advances in "adaptive clinical trials," which allow medical researchers to adjust drug trials in real-time, rather than start from scratch each time they make a discovery. This will shave years off the approval process and reduce research and development costs — thereby making R&D (a very high-risk investment) more attractive to both start-up and established companies.
More research will ultimately result in more drugs on the market and manufacturers will have to discount their medicines to win market share.
President Trump has made good on his promise to provide the FDA with the resources it needs to speedily review drug applications for both new and generic medicines. Last summer, he reauthorized the Prescription Drug User Fee Act, which allows the FDA to charge drug makers over $2 million per application. These fees enable the FDA to hire enough scientists to reach decisions about new drugs more expeditiously.