Two years ago, Congress turned the Food and Drug Administration Safety and Innovation Act into law. Now, regulators with the administration want to know if there is more the Food and Drug Administration can do. For the uninitiated, the FDASIA was developed to contain patient-centered provisions that would hopefully impact the FDA in a positive way by facilitating big changes to regulation attempts.
Two programs under the FDASIA have the potential to create the most powerful changes. They are the Patient-Focused Drug Development program and the Patient Preference Initiative regarding medical devices. The first arose out of concern that the FDA regulated products for conditions or diseases with few treatment options too stringently. The second program's purpose centers on adopting patient-focused techniques to medical device regulation much in the same way the FDA regulates drugs.