By: Malcolm Bertoni and Leslie Kux
After Congress passes a law that affects how FDA carries out its public health mission, we must begin the task of implementing the law – that is, putting the law into effect and enforcing it.
For a major piece of legislation like the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law in July, this is a complex undertaking.
FDASIA is a 140-page law divided into 11 separate sections, officially known as "titles," which address different aspects of drug and device law. FDASIA reauthorizes and makes some changes to user fee programs that provide FDA with the resources we need to maintain a predictable and efficient review process for human drugs, biological products (such as vaccines), and medical devices.
FDASIA also creates two new user fee programs: one for generic drugs and another for biosimilar biologics. These new programs will allow FDA to enhance its efforts to ensure that American consumers have more timely access to safe, high quality, affordable medicines. The law also gives the agency new authority to protect the safety of the drug supply chain, which is so important when these products arrive from all corners of the world; to combat drug shortages; and to improve products used to treat children. The law includes many other provisions, including those involving drug innovation and device regulation.
The requirements of the individual provisions vary; some direct FDA to write new regulations or guidance documents that will help industry meet the law's requirements, while some call for the agency to issue reports or develop strategic plans. Some provisions set specific timetables for action, others don't.