By: Leslie Kux and Malcolm Bertoni
As we continue to implement the exciting new tools provided by the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), we are inviting interested members of the public to use the Internet to track our progress.
FDASIA gave FDA new authorities to help FDA establish improved systems for combating drug shortages, protect the drug supply chain in an increasingly global market, and get generic medicines on pharmacy shelves and available to consumers more quickly. It is also encouraging companies to invest in discovering and developing new antibiotics, accelerate patient access to new medical treatments and breakthrough therapies, and promote the development of more treatments for children.
To track FDASIA’s progress, we leveraged an existing FDA web page that publishes pertinent information about a wide variety of FDA initiatives, and we added what we think are even better web tools for searching for specific details about a particular action.
The site currently shows that more than 30 of the tasks aimed at improving public health are completed. The site also lists numerous other steps involved in implementing the law and in each case provides a targeted completion date for the task and links to more information. Each task listed also includes a contact for more information or how to get answers to questions—either the e-mail address of an individual FDA employee or of an office specifically designated to handle that task.
Weaving the new authorities from the 140-page law into existing programs is a Herculean task, and doing it right takes time. We are committed to get the job done as quickly as possible while still making the best decisions that will serve the nation now and in the future.
We established this web page to make that process transparent, and to encourage the input of those involved. Our immediate focus is on those provisions of the law that will have the greatest public health impact for which resources are in place, allowing us to act quickly.
We appreciate that some may be interested in viewing the nitty-gritty detailed listing of the many, complex actions involved in implementing FDASIA, and some may not. But we know the actions themselves will prove important to consumers and patients, who will ultimately benefit from the provisions of this new law.
Consumers and industry can find in-depth information, including fact sheets, news releases and technical information, at the FDASIA web page. FDASIA represents the potential for major improvements, and we are using everything at our disposal, to pursue the important goals it presents.
Leslie Kux is FDA’s Assistant Commissioner for Policy
Malcolm J. Bertoni is FDA’s Assistant Commissioner for Planning