When the Affordable Patient Care Act (more commonly known as Health Care Reform) became the law of the land, it had several provisions in it that charged the FDA with very particular tasks as part of the implementation of the law. For example, a part of the law authorized the creation of a pathway for the approval of biosimilars – biologic medicines that are intended to emulate established biologics. There are a host of other tasks to which the FDA is set.
As part of the FAST TRACK program – a relatively new part of the FDA’s transparency initiative, the agency has published a list of these tasks and applied several metrics to document publicly progress in the areas in which it is working to implement the Act.
These include the following
- Section 3507 – Presentation of Prescription Drug Benefit and Risk Information
- Section 3509 – Improving Women’s Health
- Section 4203 – Removing Barriers and Improving Access to Wellness for Individuals with Disabilities
- Section 4205 – Nutrition Labeling of Standard Menu Items at Chain Restaurants
- Section 7002 – Approval Pathway for Biosimilar Biological Products
- Section 10334 – Minority Health
- Section 10609 – Labeling Changes
The most useful thing about the FAST TRACK list is the fact that it is a list. In other words, if you wanted to turn to one place to see all the categories involving FDA efforts, this is one. If, however, your aim is to get a very detailed view of FDA’s progress in that regard, you may be disappointed. Some of the metrics applied to each task do go into some meaningful detail, while others do not. The FDA chooses the metrics it wants to report, and in some cases, has chosen very few. You may be surprised to know, for example, that the list of activities that must be completed for the very complex area of a biosimilar pathway numbers only four, and two of those are about publishing a Federal Register notice about the process. Not terribly insightful stuff.
Also, the information on the site is up to date only until December 31, 2010. Some of the deadlines that occurred for this quarter may have come and gone without timely action, but you wouldn’t be able to tell.
FDA states on the site that the agency can change the type and amount of data on this site at any time. In an effort to give true meaning to transparency and to report on meaningful progress on some of these important milestones, one would hope that they do just that, and add a little meat to the bones.
And by the way, in FDA Track one could find no measure of whether DDMAC has, in a timely basis, produced a Draft Guidance on the Internet and Social Media. If they did, one would definitely see the terms “NOT ON TRACK”.