We are finally post-election. The sense of relief that one can watch or listen to broadcast television or radio without seeing campaign ads is still being felt nationwide. Facebook sidebars are free of political jabber and de-friending over politics has diminished considerably.
One of the key points of debate in the election was, of course, health care reform – embraced even by the President as “Obamacare”. Governor Romney made many statements about what he would do his first day in office, and among them setting about to repeal Obamacare. One of the many realities to sink in now is that, after going to the Supreme Court and being found constitutional and having survived an election where repeal was promised, Obamacare is now the law of the land, and here to stay. For healthcare broadly, that means a lot (and here is a handy overview on the entirety of the Act)- for FDA, the continued presence of the reform also has ramifications.
Naturally, the election has far reaching consequences for all stakeholders in health care – which by the way – is everyone. Here are just a few of the many as it relates to FDA.
In fact, while the primary focus of the Affordable Care Act (ACA) was to provide coverage for the uninsured under a national plan, there are a number of ancillary provisions of the Act many of which affect FDA. Given the milestone of the election, there is opportunity to review some of them, though I am likely to have missed many, and to provide some resources for tracking progress.
For monitoring a good part of what is happening, FDA has kindly provided a partial overview of what it is doing by setting up a page on its FDA Track system with a profile of its efforts on health care reform. Here is an individual list of the tracks that have been set up:
- Presentation of Prescription Drug Benefit and Risk Information
- Improving Women’s Health
- Removing Barriers and Improving Access to Wellness for Individuals with Disabilities
- Nutrition Labeling of Standard Menu Items at Chain Restaurants
- Approval Pathway for Biosimilar Biological Products
- Minority Health
- Labeling Changes
Of note, most of the delays noted in the dashboards have to do with the issuance of guidance documents.