By Alan M. Kirschenbaum –Two days ago, during argument before the Supreme Court on the Affordable Care Act ("ACA"), Justice Breyer referred to “loads” of miscellaneous provisions of the Act outside the core insurance provisions. One of these is section 6004, which requires manufacturers and authorized distributors of record to submit information on drug samples to FDA annually beginning April 1, 2012 (this Sunday). Today, FDA issued a brief draft guidance announcing that FDA will exercise its enforcement discretion to extend the deadline for reporting until at least October 1, 2012. The guidance states that FDA will provide notice before revising this policy, indicating the possibly of a further extension. By then, we will know whether this and “loads” of other ACA provisions will survive the Supreme Court’s decision, expected in June. If and when required, the sample information will be submitted electronically through FDA’s Electronic Submissions Gateway. read more..
Friday, 6 April 2012
Miscellaneous Provisions-The Supreme Court-Affordable Care-Drug Samples
Tuesday, 20 March 2012
The Patient Protection And Affordable Care Act-Individual Mandate-The Supreme Court
When the Supreme Court takes up the question of the "individual mandate" to buy health insurance unde the Patient Protection and Affordable Care Act ("Obamacare") it is important that we remember that they are not considering whether the mandate is a good idea. They will be considering whether Congress has the power under the Constitution to make the mandate. It is time for Constitutional purists. Activists and advocates tend to use the Constitution like a drunk uses a lamppost - more for support than illumination. You can see this in the marriage equality debates. Conservatives are all for states rights when states ban gay marriage - not so much when they permit it. Liberals really aren't any better in that regard. (Source: Forbes.... read more..