Section 6004 of the Affordable Care Act requires manufacturers and authorized distributors of record to submit very specific information on recipients of free drug samples to FDA annually beginning April 1, 2012. FDA issued draft guidance announcing that it would delay enforcement until at least October 2012, and maybe longer. Of course, by October 2012 we will all know how the Supreme Court will have ruled on the constitutionality of the law. The Court set aside an historic three days for oral arguments last week to rule on several aspects of the 2700 page law. Day 1 focused on an arcane tax protection law regarding the correct timing of attacking tax laws. Neither side wanted to have the Court defer its important decision based on a procedural technicality. Additionally, the Solicitor General had to argue the unfortunate and awkward position that the individual mandate was not a tax on Monday. The awkwardness was blatant because the Court understood that the Solicitor General’s position on Tuesday relied on the individual mandate as a tax to avoid uncomfortable commerce clause precedent. The final day of oral argument focused on striking down the entire law for two different reasons. First, if the individual mandate fails the constitutionality test, then must the whole law be struck down because the law cannot achieve the legislative intent. Second, the Court listened to arguments on the infrequently challeneged 10th Amendment. Specifically, “[t]he powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.” Essentially, the Court was concerned that the Federal law may have been overreaching when it commanded the States to create “health care exchanges.” One thing is clear, FDA has limited resources and may be saving itself some time and resources by kicking Section 6004 down the road.
FDA and HHS refuse to implement Section 6004 of the Affordabale Care Act