Family Practice News Quotes Nathan Brown on Implementation of Compounding Quality Act

Akin Gump health care and life sciences partner Nathan Brown was quoted extensively by Family Practice News for its article “Drug compounding law presents challenges, opportunities for physicians” on implementation of the Compounding Quality Act (CQA) of 2013.  The article notes that the law followed a 2012 meningitis outbreak, which killed 60 and affected hundreds, that was linked to a steroid from a drug compounder.

Among the topics on which Brown commented:

  • Awareness and the CQA: “The whole tragedy from the meningitis outbreak was a wakeup call for policy makers, but also for physicians, who in a lot of cases weren’t always focused on whether the drugs they were administering or dispensing were compounded or not. As a result, there is a lot more awareness. Under the new law, there are now opportunities for doctors to ask more questions about the source of the drugs and whether they can be confident and have assurance of whether that drug is going to be of high quality.”
  • Expanded opportunities for physicians to learn about drugs’ sourcing: “Physicians should feel empowered to ask questions about the sources of their drugs because there’s more information available now, and it’s in their interest and their patients’ interest to make sure they fully understand the source of their drugs and potential risks.”
  • An ongoing Food and Drug Administration approval process for bulk drug substances: “Physicians and hospitals are going to be in the best position to really identify those types of drugs that are critical to have on hand in hospitals or office settings, and they should be monitoring the implementation process and commenting as appropriate, to make sure the drugs they need are still going to be available through outsourcing facilities or otherwise.”

The CQA is Title I of the Drug Quality and Security Act (DQSA), signed into law by President Obama in November 2013.  Regarding the question of medical malpractice claims as a result of plaintiffs’ attorneys use of the DQSA to assign blame against doctors, Brown said that, with growing awareness regarding compounding drugs, there is a possibility that some plaintiffs might look on doctors as a “source of liability” in the wake of a future tragedy.