At HLG, we have given close attention during the past year to the regulatory challenges faced by compounding pharmacies in this new era of FDA oversight. However, in recent weeks, it has become starkly evident that compounding pharmacists are, also, squarely in the prosecutorial sights of the DOJ. At HLG, our professional focus is on legal representation in business litigation and administrative proceedings, such as FDA inspections. However, we also have years of experience in the defense of parties charged with business-related crimes. For this reason, our most recent postings have discussed what we believe to be a dramatic uptick in prosecutorial activity directed at compounding pharmacies. (more…)
In the last days of June, the final chapter of the New England Compounding Pharmacy (NECP) story unfolded in the Boston federal courtroom of Judge Richard G. Stearns. Barry J. Cadden, the head pharmacist and former co-owner of NECP was sentenced to nine (9) years in federal prison. As we previously reported on this website, Cadden was convicted earlier this spring on federal fraud and racketeering charges arising from an outbreak of fungal meningitis and related infections, which has been described as among the worst recent public health crises in the United States. (more…)
For the twenty-third year, during the early summer months, the International Academy of Compounding Pharmacists (IACP) held its Compounders on Capitol Hill meeting in Washington, D.C. from June 10-13, 2017. Keith S. Hasson, founder of the Hasson Law Group, attended the meeting as the guest of two of his long-time clients in the compounding industry. During and after the meeting, Keith has reviewed and discussed with IACP members two dramatic legislative changes that deserve the support of compounders throughout the Nation. The legislation was introduced, and all compounding pharmacists in Georgia and around the country need to review it and, hopefully, get busy supporting it. (more…)
Keith Hasson authored an article published by Law360 on March 28, 2017, discussing the ongoing regulatory updates compounding pharmacies must monitor, including changes in the U.S. Food and Drug Administration (FDA) inspection methods and the proposed rule adding new bulk substances that can be used in compounding.
The tragic and painful drama of The New England Compounding Center (NECC) came to a dramatic point last week with the conclusion of the criminal trial of its co-founder and chief executive officer. This was the latest chapter in a scandal that has, unfortunately, thrown a negative light on all compounding pharmacies. As the Boston Globe observed, the trial and the scandal “opened a window onto the little-known compounding industry.”
In 2012, fungal meningitis and other infections in twenty states were traced by the CDC to contaminated steroids, used principally to treat back pain, that were produced by NECC. This national outbreak was caused by fungal contamination of three batches of preservation-free methylprednisolone acetate (MPA). Vials of the steroid were shipped to pain management clinics, primarily in Tennessee, Indiana, and Michigan. The fungus-contaminated drugs killed 64 people in nine states. In addition to the 64 deaths, 753 people became seriously ill.
As the federal trial of the New England Compounding Center (NECC) continues, Keith Hasson was quoted in Pain Medicine News on Feb. 16, 2017, discussing the ongoing crackdown compounding pharmacies face from the Drug Quality and Security Act.
A recent report from the FDA stated that the administration has issued more than 130 warning letters to compounders over federal violations and overseen about 100 recalls since the law went into effect in 2012. Hasson notes that the report “reads like a document trying to justify (the FDA’s) efforts in the compounding pharmacy space, and they make a pretty good case.” For the full article, please click here.