Ranking GOP members of the House of Representatives Committee on Energy and Commerce sent a letter to the Food and Drug Administration requesting internal documentation of the agency’s actions, communication and decision-making regarding New England Compounding Center (NECC) from 2006 until 2008.
NECC is the now-bankrupt compounding center that marketed contaminated injectable steroid products, sickening more than 650 people in 19 states and resulting in 45 deaths. The FDA sent a warning letter to NECC in 2006, which NECC objected to in 2007, and FDA issued a response to NECC’s objections in 2008. The GOP members stated “FDA has failed to produce the requested documents in a timely manner.” Furthermore, the GOP members stated that “[b]efore the Committee can consider any proposals related to FDA’s authority over compounding pharmacies, [the Committee] must fully understand what happened with NECC.”
During the previous Congress, legislation to regulate compounding pharmacies was introduced and, in Massachusetts, Governor Deval Patrick introduced legislation giving state regulators more supervisory power. When speaking at a hearing on compounding pharmacies and the fungal meningitis outbreak, FDA Commissioner Margaret Hamburg suggested using a “risk-based framework,” which she described in an op-ed in the Washington Post as an approach to “preserve the benefits of traditional compounding and the important role states play, while reducing the risks of non-traditional compounding of drugs.”
Overall, it appears that increased regulation of compounding pharmacies and the debate over the federal government and the states’ roles in regulating and inspecting compound pharmacies will continue with some urgency. On Tuesday, the Massachusetts Department of Health reported that after unannounced inspections of 40 compounding pharmacies, it has ordered 11 compounding pharmacies to halt operations in part or completely and cited another 21 pharmacies for minor deficiencies.
Please contact the authors for any questions regarding this alert or regulation of compounding pharmacies.