BOSTON—Representative Jeffrey Sánchez, House Chairman of the Joint Committee on Public Health issued the following statement at the conclusion of today’s Joint Committee on Public Health Pharmacy Practice and Compounding Hearing:
Since late September, when the fungal meningitis outbreak was first linked to tainted drugs from local pharmacy NECC, the CDC reports that 730 patients in 20 states were infected by NECC’s tainted drugs, including 51 patient deaths. This outbreak has initiated a national dialogue among state and federal regulators in an effort to identify what wrong and how we can prevent a similar tragedy in the future.
As House Chairman of the Joint Committee on Public Health, I too have been actively reviewing the statutory and regulatory factors that allowed compounding pharmacies to operate without regard to accepted safety and quality practices. One thing has become increasingly clear to me. Deficiencies in our state’s regulation of pharmacy practices enabled pharmaceutical compounders to operate with minimal oversight and allowed many compounders to bypass even the most basic standards for product quality and patient safety.
The overwhelming number of recent violations uncovered by Department of Public Health inspectors, at sterile compounding pharmacies, reinforces this fact. With recent news that Pallimed Solutions, a pharmacy touted to me as a model compounder, was involved in a national recall of sterile compounded drugs, I am more concerned than ever.
We have several bills before this committee addressing different parts of the problem, but none are as yet complete. My paramount commitment is to protect the public health and safety of our state’s citizens. With this commitment in mind, I plan to address existing deficiencies in our state pharmacy law with comprehensive legislation reforming state oversight of the pharmacy industry. Among the reforms that I plan to investigate, the composition of our board of pharmacy must be scrutinized to ensure that it operates with a focus on public safety. I also intend to ensure that this industry is adhering to best-practice guidelines and up to date quality assurance standards. In light of the national scale of this tragedy, I also plan to explore how the Commonwealth is licensing out of state pharmacies and protecting its citizens from similar harm. Furthermore, our hearing today has confirmed that pharmacies will benefit from clear measures that can be used to guide their day to day operations. This will ensure that all stakeholders are consistently on the same page.
Ultimately, my goal is to ensure that the state is proactively regulating the pharmaceutical compounding industry and holding them to the highest operational standards, so that a tragedy of this magnitude never occurs again.