FDA, Mass Dept. of Public Health call for lawmakers to address regulation of, authority over compounding pharmacies
WASHINGTON, D.C. – Yesterday, representatives from both the Food and Drug Administration (FDA) and the Massachusetts Department of Public Health called on Congress to quickly address the federal regulatory system that oversees drug compounding. One compounding pharmacy, the New England Compounding Center, is the source of contaminated drugs that have caused a nationwide meningitis outbreak affecting 14,000 patients in 23 states. “We urge Congress to act quickly to address the needs for new laws on the federal level to fill in the regulatory gap so that there is clear authority over regulating these practices,” said Madeleine Biondolillo, MD, Director of the Massachusetts Department of Public Health’s Bureau of Health Care Safety and Quality. She was joined by Deborah Autor, Deputy Commissioner for Global Regulatory Operations and Policy at the FDA, who said, “Once the immediate crisis is contained, we want to work with Congress, compounders, the states, and all other stakeholders to strengthen the system, to try to prevent tragedies like this in the future.”
Congressman Edward J. Markey (D-Mass.), senior member of the Energy and Commerce Committee, released the following statement.
“Right now, compounding pharmacies are governed by patchwork regulations, with federal and state agencies engaging in piecemeal oversight,” said Rep. Markey, senior member of the Energy and Commerce Committee. “This is unacceptable. Congress must act immediately to address these gaps in the fragmented regulatory system over compounding pharmacies to ensure the safety and wellbeing of patients. That is why I plan to introduce legislation to directly address the gaps identified by the FDA and other agencies involved in investigating this deadly outbreak, and I look forward to working with my congressional colleagues in a bipartisan manner to move this legislation forward.”
Rep. Markey plans to introduce legislation to address loopholes in federal oversight of compounding pharmacies, which will:
- Require compounding pharmacies to comply with basic minimum safety standards
- Ban pharmacies from compounding drugs using ingredients that are not approved by the FDA
- Require explicit distinction between compounding pharmacies and drug manufacturers
- Require compounding pharmacies to provide adverse event reports to the FDA
- Require a warning to patients using any compounded pharmaceutical that it has not been approved safe and effective by the FDA.