Lawmaker wrote to FDA expressing concerns about fragmented oversight, rules governing compounding pharmacy operations
WASHINGTON, D.C. – Congressman Edward J. Markey (D-Mass.), senior member of the Energy and Commerce Committee, which has jurisdiction over the Food and Drug Administration (FDA), today announced he will introduce legislation to strengthen the oversight of compounding pharmacies in the wake of the deadly meningitis outbreak. The outbreak has been traced back to injectable steroids manufactured at the New England Compounding Center, a “compounding pharmacy” located in Framingham, Massachusetts. Pharmacy “compounding” often involves making a new drug whose safety and efficacy have not been demonstrated with the kind of data that FDA ordinarily would require in reviewing a new drug application.
The legislation will require certain pharmacies that engage in interstate commerce to register with the FDA and 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, and give the FDA authority to perform thorough inspections of pharmacy facilities. Finally, the legislation will require a warning to patients of any compounded pharmaceutical that it has not been approved safe and effective by the FDA.
“These compounding pharmacies are operating as factories, mass producing and packaging specialized new drugs in large quantities and then sending them over state lines,” said Rep. Markey. “These compounding pharmacies are compounding risk -producing complex drugs in bulk and then distributing them across the country. Unfortunately, compounding pharmacies are a 19th century service operating in a 21st century industry, and we need to update and strengthen the rules that govern these operations so that patients can safely benefit from the unique service they offer. I look forward to working with my colleagues to introduce this legislation and to ensure FDA has the authority it needs to oversee these pharmacies and protect patients.”
Yesterday, Rep. Markey sent a letter to the FDA querying the agency about current regulations and oversight practices that ensure that safety standards met by large drug manufacturing companies are also met by compounding pharmacies. There is a growing trend of larger compounding pharmacies entering the market for the preparation and creation of high-risk drugs that require utmost sterility, such as spinal injections. Additionally, there has been an increase in the web presence of these pharmacies intending to create large amounts of a drug to be sold online without prescriptions. And, as is the case with the compounding company responsible for the meningitis outbreak, there has also been an increase in much larger compounding facilities creating drugs in bulk to be shipped over state lines.