Lawmaker cites the risks of high-volume production, creation of high-risk drugs outside of standard approval process
WASHINGTON D.C. – Congressman Edward J. Markey (D-Mass.), senior member of the Energy and Commerce Committee, today sent a letter to the Food and Drug Administration (FDA) querying the agency about oversight of compounding pharmacies in the wake of the fatal fungal meningitis outbreak linked to injectable steroids manufactured at the New England Compounding Center. In his letter to the FDA, Rep. Markey asks 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. Pharmacy “compounding”, which accounts for 37 million prescriptions each year, 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.
“Compounding pharmacies currently fall into a regulatory black hole,” writes Rep. Markey in his letter to FDA Commissioner Margaret Hamburg. “While such pharmaceutical operations capable of making specialized drug formulations play an important role for many patients who cannot take traditional medication such as pediatric patients, hospice patients, and patients with allergies to common dyes and fillers, they also carry inherent risks that are not always fully communicated to patients.”
A copy of the letter to the FDA can be found HERE.
In the letter to the FDA, Rep. Markey asks for response to questions that include:
- How is information regarding the safety and efficacy of compounded drugs communicated to patients?
- Is FDA aware of how many compounding pharmacies are in the United States?
- How many enforcement actions has the FDA taken on compounding pharmacies?
- What is FDA’s view on compounding pharmacies maintaining an online presence for the purpose of advertising and selling specific compounded pharmaceuticals? Has FDA issued guidance on this specific issue?
- Does FDA have the statutory authority it needs to ensure the safety of consumers with respect to drugs made by compounding pharmacies? Does FDA believe that new legislation is needed to strengthen federal oversight over compounding pharmacies?