A CBS News investigation into expensive creams and gels billed to insurances without approval from patients led us to the manufacturer of the products: a compounding pharmacy in Dallas called Downing Labs. The owners of the pharmacy, Ashley and Chris Downing, sat down for an interview to answer questions about their business.
The Food and Drug Administration's inspection of Downing Labs in July found "sterility failures in 19 lots of drug products." The FDA asked the company to recall the products but the company's co-owner, Ashley Downing, refused.
In an interview with Downing, I asked her why she rejected the agency's request.
"Because we are compliant with every state guideline, we actually have a sterile compounding license with the state, and we've met all of their guidelines with no problems," Downing told me.
Downing says she was confident with what the company was shipping out. But the FDA was not. In September the agency issued a press release warning consumers not to use Downing Labs' sterile products as they may "pose serious risk to patients."
Oversight of compounding pharmacies falls primarily to the states. The FDA told us that under current law, it cannot require a company to recall drug products. But the agency did say it is actively investigating Downing Labs.
Ever since the NECC tragedy, in which a compounding pharmacy was linked to a deadly meningitis outbreak, more than 50 compounders have voluntarily recalled products.
Downing Labs is the only pharmacy to refuse a formal FDA request.