In the spring of 2012, the New England Compounding Center in Framingham, Massachusetts, shipped nearly 18,000 vials of an anti-inflammatory medication used in spinal injections. Produced in a facility not subject to federal requirements for sterile conditions, the drug was contaminated with a fungus, and 749 patients became ill, over half with fungal meningitis. Sixty-three died. This public health tragedy quickly drew attention to a giant loophole in the regulation of pharmaceutical products: the lack of federal oversight of compounding pharmacies, businesses that custom-make drugs.
After the uproar caused by the meningitis outbreak, Congress drafted several bills intended to close the loophole by increasing FDA authority over these pharmacies. But even if legislation passes—and there is no guarantee it will—the new laws would not protect another group of potential customers: the approximately 33 million women ages 45 to 59 who could be in the market for custom-made bioidentical hormone therapy (BHT). With partial funding from the Fund for Investigative Journalism, More commissioned lab tests of bioidentical hormones produced by 12 compounding pharmacies nationwide, and the results are clear: Without federal protection, women who use compounded BHT are risking their health.
When pharmacies operate under the radar
Until the 1990s, compounding pharmacies were small businesses. If you had trouble swallowing pills, you’d visit a compounder and have your medicine made up in liquid form. If you were allergic to an inactive ingredient in the pill’s formula, a compounder could make a substitution. Compounding pharmacies have never been regulated by the federal government because for decades they were too small, too few and too limited in scope to pose much of a health threat. Instead, they fell under the jurisdiction of state pharmacy boards—and still do, even though over the past two decades they have morphed into a big industry.
There are currently 7,500 compounding pharmacies in the U.S., up from about 2,000 in 2007, with sales of about $2.5 billion a year. Because the FDA is not in the picture, drugs formulated by these companies do not undergo the rigorous clinical trials required of medicines made by commercial pharmaceutical companies. Nor are compounded drugs—an estimated 3 percent of prescriptions in the U.S.—subject to the FDA’s strict manufacturing standards. Unless compounders are suspected of dispensing products that cause illness or death, they are under no obligation to let FDA inspectors through the door.
The bills in Congress would bring only some of these pharmacies under FDA scrutiny: the 3,000 bulk -compounders—like the New England Compounding Center—that make injectable, supposedly sterile products in bulk and ship them across state lines. Outside the scope of these bills are the thousands of compounding pharmacies that produce bioidentical hormones. Like commercial hormone therapy (HT) drugs, compounded BHT medications are prescribed by doctors to treat perimenopausal and menopausal symptoms, such as hot flashes, night sweats and vaginal dryness. But the BHT drugs are created from plant-based raw ingredients, making them seem safer. Compounded BHT is also marketed as more customized than FDA--approved HT, meaning the drugs produced by a compounding pharmacy promise to target a patient’s specific hormonal imbalance more precisely than a mass-produced medicine can.
The compounded-BHT business is booming. Some large producers formulate up to 1,500 bioidentical-hormone prescriptions a day. But with a few -exceptions—Massachusetts has become particularly aggressive—many state pharmacy boards do little to oversee the activities of compounders.