The FDA’s attempts to use its power have been thwarted by companies relying on gaps in the law and conflicting court rulings. The companies have fought enforcement orders and kept the agency out of their facilities. Some members of Congress have sought to beef up the agency’s authority, but the industry has successfully killed those efforts.
“You are seeing a bunch of people trying to do their best in a system that is legally and factually complicated,” said Howard Sklamberg, director of compliance for the FDA’s Center for Drug Evaluation and Research.
The FDA is again pressing Congress for greater powers.
In 1991, health-care entrepreneur Jim Sweeney became one of the original architects for the modern compounding industry when he persuaded a Southern California hospital to outsource some of its pharmacy work to him.
Across the country, nurses had made fatal errors mixing solutions in patients’ rooms, and hospital pharmacies were struggling with bacterial growths in their own drug therapies. Hospitals adopted new safety standards, but they were costly. At the City of Hope hospital, officials turned to Sweeney and CAPS “strictly to save money,” said Dale Adams, chief pharmacy officer.
Sweeney outfitted a double-wide trailer in the hospital parking lot, hired a team of pharmacists and began making intravenous nutritional supplements for its cancer patients. Before long, CAPS was expanding to other hospitals and making intravenous drugs.
“We typically would approach hospitals and ask, ‘What are the high-risk things you are making? How would you like us to do that for you?’ ” said Eric Steen, whom Sweeney hired from the drugmaker Baxter and made president. Sweeney sold the company in 1994.
One of the drugs in big demand was cardioplegia, a solution used in open-heart surgery to stop and restart the heart. The drug often is made from ingredients that are not sterile, so compounders must successfully sterilize them so it can be safely injected into the coronary arteries.
The pharmacies, however, cannot be compelled to test each lot or batch to check for sterility and proper potency.
In 2004, the company’s Pittsburgh facility prepared cardioplegia for Alycia Hartzell, a 2-year-old who was undergoing open-heart surgery. According to a 2007 lawsuit filed against CAPS by Children’s Hospital of Pittsburgh, the active ingredients and the sodium strengths were too strong and “the use of the CAPS cardioplegia solution led to a brain bleed, and severe permanent injuries.”
Daniel Stefko, a lawyer for the hospital, said the FDA never investigated the episode. “I remember being sort of surprised to find that there was this phenomenon out there, where if I ordered something from Pfizer, it was FDA-regulated, but if I ordered basically the same thing from a compounding pharmacy, the rules were not there.”