FRAMINGHAM, Massachusetts (CNN) — If Sarah Sellers’ warnings had been taken seriously 10 years ago, 12 people might be alive today. Sellers, a pharmacist and expert on the sterile compounding of drugs, testified to Congress in 2003 about non-sterile conditions she’d witnessed.
“Professional standards for sterile compounding have not been consistently applied,” she told the Senate Committee on Health, Education, Labor, and Pensions. “The absence of federal compounding regulations has created vulnerability in our gold standard system for pharmaceutical regulation.”
Nearly 10 years later, there are still no federal sterility guidelines for compounding pharmacies that make and distribute drugs all over the country.
Now, 137 cases and 12 fatalities nationwide are blamed on a rare, noncontagious form of meningitis linked to contaminated steroid injections made by the Massachusetts-based New England Compounding Center.
The pharmacy announced Wednesday it has established a recall operations center to manage the removal of all its products from circulation.
At least two lawmakers are introducing bills to strengthen the Food and Drug Administration’s oversight of compounding pharmacies.
“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,” Rep. Edward Markey, D-Massachusetts, said in a statement. “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.”
Rep. Rosa DeLauro, D-Connecticut, vowed similar action. “This outbreak and the corresponding recall of products from the New England Compounding Center expose dramatic gaps in our drug safety standards that create an unnecessary risk to the public health,” she wrote in a letter to Health and Human Services Secretary Kathleen Sebelius.
While compounding pharmacies were intended to create customized medications for specific patients, some “have evolved into large scale operations that produce sizeable quantities of some drugs,” she wrote. “For example, cases in the current outbreak are spread across nine states and more than 17,500 doses of the potentially contaminated drug were shipped to 23 states. At the same time, the FDA lacks clear authority for ensuring the safety of these products and last updated its guidance for (the) industry in 2002.”
The FDA has been working on new guidelines since at least 2006, but the effort is “still in progress,” FDA spokeswoman Erica Jefferson said.
Currently, the FDA does not have jurisdiction over compounding pharmacies until there is a problem. FDA officials say they have been fighting to change that for more than 20 years.
The compounding pharmacy industry has challenged those efforts, and courts have ruled that individual state health departments are in charge.
“These facilities are inspected upon initial licensure and in response to complaints,” said Alec Loftus of the Massachusetts Department of Public Health.
Massachusetts requires compound pharmacies to be licensed by the state board, but does not require accreditation. That’s a voluntary process that only 162 out of 3,000 compounding facilities have obtained, according to the Pharmacy Compounding Accreditation Board.
“The oversight appears to be quite lax,” said CNN’s chief medical correspondent Dr. Sanjay Gupta, reporting from Massachusetts about the contaminated drugs. The New England Compounding Center “can distribute thousands of doses of drugs and it doesn’t necessarily have to be accredited.”
The center’s building in Framingham is also home to a garbage compactor and recycling center. CNN observed a medical waste truck making a drop, as well as piles of garbage, boxes, and old mattresses on the back side of the pharmacy compound building. Both companies are owned by the same people.
If the site had been accredited, officials would have examined the facilities and considered whether there are concerns about the site sharing space with a garbage facility, Gupta said.
“Our investigation into NECC and the outbreak with our partners in Massachusetts are ongoing, so I can’t comment directly on how this factors in,” said Jefferson, the FDA spokeswoman.
There is no law that specifies a minimum proximity between a compounding pharmacy and other establishments.
The Massachusetts Department of Public Health has warned the NECC multiple times since 2002 about unsanitary conditions at its facility.
Statutory and regulatory requirements stipulate that compounding can be done only on receipt of a patient-specific prescription, Dr. Madeleine Biondolillo, director of the department’s Bureau of Healthcare Safety and Quality, told reporters Wednesday.
Asked if there had been a violation, she said some organizations may have operated contrary to the licensing regulations, but that is part of the investigation.
Compounding pharmacies were originally created for doctors or pharmacists to make small amounts of custom medications — for example, adding flavored syrup to a cough medicine, or creating a smaller dose for an individual patient if it’s not created commercially.
They’ve grown into a much larger business. Pharmacy compounding accounts for 37 million prescription drugs in the United States each year.
Some compounders ship thousands of custom drugs all over the country. NECC is licensed to distribute to surgery centers and pain clinics in 50 states.
CNN’s Danielle Dellorto reported from Framingham; CNN’s Elizabeth Cohen and William Hudson reported from Atlanta. CNN’s Dr. Sanjay Gupta, Josh Levs and Ann Curley contributed to this report.
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