Seven years after an outbreak of fungal meningitis linked to tainted prescription drugs killed 100 people and sickened hundreds more, the Food and Drug Administration says the type of medication involved still poses risks.
And a former top FDA official says that despite sweeping reforms that she helped implement following the outbreak, the public needs to be aware that issues remain.
"I think consumers can protect themselves by having information in hand about the drugs that they're taking," former FDA senior science advisor Julie Dohm said in an interview with CNBC's "American Greed."
At issue are so-called "compounded" drugs — specialized formulations of medications that are tailored to a particular patient's needs. So, for example, if a patient is unable to swallow a pill, a doctor might prescribe the medication in liquid form even if it is not available from the manufacturer. That is where special facilities known as compounding pharmacies come in. Millions of people use compounded drugs every year, though many may not realize it.
The 2012 meningitis outbreak was linked to injectable steroids produced by the New England Compounding Center, a compounding pharmacy outside Boston. There, investigators found deplorable conditions including mold and bacteria in supposed "clean rooms" where medications were produced.
NECC owner Barry Cadden is serving a nine-year federal prison sentence after a jury convicted him in 2017 on fraud and conspiracy charges for cutting corners to maximize profits. In one NECC sales meeting, captured on videotape, Cadden refers to cleaning procedures and other quality control measures as "boring stuff."
"He's more interested in taking the easy way out, without oversight, or any more oversight than he needs to tolerate, which makes him basically exactly the wrong kind of person to be in charge of a facility that mixes drugs that get injected into people," Massachusetts U.S. Attorney Andrew Lelling told "American Greed."
Cleaning up an industry
Following the NECC catastrophe, Congress overhauled the law that governs compounding pharmacies and sets standards for prescription drugs. The Drug Quality and Security Act, signed into law by President Barack Obama in 2013, mandates a new system — to be put in place by 2023 — for electronically tracking and tracing prescription drugs.
The law also closes a loophole that allowed companies like NECC to mass produce drugs — an activity regulated by the FDA — but claim they were customizing drugs for individual patients. That put the facilities under the jurisdiction of state pharmacy boards, which have fewer regulations and less resources to enforce them than the FDA does. At NECC, employees actually made up patient names — including "Bud Weiser" and "Chester Cheeto" — to avoid FDA scrutiny.
The 2013 law created a new category of companies known as "outsourcing facilities" that mass produce compounded drugs. Those firms must register with the FDA and maintain higher quality standards. But Dohm, who left the agency in 2019 to join the Washington law firm Covington and Burling where she advises pharmaceutical companies on regulatory matters, said the law still does not necessarily make compounded drugs as safe as their unadulterated counterparts.
"Compounded drugs, unlike FDA-approved drugs, are not reviewed by FDA for safety, effectiveness and quality," she said. "What that means is that they aren't held to the same quality standard that FDA-approved drugs are, and there may not be clinical trials or testing to show that they are safe and effective for patients for their conditions."
The FDA itself acknowledges that despite the new law, the effort to prevent the next NECC-like contamination is still a work in progress.
"While some compounders work hard to meet quality standards including avoiding insanitary conditions, we recognize that there are still compounders that are not in compliance," then-FDA Commissioner Scott Gottlieb said in a statement about the agency's progress on the issue, shortly before he resigned from his post in April.
The statement notes that in 2018 alone, the FDA sent warning letters to 23 compounding pharmacies for safety violations, and it worked with compounders on 50 product recalls.
Are you at risk?
As tragic as the NECC situation was, Dohm said it focused needed attention by doctors, pharmacists, regulators and patients on the quality of prescription drugs. But she noted that some patients may still be unaware that they are even using a compounded drug. Others may not be using one now, but they could be prescribed one in the future. That makes this yet another area where communication with your doctor is key.
"If a consumer is getting a prescription drug from their doctor and they have any reason to think that it might not be an FDA-approved drug, they can ask their doctor whether or not the drug is, for example, compounded," she said. "If it is, then they can have an informed discussion with their doctors about the risks associated with compounded drugs as compared to FDA-approved drugs, and also determine whether or not they really need a compounded drug."
The FDA website maintains an online list of compounding risk alerts, as well as recalls and warnings issued to compounding pharmacies. You can also contact your state's Board of Pharmacy. And the nonprofit Pew Charitable Trusts maintains an ongoing drug safety project to help consumers navigate the rapidly changing marketplace.
Dohm acknowledged that an NECC-type outbreak could, in theory, happen again. One of the biggest keys to avoiding it is awareness.
"It's important to understand that compounded drugs do exist," she said. "They play an important need in the health-care spectrum because they fill needs that can't be met by other drugs, but there are risks associated with them."
See how Barry Cadden's unmitigated greed became a prescription for disaster. Catch an ALL NEW episode of "American Greed," Monday, Jan. 27 at 9 p.m. ET/PT only on CNBC.