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.
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.
"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."
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.
"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.
"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.
Yessir!