Health Letter, June 2021
By Michael Carome, M.D.
On April 13, 2021, Public Citizen and its Health Research Group petitioned the Food and Drug Administration (FDA) to add a weight-loss drug and an injectable antibiotic to its official list of drugs withdrawn or removed from the market because they were deemed unsafe or ineffective, an action that is necessary to prevent pharmacy compounding of these recently banned drugs.
The FDA, in most cases over the past two decades, has taken at least several years to update the agency’s list of withdrawn drugs after the agency determined that a drug was removed from the market because it was unsafe or ineffective. According to Public Citizen’s petition, such foot-dragging poses unacceptable and avoidable risks to patients and public health.
Overview of pharmacy compounding
Pharmacy compounding traditionally involves pharmacists or doctors combining, mixing or altering drug ingredients to create customized medications prescribed for individual patients whose medical needs cannot be met by drugs that have been approved by the FDA. For example, a patient unable to swallow a pill may need to have their medication ground up by a pharmacist and dissolved in liquid to be administered through a feeding tube. Unlike FDA-approved drugs, compounded medications have not been evaluated by the agency for safety, effectiveness or quality and therefore pose greater risks to patients.
Starting in the 1990s, many compounding pharmacies began expanding their reach by engaging in large-scale production of drugs, moving from the narrow role traditionally filled by such pharmacies into a realm that more closely resembled drug manufacturing and the distribution of standardized formulations of drugs. In many cases, these compounding pharmacies now sell their drug products across the U.S. Often, the compounded drugs sold by these pharmacies are very similar or nearly identical to FDA-approved products.
Laws passed by Congress in 1997 and 2013 established the legal framework for the FDA’s regulatory oversight of pharmacy compounding. Under these laws, compounding pharmacies — including large-scale compounders known as outsourcing facilities that engage in compounding of sterile drug products — are exempted from many requirements that apply to mainstream drug manufacturers, like Merck and Pfizer, such as the requirements for FDA premarket approval, product labeling and adverse-event reporting.
To be eligible for these exemptions, compounding pharmacies must satisfy several conditions. One of these conditions, which was central to Public Citizen’s April petition, is that compounding pharmacies may not compound a drug product that appears on a list published by the FDA of drugs that have been withdrawn or removed from the market because such drugs (or components of such drugs) have been found to be unsafe or ineffective. This list, which is found in a section of the FDA’s regulations related to prescription drugs, currently identifies 85 drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness.
Public Citizen’s petition
On March 4 and 12 respectively, the FDA issued notices indicating that the weight-loss drug lorcaserin (which was sold under the brand name Belviq) and injectable forms of the rarely used antibiotic bacitracin (which was sold by multiple generic-drug manufacturers) had been withdrawn from sale for safety reasons. In both cases, the FDA had asked the manufacturers of these medications to voluntarily withdraw them from the market because the drugs were unsafe. Specifically, lorcaserin was removed from the market because of data suggesting that it increased the risk of cancer, and injectable forms of bacitracin were banned because the drug can cause serious kidney damage and life-threatening allergic reactions.
Despite these concerns, until the agency updates the official list of withdrawn drugs, compounding pharmacies and physicians are legally allowed to continue making compounded versions of these dangerous drugs.
Public Citizen’s petition asked the FDA to promptly initiate the notice and comment rulemaking process for adding lorcaserin and injectable bacitracin to the official list of withdrawn drug products. The petition also seeks implementation of an agency policy that would simultaneously begin such rulemaking whenever the FDA announces a determination that a drug product was withdrawn from sale for reasons of safety or effectiveness. Such simultaneous action could shorten the rulemaking process for amending the list of withdrawn drugs by several months to years.
The expeditious regulatory action sought by Public Citizen’s petition is crucial to minimizing the period during which patients could be at risk of harmful exposure to compounded formulations of drug products that were withdrawn from the market by drug manufacturers due to safety or effectiveness concerns.
An FDA decision on whether to grant or deny the petition is pending.