As public concern about the affordability of prescription drugs grows, companies that compound drugs are trying to provide lower-cost alternatives.
Although compounded drugs are often less expensive than mass-produced branded drugs, there are competing concerns compounded drugs could put patients at risk. Recently, drugmakers have been fighting back against compounders, raising concerns about whether compounders are complying with applicable Food and Drug Administration regulations as well as concerns about whether those drugs are safe and effective.
Drug compounding is the practice of combining, mixing, or altering an existing drug’s ingredients to create medication specifically tailored for an individual patient’s needs. New regulatory controls were imposed on compounders under the Drug Quality and Safety Act of 2013 after a deadly fungal meningitis outbreak caused by contaminated compounded drugs sold by the now-shuttered New England Compounding Center.
So far, Endo International plc and Allergan USA Inc. have filed lawsuits targeting what they contend is unlawful and unsafe bulk compounding.
Endo, along with co-plaintiff Par Sterile Products LLC, is suing the FDA over its failure to enforce the DQSA’s statutory provisions governing bulk compounding. Endo claims the FDA has chosen instead to implement its own “interim” bulk compounding program in contravention of the statute, essentially allowing compounders to engage in mass production of drugs while sidestepping the FDA’s drug approval process. The suit seeks to enjoin the FDA from authorizing bulk compounding of the septic shock treatment drug Vasostrict (vasopressin).
Meanwhile, Allergan has two separate suits pending in federal court in California against drug compounders themselves—one against Imprimis Pharmaceuticals Inc. over its compounded eye drugs and the other against Prescriber's Choice Inc. and Sincerus Florida LLC over compounded dermatology drugs. Those suits allege the compounders are misleading consumers and doctors about the lawfulness of their business practices and about the safety and efficacy of their products.
In a press release responding to Allergan’s suit, Prescriber's Choice and Sincerus vowed to “vigorously defend ourselves against this baseless attack” and called Allergan’s suit an attempt to eliminate competition.
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