Cheap custom-made versions of expensive drugs spur backlash

Federal regulators are pushing back against drugmakers emerging to meet demand for lower-priced drugs by custom-making medicine. The cheaper versions of brand-name drugs differ from traditional generic drug makers because they operate much like pharmacies that mix their own medicines, though often in larger quantities.

Federal regulators are pushing back against drugmakers emerging to meet demand for lower-priced drugs by custom-making medicine. The cheaper versions of brand-name drugs differ from traditional generic drug makers because they operate much like pharmacies that mix their own medicines, though often in larger quantities. That allows them to skip the regulatory approval process through which safety and efficacy of medicines must be proven. FDA is taking steps that could halt the effort of such compounders. Laws do not allow compounders to merely copy medicines. Drugs may only be compounded under limited circumstances: to address a drug shortage or meet medical need, by modifying the custom-made version—such as adjusting ingredients to address an allergy. In January the agency said high prices are not a valid reason. In August, FDA proposed taking some drug ingredients off a list that can be used for bulk compounding. Meanwhile, pharmaceutical companies have filed lawsuits that seek to stop rivals from compounding drugs at large volumes.