Three years ago, the FDA gave its approval to a 3D-printed drug, designed to help people who suffer from epilepsy. The technology behind the prescription, known as Spritam, makes it easier to consume – the pills printed at home are more porous and dissolve more quickly. Also, because Spritam can be printed on a moment’s notice, prescriptions would be easier to fill. Patients would be less likely to miss a dose. 3D printing could also make it easier to customize prescriptions, offering precise combinations and dosages that larger-scale drug manufacturing cannot provide. Further, 3D-printed pharmaceuticals could deal a blow to counterfeit drugs: if prescriptions can be printed according to fixed algorithms or formulas at home, patients are less likely to receive drugs in which active ingredients have been replaced with useless or dangerous ones. Patients simply feed base compounds that are easily obtainable into 3D printers adapted to synthesize chemicals, and voila: they can fill their prescriptions at home.
But, as promising as this technology is, its drawbacks are just as clear. People with access to 3D technology might be able to manufacture illicit drugs. Aside from that possibility, which presents obvious legal and medical issues, there are other considerations. The FDA handed its approval of the 3D medication printing process to a single medication manufactured by Aprecia Pharmaceuticals, an established manufacturer; it has not extended its approval to other companies. While being an established manufacturer does not guarantee that the drugs will not be defective, such companies have experience with creating pharmaceuticals. Other companies providing recipes and instructions for 3D medications do not have the same background. Companies like Four Thieves Vinegar Collective, which offers a home-printed EpiPen and a version of anti-addiction medication Naloxone, is made up of hackers and technicians with no formal medical training. The FDA has not extended its approval to Four Thieves’ efforts, although the agency cannot prevent the hackers from sharing their recipes with anyone who has a legitimate prescription for something like an EpiPen. However, the FDA has warned that these products may be unsafe.
Beyond the issue of safety is the question of legality: the Four Thieves hackers were inspired to set up their enterprise in response to restrictive state abortion laws, aiming to give women access to pharmaceutical abortions at home. If Four Thieves and other groups like them succeed, it is unclear what sorts of liabilities they might create. Would women who access their technology be in violation of state laws? Would anyone involved with the manufacture of the algorithm or equipment be liable? 3D printing is opening a brave, new world of medical possibilities, but the technology may have outstripped the law.