Quantum leap innovation from the point of view of health authorities
Digitization changes the assessment and thus also the approval of medicinal products by health authorities. In the following an example from the field of future individualized provision of personalized medicine.
So far, however, only the Food and Drug Administration (FDA) has issued initial guidelines for technological requirements for 3D printed products for medical applications (FDA, 2016). However, no instructions are given for the decentralized manufacture (e.g. pharmacy) of 3-dimensional (D) tablets. After all, the FDA is very open to the 3D printing of tablets or implants. In 2016 the FDA consequently approved the first 3D printed tablet of a US company (Aprecia) for distribution and marketing. This is a tablet containing the active ingredient Leviracetam (Spirtam®) to treat epileptic seizures. This tablet is characterized not only by the high active ingredient content of 1000 mg per tablet, but also by an extremely rapid dissolution (approx. 2 seconds after contact with liquid) already in the mouth of the patient. Such a rapid release could also be of great importance for other ingredients.
It can be assumed that patients will provide a wide range of health data to physicians, who will create individualized therapies using additional biomarkers, in particular orally active drugs, using special algorithms. The physician then issues a prescription with an individual dosage of the drug.
The patient therefore comes to the pharmacy as usual with a prescription for a prescription drug. Pharmacists who specialize in the production of 3D tablets produce the 3D tablets in the exact dosage and quantity required and are thus responsible for decentralized production, packaging and distribution.
Authorities still have to determine whether the 3D printers, printing materials and software drivers for the printers themselves are to be classified as medical devices or not. Furthermore, the question has to be clarified whether not only the production in the 3D process but also the final product (3D tablet) must be subject to the regulations. In any case, the quantum leap innovation of 3D tablet printing will also make a decisive contribution to health authorities in making personalized therapy and medicine available to patients more quickly. Even if the mass-produced traditional tablets, which can be manufactured in large volumes, will still be needed in the future, a new important field for individualized orally effective medicine will emerge.
How do representatives of health authorities or other public institutions assess this assessment of the quantum leap potential of the 3D tablet?
Note: the entire contribution represents the opinion of the author and not that of any of his previous or current employers, and this publication is not supported by them in any way.
Interested in more blogs about 3D printing?
In the previous episode a quantum leap innovation from the point of view of health insurers was explained.
In the next episode the quantum leap innovation from the point of view of technology providers is explained.
References: FDA (2016) Technical Considerations for Additive Manufactured Devices.
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