In a blog post published this week, Gottlieb wrote on how the US Food and Drug Administration (FDA) needs to take steps to foster a clearer regulatory pathway to what it terms ‘advanced manufacturing’, which include 3D printing and continuous manufacturing.
Gottlieb states: “The bottom line is this: Drug makers won’t switch to these systems until we create a clear path toward their adoption, and provide more regulatory certainty that changing over to a new manufacturing system won’t be an obstacle to either new or generic drug approvals. The FDA recognises that it’ll require additional investment in policies and programmes that’ll provide regulatory clarity to enable these new methods to be more quickly and widely adopted.”
In terms of how much financial backing the new technologies had, Gottlieb identified a budget of $58m (€50m) that would be used to develop the ‘regulatory and scientific architecture’ to encourage adoption of the technology.
The future is 3D
In order to hear from the perspective of a company already working in 3D printing as a means of drug manufacture, we spoke to Tim Tracy, CEO of Aprecia Pharmaceuticals – the first company to gain FDA approval for a 3D-printed drug.
“From my perspective, I think he is raising some important issues, particularly around continuous manufacturing and how it’s becoming more efficient, but also around 3D printing and how it can be used to in a different fashion – with novel doses, novel shapes, sizes and characteristics of the drugs produced. I applaud his thoughts on this.”
Regarding how much direct contact his company had a “great relationship” with the FDA, he commented: “We were the first company to bring a drug through the drug approval process with 3D printing. They were very helpful all along the way and very interested in learning about our process, and how it differs from traditional methods. Even after approval, they sent a number of people from the FDA to visit our facility to learn more.”
He continued, “They have their own group, within the FDA, that is conducting research on 3D printing so it’s something that is of great interest to them, I believe.”
Tailored to patient's needs
One of the major strengths Gottlieb highlighted was the potential for medicine to be designed for the individual needs of patients.
Tracy explained how Aprecia is able to achieve this through 3D printing by producing tablets that have a harder outer coating and a softer inner coating – allowing the tablets to dissolve in a patient’s mouth in five to eight seconds when taken with liquid.
Gottlieb said he foresees a bright future for advanced manufacturing. He estimates that such technologies could potentially save a total of $60bn (€51bn) per year in the US should advanced technologies be adopted of the industry, which he states could then be passed onto lowering drugs prices.
Tracy is confident that 3D printing will play its part in this process: “We think it has a bright future, I think it’s going to provide opportunities to create doses in a more customisable way, compared to traditional methods. There are times when a tabletting press is just fine and it’s going to do what you need but we’re coming upon some circumstances now, such as the easy-to-swallow doses, where it will have strong benefits. I think this area will continue to grow in the pharmaceutical industry.”