Regulating a 3D-Printed Future

Were you interested in science as a child?

Always! When I was in eighth grade, I really wanted to build my own chemistry lab. I collected test tubes, conical flasks, beakers and other glassware, and piled them up underneath my bed. But you can’t hide those things from your mother for long... She found – and confiscated – everything while cleaning. And though that was the end of my home-based chemistry lab, it was the beginning of my science journey. I went on to earn my bachelors of science in pharmacy, and then worked in retail and pharmaceutical marketing for a few years before attending graduate school. I wanted to understand the science behind every pill – and I worked in preformulation and formulation research and development for a pharmaceutical company for seven years prior to joining FDA.

Why the FDA?

After working at one pharmaceutical company, I wanted to see how other companies develop their products. But if I worked for one company, then I would never learn about the full spectrum of products and processes: new drugs, generics, devices and drug-device combination products, novel therapeutics, complex formulations, biologics, biosimilars and emerging technologies. I was also interested in learning how FDA regulates different types of products. FDA really is the only place where I can see all of these types of products through my work in application review.

You are very involved with 3D printing at the FDA...

That’s right. I have been following the development of 3D printing technology in the design of pharmaceutical dosage forms since 2009. I find this technology fascinating because of its uniqueness and potential capability to realize personalized medicine. 3D printing is only in the early stages of adoption in the pharma industry, but it is a hot topic in academic research, with universities working to develop other dosage forms using 3D printing, such as transdermal, complex solid oral dosage forms, fixed dose combination products, and drug-on-device products, among other advances.

How long has the FDA been examining 3D printing?

The Center for Devices and Radiological Health has been dealing with 3D printing for more than 10 years; numerous medical devices made with 3D printing have been cleared. In contrast, the Center for Drug Evaluation and Research (CDER) only approved the first 3D printed solid oral dosage form in July 2015 – the application of this technology to drug products has taken longer to yield results.

The FDA has initiated several internal regulatory science and research projects (I’m involved in one) to advance understanding of the relationship between material properties and process parameters on product quality for 3D printed drug products. By ensuring that FDA quality experts understand the science and its application, we can encourage the adoption of innovative approaches to pharmaceutical manufacturing, while providing meaningful and appropriate regulatory oversight.

What are the main challenges of regulating this area?

Although 3D printing technology is new, it does not require a unique regulatory pathway; it can use existing approval pathways that are flexible enough to address new technologies. The regulatory challenges we face include defining a new dosage form, and identifying labeling claims for the product. And because 3D printing equipment can be portable and could be used to make multiple medical products, other factors may need to be evaluated as part of the regulatory process, such as robustness against shipping and changing environmental conditions, or the potential for cross-contamination.

How can the adoption of new technology be accelerated?

To help examine and eliminate the potential delay of using new technologies – including 3D printing – CDER established an Emerging Technology Team (ETT), which works directly with stakeholders to help identify and resolve scientific issues that could hinder progress or uptake. Through the ETT, the FDA can discuss novel approaches early in their development, as well as identifying and addressing potential roadblocks. In fact, the FDA worked closely with the manufacturer of the first approved drug product made with 3D printing.

What makes the ETT approach novel is that the dialogue can occur during early technology development – prior to the submission of a drug application to the FDA. When the FDA receives regulatory submissions that involve novel manufacturing technology, the ETT also works collaboratively with the review team to ensure timely assessment of the submission.

How do you think 3D printing will affect the pharma industry?

The genomic revolution and personalized medicine have been huge topics in the field of medicine for a few decades now. 3D printing technologies have the flexibility to produce final dosage forms that allow patients to be given a personalized regime, which could include multiple active ingredients in a multi-layered printed tablet. In the past, it would have seemed like science fiction to make pills with 3D printing technology, but it is now reality – and I believe this technology will only grow further.