The FDA has toned down its support of QbD in final guidance on cutting residual drug in transdermal delivery systems following industry criticism.
Draft guidance published in August 2010 specified quality-by-design (QbD) as a method for cutting drug residues in transdermal delivery systems. However, industry responses were critical of the wording and in the final guidance QbD is reduced to being “one example” of a development method.
“Provided that the end goal is achieved and the development process is scientifically sound there is no need to specify the use of QbD”, Paul Eisenberg, senior vice president, global regulatory affairs and safety at Amgen, wrote in response to the draft guidance.
A response from the Biotechnology Industry Association (BIO) also raised concerns about QbD. For BIO, the problem is that the FDA recommended how companies should cut residual drug substances, namely by using QbD, instead of simply explaining what they should be trying to achieve.
“BIO generally supports QbD as a voluntary, alternate approach…but as described in this guidance it may become unnecessarily burdensome and may not reflect the optimal development process”, Andrew Emmett, managing director, science and regulatory affairs at BIO, wrote .
Pfizer, which recently spoke of its support for QbD , also responded: “Even in the event a QbD approach is not employed for a product, any overage should be justified based upon product specific scientific understanding and risk/benefit analysis”, Pfizer wrote in its submission to the FDA.
The other major change is the addition of a final paragraph. In the section the FDA writes that, regardless of the approach taken, “product and process understanding” should be demonstrated and “a scientific, risk-based approach” taken.
GlaxoSmithKline, Sanofi and others made no reference to QbD in their responses.