In the 2008 PharmTech Employment Survey, participants cited “regulations” over and over again as one of the hardest aspects to deal with in their jobs. Well, I’m sorry to report that there may be a new series of regulations forthcoming tied to combination products.
According to a white paper by former FDA official Steven Richter, there was a 42% increase between 2006 and 2007 in original applications for combination products. The combination product market, says the paper, may be valued as high as $9.5 billion in 2009.
A combination product has a drug/biologic component and a medical device component (see FDA’s full definitions here). With nearly 30% of new products under development considered to be “combo products,” says Richter, manufacturers will be challenged to apply and implement a series of quality controls at the same time, including drug GMPs, biologics product standards, and medical device quality system regulations. A significant issue may be scale-up, explains the paper, because “additional quality control measures are required to determine process scale-up parameter shift,” and because “combination biologic products create new dichotomies in terms of scale-up and marriage downstream.”
FDA is likely to issue guidelines specific to combo products to address these issues, resulting in increased GMP regulatory action along both the laboratory and manufacturing lines, concludes Richter. There are already a few draft guidances and an agenda for combination products available for public comment from the agency’s Office of Combination Products. What’s your take on where combo products will lead industry?