IPQ’s coverage of the developments during March provides a wealth of insights into the quality regulatory challenges posed by products outside the typical pharmaceutical profile – high technology products with complex delivery systems on the one side, and products which elevate standard excipients into the active drug category and/or do not meet the approved drug criteria on the other.
The Monthly Update includes three stories stemming from the presentations and dialogue at a recent DIA/AAPS CMC workshop around the regulatory complexities presented by pharmaceutical/device combination products and the approaches to addressing them in the US, Europe and Japan. The session included agency and industry experts who provided their insights on the emerging CMC and GMP expectations and offered valuable advice on handling the challenges in the application and inspection processes. Our stories focus on: ● how FDA’s Office of Combination Products is wrestling with the wide variation in the types of products and technologies involved ● nuances in the European and Japanese approaches, and ● a proposal for a risk-based approach to regulator/industry interactions on CPs.
Positron emission tomography drugs were also on our high-tech regulatory radar screen during March. A year-end deadline for bringing all PET drugs under FDA’s drug approval umbrella is spurring attention on the CMC and GMP expectations that manufacturers will need to meet. FDA held a workshop and has issued a guidance to help PET drug producers get into compliance. The March Update provides a pair of stories analyzing FDA’s current advice on the filing and inspection components, with implications for other similarly high-tech products now emerging into the marketplace.
On the low-tech side, the issues around atypical actives – materials normally manufactured and used as excipients, but which in various products take on the role of active ingredients – came out of the closet at a PDA/FDA workshop in early March. The problems presented by atypical actives and the potential solutions are explored in a pair of stories in this issue.
With implications for some atypical actives, FDA continued to strengthen its initiative to get drugs that have not gone through the new drug approval process and do not meet monograph requirements off the market or into the application review pipeline. The agency announced in March that its unapproved drugs crackdown was expanding to include about 500 cough/cold products, bringing a new bevy of manufacturers and distributors into the enforcement picture.
Also in focus in the FDA enforcement realm is a pair of consent decrees – one of which, against Texas-based Rx and OTC drug contract manufacturer Deltex, involved the marketing of unapproved cough-cold products along with GMP problems centered on the QC lab. FDA has not been looking kindly on firms that combine GMP non-compliance with the marketing of unapproved new drugs, and the Deltex injunction provides a case-in-point.
McNeil was the other consent decree signer. The injunction action followed a year and a half of high-profile compliance and recall problems at the firm’s Fort Washington, Lancaster and Las Piedras facilities, which IPQ – as our readers know – has been closely following. What the McNeil consent decree did and did not include – disgorgement, for example – and its context is provided in our story.
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