The role of human factors analysis in the development and approval of combination products has been getting increasing attention from both industry and regulators. The first story in the May Monthly Update explores how better HF understanding is driving the development of new combination product technologies and training devices that have the potential to significantly cut down on user errors and facilitate application clearance. The players featured have some very compelling stories to tell and a lot to teach on realizing the potential that HF analysis offers.
In the April Monthly Update, we provided insights from CDER Director Janet Woodcock on the heavy impact the FDA Safety and Innovation Act (FDASIA) is having on the center for drugs as it tries to come to grips with understanding and implementing the act’s multifaceted provisions, including those on breakthrough therapies, biosimilars, and generic drug user fees. In this month’s issue, IPQ hones down on the drug supply chain part of FDASIA – Title VII – which has far-reaching implications for the agency and for pharma and suppliers globally.
The Commissioner’s Office has been concentrating on prioritizing the multifaceted provisions Title VII contains and putting implementation plans in place. The IPQ story focuses on a comprehensive report presented at a recent IPEC conference by a key official on how the plans are taking shape for each of 18 sections, their potential impact, and where industry is going to be asked for input. The analysis will help readers be prepared and get involved in shaping the implementation.
The issue then provides a series of three stories on the aggressive efforts FDA, USP and Congress, respectively, are making to come to grips with the problems of pharmacy compounding – with significant implications on the pharmaceutical manufacturing industry and the integrity of its downstream supply chain.
The first in the series focuses on a recent forum at USP that provided an opportunity for some of the top experts in the field to take a realistic, shop-floor look at the aseptic practice, training, lab and regulatory problems among pharmacy compounders in the US, where practical solutions may lie, and how the pharmacopeia can help in their implementation. One of the messages that emerged is that sterile compounding technicians have a lot harder job with less training and expertise to accomplish it than their pharmaceutical counterparts. The lack of understanding of the human factors issues impacting sterile compounding operations is an important subtext, and one, again, with high pharma industry relevance.
The second story focuses on the wave of recalls of contaminated preparations and FDA-483s that has resulted from FDA’s extensive inspection blitz of compounding pharmacies since it began in February. Most of the 483s contain an extended list of significant flaws in aseptic practices and controls across the recipient’s operations, and most of the recalls have involved all of the firms’ recent sterile preparations.
The last in the series takes a look at the notably similar bills that have been introduced in the US House and Senate aimed at better delineating the regulatory boundaries and shoring up the oversight of pharmacy compounding. Congress is looking to provide FDA with the power and flexibility it needs to define the appropriate rules for high-risk operations and the authority to inspect those that engage in interstate commerce.
On the international front, the Asia Pacific Economic Cooperation (APEC) organization is emerging as a significant force in the search for global regulatory solutions to the problems of a globalized supply chain. At the early June PDA/FDA supply chain workshop, the FDA representative to the APEC effort provided insights into a just initiated five-year plan engaging all the key regulatory players that cuts across GMPs, GDPs, pharmacy practices and internet sales.
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