ISPE marches forward with plans to address drug shortages

Everyone looking at the ongoing drug shortages problem agrees that it is “multifactorial:” no one cause can be identified, and shortages arise for specific drugs from different factors. A Drug Shortages Task Force at FDA emphasizes close communications with the agency, and responsible allocations of inventory across supply chains; various commentators point to the low price to which generic products have been driven in the US, such that there are few manufacturers remaining, creating a shortage when one or a few of them experience manufacturing upsets.

In some cases, a shortage begins (or is exacerbated by) manufacturing quality problems—something that the manufacturing engineers at ISPE (Tampa, FL) should know something about. The Tampa, FL, professional society created a task force on this topic in 2012, and a year later came out with a survey of industry members. Among the points that John Berridge, a senior advisor to ISPE, makes from that report are that: the problem is global, which argues against reimbursement practices in the US alone; and that even with organizations that have dedicated resources to maintaining manufacturing quality, shortages have occurred. “From the survey data it is clear that strong leadership and management are key, and resources are important [but] it is worth recognising that, even within organisations which are highly committed to investment in both people and facilities, shortages can still arise. Several respondents commented that a shortage occurred during remediation or upgrade activities, when reduced capacity ensued.”

ISPE will be issuing a second report later this year, and is part of an “inter-association” group to address the shortage problem internationally. "I'm delighted to be collaborating with colleagues from the Parenteral Drug Assn. to deliver our proposal to the EMA later this year, said Berridge in a statement, “and appreciate the support we are receiving from EFPIA, EGA, AESGP and PPTA as well as regulators representing the EMA, the UK, Irish, Spanish and French national agencies." EFPIA is the European Federation of Pharmaceutical Industry Assns.; EGA is the European Generics Assn.; AESGP is the Assn. of European Self-Medication Industry (i.e., OTC products); and PPTA is the Plasma Protein Therapeutics Assn.