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Both intra- and inter-agency communications will be enhanced; a proposed rule codifies manufacturers' early-notification obligations
Drug shortages continue at an elevated level relative to recent industry history; FDA’s website currently lists 108 shortages, which is down substantially from 2012 but still higher than recent years past. Addressing drug shortages was an important element of the FDA Safety and Innovation Act of 2012 (FDASIA); under that law, FDA was obligated to develop a plan and issued new industry rules on early notification; both of these have now been fulfilled.
The proposed new rule, for which a comment period is open until Jan. 3, requires manufacturers of “medically necessary” drugs (those that are life-supporting, life-sustaining, intended for treatment of a debilitating disease or condition, or emergency medical care, among others) to notify FDA electronically at least six months before discontinuing production of the drug or, in unforeseen circumstances, as soon as possible and not later than five days after the interruption or discontinuance. Biological products are expressly included, as are certain blood products. FDA notes that it has experienced a sixfold increase in voluntary submissions since mid-2012; now, that response will be mandated.
The strategic plan highlights more-coordinated response to shortages; Studies issued in the past couple years by FDA and others generally attribute drug shortages to manufacturing problems, especially of generic injectable products. In light of this, FDA is “considering” a proposed Office of Pharmaceutical Quality within CDER and a more sophisticated risk-based analysis of manufacturing quality problems. Another possible action: establishing a “Qualified Manufacturing Partner Program” (QMPP) that would designate certain manufacturers as resources to address a shortage. This was suggested in FDASIA, but FDA says that it still needs industry input on its feasibility.
The Strategic Plan also makes passing reference to shortage-related situations outside FDA’s direct control: grey market trading in short-supply drugs, and financial arrangements among drug buyers. “Payers might explore financial or economic incentives to encourage high-quality manufacturing that could help reduce the occurrence and severity of shortages,” is one thought. As to the grey market, FDA says that there is only limited data available, and only encourages unnamed “stakeholders” to take action.
It’s also worth noting who FDA depends on from outside government to address the ongoing drug-shortage problem: The American Soc. of Health-System Pharmacists (which tracks shortages and provides guidance on alternative treatments); the Univ. of Utah Drug Information Service (a clearinghouse for shortage notices); the International Soc. for Pharmaceutical Engineering, which did a study of the topic earlier this year, and is sponsoring a series of workshops and events during 2014; and IMS Health, which generates prescription sales data that FDA uses to analyze marketplace trends.