Hospira has urged the FDA to create a list of critical drugs to limit the subjectivity of its draft guidance on drug shortages.
In the draft guidance the US Food and Drug Administration (FDA) asks manufacturers to report if they stop producing drugs that are “life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition”. Hospira fears the requirement is too vague and subjective.
“There appears to be some subjectivity to this definition. It is imperative that FDA publish such a list of critical drugs”, Jean Kirkeleit Davis, associate director, regulatory affairs at Hospira, wrote in feedback to the Agency.
Catholic Health Initiatives, one of just three organisations to comment on the draft so far, also called on the FDA to create a regularly updated list of drugs and biologics that it considers to be critical. The third organisation to comment is the professional society Academy of Managed Care Pharmacy.
Hospira is, to date, the only biopharma firm to comment on the draft, although Pfizer and PhRMA (Pharmaceutical Research and Manufacturers of America) both responded to the interim final rule.
PhRMA and Hospira both raise concerns about how difficult it is for a company to determine if it is the ‘sole manufacturer’ of a product. The FDA thinks a company can use commercial data to decide if it is the sole manufacturer but both PhRMA and Hospira have their doubts.
“A pharmaceutical company can easily know when it is the only firm to own an approved application for a drug. Knowing when a firm is the only company able to supply a drug at a particular time is more challenging”, Kirkeleit Davis wrote.
Hospira makes a similar point in its third and final comment. The FDA is asking for firms to notify it when a temporary discontinuance may lead to supply disruption. However, assessing the likelihood of disruption requires knowledge of competitors’ output that Kirkeleit Davis doubts firms possess.