Supply Chain Confidentiality Doesn’t Stand 'Sunshine Test', Califf Says

Pharmaceutical manufacturers must stop holding supply chain data confidential if the US Food and Drug Administration is to help them respond to drug shortages, which will likely continue until the generic drug sector can secure an economic footing that’s strong enough to prevent them, the agency’s commissioner, Robert Califf, told the International Society of Pharmaceutical Engineering.

“We have in front of Congress the proposals that first of all, we actually get the amounts of materials that are in the various phases of the supply chain and secondly, that we get earlier notification when demand goes up that there’s a potential for an impending shortage,” Califf said in a pre-recorded fireside chat that aired 16 October at ISPE’s annual meeting in Las Vegas. (Also see "Transparency Looms Large In US FDA’s Next-Pandemic Legislative Agenda" - Pink Sheet, 15 March, 2023