NPR Addresses Drug Shortages with ISPE Board Chair

ISPE Board Chairman Joseph Famulare (Vice President, Global Quality Compliance and External Collaboration Genentech/Roche, Pharma Technical Operations) appeared on NPR’s The Diane Rehm Show Monday to talk about Drug Shortages.

Along with three other experts, Famulare explained the importance of this global issue, the root of the problem, and ISPE’s role in solving it.

“The majority of the issues in [ISPE’s] study…attributed the issue to manufacturing and quality problems,” said Famulare.

More than 150 drugs are in short supply right here in the US, and the NPR segment focused largely on “chemotherapy and related cancer-fighting agents” that have been especially limited. “In some cases, it's a child versus an adult, who’s going to get the standard of care and who's going to get an alternative care that we don't know as much about,” said New York Times reporter Sheri Fink.

It’s not just cancer patients who are affected by drug shortages, but as Dr. Yoram Unguru from the Children's Hospital at Sinai in Baltimore and Johns Hopkins University explained, children with cancer are particularly impacted because “these are the particular drugs that we depend upon, and there’s not alternatives.”

Why is this such a big problem in a country as technologically advanced as the United States?

As FDA’s Captain Valerie Jensen put it, “most of these shortages that were really critical… were due to large manufacturers that had these ongoing quality problems that suddenly really ballooned into something even worse and they ended up shutting down.”

The Drug Shortages problem runs deep – it’s caused by manufacturing failures, economic difficulties, company leadership issues, and regulatory problems. Shortages aren’t going away on their own. That’s why ISPE’s Drug Shortages Prevention Plan is so vital. “We’re bringing together all the various facets of industry: those that build the plants, manufacture equipment that are used to manufacture products, and the actual manufacturers,” said Famulare. “To focus on lifecycle management of products to maintain their quality and proper supply.”

The next step in the ISPE Drug Shortages Prevention Plan: a joint research project with Pew Charitable Trusts (Pew) to explore the relationship between drug shortages of sterile injectable products and U.S. market forces. If your company would like to participate, contact Sam Venugopal of Pricewaterhouse Coopers at sam.venugopal@pwc.com or (408) 396-9649. Drug Shortages are affecting patients across the U.S. and around the world, and it’s an issue that ISPE, FDA, and healthcare professionals are not taking lightly. We thank NPR for bringing further attention to the problem. Listen to the whole segment to hear all of Joseph Famulare’s comments.