A new survey of pharmaceutical executives found that even as they expect to send a larger share of drug manufacturing, sourcing and sales to emerging economies such as China, India, and Brazil, many are not confident in the willingness or ability of their suppliers to meet regulatory requirements, and rely overwhelmingly on periodic audits to assess supplier’s safety and quality practices.
The findings are part of a PwC/Axendia survey of 112 global pharmaceutical and life sciences executives. Ninety-four percent said global product sales outside of the United States will increase in the next few years, according to the PwC summary, while 78 percent said global sourcing outside of the United States also will increase. Nearly as many—76 percent—said their global manufacturing outside of the United States would grow, as well.
It’s striking to note that despite these near-guarantees of an increasingly spread-out supply chain, companies oversight of suppliers’ manufacturing practices and their confidence in them is flagging. A Pew Prescription Project survey released this summer suggests consumer confidence in the safety of drugs made in these newer markets is low, too.
Counterfeiting is also on pharma’s radar more than it was a decade ago: 44 percent of the executives surveyed cited it as a business risk. One safeguard against counterfeiting and adulteration is track-and-trace technology, which would establish a unique electronic ID tag for each medicine bottle so that drugs can be traced back to their original source and verified at each transaction point along the supply chain, from the factory to the pharmacy shelf. Interestingly, among the obstacles the respondents cited to implementing track-and-trace technology was lack of external regulation and guidance. They also cited cost and lack of industry standards. Requirements that drugs carry such “e-pedigrees” have appeared in the FDA appropriation Chairman’s Mark this summer and in bills before earlier sessions of Congress.
The survey is free to download here (registration required).
–Kate Petersen, PostScript blogger