Drug shortages continue: new report

By Nicholson Price

The GAO released a report yesterday on the continuing problem of drug shortages, which unfortunately seem like they’re becoming a permanent part of the U.S. healthcare system.  Hundreds of drugs have at least temporary shortages–456 in 2012. The majority of drugs facing shortages are sterile injectable drugs, including some cancer drugs which have become part of the standard of care and other staples like nitroglycerin and basic IV fluids.

Although the FDA has increased powers to deal with drug shortages under the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), those powers are still quite limited.  Manufacturers are now generally required to report shortages in advance to the FDA (previously only some types of manufacturers were so required), and the FDA can try to help.  But the FDA cannot require manufacturers to make drugs if they choose not to, and can offer little in the way of incentives to encourage them to continue making drugs or to increase production.

The causes of drug shortages are complex, and include regulatory, technological, and economic aspects.  A 2013 paper by FDA officials identified manufacturing quality problems as the single biggest proximate cause of drug shortages, and I’ve argued elsewhere that these quality problems stem from a lack of innovation in drug manufacturing.  Though FDA will do what it can to try to decrease shortages, it seems to me that without addressing the root causes (poor quality and relatively uncontrolled drug manufacturing, in addition to challenging–and linked–economic dynamics), we’re likely to see drug shortages continuing for a long time.

W. Nicholson Price

Nicholson Price is an Assistant Professor of Law at the University of Michigan Law School. Previously, he taught law at the University of New Hampshire. He holds a PhD in Biological Sciences and a JD, both from Columbia, and an AB from Harvard. He clerked for Judge Carlos T. Bea on the Ninth Circuit, and was then appointed as an Academic Fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard. Nicholson teaches patents and health law and studies life science innovation, including big data and artificial intelligence in medicine. He recommends reading Bujold, Jemisin, and Older. His work has appeared in Nature, Science, Nature Biotechnology, the Michigan Law Review, and elsewhere. Nicholson is cofounder of Regulation and Innovation in the Biosciences, co-chair of the Junior IP Scholars Association, and a Core Partner at the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law.

One thought to “Drug shortages continue: new report”

  1. The problem is complicated only if you don’t make an effort to understand it. It’s all about economics—and politics. It is not one of the great unsolved mysteries of the universe. It can be fixed with a presidential pen stroke. For a primer, read our 9/3/13 op-ed in The New York Times, “How a Cabal Keeps Generics Scarce”: http://www.nytimes.com/2013/09/03/opinion/how-a-cabal-keeps-generics-scarce.html.

    The other thing is many of your Harvard medical colleagues know all about this, but they lack the moral courage to act on that knowledge for fear of stepping on the wrong toes.

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