Oct 25, 2019

The downside of cheap generics

Caitlin Owens, author of Vitals

Illustration: Aïda Amer/Axios

Generic drugs are becoming both more available and cheaper, but that can have steep consequences, including shortages and safety issues.

The big picture: The number of generics being approved keeps hitting new records, they now make up 90% of all prescriptions dispensed, and these generics keep getting cheaper.

At the same time, the number of quality inspections done by the FDA is decreasing, as Bloomberg's Anna Edney has reported in an investigation of the generics industry.

  • The industry has adamantly pushed back on the idea that generics are any less safe than brand-name drugs.

Shortages are also a problem — while the number of new and ongoing drug shortages was lower in 2018 than in the recent past, it's trending up again, per an FDA report.

  • “Generics by and large are very safe and very effective and increasingly at price points so low that it is impacting the sustainability of the industry moving forward," said Chip Davis, president and CEO of the Association for Accessible Medicines, which represents the industry.

Driving the news: A generic pediatric cancer drug has become "increasingly scarce" to the point that doctors are warning they may have to ration doses, the New York Times reported earlier this month. There's no appropriate substitute for it.

  • Over the summer, one of two manufacturers announced it will no longer make the drug. The remaining supplier has recently had manufacturing issues.
  • Shortages tend to impact older, generic injectable drugs the most, the NYT notes, which are difficult to make and have low prices.

What's next: "There are solutions to the safety and shortage problems that don’t necessarily involve paying much more for these products," said Rachel Sachs, a law professor at Washington University.

  • Civica Rx, for example, is a nonprofit manufacturer that was formed partially to address shortages.
  • On the more extreme side of the spectrum, Sen. Elizabeth Warren has proposed having the government manufacture some generics.
  • More resources could be devoted to FDA inspections, addressing the safety issues raised by Bloomberg's reporting.

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