F.D.A. Approves Generic EpiPen That May Be Cheaper

By Noah Kalina from Flickr

Sheila Kaplan – The New York Times 

Published: August 16, 2018

Difficulty rating

Rating: 1 out of 5.

Credibility rating

Rating: 4 out of 5.

Preview

This article discusses the approval of a new, more affordable kind of EpiPen. Kaplan discusses the importance of EpiPens to consumers, and the ways the introduction of a new substitute may alter the current market situation.

Author

Sheila Kaplan is a recognized investigative reporter. She has written for a wide variety of newspapers and media sources and is currently a domestic correspondent for the New York Times. Kaplan has a Masters degree in Journalism from UC Berkeley. She also lectures on Journalism at Harvard Law and Stanford University.

Sources

https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-version-epipen
https://www.nytimes.com/2018/05/10/well/live/epipen-shortage-allergies.html
https://www.cnbc.com/2017/08/17/mylan-finalizes-465-million-epipen-settlement-with-justice-department.html
https://www.nytimes.com/2017/09/07/health/epipen-fda-malfunction.html

Analysis of Potential Bias

This article remains clean from biases. It presents facts, and quotes individuals from both sides of potential issues. It is highly factual, and provides an adequate amount of sources.

Article Decryption

In 2018 the FDA approved the first, generic version of the EpiPen. This new, generic version is manufactured by Teva Pharmaceuticals USA. Consumers hope that due to the increased competition in the EpiPen market, prices will lower and become available to more consumers. EpiPens work by injecting epinephrine into the thigh, to increase blood flow and reducing swelling in the airway. It is an important tool to save lives when an individual is having an allergic reaction. According to the Food Allergy Research & Education, 15 million Americans have food allergies with a substantial chunk of those being life-threatening.

The commissioner of the FDA believes the timing for the approval of the generic version was crucial, especially for parents who need to purchase them for their children in advance of going back to school. The FDA is dedicating extra resources to speed up the process.

Previous to the approval of the generic version, one of the current versions (Mylan), had skyrocketed in price and all versions have been subject to periods of unavailability. According to suppliers, the EpiPen shortages were due to manufacturing issues, but overall EpiPens have had a controversial past.

In 2017 Mylan paid large fines for overcharging the federal government for the product, and in the same year, the manufacturing company (Pfizer) received an official FDA warning for not investigating malfunction reports, particularly pertaining to issues with the mechanism that makes the epinephrine fire. Pfizer claims their EpiPen is safe and effective, and there is no causal evidence between the complaints and deaths.

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