9 Articles Worth A 2nd Look | July 2016

Reading through the news, here were 9 articles that were worth a closer look.

  1. Interview with Director of Celogen Life Science: “Sun Pharma will be unstoppable if it integrates Ranbaxy well.” – Jun 11 – The Economic Times interviews Amit Rajan, director of Celogen Life Science, who discusses India’s Pharmaceutical industry and the significance of Ranbaxy’s former role in Indian Pharma. This article is alarming for its numerous factual errors. For example, it appears that neither party in the interview knows the purpose of definition of an EIR. Additionally, the interviewer is clearly uninformed about basic FDA inspection protocol — the author frequently misrepresents the order of issuance and meaning of documents like 483s, warning letters, and import alerts. 
  2. In a big clean-up drive, government plans to scan 500 Indian drug facilities – Jun 11 – Another article from The Economic Times covering Indian Pharma. The CDSCO (India’s regulatory organization for drugs and devices) will crack down on shortcuts in testing, subpar products, inadequate procedures, and even employee hygiene. Their hope, according to an official, is to “cleanse the system completely” — they want to cut drug deficiencies by 80-90%.
  3. FDA Warning Letters: Alerting Signs are Always There – Jun 24 – A nice review of the 5 major consequences of receiving a warning letter, and of the warning signs before warning letters.
  4. Mylan fire workers at Agila plants after getting FDA warning letter – Jun 27 – In response to a negative experience after purchasing plants in India, Mylan has significantly reformed their diligence process. 
  5. Independence Would Be Good for the FDA and the Public – Jul 5 – Six Former FDA commissioners on a stage together advocating for more independence.  Maybe a cabinet seat?
  6. Data Integrity Has No Relationship With Product Quality – Jul 07 – A pharma API CEO makes the case that the FDA is “unnecessarily obsessed” over data integrity. Do you agree?
  7. Secrets and Lies: Faked Data and Lack of Transparency Plague Global Drug Manufacturing – Jun 10 – Gotta love this quote: “In one case, during an FDA inspection of an Indian company last year, an employee ran away with a USB thumb drive when he saw FDA inspectors. Fifteen minutes later, a manager came back with what the company claims was the same USB drive.”
  8. FDA Bans Imports from Four Indian and Chinese Drugmakers – Jul 14 – Oddly enough, this ban wasn’t for data integrity or quality issues. The firms didn’t pay user fees.
  9. Hanmi’s $200M China plant likely to make branded drugs versus generics  – Jul 14 – South Korea pharma company continues its pivot towards higher-margin, higher-risk branded pharmaceuticals.

And one bonus: if you want to understand data integrity, just read this write-up of 6 483s from Barb Unger.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence. Contact me if you ever have questions at tony@fdazilla.com.

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