The Drive with Peter Attia — Katherine Eban

On: Fraud in the generic drug industry

Episode: 71

Date: 16 September 2019

Investigative journalist and author of “Bottle of Lies”.

Key Subjects:

  • Generic and brand name drugs.
    • Generic is a cheaper version of a brand name drug.
    • Made either after a brand name drug has gone off patent so it’s no longer legally protected.
    • Or, if patent has been challenged and FDA gives permission to make a generic version.
  • Process to get a branded drug approved is complicated and costs up to $ 1 billion.
    • FDA multi-phase approval protocol on safety and efficacy.
    • In essence: does this thing do what it’s supposed to do and does it not hurt people.
  • Regulatory steps take to encourage generic drugs (avoid cartels, lower healthcare costs).
    • Simple approval protocol (for US manufacturers).
      • Don’t have to re-prove safety and efficacy.
      • Reverse engineer the branded version (molecules, manufacturing process).
      • Prove to FDA that generic version is bio-equivalent and manufacturing process is under control.
      • Absorbed properly, remains stable at certain temperatures, dissolves properly in the body.
    • Exclusivity.
      • First to file = 6 months exclusivity.
    • Allow foreign manufacturing.
      • FDA expedited review and approval.
      • Data review, inspection.
      • But ultimately very limited authority.
  • Leads to widespread use of generics, corruption and fraud.
    • Generic drugs make up most of the drug supply (90%).
    • Most of generic drugs (and/or their ingredients) come from India or China.
    • FDA struggles to keep up supervisory role.
    • Complaints about side effects from generic drugs and / or they aren’t working.
    • Example: story of Ranbaxy, Indian fraudulent generic drug manufacturer.
  • Using generic drugs.
    • Understand the origin (guide).
    • Look into authorized generics (licensed by the brand name manufacturer).

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