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).