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.
- Simple approval protocol (for US manufacturers).
- 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).