Generic drug scandal undermines faith in regulator
China is in the midst of a huge drug scandal.
Pharma 101: Generic drugs must undergo bioequivalence studies to prove they have the same therapeutic effect as the original drugs.
The scandal: In late January, Chinese doctors spotted some funky data on the website of the pharmaceutical drug regulator (NMPA). Specifically, a bunch of clinical trials – each testing bioequivalence across different drugs – posted near identical bioequivalence data, which is highly unusual.
- This raised suspicions of data fabrication and potential corruption on NMPA's part.
NMPA’s response: Relax, it was just a copy-and-paste error!
- NMPA then re-released corrected data.
The plot thickens: Analysts found statistical errors and duplications in the new, 'corrected' data.
Get smart: This scandal will severely undermine public trust in the NMPA, and the generic drugs they are supposed to regulate.
- Chinese consumers will likely opt to buy the expensive version of the original, branded drugs – increasing healthcare expenses.
What happens next: Drug safety is a red line for Beijing – we expect regulators to launch a probe into the scandal, and to knock heads.