The long development time of a pharmaceutical or biological product results in thousands of pages of chemistry, manufacturing, non-clinical, and clinical safety/efficacy data. The data generated is usually based on what the regulators would expect during the evaluation and approval. The regulatory scrutiny of data and its credibility is done by a team that has domain expertise. The context of competency may be subjective, and for that matter, it might be well established within the US FDA or EMA.
For the regulator, at the time of review, substantial or wide geographical population data and epidemiological data from the real world may be limited. Many decisions are based on scientific facts while some decisions may be derived from unbiased scientific assumptions.
The class action lawsuits against several well-established medicines after many decades of being in the market, with millions of years of patient exposure data available for analysis of risk/benefit, a late response despite evidence of credible risk signals lowers the credibility and could be considered as legal negligence in anticipating, planning, laying directions and quick overall risk mitigation. But a prudent man would not implead the regulator and seek damage compensation as the amount might get arranged overall from the national exchequer, i.e., his personal tax.
The case of nitrosamine impurities and recalls of several blockbuster drugs and several potential candidate chemical compounds that might stand future scrutiny and regulators' response is the subject of future blog posts. Remain calm!
Comments