A rush of new and generic 'me-too' drugs has been putting the regulator under pressure to grant approvals quicker. Review times have fallen dramatically, and drugs are being passed with less safety data.
It's a recipe for dangerous drugs to slip through the regulatory net, as researchers from Portal (Program on Regulation, Therapeutics and Law) have discovered after reviewing the FDA's approvals process from the 1980s until 2018. In the earlier years, 34 drugs were being approved every year, but the average has now risen to 41 drugs. The biggest jump was seen among generic drugs—where a drug has passed out of patent protection and chemical modifications have been made to it by other manufacturers—with approvals rising from 170 per year in 1970 to 588 each year between 2013 and 2018.
A typical approval 20 years ago was based on at least two clinical trials that demonstrated a drug's safety and effectiveness, but today half of drug approvals are given with just one trial being completed.
This is also reflected in the time taken to give approval. In 1983, average approval time was three years, but this had fallen to less than a year by 2017.
This fast-track approach has resulted in more dangerous drugs getting onto the market. One analysis discovered that fast-tracked drugs were getting one serious 'label' warning a year, which highlight life-threatening adverse reactions.