Unforeseen consequences of old drug policy
by jerry on April 18, 2021
Kaiser Health News reported on a federal program known as Unapproved Drugs Initiative (launched in 2006). It appears the original intention was to give drug manufacturers of older drugs an incentive for them to apply for FDA approval. These older drugs seem to have existed before FDA had its current processes in place, and were therefore "grandfathered" in. The incentive was seven years of exclusivity -- less than the standard patent, but still potentially very valuable.
The article reports that unsurprisingly, during the seven years of exclusivity, prices of drugs skyrocketed: the example given rose from $0.10 per pill to about $4.50 per pill. The article does note that after generic competitors were approved, prices dropped, but not to the original amount. The approval process is likely so expensive that generic competitors need higher prices in order to recover their upfront investment.
Safety can come at a price, especially when the drug approval process requires volumes of data and many participants in clinical trials. Such safety measure might be deemed worthwhile, but patients might be shocked at the cost. Fortunately, people are thinking of cost-saving measures to still collect safety data without going through a traditional clinical trial.