Why Drug Approval Takes So Long: The Pipeline Has Been Clogged for 20 Years

Twenty years ago it took 12 years after the average drug’s original patent was filed to go through the approval pipeline to eventually be launched. Today, however, it takes—12 years. No change, in other words.  That’s the finding in a report issued Monday by QuintilesIMS Institute, in consultation with STAT Plus that’s raised eyebrows. The silver lining is that new drugs are moving faster to market after they get final approval than they did during the Great Recession. There are outcomes and financial reasons that the pipeline needs to be speeded up, STAT Plus reports. The faster a drug can get through the pipeline, the faster patients who need the medications can be helped and the sooner drug companies can start to see a return on investment in research and development.   

Murray Aitken, executive director of QuintilesIMS Institute, tells STAT Plus that there are two reasons for the pipeline backup. The FDA wants better evidence to get drugs approved and “we haven’t seen as much progress in revolutionizing the approach to clinical development that we might have expected 20 years ago.”

Also, two decades ago companies could expect 14 years of patent protection for their new drugs; today it’s 12 years. “All of this helps to explain why drug prices have soared in recent years,” STAT Plus reports. “Companies that cannot quickly push their drugs through the pipeline get a return on their investment later, creating incentive to charge more to make up for lost time. That also translates into fewer years on the market before a patent expires, which may also drive companies to charge more to squeeze the most out of the time they have to reap big profits before the floodgates open to generic competition.”

Source: QuintilesIMS Institute, “Lifetime Trends in Biopharmaceutical Innovation: Recent Evidence and Implications”