Alterations in Processes and Priorities Needed for New Drug Development

During the 1990s, the U.S. drug industry launched one big new drug after another—the list included statins, proton-pump inhibitors, antidepressants, osteoporosis therapies, and nonsedating antihistamines. Pharmaceutical companies predicted that the number of new drugs would continue to grow in the years to come, a prediction supported by the investment of more than $100 billion in drug research and development by the National Institutes of Health (NIH), public institutions, and private companies. Furthermore, scientific advances related to combinatorial chemistry, genomics, and proteomics promised to make drug discovery and development more efficient.

Unfortunately, instead of prospering, drug development has stalled. The U.S. Food and Drug Administration receives significantly fewer applications from the drug industry than they did in the mid- to late-1990s, and regulatory sources say the number of new drugs approved by the FDA is at an all-time low. Drug companies are reporting a higher failure rate of candidates in clinical development, as new drug development technologies have failed to deliver on their potential. In the past decade or so, average development costs have tripled to an estimated $860 million per drug, while typical development times have increased to 15 years.

The drug industry is complex, and there are many causes for the current drug slowdown. Many easy drug targets are already taken, and developing drugs for chronic diseases is hard. Harnessing new scientific advancements, such as genomics, for use in the discovery process is taking longer than expected. However, the roadblocks to development also include a shortage of adequately trained physician-scientists, outdated and inefficient drug development tools, expensive and lengthy clinical trials, and a drug approval system that does not adequately reward innovation and risk-taking.

There is a widespread effort going on in government, in academia, and among pharmaceutical and biotechnology companies to remove the roadblocks and stimulate the …