New Medicines - the Long Path to Approval

Lupus is a chronic, painful autoimmune deficiency afflicting somewhere around 1.5 million Americans. For the first time in 50 years, the Food and Drug Administration approved a new treatment for the disease. That's good news for those afflicted with lupus.

One thing that struck me in news reports on the new treatment was how well the struggle to research and develop this new medicine reflects the challenges - both scientific and economic - faced today by America's biopharmaceutical research companies. As the article noted, Lupus has been a particularly challenging disease. At least seven possible medicines have been turned back in the last several years in the clinical trial stage.

The newly approved treatment, like most new medicines, was a long time in the making. The story of how it got from the laboratory through clinical trials to approved for patient use underscores many of the hard realities of drug research and development that we focus on here in the Catalyst and at PhRMA in general.

And, critically, most new medicines will likely mean incremental improvements in a treatment rather than some transformative breakthrough. But, if you're a patient struggling with cancer, heart disease, diabetes, HIV/AIDS or any number of other conditions, the nearly 3,000 new medicines now in late stage development, clinical trials or before the FDA for approval offer some hope of better health and a longer, healthier life. That is what keeps the approximately 650,000 men and women who work directly for one of America's biopharmaceutical research companies coming to work every day.