US Pharma Drought

US pharmaceutical manufacturers invested a record amount in drug development for 2005, yet their pipelines did not show significant growth.

The US FDA approved only 20 new drugs in 2005, down from 36 in 2004, the second lowest approval amount in the past 10 years. Major pharma makers, including Pfizer, Eli Lilly, and Johnson & Johnson, did not receive approval for a single new drug invented in their own labs.

The pharma industry spent over $38 billion on drug development research in 2005, a new high. Researchers are making advances in genomics and other disease development research, creating potential new targets for treatment.

Some experts content that the pharma industry is in a cyclical trough, and that the number of new drugs and new applications for drugs already on the market will increase in the next few years. However, both the FDA and manufacturers note that the process for testing and developing new drugs needs improvement.

According to Dr. Scott Gottlieb, the FDA’s deputy commissioner for medical and scientific affairs, "the development process itself is not keeping up at a fast enough pace to match the progress on the discovery end."

The FDA is looking for ways to speed the approval of new treatments, like approving drugs based on "surrogate endpoints," whether, for example, a cancer drug causes tumors to shrink instead of whether it prolongs the life of patients. This was the basis for the FDA approval in late 2005 of Bayer’s Nexavar, a renal cancer treatment. However, Congress and consumer groups are calling for even more testing before drugs are approved.

Other industry analysts contend that the FDA is denying approval to good new treatments because of the backlash it faced after Merck pulled Vioxx from the market in September 2004. Merck withdrew the arthritis painkiller after a clinical trial showed it increased the risk of cardiovascular events in patients taking it for 18 months or longer. Studies had found the risk in 2000, and the FDA was criticized for not forcing Merck to withdraw the drug earlier or to warn doctors of such risks.

Source: International Herald Tribune, January 12, 2006.