By Bruce Rubin
Although politicians and patients may debate the benefits and drawbacks of the U.S. healthcare system, when it comes to inventing new medical technologies and discovering life-saving treatments, no other nation matches the U.S. in terms of innovation and delivery of care.
One reason the U.S. is so successful is that our regulatory system fosters the right balance between the need to ensure patient safety and the desire to produce cost-effective treatments.
Yet, the Food and Drug Administration is currently faced with another issue that will test its ability to find that balance.
The 2010 healthcare reform bill included a provision calling on the FDA to create an expedited pathway for approving biosimilars — the nonidentical “generic” versions of advanced prescription drugs to treat multiple illnesses from cancer to rheumatoid arthritis. The FDA may issue guidance on the subject any day now.