Let’s not forget the reason for the FDA’s existence. The agency was formed to assure the purity of food and drug products (1906). They went on to regulate drug safety (1937) and then drug efficacy (1962). The efficacy regulations were in response to what was truly a safety issue—the use of thalidomide in pregnant women. The FDA is the institutionalized embodiment of the Hippocratic Oath to “first do no harm.” They are cautious because that is their job. Safety does come first. You can always replace a drug that’s not working, but you cannot replace a patient who has died. Suggesting biosimilars could be approved without clinical data is not a very cautious position to take and leads one to wonder about the possible motivation of the FDA in taking that position.

The eagerly awaited draft guidance on biosimilars* was finally issued by the FDA on February 9, 2012. It was drafted in the spirit of enlightened health care reform, with a view towards fiscal responsibility and. . . to annoy the nemesis of all that is good in health care, “Greedy Big Pharma.”

I have never minded spending any amount of time when a patient needed me or to do anything that bettered patient care. I am sure that none of you have ever minded being awakened at night by a patient who was ill and needed attention: hey, we’re ObGyns. I would not object to spending any amount of time on the conversion to an electronic medical records (EMR) system if I thought it would really benefit patient care. But I am convinced that it does not.

I knew that I would have problems with our new electronic medical record (EMR) system on the first day of training. The initial training was conducted by a programmatic, not medically trained “yuppette” from the IT Department, who extolled to a 60-year-old Mac user the wonders of the EMR system: you should right click here, single click there (oops, don’t double click!), and then enter some esoteric bit of medical history.