I have been a licensed physician for over 30 years. I have enjoyed practicing medicine and teaching the practice of medicine that entire time. Even with the increase in regulations concerning the practice of medicine, I am grateful for the opportunity to be a physician and the privilege of helping people. I have several concerns about our current system. I understand the need for a FDA. However in our zeal to protect patients, we are throwing out the baby with the bath water.
1. Many manufacturers will not spend the resources needed to get products approved or indications expanded for purely financial reasons. Wavelight will not spend the money needed to get an indication for PTK, because the cost of getting the indication is greater than the reward. The end result is patients in the US are not able to get PTK with one of the best lasers on the market. Morcher will not spend the money needed to get their lenses for aniridia approved, because once again the cost of approval is far greater than the money they could make from the product. If I have a patient needing this lens they either have to do without, leave the country to get it, or I have to smuggle one in to the US (which I have not done). The FDA needs to develop a method of using experience with devices and drugs in other developed nations as a guide for approval especially in products with limited potential.
2. Most uses of many ophthalmic drugs are off label, i.e. they do not follow the FDA approved indications. That was not a problem until the past few years. Now some insurances are using these indications to guide payment which hurts patients. Those same indications are the reason samples have been decreased which also hurts patients.
3. These new guidelines pose another problem. They restrict my right to free speech, and they force me to violate the Hippocratic Oath. I can no longer freely share what I have learned with my colleagues which definitely hurts physician education and thus patient care.
If any of you would like to comment you may do so through the website at http://www.regulations.gov. In the keyword box enter FDA-2011-D-0868-0001 and it will open the docket. You can submit comments directly there and/or upload a pre-written letter. Comments need to be received no later than March 29, 2012.
Here is a copy of my OSN article on these Regulatory Issues.