Seems to me the FDA Warning Letter is following established protocol in regulating applicants in not jumping the gun - therefor they are protecting the public. The old philosophy 'it is sometimes better to beg for forgiveness than to ask for permission' will not work in an FDA situation - BIEL must comply with the regulators.
However, I'm miffed that the FDA can regulate actipatch.ca, since that is a Canadian regulated URL. Would it not work for the company to simply put an accurate and honest statement in large font on all websites that it is not currently permitted to market or sell any products not approved by the FDA in the USA but that applications to the FDA for approval have been made? Maybe they are not permitted to do that, but makes no sense to me.
I could not buy actipatch in the US and had a buddy in Toronto who had used it a few times courier me 3 after I badlly sprained my ankle playing tennis. It worked amazingly well, couldn't believe it. Days to complete recovery instead of weeks and weeks. My doctor was amazed and said he could not prescribe it, so I didn't do anything wrong, I asked my buddy to send them to me because I remembered him telling me about them. He used them for sprains and for tennis elbow, then put a strap on his elbow and hasn't hasd a problem since. That was over two years ago and he plays 4 times a week. The FDA knows all this since they have all the trial results.
As far as I'm concerned, the FDA reiterates its approval for post eye surgery use - perfect - the rest is therefor a no-brainer, however the company must wait for approval. Seems clear the FDA was only doing its job to write the warning letter-they are not stupid and would never risk writing such a letter if the company was in full compliance. The FDA is there to protect us, but the cat's out of the bag with the eye device. So, the company must respect the process. So get compliant people and don't mess with City Hall. The FDA probably writes thousands of warning letters-it should. But the great thing is the BIEL approval for doctor prescribed post eye surgery use is a reality - hmmmmm, okay to put on my eye after surgery, but we don't think it is good for a sprained ankle? Please....
So, assuming BIEL is going to get and stay compliant, when is ActiPatch going to be approved for all the less sensitive parts of the body, than the eyes?
