Friday, January 9, 2009
I have been mentioning this several times to several VC firms and to several small companies. If your business plan or investment does not have a section devoted to getting FDA approval, you will soon see that business do 1 of 3 things.
1. Be sold to a commercial lab who can get FDA approval quicker
2. Become extinct
3. Struggle to create a plan to attain FDA approval and be 6 months to 1 year later to launch.
Why am I saying this today????
Did anyone look at the NY Times yesterday?
On Good Morning America Diane Sawyer said "I didn't know that the tests which my doctor ordered are not FDA approved"
Translation: A huge amount of public demand on an already strapped organization to regulate and assure the quality of laboratory testing, just as they do drugs and food.
This plays perfectly in President elect Obama's plan to create an interagency organization for regulating these and other IVDMIA tests.
Meanwhile, the F.D.A. is considering increasing its role in regulating diagnostic tests. Now, test kits sold to labs, hospitals and doctor’s offices must be approved by the agency. But tests developed and offered by a single laboratory, like the Quest vitamin D test, do not.
I am jumping on this as I read a report from one of our Yale laboratories which says
"THIS TEST WAS DEVELOPED AND ITS PERFORMANCE CHARACTERISTICS DETERMINED BY THE LABORATORY. TESTS DEVELOPED AND USED BY INDIVIDUAL LABORATORIES ARE NOT SUBJECT TO FDA APPROVAL........
Well, that is going to change. And I predict it will happen very, very soon. Especially now that there is public awareness that people were getting false negative Vitamin D results because the FDA doesn't regulate home brews......
Imagine all the people who could have been taking supplements. Especially as more literature comes out about Vitamin D deficiency being linked to all sorts of diseases....Including heart disease...the biggest killer in the United States....Yikes.
The Sherpa Says: This is a good thing. I promise. Yes it may burden the FDA and HHS and CMS and all the little labs looking to jump into diagnostics, but in the end, it will start to restore the public's trust in healthcare....which is something we sorely need!