Friday, January 9, 2009

Attention Lab Directors!!! The FDA is coming!!!

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


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!


Andrew said...

FDA approval may be an expense, but the alternative is a no trust system which is far worse. The ongoing marketing scheme to normalize "not evaluated by the FDA" needs to end. Would you accept self-disclaimed unevaluated financial statements? Could you trust financial derivatives based on information of unknown accountability? Of course not. So why treat health information with less rigor than we expect in finance?

H Lewis said...

FDA approval of lab diagnostic tests is included in the Laboratory Test Improvement Act (S.736), which was introduced in March of 2007. It was sponsored by Sen. Ted Kennedy and does address many of the trust, quality, and access issues surrounding home brew as well as direct-to-consumer lab tests. I agree that it will increase the burden on the FDA, but it the benefits outweigh the cost. If this issue is important to you, send a letter to your Senator and let them know you want them to sign on as a cosponsor of the bill.