Monday, January 25, 2010

Challenging the Pre-Market Approval Process and a commentary on the future of FDA's public meetings

There are two things I would like to highlight in this post. Let us look at them one by one, even though there is a thread relating them out there.

Reviewing the 510(k) Process

The dust has settled on the results of the study that the Institute of Medicine made for the FDA. A few things, such as the Massachusetts vote have caused the "media frenzy" to move on to other much clichéd "low hanging fruits". If you haven't heard, the report concluded that the FDA was handing out 510(k) notifications like sugar to kids...

Seething from yet another thorn on it's side, in a quiet mode, the FDA has called for a public meeting on February 18, 2010 to discuss the challenges it faces with the more than 30-year old pre-market notification process (somewhat like the unkempt twin I almost never had), also know as the 510 (k) process.

The 510(k) approval process is used for medical devices that are claimed to be "substantially equivalent" to another medical device that did go through the more rigorous "Pre-Market Approval" process before heading out to the markets. If the FDA agrees that the device is substantially equivalent to an existing, approved device in the market, then it is pretty much smooth sailing through the 510(k) notification process.

If you are new to all this, and would like to hear it straight from the horse's mouth:

Here are a few predictions I have as to what will ensue on the 18th:

1. A few "non profits" of note will show up and claim that everything is "mighty fine" with the process as it is now, and that any changes will only "hinder innovation". Of course, we all know those who throw "innovation" around like monkeys lobbing something around quite well.

2. A whole host of lawyers from large lobbying firms will show up and argue that it is probably a bad idea for the above stated reasons.

3. In all likelihood, the FDA public meeting will end in a date being set for another public meeting.

4. A few years down the line, there will either be two line items added or an extra document added to the process, to tighten it, include superficial data and conclusions from studies, or initiate some limited edition, post market approval observations.

Of course, I hope I am wrong and something good comes out of it. Only time, as a consequence of the reports on the 19th of February can tell.

What should be done anyway?

1. It was 30 days overdue anyway. The FDA should re-classify the severity of diseases and create separate "channels". A dermatological device definitely deserves difference in treatment than a cardiovascular device.

2. The onus must be on the companies. I have mentioned several times that the Democrats' attitude of "FDA takes David, Goliath et. al" in terms of regulation is definitely not the right approach, not by a long haul. While there cannot be any immediate changes till they fail and find this out, they can at least use the "Divide and Conquer" approach for the smörgåsbord they have come to take on.

Companies need to do more to ensure that the FDA has good quality information. Any shenanigans must be punished aptly and well documented applications must be honored and rewarded.

3. The review process should probably be more frequent than "once in 30 years". All review processes, pre-market and post-market need constant reviews and refocusing. With specific failures such as the ones that have come out in the past year or so, the FDA can convert accident into opportunity and create case studies to ensure that mistakes don't repeat.

Conducting meetings that actually bring in public opinion

Washington D.C., has Capitol Hill and Maryland is the base for the FDA. Yeah, we get it. It does not mean that the FDA needs to conduct every one of it's meetings in Capitol Hill or near it.

I am wondering other than the luminaries (lobbyists) present in and around Washington D.C., where does the general public actually have a chance to comment about anything?

1. First off, written comments don't always cut it.

2. It is sad to see that the party which used the power of social networks, YouTubes and BooTubes first lost a senate seat without putting up even a passable fight. It is worse still to see that the whole shebang of using the internet and modern technology has not been pushed into how the Obama Administration runs Government.


How about changing the style of meetings? How about relying less on "industry experts"? That obviously hasn't worked - er, for 30 years and more! A change at the top, should also mean change of behavior. Good quality, meaningful change in the interest of the larger public and medical device companies (yeah, we care too) will come only through universal "out of the box" sourcing, and not the "lather, rinse, repeat" mode that the FDA seems to be stuck in.

Let us wait until after the 18th to see how much of what I predicted comes to be true.


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