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Is a 510 (k) a Race? Sort Of.

Is a 510 (k) a Race? Sort Of.


Well, I guess it’s safe to come clean now.  I cheated on my French test in high school by conjugating the verbs on suede shorts I bought with the intention to cheat.  Right before the test I wrote the verb tenses with my finger on the shorts and with a swipe of the hand the evidence was gone! (That one of my favorite watches I wore in high school-yes I’m showing my age).

I have a feeling many of us were ahead of our time.  A new study will give cheaters more of a reason to lie (as if they needed more of a reason).

“Our research raises the possibility that one of the reasons why dishonesty seems so widespread in today’s society is that by acting dishonestly we become more creative.  This creativity may allow us to come up with original justifications for our immoral behavior and make us likely to keep crossing ethical boundaries.”

It’s suggested we take breaks or play board games to get the creative juices flowing.  Coloring outside lines sure can get sticky for a company like Johnson & Johnson.

 The lubricants are considered medical devices, rather than medicines. Devices that are equivalent to one already on the market can be sold without a detailed review by the U.S. Food and Drug Administration.

“As part of ongoing and detailed internal reviews we decided that these products may require submission of new data and application for a new medical device” approval, McNeil (a division of Johnson & Johnson) spokeswoman Samantha Lucas wrote in an email response to questions. “Because we decided against submitting new paperwork, we recalled the small amount of product that was still in the market.”

Bonus points if anyone knows what the application for a medical device is called! (Or you can cheat and hit the link-I know you want to!) Maybe it’s just me, but messing with  a 510 (k) doesn’t seem like an ethical business plan and I’d imagine the FDA probably feels the same way since Johnson & Johnson decided to pull product.   Or is the FDA part of the problem (1.14.2014):

The New 510(k) Paradigm

To streamline the evaluation of premarket notifications for the reserved Class I devices, Class II devices subject to premarket notification, and preamendments Class III devices for which FDA has not yet called for PMAs, the Agency has developed “The New 510(k) Paradigm.” Attachment 1 outlines the New Paradigm, which presents device manufacturers with two new optional approaches for obtaining marketing clearance for devices subject to 510(k) requirements. While the New Paradigm maintains the traditional method of demonstrating substantial equivalence under section 510(k) of the Act, it also presents the “Special 510(k): Device Modification” option, which utilizes certain aspects of the Quality System Regulation, and the “Abbreviated 510(k)” option, which relies on the use of guidance documents, special controls, and recognized standards to facilitate 510(k) review. Use of either alternative, however, does not affect FDA’s ability to obtain any information authorized by the statute or regulations.

But I guess a 510 (k) is a race of sorts and it’s nice to see the FDA supporting their efforts at the expense of the rest of us, according to Johnson & Johnson CEO, Alex Gorsky, is quoted as saying:

“You don’t have to get it 100% right. When you get it 60%, go! Any more time that you spend trying to figure it out, you’re going to lose in the speed that you’re missing out on.”

Substantial equivalence should be determined by a board made up outside the FDA working in conjunction with the FDA on product approval.  Too many companies subscribe to Alex Gorsky’s mentality and FDA seems to have dropped the ball on the subtle changes used to get products approved.  Making the system easier to commit fraud is not the answer. People who want to keep both our government and our companies in check, is however, the answer.

Paper work is hard.

Lost product sales and expensive, ongoing factory upgrades have cost J&J, based in New Brunswick, N.J., well over $1 billion. In addition, Johnson & Johnson’s manufacturing operations remain under increased scrutiny from the FDA.

I’m not sure how difficult it would be to fill out the correct paper work but if something doesn’t seem right, it usually isn’t.  We need to start asking the tough questions and demanding more from both our government and big business.  By this reasoning Johnson & Johnson must have money to burn to leave $1 billion on the table.

Does Johnson & Johnson have money to burn?  

All the negative headlines about Johnson & Johnson  may require consumers, pateints, their employees and taxpayers to start demanding more of the company.

So to Mrs. Cumo, my high school French teacher, I apologize for becoming a little too creative with fashion; and, to companies that like to color outside the lines and to our government that turns a blind eye at the expense of consumers, pateints, their employees and taxpayers alike?   Well, we’re going to start demanding more from you!

If you liked this story about corporate spin unspun:  Read Here


Read the full article from Fast Company:  Cheating Fuels Creativity


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