FDA Can't Make Up Its' Mind

Tell me if this isn’t two-faced. A day after recommending against allowing silicone gel breast implants to be sold to the general public, a Food and Drug Administration advisory panel now says that a company called Mentor should be allowed to sell its product on the general market. Although they did say that there would be a number of conditions to be met. Sounds like the Food and Drug Administration is picking favorites. Sometimes I wonder if there are truly conspiracies when things like this happen. Or perhaps the new company had done more research than the previous.


stockton said...

I think that the FDA is two-faced at times. With the post about the implants, I believe that the company that was allowed to sell them to the public possibly paid off the FDA in some way or another. The FDA is all about the money in more ways than what we think or know. Think about all of the bad drugs that have been allowed to be put on the market and have later been removed. I guess that money talks in certain industries.

BOB said...

The FDA harms society more than it helps it. It attempts to protect people by taking away their right to make decisions on their own. If someone desires to have breast implants and they fail, too bad! The FDA should do something productive.

Ralph said...

The FDA has had many problems the past 12 months. They have questioned many drugs such as Ephedra, Vioxx, Bextra, Celibrex, and all prohormones. Some of these drugs been banned, some have come right back on the market. The FDA is inconsistent with its actions and recommendations. It is like they are following the latest health rumors. I think they should be held liable if they give bad information.

Dr. Tufte said...

This is pretty bizarre. However, note that this is a preliminary ruling that has to be finalized in the next 6 months.

The facts are that two companies are in this market. Mentor went to the FDA first and was declined. They came back this year and were approved, along with Inamed who were declined. It is possible that Mentor just has a longer paper trail.

Having said that, it is a bad precedent when the FDA is picking winners and losers. They have just created a monopoly, and removed consumer surplus from future buyers of implants. In a very real sense they have factually hurt everyone who might be interested in buying implants, to prevent a potential hurt. That doesn't make much sense when you put it that way.