I had eye surgery and in the post-op pack was MAXIDEX(dexamethasone) drops by ALCON LABS.

Two days later I was BLIND

Use Google and enter EPOCRATES MAXIDEX to verify

Re: FDA, read thread on preemption if you have some time! But, with your conclusion, yes, there is an Alice-in-Wonderland quality in investing preemptive power in an agency which - as every few weeks another major study concludes, including those commissioned by FDA itself - is “broken.”

As the current FDA Commish said (one of my favorite quotes): “Peril exists.”

There was also mention of the “quality” of the FDA. It is not always (but often) pharma hiding the negative results of clinical trials in order for a drug to be approved, but the FDA - in industry’s pocket - NOT acting on information that it has. For example, FDA knew long before it put on any labels or announced to the public, that Lilly had been required to place a warning for diabetes, hyperglycemia, and death in both Japan and the UK. The FDA did nothing about warning the American public for well over a year after that news was available to them. So if there is pre-emption, victims or their families may not be able to sue, but it still leaves a failed agency not protecting the public health.

Sorry for taking so long to get back to you.

I really don’t know how long it takes an AE to go from the company to the FDA. I know if I hear about an AE I need to report it in 24 hours, but I don’t know the lag between my internal reporting and then my company’s internal group reporting the AE to the FDA. Clearly, it must take some amount of time; I don’t know if it’s a day, a week, a month etc.

Also, yes, anyone can get the information from the FDA because of the FOIA. On the other hand, in FORMER’s first post in this thread he says the new rule will undermine patient’s right to total knowledge (I think he would conceed total knowledge is impossible, but he would like to strive for more knowledge). By the same token anyone can contact the FDA for this information - not just the company.

As for the rest of your two stories I think it falls into one central theme. The FDA may have all of the data. On the other hand, the FDA doesn’t employ multiple people all day every day just to think about one product, like the pharma company. I concede that fact.

“And, in a sentence that may occasionally prove useful in litigation [meaning, defense of company], the FDA writes that “at least when a sponsor did not meet the standard to change its labeling through a CBE supplement under this rule to include the warning a plaintiff alleges should have been added to labeling, State law liability that is premised on a failure to warn is preempted.” Id. at 24. [Hat tip to DDL]

In other words, FDA is saying that a company cannot be held liable for “failure to warn,” if the risks about which they did not unliaterally warn do not rise to the (new and higher) criteria that the new CBE rule sets out.

It cannot get much clearer than that, and it supports Jaynesday’s early surmise on this thread that the new CBE rule is a kind of “preemption in miniature.”

I guess the problem with reporting AE’s is that not all doctors report them. You would be amazed at the number of doctors who have quite frankly stated they do not have the time. So, I have often thought that the number of reported AE’s is much less than what it really is.

When I did some clinical work in the past, I remember being told that the paper work to complete it was arduous and time consuming. The process itself is very time consuming. In the case of medical device the device has to undergo thorough testing to determine did it fail or was it used improperly?

Then of course take the instance where during the clinical phases of the drug testing the company is the only one who has access to all the data. We know what has been withheld from the FDA with regards to clinical trial information.

Additionally, having worked in clinicals before we do get access to the FDA AE stats, so we do see what is happening with competitor drugs, but not during clinical development stage.

However, we do get information from the primary physicians who are willing to talk. So very often we can hear what is happening with a competitive drug before the trial data is submitted.

Compliance in all aspects of the process is an issue….

Both companies were “in compliance” with FDA reporting regulations.

I don’t think DOJ pursued criminal action against either one.

In circumstances like this, does it make moral sense to anyone to take away the right to bring suit by victims of these drugs or their survivors?

If your answer is no, you are against FDA preemption.