“Because they are cheap, generics typically drive the pioneer manufacturer’s drug off the market (or into a very small market share) within a few years, if not sooner. Generic drugs will stay cheap under Conte. But imposing liability in perpetuity upon pioneer manufacturers for products they no longer sell or get any profit from means that the pioneer manufacturers (being for-profit entities) have to recoup that liability expense somewhere. There’s only one place it can come from. That’s as an add-on to the costs of new drugs that still enjoy patent protection.”

http://pipeline.corante.com/archives/2008/11/17/liable_for_generics_you_are_now.php

What’s good for the goose should be good for the gosling too though. The big companies shouldn’t get away with such little testing when they make changes to their formulas either. Not if you want the public to be safe.

“Brand-name drugs are subject to the same bioequivalence tests as generics upon reformulation.”
http://www.fda.gov/cder/Regulatory/applications/ANDA.htm
What does that do to the more complete testing that gained the NDA approval? Why bother with such scrutiny if they can be reformulated and approved with simple bioequivalency studies later? Give a few people a pill and draw their blood a few times. Makes perfect sense.
(eye roll)

So yep, I do agree with this ruling. If the big companies couldn’t be equally careless I would have a different opinion on the matter. No one should get to have it both ways. Keep your standards high and the copycats will have to keep theirs high too.

Yes, that’s correct. And you can see that in the conclusion at the end of the ruling, which is worth reading.

Cheers
ed

Moreover, I’m unclear on whether the generics are ALSO liable or not. From Ed’s and Quibler’s post, it appears that ONLY Wyeth is liable — not the generics. They got off scott-free. Is that right?

This decision reduces the incentive for generic manufacturers to carefully pick the products that they commercialize, because they can expect that some (or potentially all) of the liability can be transferred to the original manufacturer of the product.

Conversely, this decision reduces the incentives for innovators to develop and commercialize new medicinces, because they will be saddled with additional liabilities at a point in the product life cycle when they cannot possibly recover costs associated with such liablities.

I’m guessing that the judges that rendered that decision really didn’t pay much attention in law school to their product liability law lecturers. One can only hope that their decision gets overturned on appeal.

My mistake. The summary judgements in favor of the generic makers was upheld. I have just corrected that in the post. My sincere apologies.

Ed

“Meanwhile, summary judgement against the generic drugmakers - Teva Pharmaceuticals, Pliva and Purepac Pharmaceuticals - was upheld.”

That’s pretty unambiguous, isn’t it? The generics had already lost. This just means thet Wyeth is liable too.

Or am I missing something?

Congress is so busy with so many major things. That they only have time to listen to really major things like actual numbers of suicides on antidepressants that has been sent in a table. They don’t have the time to deal with all the specifics. They need to rely on the next commissioner to fix things.

Harassment can force out nearly anyone who raises a question about general science, guidances, procedures, or why management wouldn’t listen to review staff (Von Eschenbach we want to listen to you so talk to me) especially since raising a question identifies the person as a potential troublemaker, or someone who will help change things back. Nearly everyone of those individuals don’t have specific big safety issues to whistleblow on like Vioxx, or suicides and antidepressants. With the experienced reviewers who would speak up gone. Some of the people remaining who were part of the problem will jump on the new bandwagon and may even be intentionally placed there to minimize changes away from industry. (There’s been a lot of talk about succession planning at FDA over the last 1 - 2 years).

During the past 10 - 15 years sychophants and people from industry have been brought in and rapidly promoted into critical positions. This is especially true of those who control the evaluation of the science and approvals. That doesn’t mean that there would be sufficient PROVABLE grounds to remove those individuals. However, the depth of the takeover has been so complete and has occurred over such a long period that it permeates every level. Including the new reviewers who have been hired from the industry layoffs. Thus a new administration will have a virtually impossible task to change things back as the changes are so deep. This is a problem especially if Pharma is planning on submitting a lot of dangerous drugs in a short period of time during the end of the current and during the beginning of the next admin, and getting them through before changes can be made or problems realized. Based on published FDA IND data I believe this is the case.

What we really need is the whistleblower protection act. Unfortunately a single senator (likely Kyle) is holding it up. Sunshine is the best disinfectant and allowing reviewers to speak publicly e.g. via a book that includes numerous examples and shows exactly how the FDA takeover has been orchestrated and the subtle problems still around that need to be addressed. (e.g. guidances allowing valuating metabolites that are only 10% or greater than parent drug - what is 10%. I can jump over an anthill, I can’t jump over 10% of mount everest.

Also it doesn’t matter what the law says. It says you can’t retaliate against someone who reports a crime, but if it’s not vigorously enforced and the people punished then no one’s going to come forward in the future. It isn’t a matter of vindictiveness, it’s really a matter of what is best in the long run as a whole.

In addition, there are those who go along whole heartedly simply to get ahead even if they really don’t understand the big picture and what’s really going on. Vs. those who won’t help fight and go along simply because they’re afraid. No one should be excessively penalized, but some consequence is definitely needed for the first group.

For anyone who’s reading my comments. I don’t post things that I learned via information in submissions. Rather I also read on my own time for myself and I also talk to people in companies who suggest certain scientific areas for me to look into. So in a number of cases I happened to connect dots based on public information, this also helps me in my review work.

As for suicide. I believe I’ve already committed professional suicide and I really don’t know what I’ll be doing for the rest of my working career.

I was especially struck by the ending: “I know many good people at drug companies and they used to let FDA catch things that they couldn’t convince their own management was a problem. With the way FDA management steps in now that’s gone.”

The situation parallels some of what we’ve also seen in the context of potential litigation, in which that threat was useful to “moderates” in companies to help reign in the “cowboys.”

As DDL makes clear, the preemptors’ core mission of seeing “prescription drug litigation vanishing from the face of the earth” [their words] has not changed.