It’s all about money, as usual.

The generic manufacturers should use their lobbying and PR money to push the government to cancel all Pharma funding of the FDA in order to level the playing field and eliminate the gross conflict of interest.

So Teva Pharma is “pharma, from nature”.

Who knew?

Now, as to particle physics — what may happen in late-2014, at CERN’s LHC, when those two nearly-light-speeders collide. . . . may be the creation of a singularity — a black hole — just big enough to swallow a pill, whole.

So, whose pill should it be?

Alice’s, Morpheus’ or someone else’s?

[More seriously, as a true and careful student of science, I do not adhere to the theory that either the Batavia, or CERN particle accelerator is capable of creating any dangerous black hole. But it sure would be a hoot -- if either could!]

G’night.

How ironic if it turned out the “God Particle” was, in fact, Dr. Biederman.

Any physics enthusiasts on this board?

This is a win win for anyone who needs drugs. The longer it takes to get these drugs through approval process, the longer it takes for patients to access the generics…

How neat, we finally have a consensus about something here….

A remarkable day in history!

There are a few things to take into consideration and CDERs role is a big part. It might not surprise you to know that some of us wrote directly to CDER when reporting to MedWatch didn’t do any good, when Dilantin was reformulated and approved by the Office of Generic Drugs- but before we were aware of (or understood) the CRADA between Pfizer and FDA to conduct their “research” using that product and it’s consumers.
Of course we were also writing to the Committee for Energy and Commerce and hundreds of other entities as well.

Is the log jam partly due to big companies altering their products to compete with generics, and thus, making their branded drugs generic?

There is no post-marketing commitment for generic drugs, generally. And branded drugs can be reformulated using the same approval criteria as a generic. That is, to sometimes conduct one dose studies to determine AUC.

I’m not so sure that the recent history of approving generic drugs shows a big drain on FDAs budget or resources. In fact, they said that they didn’t review the unusual application that Pfizer presented before they approved the “New Look” Dilantin.

I’d bet that a ’strictly generic’ drug maker does go through a little more scrutiny than Pfizer did in that situation- as FDA was so grateful to Pfizer for allowing them to use it’s facilities to conduct said “research”- and for answering the call for companies to develop new monitoring systems.

(My question to Pfizer, FDA, CDER, & Congress is this- if it results in reducing the quality of products- what good does it do to be able to better monitor them? You know your research project resulted in a difference in AUC for a drug that requires precise dosing.
I have lost my house. My joints are so bad that I cannot straigten my arm. I am in constant pain. I expect my life will be short. Rashes, internal pain, and what the hell are we using in these products? QbD is to throw it in the hopper and if absorption rates are close enough then it passes. Quality by Design (and like systems), along with generic approvals, are an incomplete science- with little, if any, studies for complications.
Not paying enough attention to the quality of excipients. AUC is not the only thing to consider. And I can say all of this with complete confidence- and without fear- because, baby, I have nothing left to lose.
I am not on Pfizer’s phenytoin now, but they took a good product out of my reach, sent me into a tail spin, and I do hold them and CDER accountable. For all that’s worth. Getting medical care always results in the suggestion of another drug. They must be kidding.)

My thought is that- if robbing from CDER reduces their ability to continue to allow “research” conducted on perfectly good products, then keep them broke, as safety appears to be an after thought.

With the big drug companies moving toward “Branded Generics” and getting into the generics market- and I am tempted to vote yes.

Someone needs to change the system instead of continuing to toss more funding at it- and I am tempted to vote no.