The increasing cry for lower health care costs usually includes an emphasis on wider use of generic drugs, but some data from the FDA suggests it will take longer for US payers and consumers to reap the benefits because approval times are lagging - creating a large backlog of Abbreviated New Drug Applications.
The median NDA approval time by the agency's Office of Generic Drugs rose about five months – to 26.70 months – in fiscal year 2009 compared with 21.65 months in fiscal year 2008. Yet the number of ANDA's received is remaining fairly steady - 766 in fiscal year 2005, 880 in fiscal year 2007 and 859 in fiscal year 2009.
As a result, a backlog is festering - from 891 in fiscal year 2005 to 1,912 in fiscal year 2010, according to OGD data presented at the recent Generic Pharmaceutical Association meeting, the FDA Law Blog writes.
In a speech, FDA commish Margaret Hamburg laments the fact that "the unprecedented spike in generics applications has simply outstripped our capacity to properly review." She goes on to press the case for generic drug makers to pay user fees, something brand-name drug makers do. The proposed White House budget request calls for about $38 million in fees from companies, and the FDA estimates mean times would be cut in half (see this). And the generic trade group, as the FDA Law Blog notes, appears willing to negotiate fees (see this). What do you think?
Should generic drug makers pay user fees, too?
- Yes (90%, 175 Votes)
- No (10%, 20 Votes)
Total Voters: 195
Hat tip to the FDA Law blog
22 Comments
I voted yes, if anyone cares..
As did I.
Namaste
hmmm....I thought one of the big complaints with PDUFA was that the user fees were corrupting FDA and giving the bigger companies an advantage. wouldn't this just add to the problem?
Good to see we finally agree on something! No concerns here that pdufa fees will create undue influence by generic drugmakers over the FDA? I don't see it myself, but I've seen many comments here along these lines with regard to the current pdufa fee system.
$38M is chump change to the government. The economic benefit/cost ratio of that measly investment is huge. Congress should just allocate the money and get it done.
P.S. Of course it won't because it's too logical.
Yes; this one's a no brainer.
Harpy and John are right that PDUFA has been seen, by some, to directly influence approvals. Personally, I've never found that argument compelling. Rather, the influence is indirect, so that PDUFA requirements forced CDER to raid its budget otherwise set aside of post-approval studies and collaborations with independent surveillance groups. The proportion of CDER's budget went from 50% for NDA reviews to 80%.
I think the bigger issue is Congress and the administration taking responsibility for actually funding and empowering FDA in an appropriate way. Noe of the big talkers--Dingell, Grassley, Waxman, et. al.--seem to have the kohanes to do it.
"cojones" - just fyi
show off....
I meant the family, who have been very active on this issue.
http://www.genealogytoday.com/surname/finder.mv?Surname=Kohanes
User Fee= increase in product costs for consumer.
If the company that innovated the product does than the copy-cat should, especially given the fact very little RD is required by the generics.
The Center for Veterinary Medicine is already doing this for veterinary drugs. There are AGDUFA fees on generic drugs that run parallel to the ADUFA fees for pioneer drugs.
This is a tough question.
It's a shame that the FDA is not properly funded so problems like this don't arise.
Generics have a tremendous impact on overall public health spending. The government should be happy to make generics happen - it lowers costs overall.
I have not yet voted. If my assessment is wrong then plz excuse me and offer a correction.
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.
So, would the user fees also cover things like foreign inspection/inspectors....seems like China could use a few more, not to mention Hungary
I voted yes, they should pay user fees....
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!
lol, justice!
Big companies do have an advantage! The argument is this. User fees for generic drugs provide a significant financial hurdle for small generic development companies to compete on a level playing field with the largest generic drug companies. In effect is it excludes small businesses from the field and/or forces these developers to collaborate in some way with the largest companies in order to submit applications. This policy only increases generic industry consolidation and monopoly making, ie Teva, Mylan, etc. Therefore, all user fees should be waived for small business developers until they reach a certain income level.
Speaking of Teva, there's some pretty intereesting stuff going on with the Tevatron at Fermilab in Illinois for any particle physics enthusiasts. Relatedly they've got the Large Hadron Collider(LHC) back up and running at CERN, preparing for the largest collider experiment in history. If all goes according to plan, sometime in 2014 they will launch two proton beams at each other at the speed of light and at energies approximating 14 trillion electron volts (TEV'S). When the beams collide they will produce a brave new world of subatomic particles, including perhaps the long theorized Higgs Boson ("God Particle"), which would explain how all matter in the universe acquires mass.
Any physics enthusiasts on this board?
Cool. I don't understand the physics, but I'm wondering if TEVA is named after those TEVs.
How ironic if it turned out the "God Particle" was, in fact, Dr. Biederman.
Okay -- I can't resist: actually, in Hebrew (and HQ for the company IS in Israel), I think "Teva" translates as "of (or from) nature".
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.
NO. It is very tempting to say "Yes" but having generic manufacturers join Big Pharma in "owning a piece" of the FDA is pretending that two wrongs will make a right in this instance.
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.
I don't believe in user fees at all. The bigger the company the faster its drug will be studied and brought to the market place.
It's all about money, as usual.