Sunday, February 15, 2009

Beyond Funding at FDA

Just How Radical Does FDA Reform Need to Be?

As we've heard often enough over the years, the FDA is woefully underfunded in the views of many. Indeed, by federal agency standards it is tiny--about $2 bil for the whole shmoo, of which approximately 25% is CDER. And then the inevitable stat that follows--the agency regulates close to 25% of U.S. goods and services.

The Miami Examiner had a brief piece on FDA funding in response to the Poison Peanut episode. The link is below

But the questions remain: If most of the old guard senior managers remain in place; if the various means continue that have seemed only to increase suppression of scientific debate; if the agency is viewed as a stepping stone to getting a "real job" in pharma (as one of my students recently told me she was advised); if PDUFA and its trimmings continue....What, exactly, will more money buy us? And what should it buy us?

You all know what the IOM, GAO, Science Board, et. al. have said. Are these reforms sufficient? Is there a chance in Hoboken they will happen?


  1. Just to get the ball rolling, here are some of my own favored suggestions. Some were in versions of the FDAAA before it was gutted.

    1. All new drug approval is initially conditional on (a) completion of required phase IV studies and (b) other independent reviews as required.

    2. No DTCA during the first three years post-approval, with some version of a "black triangle" warning, as in the UK, that the actual risks and benefits cannot yet be known until the drug is in wide use.

    3. A _guaranteed_ post-approval patent protected period on all new drugs, regardless of how long or short the approval process took. Something like 10-12 years, assuming manufacturers are in regulatory compliance.

    4. An explicit rejection of the preemption premable and revised CBE guidelines, with language such as this:

    "For fifty years, FDA in its expert scientific judgment has affirmed an optimal balance between its own regulation and civil liability. The doctrine of preemption is a radical disruptio of the FDA's seasoned expertise in these matters, a second-guessing of the agency that would run roughshod over the FDA's profound interest in public health, patient rights, industry accountability, and the agency's own means and mission. It is time to restore FDA's preeminence as it has viewed these matters for most of its history."

  2. If I were the drug industry, I would consider PDUFA as paying the hand that feeds me. As a consumer I consider it a convenient conflict of interest by both sides.

  3. So Dianne, what do you say to those who argue that PDUFA kept the agency going when Gingich and Company were ready to dissolve it entirely?

    That includes former Commmish David Kessler and Bill Schultz, who will probably be Obama's choice for HHS Senior Couselor?

    My question has always been whether there is anything _inherent_ in PDUFA funding that creates undue "coziness." My own sense has been that the greatest negative impact has come through:
    - fast-tracking drugs that had no cause to be (e.g., Vioxx)
    - taking resources away from other CDER initiatives--both internal studies and contracts with other surveillance groups-in order to fund CDER's side of PDUFA obligations and meet the "PDUFA clock."
    - Thus, before PDUFA, about 30% of CDER's budget (the not-PDUFA part) was devoted to new drug review. After PDUFA, something like 60% has been. In essence, they had to "sell off" other things in order to pay for PDUFA obligations.

    So it comes back to your point, but with a few stops along the way. In any event, the _entire_ PDUFA contributions are, what, a bit over $300 mil now? About eight hours in Iraq? Or 1/270th of the initial TARP bail-out? A few corporate jets?

    Obviously, the money is there if it were a federal priority to use it that way.

  4. If it’s not a lot of money, why did we create this conflict of interest in the first place? Any payment to the “judge and jury” is too much. As you say, the money was there to do otherwise. Why didn’t we do all that is humanly possible to safeguard the public’s health? Who benefited? Not the American public. Why did we let the fox in the door?

  5. Well, if I were PhRMA, I'd say:

    Geez, Dianne, we are not paying for new drug approval! We are paying for speedier new drug _review_. The FDA, in its seasoned wisdom, will decide independently whether or not a drug is approved, as it always has. So this only helps get life-saving medicaiton to the folks (we speak O'Reilly) that much sooner.

    We are your heroes! It's a win-win-win!



  6. Oh, I agree. You guys get the award for speedballing.

    "If you think these guys speed now, wait and see what happens when they get pre-emption,..."

    - Quote by Mr. Tommy Fibich, Houston lawyer hired to represent Alaska against Lilly. See: Alaska settles suit against Eli Lilly - International Herald Tribune

    How much does it cost for Express Check-out?

  7. Let us not forget the comment of a one Dr Howes writing a letter to the editor of his local paper, that more people die in an hour of prescription medications than have collectively died from peanut butter (go Georgia!)

  8. Thank you, Dianne.

    Let us know if there is any other way we can be helpful. We are always here for you. Call our toll-free number, 1-800-GET-DRUG.



    p.s. Express Checkout? Do you have six items or less?

  9. Thank you, Dr. Bremner. We can use that.

    We are always here for you. Call our toll-free number, 1-800-PEA-NUTS.



  10. Doug, Let us also not forget that peanut butter has never saved the life anyone -- not a single person.

  11. Sorry, meant to say:
    Let us also not forget that peanut butter has never saved the life OF anyone -- not a single person.

    I seriously doubt it has even improved the quality of anyones life! But what do I know...

  12. Well Nathan, actually peanut butter has saved the lives of quite a few people. It is cheap and it is a way to get protein when you can't afford to put other forms of protein on your table. But now, sadly, some of the poorest people in this country are going to have to do without. This isn't a joke.

  13. Ah, well, if you want to go into that level of detail, I will also point out that peanut (allergies) result in ~15,000 emergency room visits and ~100 deaths every year in the US! Nothing we consume is safe: peanuts or drugs. At least the drugs we consume go through a rigorous approval system to weed out most of the problems!

    I would dare suggest that a drug that caused 15,000 ER visits and 100 deaths every year would not be approved by the FDA!!! Do you disagree?

  14. Dr. Bremner, thank you, so much, for the link to Dr. Howes's letter. I could not a agree more with what he said. The American public will demand more if what they need to know, but were not told, is made public. And that’s a difficult task as pharma seems to be controlling the airways and press. Where do we find a “gold-plated fist?” How do we break through?

    “In the America that I love, we will demand more accountability and better regulation of an industry that rules with a gold-plated fist and that is powerful enough to control Congress, to the detriment of the citizenry.” See: Death by peanut butter or drugs? | | The Courier | Houma, LA, by, Dr. Randolph M. Howes

  15. Nathan,

    Thanks for reminding me about the peanut allergies deaths.

    Vioxx deaths are around 27,700 and counting...Rigorous approval testing?

    But you are right, we are not completely safe with anything. Much like you, I advocate that we all have to stay informed and educated on the issues so that we all make the appropriate decisions.

  16. Click on me for an update on the FDA chief candidates.

    Let's get this party started!

  17. Thanks for the update, PB.

    I coulnd't get the youtube link to work for me, but I got the link. Hadn't heard of Hamburg before.

    In general, I'd assumed they'd redo HHS before FDA. But we'll see. Again thanks.

  18. Justice, did you copy and paste the link into your browser? You must see the "party" video - it is so apropos.

    I have linked the party video to my name now, so click on "Peanut brittle" to see the show.

  19. Thanks, PB.

    For a while, I thought it was going to be a Vioxx commmercial. Then Viagra. I was hoping they would haul out a couple of bathtubs.

    Anyway, pretty good beat and you can dance to it. I'd give it an 8.

  20. Is there a chance in Hoboken that FDA reform will happen?

    Steven Reinberg at HealthDay reports: FDA has halted drug applications from a pharmaceutical plant in India, which was reportedly submitting falsified scientific data in the applications. The plant makes generic drugs.

  21. Authorities believe medical device company CEO may have fled to his native country, India...

    Click on "Glad Is Night" to read the full report.

  22. For more news on FDA reform, click on "Glad..."

  23. Thanks, Glad. Andrew Von E's comments are a little bizarre. Remember when Dingell grilled him to say how much they needed and why? He kinda dissolved like the Wicked Witch under a pail of water.

  24. Re: Is there a chance in Hoboken that FDA reform will happen? Yes, a good chance. Click on Peanut brittle for the story.

  25. President Barack Obama speaks on food safety...

  26. Thanks for link, Nancy. Looks like we still don't officially have the commish--probably this week. I hope it isn't tax problems.....

  27. Whoops....Just watched the video. The Hamburg and Sharfstein announcements are included in it. So it is, indeed, official!


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