Terra Sigillata

Why lay off 25% of the FDA

You read correctly. If the US Senate does not pass an FDA funding bill today, 2,000 employees, nearly one-quarter of the FDA staff, will be relieved of their duties. (There were 8,157 FDA employees in 2006 – source). The House has already passed the bill but there are concerns:

Senate staffers were poring over the bill’s 400-page text, and leaders were hoping to be able to pass it by voice vote. But some Senate Republicans raised concerns. “We’re getting a bill that has been mashed together at the last minute,” said a GOP aide involved in negotiations with the House. “It’s very worrisome.”

The legislation, which the House passed 405 to 7, would renew and increase fees drug and medical device makers pay that fund much of the FDA’s analysis of drugs submitted for approval. It also would overhaul the drug safety system so problems that emerge after medications have been approved for use can be spotted faster.


Yes, “renew and increase fees drug and medical device makers pay that fund much of the FDA’s analysis of drugs submitted for approval,” refers to PDUFA (pronounced puh-DOOF-uh) or the Prescription Drug User Fee Act. Dr David Michaels has a lovely post on this legislation at The Pump Handle and the good folks there have a whole category devoted to PDUFA. From a New England Journal of Medicine article quoted by Dr Michaels:

One FDA scientist who was often criticized for being too concerned about drug-risk data was told by his supervisor to remember that the agency’s client was the pharmaceutical industry. “That’s odd,” he replied. “I thought our clients were the people of the United States.”

In the late 1980s and early 1990s, many groups including HIV/AIDS advocates complained (rightfully) that the FDA was taking too long to approve drugs for life-threatening diseases. The FDA response was that they were too short-staffed to handle the volume of new drug applications (NDA). The passage of PDUFA in 1992 allowed drug companies to pay fees that essentially cover new labor in FDA to evaluate NDAs more rapidly. Revere at Effect Measure and his commenters note that this well-meaning legislation has now been taken to suggest that drug companies underwrite the US drug regulatory authority such that the viability of the agency depends on the contributions of drug companies.

The major concern, among others, is that PDUFA does little to fund post-marketing surveillance of drug toxicity – the time where we really get a feel for how safe a drug is. It’s all well and good to assess drug safety among a few thousand carefully selected patients in highly-controlled clinical trial environments; it’s another thing entirely when a drug is released to millions or tens of millions of genetically-diverse patients taking numerous other drugs. The latter case is where PDUFA funds might be better spent.

Moreover, if the FDA is going to lay off 25% of its workforce if the new funding bill is not passed, what does that tell us about how much of the agency is funded by drug company fees?

Rather than increase the fees paid by drug companies, why not propose a funding bill that does away with this apparent conflict of interest?

I certainly support a strong FDA that can balance its duty to the public health with the need to get life-saving medicines to the public as soon as possible. But everything has its cost.

If we’ve learned anything over the last several years, assurance of drug safety is not an area where we should skimp.

Comments

  1. #1 blf
    September 21, 2007

    Perhaps 25% of the congresspeople and senators should be laid off instead? No-one would notice they aren’t there. Whilst doing so may mean congress would do even less, less than nothing is still nothing. The salaries and other costs saved could be used to help keep, and maybe even increase, FDA staff.

    And it would even get the political commentators something new to write about, as they argue which states should loose part or all of their so-called representation.

    Any disadvantages? Well, err… um, ah, hello? Are there any?

  2. #2 John Johnson
    September 21, 2007

    This passed the Senate last night (Thursday).

    This process has been (and still is, until Bush signs it) a pain for FDA employees and pharma/biotechs (of whom I’d say more than 99% are tiny companies with one drug and a lot of uncertainty). In fact, I’ve made the recommendation at least once to hold off a submission until PDUFA IV passed because correspondence from the FDA has seemed crankier than usual.

    Hopefully in 2012 Congress won’t wait until the witching hour to pass PDUFA V.

    The blog of Hyman, Phelps, and McNamara (fdalawblog.com) is supposed to be coming out with an entry or a series on the final form of PDUFA in the next few days. I do know that there is some provisions for strengthening post-marketing safety surveillance, but I don’t know exactly what those are yet. I was hoping HPM would enlighten.

    As for getting rid of fees, it’d be nice to do that to remove that debate. However, to at least maintain current review timelines and quality you would have to come up with 25% of the FDA’s budget from somewhere else, and to increase drug safety monitoring you would have to come up with even more money. If Congress can do it, more power to them. Just keep in mind that while money is a powerful source of conflict of interest, it is not the only one.

  3. #3 Abel Pharmboy
    September 21, 2007

    John, thanks very much – I heard this morning that it passed in the Senate (I wrote the post last night and scheduled it to appear this morning – a nice feature of Movable Type).

    What I don’t understand is how renewal of PDUFA got linked in with S.242/HR 380. I had thought that PDUFA IV was a separate piece of legislation than the drug importation bill.

    Thanks for the link to the FDA Law Blog.

  4. #4 John Johnson
    September 21, 2007

    I don’t understand the importation/PDUFA IV link either. Drug importation is going to require a complete different set of resources than pre-approval inspections for domestic companies (even those with foreign factories). Trying to tie in this issue, which is much more complex than most people realize, in with a must-pass bill, while seemingly a favorite tactic of lawmakers, in this case endangers the bill, and in this case I think endangering PDUFA IV even with its warts and blemishes is endangering public safety.

  5. #5 Abel Pharmboy
    September 21, 2007

    John, I learned through some blog friends that the bill that passed was HR 3580 which combined PDUFA, the post-marketing surveillance, etc.

    I also should’ve read Angry Toxicologist this morning.

  6. #6 Julie
    September 22, 2007

    To go off on a tangent: If the FDA is remiss of its duties re Big Pharma already, what do you suppose is the likelihood of their being minimally vigilant about generic drugs?

    I’m asking because I recently got a prescription for penicillin, codeine, and also lorazepam to deal with a very painful infection, all of which was given to me in generics by my provider MediCal.

    I am familiar with the effects of the brand-name versions of these drugs from an earlier occasion, and I found that the generics didn’t do the job. I had to take the stuff by the fistful to get through the night, a dose that with the brand-name meds would have knocked me unconscious for a week …

    So I am a smidgen suspicious.

    MediCal is for low-income people and operates on a shoestring as is. Painful to imagine that on top of that they are maybe also being defrauded by the generics manufacturers. Oh, well…

  7. #7 Abel Pharmboy
    September 22, 2007

    Julie, your point is well-taken and not at all surprising. While generic drug manufacturers do indeed have to meet very high standards demonstrating bioequivalence with the corresponding brand-name drug when their formulation is originally approved, subsequent monitoring is reportedly quite poor due to FDA short-staffing.

    This issue has been taken up by syndicated NPR radio hosts and newspaper columnists, Joe and Teresa Graedon, of The People’s Pharmacy. Their website discusses generic prescription drugs and is currently soliciting reader reports of subtherapeutic effects with generics.

  8. #8 Julie
    September 23, 2007

    Thank you very much for the web site, Abel.
    I had been googling for hours in vain to find just such a web site.
    The testimonials are making the picture pretty clear.
    I guess it will take several patient deaths and law suits before this mess is cleaned up, (if at all, considering the state of lawlessness loved by this administration).

  9. #9 anonymous
    December 22, 2007

    to at least maintain current review timelines and quality you would have to come up with 25% of the FDA’s budget from somewhere else, and to increase drug safety monitoring you would have to come up with even more money. If Congress can do it, more power to them. Just keep in mind that while money is a powerful source of conflict of interest

  10. #10 kozmetik
    December 23, 2007

    Thank you very much for the web site, Abel.

  11. #11 Abel Pharmboy
    December 23, 2007

    Hey gang, this marks the first time that I am closing comments on a post. Apparently, this somewhat older post has been drawing spam comments that direct the reader to URLs for shops selling sex products. Of course, you are free to patronize these purveyors, just not via this blog.

    Should you have any questions or comments on the content of this post, e-mail them to me and I’ll put them up in a separate post.