PDUFA and its corrupting influence on the FDA. From Consumer Union.


FDA Should Put Hold on User-Fee Deal with Pharmaceutical Industry until Specific Safety Goals Included, Consumers Union Says

CU testifies at Friday public hearing on PDUFA IV proposal

(Washington, DC) – The FDA should put a hold on its proposed user-fee deal with the pharmaceutical industry until specific safety benchmarks are included, such as investigating all serious drug adverse-event reports and taking action against companies that fail to perform promised safety studies, Consumers Union said.

“Consumers should get the same tough deliverables on safety, just like the pharmaceutical industry gets on drug approvals,” said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports. “When it comes to ensuring drug safety and effectiveness in this agreement, you have to ask ‘where’s the beef?’ ”

The FDA is holding a public hearing Friday on its proposed agreement with the drug industry to extend the Prescription Drug User Fee Act, or PDUFA. Congress first passed PDUFA in 1992 to speed up drug approvals by having the industry help fund the approval process. The original act has been extended twice and is slated to expire this year unless Congress reauthorizes it (PDUFA IV).

Some of the safety goals Consumers Union is requesting the FDA include:

• Investigating all serious adverse event reports within 15 days, and conduct a set amount of investigations per year into patterns or clusters of adverse event reports to determine if more action should be taken.

• Levying monetary penalties against at least 50 percent of the drug applicants who have failed to complete follow-up safety studies or trials.

• Doubling the audits of clinical trial data and Investigational Review Board applications to ensure the ethical treatment of enrollees in drug trials and the sponsor’s compliance with good scientific practice.

• Requiring drug trials for a set amount of medicines being used off-label to determine if they are safe and effective for that use. A recent report estimated that 21 percent of 160 commonly prescribed drugs are prescribed off-label, and in 73 percent of the cases, there was little or no scientific support for that use.

“The industry gets 90 percent of new drug applications decided within a certain number of days, and requests for meetings answered within two weeks. But what does the public get?” Vaughan said.

To read the complete testimony, click here

The proposal calls for industry to pay $393 million annually to the FDA, an increase of $87 million over the previous PDUFA agreement. Of the increase, $29.3 million is earmarked for drug safety efforts over the life-time of a drug.

“The $29 million in increased funding for safety is a start, but it’s woefully inadequate,” Vaughan said. “The Institute of Medicine called for more than $100 million in new safety and scientific resources.”

Vaughan said if a user-fee system is necessary to help fund the drug approval process because of pressures on the budget, then there should be no strings attached to the money. Many FDA employees have said the current system of having the industry fund FDA operations is having a corrupting influence on the agency’s safety responsibilities.

“We strongly endorse legislation that has been offered in the past by Congressman Maurice Hinchey that proposes any FDA revenues derived from the regulated industry not be burdened with conditions on their use set by the industry,” he said.

Be Sociable, Share!
You can leave a response, or trackback from your own site.

15 Responses to “PDUFA and its corrupting influence on the FDA. From Consumer Union.”

  1. Kristina says:

    Foг examplе, when thhe primary utilization οf ʏouг vehicle would bе tto support yߋur ѕmall business, ʏou ɦave
    to tawke іnto consideration insurance as ԝell
    ɑs any payments mɑybe youu have aroսnd thе vehicle.

    Thhis article ѡill mention Internet marketing resulting in oobtaining a master’s degree iin Internet
    marketing online. Τhat’s the easiest method to confuse your website
    visitors аnd mɑke tɦat itt iѕ hard foг them tߋ locate

    Check oսt my weblog: excellent fat burning (Kristina)

  2. Hi my loved one! I wish to say that this article is awesome, nice
    written and come with approximately all important
    infos. I’d like to look more posts like this .

  3. Thank you for some other informative web site. Where else may just I am getting that kind of
    info written in such a perfect approach? I have a challenge that I’m just now working on, and I’ve
    been at the glance out for such information.

  4. What’s up to every body, it’s my first visit of this weblog; this web site
    carries remarkable and in fact fine material designed for

  5. Even so, Venapro doesn’t give you immediate
    relief from your hemorrhoids.

  6. Of course, not all religious people are against marriage equality,
    and even some of those who are treat gay people with compassion and respect.
    Finally you need to be very disciplined if you are
    to succeed in this kind of trading. It is also essential
    for the 501c3 nonprofit organizations to register using
    the government.

  7. parody songs says:

    If you take herding dogs, expect that it will lead groups of children or pets.

    • If you have recorded a video of you lying by the pool at a hotel, you will not be able to get
    a lot of hits if you just tag it as, ‘video of me lying by the pool.
    The thesis is the main argument that the student intends to advance within the paper.

  8. feminism says:

    The animated videos come out frequently, so you’ll want
    to check back often to see what sorts of things your favorite characters
    are up to next. Instagram sent Chelsea a notice of why her photo was
    removed. If you are dating a Colombian woman, there is no need to withhold your ideas
    or principles.

  9. vimax italia says:

    If you would like to get a great deal from this piece of
    writing then you have to apply these techniques to your won webpage.

  10. Noreen says:

    The warmth that is used for geothermal power could be from
    deep within the Earth, all the way down-to-earth’s core – 4,000 miles (6,400 km) down. Department of Agriculture, The united state Division of Power (DOE),
    and also It would suggest the most effective way to develop
    works would certainly be digging holes California Renewable Energy Overview and
    Programs (Noreen)
    also filling them up once again.

  11. her response says:

    her response…

    PDUFA and its corrupting influence on the FDA. From Consumer Union. | “Levaquin Hurts” Brain/Body Toxic Drug…

  12. eggfeather.com…

    PDUFA and its corrupting influence on the FDA. From Consumer Union. | “Levaquin Hurts” Brain/Body Toxic Drug…

  13. http://www.myklassic.studio2108dev6.com...

    PDUFA and its corrupting influence on the FDA. From Consumer Union. | “Levaquin Hurts” Brain/Body Toxic Drug…

  14. graded electricals direct…

    PDUFA and its corrupting influence on the FDA. From Consumer Union. | "Levaquin Hurts" Brain/Body Toxic Drug…

Leave a Reply

Design by Aaron Melvin