FDA “Negotiating” to Get More Money from Big Pharma—Again!

September 13, 2011
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iStock_000001344100XSmallIncreasingly Pharma is funding the FDA. No wonder the agency seems to dance to their tune.

The Prescription Drug User Fee Act (PDUFA) authorizes the FDA to collect fees from companies, allegedly to fund and expedite the drug approval process, but really to pay the agency’s bills. Under this authority, pharmaceutical companies pay fees for certain new human drug applications, biologics applications, and supplements submitted to the agency for review—and the FDA’s review of an application cannot begin until the fee has been submitted.

The law was enacted in 1992, and Congress needs to renew it every ten years; the next deadline for renewal is September 2012. To make this happen, the FDA has been performing its usual ritual of begging and blustering at the same time.

The FDA has been discussing a raise in the FDA “user” fees with industry since July 2010; in fact, Big Pharma had already agreed to a 6% increase in fees for new drugs through 2017. The increase is expected to produce an additional $40.4 million in user fee revenue in fiscal 2012, bringing the fiscal 2013 total to $712.8 million. But FDA still hasn’t arrived at a deal with companies on user fees for medical devices—the FDA made a proposal, but industry rejected it, so the negotiations continue.

According to the FDA itself, drug companies provide fully 60% of the FDA’s drug review costs—which means that the FDA’s review and regulation of pharmaceutical drugs is largely funded by the very drug companies under review!

Could this brand of crony capitalism be part of the reason why the FDA is apparently so biased against supplements, which it regards as competition for drugs? Or why the drugs the FDA approves are so dangerous that, as we reported last year, they kill 50,000 Americans and send more than 700,000 more to emergency rooms each year?

PDUFA is what is known as a “must-pass” bill. Such bills become vehicles for other, smaller bills looking to slide through unnoticed as riders. We will keep a close watch on that—as well as on the FDA’s so-called negotiations with its friends in the pharmaceutical industry.

57 Responses to “FDA “Negotiating” to Get More Money from Big Pharma—Again!”

  1. rita Butler says:

    Getting rid of the FDA is not the solution. We do not want to go back to the days of no regulations (read Upton Sinclair’s The Jungle) Some of the products we have gotten from China with poisonous fillers in them is another good example. What we need are agencies that are not funded by corporate substities.
    The solution is to close all the corporate tax loop holes and make them pay their share of the Federal budget. Then the tax money can be used to properly fund the agencies. Also, no one from the drug industry should be hired to be on their boards or fill top positions.

    We need them to do their job and protect the health and well being of the people and not the corporate bottom line.


  2. Sarah Lever says:

    So, if a company has money it can buy its products into approval. I think that if a drug or product is proven (by Dr.’s successful use to improve patient health, or testimony of a supplement being beneficial over years of use), that the FDA should be required to assist that company in making its proven product available to the public. Once again, the people suffer so big business can profit, aided by our own government.


  3. Ronnie Brown says:

    Can we write to FDA to let them know we do not approve of such thing like taking money from drug companies? it’s up to us to do something.


  4. Marsha Lackey says:

    Seniors have fought the choice of food or meds far too long. Thank you ANH-USA for being there for us….I am still scraping by though.


  5. D Johnson says:

    FDA must be dismantled and done away with. There are enough troubles in the world without this insidious corporatism going on.


  6. judie virzi says:

    i would only hope the congress would not pass the renew it bill for the fda to increas the user fee, as it is getting out of hand, a lot of the drugs are dangerous, the side effect are worse than the medical problum.


  7. dudley smith says:

    Ciprofloxacin antibiotics and mercury in fillings made me very ill and i have not been able to work now for 4 years. I get no help from the UK goverment or Drs.

    Before this i had a successful business and was vey fit and happy.

    Dudley Smith


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