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

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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.

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  • http://msn Roger Yandell

    The FDA should be in prison. They appear to be hired killers.

  • Arnie Welber

    ‘The China Study’ book tells us about the fox watching the hen house. Heaven only knows when government will be functional for the citizens. :-)

  • Marc Battaglia

    Anyone ever consider suing the FDA for gross incompitence and conflict of interest???? Shame on them. They should be disbanded all together and be held accountable for their unfair and unjust actions!!!!!

  • Marc Battaglia

    Anyone ever consider suing the FDA for gross incompitence and conflict of interest???? Shame on them. They should be disbanded all together and be held accountable for their unfair and unjust actions!!!!!

  • Marc Battaglia

    Anyone ever consider suing the FDA for gross incompitence and conflict of interest???? Shame on them. They should be disbanded all together and be held accountable for their unfair and unjust actions!!!!!

  • Marc Battaglia

    Anyone ever consider suing the FDA for gross incompitence and conflict of interest???? Shame on them. They should be disbanded all together and be held accountable for their unfair and unjust actions!!!!!

  • Marc Battaglia

    Anyone ever consider suing the FDA for gross incompitence and conflict of interest???? Shame on them. They should be disbanded all together and be held accountable for their unfair and unjust actions!!!!!

  • Marc Battaglia

    Anyone ever consider suing the FDA for gross incompitence and conflict of interest???? Shame on them. They should be disbanded all together and be held accountable for their unfair and unjust actions!!!!!

  • Kathy

    The government indorses anyone that will put money in their can. When will we learn that the government has gotten way out of control and needs to be cut back. They have their fingers in too many pies and cannot possibly be an authority on everything, but yet they are making all our decisions that really matter. It’s time to throw them out and rebuild a government that suites the people.

  • Vivianne Mosca-Clark

    Big money is working at controlling every aspect of our lives.
    This aspect is our health.
    They have no right to say what i need or can use for my health.
    I am 69 years old and do not look like it or move like it. i take supplements and use natural herbs and vitamins to keep me healthy. I do not want some money hungry person telling me what i can and can not use for my health.
    If the FDA can’t not understand the the people comes before any corporation…..then they need to get a different job…out of the government.

  • Judith A. Goodwin

    I feel the FDA has become a corrupt, completely useless part of the govt. I no longer feel safe taking any prescription drugs that are approved by the FDA, especially since the pharmecutical companies are pretty much supporting the FDA. I am so tired of drugs that have way too many side effects, many serious, life-threatening side effects. I take supplements instead, at least I can rest assured I won’t die from them.

  • Lauren Graham

    Talk about the fox guarding the chicken coop! It is time to stop selling the American people out to corporate America.

  • Albert Dardanelli

    The U.S. no longer is a democracy, but a dictatorship under a financial-military elite. Should a miracle happen and become again a Republic with a Bill of Rights and full freedom, this would no longer happen.

  • A Concerned Physician

    The FDA is operated as such a charade! How can professional objectivity be maintained when the manufacturers of a drug under testing and review are paying for the review? The FDA needs a complete overhaul. Yes, I know its been said before but it will continue to be said until it happens, until someone listens.

  • Pat Kersten

    this is an abuse of power!!!

  • http://ALLIANCEFORNATURALHEALTH Ann

    I think its High Time that all people start protesting against BIG PHARMA and the FDA. This should be a very important issue in the next election. Does government protect human health or allow BIG PHARMA to endanger the health of humans in order to make their astronomical profits and allow the FDA to be bought out by BIG PHARMA. Government officials should also prove that they aren’t in the back pockets of the FDA and BIG PHARMA and prove that they are ethical and really care about the health of American citizens and this will bring down health care costs at the same time. People should be getting off all these horrible drugs with all the side effects and be allowed to try natural products. Let’s force all upcoming potential presidential candidates to make this a BIG issue in the upcoming elections.

  • Lucinda Kiessling

    It’s very unfortunate that we as a society do not take better care of our health and then turn to our doctors for a quick fix via prescriptions. In a perfect world people would educate themselves on diet, exercise and lifestyle choices. If we were healthy we wouldn’t be pumping millions and millions of dollars into the hands of Big Pharma. Wake up people. Treat your body like a car and put the right fuel in it as step one on your route to good health.

  • http://www.jam2day.blogspot.com Johann

    This is rapidly turning into a way for the drug companies to police themselves, or, put more accurately, to do whatever they please.

    The FDA is increasingly being used as a tool to give the large pharmaceutical companies a legal right to do whatever they want. And, of course, they want to do what’s best for them, not what’s best for the public.

    The FDA has to either be stopped or be completely revamped! If not, there eventually won’t be any Americans left for them to help the drug companies kill!

  • Suzanne Williams

    This is almost as upsetting as the FDA trying to take our Natural Supplements away. We all need to email our Representatives on both issues. They want to control our every thoughts, what we eat, what we do, what we take. I think they prefer that Americans die off so they don’t have to pay for our health costs, or Social Security. It’s sad that we have the most Obese society in the world, not to mention embarrassing. But even scarier when you look at what kind of “nutrition” is taught at our public schools. I have to tell my children to forget everything they teach you about it and teach them myself. How pathetic is that food pyramid?? They know it’s wrong yet they refuse to change it. The Govt will always refuse to admit something is “wrong” even if it’s at the cost of lives! And as long as they get paid millions we will not have a leg to stand on. Sad.

  • Sharon Intilli

    I think it’s time to begin a petition to get the FDA out of our food decisions. Let’s not only try to get
    Michael Taylor out of this office but at the same time, let’s support those Congressional representatives that want to lessen the impact of the FDA. I believe it is time to tell the President and Congress that the FDA can do whatever it wants regading pharmaceuticals since it seems to have such a cozy relationship with Big Pharm but the FDA has no business – or qualifctions – for making decisions about vitamin supplements or food choices! It’s time for this revolution to begin!!

  • http://fnnc.org Roger Pariseau

    Paid-for regulators are just as bad as paid-for “scientists.” Neither can or will do an honest job. The FDA must be fully funded by Congress with our Treasury setting and pulling the fees. Members of the FDA should be totally ignorant of the amount of those fees or how they’re applied.

  • http://[email protected] Russell Riley

    All new drugs and medical devices NEED testing to the fullest extent possible to ensure the safety of the products. FDA and ALL federal agencies should not accept one penny or favors from the Rx company or lobbyist. “Conflict of interest” use to mean something and not worn as a “badge of honor” for the FDA/testers. People and children’s lives are at stake here. All people involved need to get a consciousness. There is entirely to much greed in our government and the companies we trust with our lives . Maybe if people put God back in their lives things will change.

  • Gerald Burtge

    should start campaign to get the FDA out of receiving funds from Pharm. Co. Be it fro application for approval of Drugs , Machines , or anything esle. If the fees are necessary they shoulr go the genereal tresury and be accounted for as income to the government in general fro services or fees snd the funds are to be used for the general budget.. GTE THE FDA and all government regulators out of the business of using incoming revenue for themselevs . It belongs to the PEOPLS of his great country of ours.

  • Donald Klepach

    Of course, that is why pharmaceuticals are the most expensive in the US of any other place in the world. Also MANY other nations sell many drugs that are sold by prescription only in the US over the counter in their nations. I know because I have bought many of them before.

  • Warren Osborn

    So, who is lobbying and paying for the most harmless “drug” in existence? Naturally I mean marijuana.

  • AZgirl7

    The agency “SEEMS” to dance to their tune?? They are blatant in their malfeasance of their stated public ‘protection’ duties. With all the new drugs constantly pumped out, there’s NO WAY they can protect us. WE are Big Pharma’s uncompensated clinical trials. The FDA just rakes in the fees for their big fat salaries. Director Margaret Hamburg needs to be removed. Her collusion with the ADA on the issue of mercury in tooth fillings is absolutely criminal. Even after signing an agreement to sell the stocks and stock options she owned from her former employer (a dental analgum seller) before her nomination was approved, she did not comply. She comes from a family of eugenisits, and it’s quite clear she has no qualms about hurting pregnant women and children, even when the rest of the world AND the FDA’s own scientists are screaming “no more mercury fillings’! This very day the FDA is stalling for even more time, by having public ‘hearings AGAIN, this time in San Francisco. Will WE ever be tops on their list? Maybe after the public has convinced the other 50% of dentists to be ‘mercury free, making the refusal of the FDA to finally issue clear warnings moot’. Look here to see the mercury vapor coming off a 25 yr old filling: http://www.youtube.com/watch?v=9ylnQ-T7oiA&feature=player_embedded

    Then, if you like the feeling of your blood pressure spiking, read this! : http://articles.mercola.com/sites/articles/archive/2011/09/09/fda-coverup-on-the-mercury-dentistry-issue.aspx?e_cid=20110909_DNL_art_1

  • Patricia Valiquette

    Th F.D.A. and the pharmaceutical companies should be rounded up and thrown in jail.
    and more whistle blowing, to protect the good and innocent Natural, and organic world
    Patricia V.

  • cosmo

    Nothing new hear.

    I read about this way back several years in the book, Trillion Dollar Conspiracy, by Jim Marrs.

    The Empire is doomed.

    The emperor is naked.

    Cosmo

  • http://InternetExplore Dr. Anthony Ford

    Look at Big Pharma and the FDA are all thieves in one hive, this is something we don’t need
    control over. FDA should stand up and tell Big pharma we don’t need your payoff, we need to
    send a note to the all Senators to stand up against the FDA no longer need to cater to Big Pharma.

  • Kathy Crose

    This should not be allowed and it could lead to dangerous consequences. There would be no monitoring or testing before it goes out and the FDA is just greedy and does not care what happens to us.

  • http://[email protected] Michael Carpenter

    The Whole system is crooked ,The FDA don’t care who they kill as long as Pharms line their pockets.I think the whole Goverment is the same.way.

  • Richard Sheeler

    Well if this isn’t just more proof of WHO IS IN CHARGE and why the FDA needs to be disbanded . Just who benefits , certenly NOT THE PEOPLE of this country

  • Geminga

    Issues surrounding the FDA such as blatant censorship of peer reviewed science, suppression of any cancer treatment which strays from big pharma such as the drama surrounding antineoplastons and Dr. Burzinski, approval of big pharma drugs without testing other than that controlled by pharma surely rises to a class action constitutional issue. So much harm has been caused due to sweethart relationships between FDA and pharma it seems surely the citizens have a valid cause of action. Dr Bruzyinski’s case and many like his,denying promissing cancer treatment should be a crime in itself. If one of my loved ones had cancer I would use my constitutionally guaranteed life and pursue their liberty to save it. This agency needs to be taken down but short that we the people need to be sniffing out a strong constitutional case to severely clipp their wings with a class action.

  • berry lee

    Today I received the latest issue of Life Extension Magazine and the main story is how the FDA is ripping folks off on things like testosterone cream ect and helping bankrupt the country!!!
    Thankfully Im a low income vet and dont take any drugs but I do take suppliments and hope I can continue to take heal;thy suppliments like fish oil and vit D and C w/o being ripped off by FDA

  • ellen

    Question: how can we protect ourselves from dangers of drugs prescribed?.

  • http://www.silverstealers.net Charles Savoie

    Federal regulatory agencies were all without exception set up by the elements they are supposed to regulate. The Securities Exchange Commission was warned for years of the Madoff frauds, and took no action. The SEC is not there to protect innocent investors. Rather it exists to assist Wall Streeters to fleece the public. The Commodity Futures Trading Commission is supposed to insure free markets in commodity trading and act to prevent concentration of positions however the CFTC has been warned for over ten years as to a short corner control in silver, and has taken no action. In fact the ex chief of the CFTC Newsome, addressed the Silver Users Association while at CFTC, telling them “I look forward to working with you as we move forward.” The Silver Users Association is the enemy of rising silver prices and is the only users group in any commodity. The CFTC is not impartial, it allows “naked shorting” in silver just as the SEC allows naked short sales of securities in order to unfairly profit, and even bankrupt vulnerable companies. The FDA is the same—regulators go to Washington, drawn from the ranks of the “regulated,” and afterwards, these “regulators” get positions with the interests they allegedly regulated. No gangsters on “The Untouchables” were ever as frightening as these I just described.

  • Tory Salmon

    Why isn’t the FBI or some other investigative agency looking into your “Pay to Play” practices? How many people have you killed due to your greed and negligence. FDA, USDA and whatever other agencies are that are supposed to be looking out for the welfare of this country’s citizens are thoughtless pukes!

  • guestresponder

    Tell big pharma to take a flying leap and tell the fda to start testing their drugs and stay away
    from natural supplements. I have been taking natural supplements for years and they have never
    harmed me, can’t say the same for so called medicine.

  • http://nasaleze.com Mike James

    Come to think of it with the cheap,effective,safe and readily available alternative to most antibiotics already available and proven to work with no side effects (over many decades), it is little wonder that they are having to do their absolute best to keep this sort of thing off the market. I know that it is not in my best interests to do anything about this.

  • Ken Kalcheim

    This is probably the greatest conflict of interest in the history of the U.S. government. If the Congress abolished the FDA, I would sleep better at night. The FDA does far more harm than good.

    Ken Kalcheim
    Clinical Nutritionist

  • Carol Wolfhagen

    Unreal! Sounds like bribery to me.

  • http://B&HSupplements Howard Hill

    The FDA iseems like they want to get rid of natural items that work better tha drugs. You could buy liquid vitiman C at a drug store. As of Jan 1st this year you can not.. Our congerss forbie it. You have to get a DR to prescribe it. It must do better than drugs or they woult it alone. Have you
    heard of a cancer cure lately ?. A 12 year girl had blood cancer at age 4 and at 12 was taking Chemo at a hospital. Had Ataff infction and a temp of 105.5. the staff infection was cured. Her grand mother told me about this and I told here that was the best thing that could happen to her.
    I told her that was the best thing that could happen to her. They checked her for cancer and she is CANCER FREE at 13. This discovered in 1859 with a high cure rate. Seems like at 105.5 allcancer cells die. No mention in any news paper. I thought I would try to heat my body to that
    105.5 in my bath tup. The hotwater heater was set at 110 degrees. My body temp went to 107.
    I even felt better. Shoul I get cancer I will try this.

  • Steve

    It is truly pathetic how obvious the revolving door and conflicts of interest are between the pharmaceutical companies and the regulatory agencies. But it’s the same with media, telecom and agribusiness.

  • Diana

    Go Figure! Everyone and everything is for sale! The Federal Government should be paying the FDA to exist, not the companies that produce drugs that are then sold for huge profits and make us all sicker than we were before we started the meds!

    I am a healthy person because I take herbal supplements for my ailments and they work very well, not because I take fake chemically produced meds that cause other health issues! America Wake Up!

  • Bev Stone

    The FDA will always be corrupted until absolutely none of its funds come from the companies they are compelled to review. Let’s quit having the fox guard the hen house, please.

  • Molly Mysliwiec

    How is this democratic and how is this permissable?

  • Dan Burke

    Thanks so much for the data and your showing the blinded people what is being done!
    My son sent me this link.
    Dan

  • B. Talbert

    Glad you are keeping an eye on the PDUFA. I think the FDA and all related agencies should be de-funded as they are not relevant to the needs of the people today and could be rebuilt from the ground up.We definitely do not need more regulation on natural supplements or other losing ways they are thinking up to make money and causing us to pay for supplements twice, once with our tax money and once when we have to buy them.

  • Carole Onderdonk

    Not only is the FDA in the pocket of Big-Pharma, it’s also in the pocket of Monsanto and other bio-tech companies who want to flood the world food supply with dangerous GMO foods.

  • Dan Parow

    Was the government to prescribe to us our medicine and diet, our bodies would be in such keeping as our souls are now. Thomas Jefferson.
    I think we’re in pretty bad shape.

  • Ladawna Nelson

    STOP IT!

  • Ladawna Nelson

    The greed knows no limits. Stop!

  • http://www.theherbprof.com Dr. Paul Blake, N.D.

    THE FDA IS A PRIVATE CORPORATION. They have an EIN number (employer identification number). They pay taxes. A private corporation has no authority over a private business. So how do they get authority? They must get a contract with any business in order to get the authority. The way they do that is they call you up and ask for permission to visit. Then they will come and visit and discuss many things, and during that time there will be numerous things you can say that will be assumed contracts.
    The law says that the FDA must notify the people before coming and then when they arrive they must tell the owner in clear language why they are going to investigate him. They may then make further appointments.
    These errors are covered by the following court cases.
    ● Davis v. Scherer, 82 L. Ed. 2d 139 at 155;
    ● Armstrong v. Mauzo, 14 L. Ed. 2d 62;
    ● Grannis v. Ordean 58 L. Ed. 1363;
    ● Mathews v. Eldridge, 47 L. Ed. 2d 18.

    Doc Blake

  • Gregory Clifton

    If the government and legislators want Americans to cut health care cost through preemmemtive measures, then they need to keep natural dietary supplements and remedies available to the common man. Mainstream medicine does not rely on prevention nor cure, but only on costly maintenace and symptom concealment.

    If supplements are so dangerous, where are the bodies? Show me the evidence that any nutritional supplement currently on the market is causing serious harm. Now, consider the hundreds of thousands of deaths and millions of adverse effects definitively linked to prescription drugs every year. There’s just no comparison.

  • Rosemary Watterud

    We do need to stand up for natural products. What a shame Big Pharma and the FDA are working so closely together. Should be some law against that! Too bad money talks so loudly!

  • dudley smith

    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

  • judie virzi

    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.

  • D Johnson

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

  • Marsha Lackey

    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.

  • http://www.flightcheapflights.com Ronnie Brown

    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.

  • Sarah Lever

    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.

  • rita Butler

    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.