New Budget Puts the FDA Even Further into the Pocket of Big Pharma

This isn’t the way to fix American healthcare.
Last week, the Trump administration released its proposed 2018 budget. The document includes a proposal to increase the user fees the FDA collects from pharmaceutical companies to $2 billion—twice as much as in 2017, according to the president’s budget.
The rationale provided in the budget for this change is to speed the approval of new drugs.
User fees are connected to the FDA’s mandate to ensure not just the safety but also the efficacy of drugs. This was instituted following the passage of the Kefauver-Harris Amendment in 1962. We believe this was a wrong turn. The agency has never shown itself qualified to handle the task of proving that the drugs it approves are effective. This system also caused the cost of approval to soar, because it required effectiveness to be demonstrated through outrageously expensive double-blind random-controlled trials (RCTs).
When drug companies pay the FDA to review drugs, there is obviously a tremendous conflict of interest, and many opportunities for cronyism. The result is the approval of a huge number of dangerous drugs, which have been responsible for thousands of deaths—not to mention the glacial pace of approving substances or devices already proven safe.
We shouldn’t be doubling down on this system by having drug companies give even more money to the FDA. We should be doing the exact opposite by dismantling the current drug regime—by eliminating the requirement for the government to prove the efficacy of drugs. Once a drug has been deemed safe, effectiveness should be worked out by the medical profession, not by unqualified government employees whose salaries are covered by Big Pharma.
 
Other articles in this week’s Pulse of Natural Health:
Chemicals Making us Sterile, Dumber
EPA: Carcinogens Are OK with Us
Want Alzheimer’s? Keep Consuming Sugar

11 comments

  1. I love President Trump with a passion and think he is doing the right things for just about everything but what you are talking about. I am 81 years old and luckily I am allergic to every prescription drug on earth. Was kicked out of Lincoln Hospital in Phoenix and told never ti return. Was fortunate I wasn’t a statistic. I think MD stands for Medical Dummy, who has given their devotion to Big Pharma, rather than to their patients. I wish I could talk to President Trump all about this because part of him would understand. He serves mostly Non GMOs at his resorts and doesn’t believe in taking all those shots. Hope there a way to get in touch with him instead of expressing anger.

    1. Ivanka and her husband cook organic at home at 3-4x/wk too. I totally agree with you. Although I do wish he would have put a farmer/person in the ag position who is pro organics instead of Sonny Purdue, a grain guy. Keep up the good work. I’m almost 58 and aim to be like you — taking no meds at 81!

    2. YOU ARE SO RIGHT! I THINK HE IS COMING UP WITH SOMETHING GOOD FOR THE NATION! WATCH AND SEE!

  2. it seems to me the biggest issue is tying the FDA budget to the Drug corporate fees. It is the same ol, same ol-he who controls the purse strings, controls! The FDA has never been independent of the drug and chemical corporations and so has a strong history of being ruled by them. We need an agency that actually reviews ALL the study data on every study. If independent doctors and research people can read the original study and its data and can see the aberrations in design as well as the unethical and fraudulent manipulation of data, an agency filled with people who know how to read science should be able to arrive at the same conclusions.
    It is also a travesty that corporations like Monsanto can withhold their study data so it cannot be evaluation independently. Their intellectual property right argument is phoney. They just do not want their work exposed for the bogus crap that it is. People like Arpad Putsai clearly demonstrated this when he was going to go public on his findings but found himself rudely sacked the day before he presented. This man was a very well respected scientist who actually trusted GMOs and was assigned, via grants, to show this. Try as he might, safety was not a result and he felt obliged to inform the public of this. The US called the UK and overnite Putsai was gone with his papers.
    Thus, the FDA should be demanding ALL documentation on a drug or product and they need to examine it with a fine tooth comb. I do not agree that efficacy should be left to the medical personnel as that implies using the public as guinea pigs which they already are. If a drug cannot be shown to be safe AND effective over a long period of time, it should not be approved.
    The Codex Alimentarius use of the Napoleonic policy of making everything illegal until proven is also rotten as it is used only for natural/holistic protocols like herbs, and food supplements and homeopathy, etc. Also the precautionary principle which the Codex promotes is also applied differentially. For example GMOs are totally promoted along with hormones and antibiotics for animals. The FDA has been pushing the Codex for years trying to destroy the DSHEA regs of 1996? which state herbs and supplements are all legal unless proven unsafe. The US needs to withdraw from the Codes just as it needs to withdrawn from these Free Trade Agreements.

  4. I am very concerned about this, and agree that Trump seems naive about the corruption concerning the FDA & Big Pharma. I do believe he would NOT allow these fee’s IF he knew of the treachery behind these entities. IF he knew what many of has come to learn (either from personal experience or someone we know) ; how horrific and fraudulent the science is behind these drugs and the propaganda marketed to the public all the while causing disease, and injury and worse.
    Robert Kennedy has his ear regarding the vaccine dangers loaded with Aluminum and Mercury causing brain injury also known as: Autism.
    I pray for our country, and our President, and our leaders.

    1. There is a simple way to get rid of the FDA and improve health care. Oblige health companies to get liability insurance for the products they sell. That way insurance companies would do the evaluation of the products for the risk/reward ratio and the most dangerous products would have to have an extremely high reward level to justify them being on the market. Another thing that should be done is to allow for competition and insurance payments to be made for what all different types of health service as long as they are effective. Open up competition across all forms of medicine. If these things are done, you will watch the quality of health care improve dramatically and the cost of health care drop as quickly as did computer and smartphone prices.

      1. Possibly….But with out question it is important to hold accountable the individuals in the FDA who have decidedly allowed and participated in hiding the dangers of many drugs that are sold as if they are “medicine”. They are NOT. They are products that are allowed to be distributed to the public by a duped medical system that knows NOTHING about what these drugs are and the devastation that occurs. It is obscene and wicked that ALL of them profit handsomely at the public’s expense. Never ever reported in the news media which is financed by BIG Pharma….about the very real horrors of this industry.
        Margaret Hamburg the head of the FDA before she was indited for racketeering and using her position to profit with her hedge fund husband. Former Food and Drug Administration (FDA) Commissioner Margaret A.
        Hamburg, her hedge-fund executive husband, and Fortune 500 giant Johnson & Johnson colluded to enrich themselves by failing to warn the
        public about a “deadly” antibiotic.
        Had this information been disclosed to plaintiffs and the public at
        large, her and her husband’s financial gain and net worth would have
        plummeted, since Dr. Margaret A. Hamburg’s husband, Peter F. Brown,
        reaped and continues to reap huge financial gain as a result of
        Renaissance Technologies, L.L.C.’s holdings of Johnson & Johnson
        stock,” according to the complaint.
        She made significant financial contributions to Hillary Clinton and Barack Obama. Then was placed as head of the FDA…never mentioning to Congress about her husbands conflicting relationships with Johnson & Johnson. It is plain and simple evil. This people dont care…..and chose to be criminals and they should be treated as such.

  5. I am tired of seeing tv commercials for newly approved drugs for all sorts of ailments only to see lawyers advertising for these same drugs because they caused all kinds of harm and even death to those who use them. Speeding up the approval of bad drugs will only keep big pharma and lawyers rich. The little guy(you and me) its okay we die.

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