The US Food and Drug Administration (FDA) is responsible for promoting public health through the regulation and supervision of food safety, prescription drugs, dietary supplements, medical devices, tobacco products, vaccines, cosmetics, and more. The FDA has tremendous power, regulating about 10% of the US economy. The FDA’s budget in fiscal year 2015 was $4.7 billion.
Unfortunately, the FDA has proved time and again that it is unable to carry out this mission and protect the American people from preventable harm.
In these pages, we will lay out our argument that the FDA is fundamentally broken and is in desperate need of reform—from the ground up. Here we present our case against the FDA and articulate the many ways the agency fails to protect Americans’ health and well-being.
The root of the problem
One of the greatest and most pervasive problems is that the FDA is in the pocket of the drug industry. “User fees” provide 60% of the FDA’s drug review costs, which means the FDA is immediately caught in a colossal conflict of interest—to protect its own bottom line, it does everything it can to support the pharmaceutical industry, including refusing to prosecute them for wrongdoing, creating a revolving door policy in which government decision-makers who produce Big Pharma-friendly policies are richly rewarded with top-level industry jobs.
One reason FDA-approved drugs, vaccines, and medical devices are so dangerous, as our FDA Death Meter makes clear, is that the FDA drug approval process is deeply flawed. There are five major reasons for this:
- First, the FDA does no safety testing itself, and says drug companies’ own studies are good enough. Safety and efficacy information is supplied by the pharmaceutical industry; the trials are conducted by drug industry insiders and academics on the Big Pharma payroll, and the drug companies are allowed to cherry-pick the studies they like, and bury the rest.
- Then, the FDA and industry conspire to suppress drug trial safety concerns, even when the FDA uncovers scientific misconduct in clinical trials of pharmaceutical drugs. By keeping drug safety data from the public, more dangerous drugs are approved—and more Americans are sickened, hospitalized, or killed.
- Worse, the FDA often approves drugs it knows full well are dangerous. Over and over, whistleblowers have revealed the frightening extent to which the FDA does the bidding of the drug industry, including approving drugs as safe when the evidence reveals them to be unsafe, as was the case with Vioxx.
- In addition, the FDA approves mind-altering, violence-inducing drugs: even though patients who take SSRI antidepressants are warned that young people taking these drugs may want to kill themselves.
- There’s one more way Big Pharma benefits from its incestuous relationship with the FDA: by taking advantage of the many lucrative protections given to the pharmaceutical industry. Patents on an approved drug can last up to twenty years. In addition, the FDA grants exclusive marketing rights for up to twelve years, depending on the class of drugs. They even get to tweak the formulas of OTC drugs and get them reapproved as extremely expensive specialty drugs—with another twelve years of market exclusivity.
The overarching issue is that the FDA puts profits before people. An unconscionable number of drugs for chronic conditions have profoundly negative side effects: statin drugs, for example, weaken the immune system, worsen diabetes, and can cause memory loss, confusion, and depression. But because these are blockbuster drugs that bring big profits to Big Pharma, the FDA allows demonstrably dangerous drugs to remain on the market.
The FDA’s war on natural medicine and natural food
The FDA’s partiality toward the pharmaceutical industry means it is biased and openly hostile toward natural products and integrative medicine:
- The agency has for many years been waging a multi-pronged war on natural medicine—the best example of which is its animosity toward dietary supplements—in an effort to eliminate Big Pharma’s competition. In fact, the FDA has proposed new rules that threaten the existence of tens of thousands of supplements.
- The agency is also attacking compounded natural medicines and trying to crush innovations like laboratory-developed testing. Anything that competes with the pharmaceutical industry’s market share comes under fire from the FDA—see, for example, its assault on medical foods specifically formulated to manage a disease or condition, or its antipathy toward homeopathy.
- Even when the FDA is dealing with foods rather than drugs, it favors “Big Farma” and tramples on small food producers, particularly those who produce raw dairy products and artisanal cheeses, and is pushing the industry toward irradiated, processed food in the mistaken belief that sterile food is “safer.”
What can be done? We have identified the one big fix for American healthcare: a tremendous number of problems could be solved if the FDA would allow free speech about science! The current restrictions on free speech keep consumers in the dark about the benefits of safer, cheaper, and often more effective natural products—and that means American medicine will continue to be dominated by pharmaceutical drugs.
Clear and present dangers
As our FDA Death Meter demonstrates, the FDA ignores medical device safety concerns, which causes a tremendous number of illnesses and deaths. But endoscopy and colonoscopy are enormous businesses, producing tens of billions of dollars of revenue per year, and powerful special interests do not want to see any changes in this area of medicine—no matter what the risks are for the patient.
The FDA actively promotes genetically modified organisms (GMOs), and has even approved “Frankenfish”—GMO salmon—for sale in the US, though a number of national retailers are refusing to carry it, and millions of Americans have protested its approval.
The agency approves harmful food additives like artificial sweeteners (“by far the most dangerous substance added to most foods today”), allows wood pulp in grated cheese, and puts potassium bromate in baked goods. Worse, the FDA wants to treat supplements as additives, even though the agency’s previous efforts to do so were rejected by two US courts of appeals. The FDA is giving bad nutrition advice to the government’s Dietary Guidelines Advisory Committee, and has essentially capitulated to the sugar lobby.
Few areas of public health have attracted as much controversy as vaccines. Much of the debate seems to be more emotional than reasoned (or, indeed, firmly based in solid scientific research). The fact is, as you can see from our FDA Death Meter, FDA-approved vaccines have caused between 35,000 and 700,000 serious adverse events, including hospitalizations and deaths. The science is clear: the FDA promotes harmful vaccines—and it’s all because of money. FDA, the media, and the drug companies conspire to fabricate data and hide significant safety concerns—and our most vulnerable citizens, children and the elderly, are saddled with the consequences.
What can be done?
We invite you to sign our petition! We believe the FDA is a broken agency that needs a complete reform and restructuring. Join us in calling for a complete overhaul of the US Food and Drug Administration!