Lawyers who want to sue drug companies will be drooling over the news that the FDA has “certified” a 2009 letter sent anonymously by FDA staff to President Obama describing “systemic corruption and wrongdoing that permeates all levels of FDA.” FDA is riddled with politics, conflicts of interest and outright corruption, and is, as the letter says, “fundamentally broken.” https://www.cbsnews.com/news/fda-corruption-letter-authenticated-lawyers-start-your-engines/
Nine FDA scientists appealed to President George W. Bush and at the time, President-elect Barack Obama over pressure from management to manipulate data, mainly in relation to the review process for medical devices. These concerns were highlighted in a 2006 report[2] on the agency as well.[76]
Hidden conflicts? Pharma payments to FDA advisers after drug approvals spark ethical concerns https://www.sciencemag.org/news/2018/07/hidden-conflicts-pharma-payments-fda-advisers-after-drug-approvals-spark-ethical
Then very effective mass marketing takes over, and the FDA devotes only a small percent of its budget to protect physicians or patients from receiving biased or untruthful information. 34 The further corruption of medical knowledge through company-funded teams that craft the published literature to overstate benefits and understate harms, unmonitored by the FDA, leaves good physicians with corrupted knowledge. 5 6 Patients are the innocent victims. https://ethics.harvard.edu/blog/risky-drugs-why-fda-cannot-be-trusted
When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. On the contrary. For more than a decade, the FDA has shown a pattern of burying the details of misconduct. https://slate.com/technology/2015/02/fda-inspections-fraud-fabrication-and-scientific-misconduct-are-hidden-from-the-public-and-doctors.html
Exposing the FDA’s Betrayal of America is a stunning exposé into the secret world of the FDA, Wall Street, and drug companies. At stake is the health and well-being of all Americans. Adverse reactions, even deaths, are hidden while dangerous drugs are pushed on Americans, especially children simply for profit. https://www.amazon.com/Fight-Your-Health-Exposing-Betrayal/dp/1933927178
FDA documents obtained under the Freedom of Information Act, revealed that the FDA has been concealing from the medical community and the public serious research misconduct; including fraud, deception, avoidable risks for human subjects — even deaths — that occurred in clinical trials. https://ahrp.org/fda-conceals-collaborates-in-serious-research-misconduct-fraud-deception-adverse-events/
The Food and Drug Administration has a sordid history of scandals involving conflicts of interests, cover-ups, corruption and congressional investigations. A recent investigation into the approval and continued protection for the controversial sterilization device Essure, depicts classic examples of controversial conduct by the FDA https://www.ennislaw.com/blog/essure-depicts-classic-examples-fda-conflicts-and-corruption/
former U.S. Food and Drug Administration official pleaded guilty to accepting a $20,000 bribe to expedite a generic drug maker’s application https://apnews.com/4341009a667c3195829a79728d6774b3
A $1.8 million 2006 Institute of Medicine report on pharmaceutical regulation in the U.S. found major deficiencies in the FDA system for ensuring the safety of drugs on the American market. https://en.m.wikipedia.org/wiki/Criticism_of_the_Food_and_Drug_Administration
The FDA has been criticised for allowing the use of recombinant bovine growth hormone (rBGH) in dairy cows. rBGH-treated cows secrete higher levels of insulin-like growth factor 1 (IGF-1) in their milk than do untreated cows. IGF-1 signalling is thought to play a role in sustaining the growth of some tumorshttps://en.m.wikipedia.org/wiki/Criticism_of_the_Food_and_Drug_Administration
Dr. Herbert L. Ley, Jr. In an interview to The New York Times, warned the public about the FDA’s inability to safeguard consumers. People were being misled, he believed “The thing that bugs me is that the people think the FDA is protecting them – it isn’t. What the FDA is doing and what the public thinks it’s doing are as different as night and day,” he said.Ley stated that the entire issue was about money, “pure and simple”.[50][51]
In a 2005 interview, Dr. David Graham, associate director of the FDA’s Office of Drug Safety, stated that “FDA is inherently biased in favor of the pharmaceutical industry. It views industry as its client, whose interests it must represent and advance. It views its primary mission as approving as many drugs it can, regardless of whether the drugs are safe or needed”[53][54] https://en.m.wikipedia.org/wiki/Criticism_of_the_Food_and_Drug_Administration
It also has been shown that oftentimes, the FDA expert advisory panels had direct financial interests in the drugs or products being evaluated.[57] Former Editor of The New England Journal of Medicine, Marcia Angell, has stated that “It’s time to take the Food and Drug Administration back from the drug companies https://en.m.wikipedia.org/wiki/Criticism_of_the_Food_and_Drug_Administration
‘We knew there were payoffs,” said Roy McKnight, Mylan’s 68-year-old chairman. ”We knew we were being pushed back behind other companies’ applications and discriminated against.” Added Milan Puskar, the company’s 54-year-old president: ”We had to blow the whistle on the F.D.A. The F.D.A. generic division was just totally out of control. The industry was going to fall apart if we allowed the situation to continue.” https://www.nytimes.com/1989/09/10/business/exposing-the-fda.html
Critics of the 1992 Prescription Drug User Fee Act argue that industry funding of the drug review and approval process gives pharmaceutical companies, and their lobbying arm, PhRMA, too much… https://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/independent.html
These sometimes create incentives (for drug firms and their employees) that conflict with the development of knowledge, drug safety, the promotion of public health, and innovation. https://ethics.harvard.edu/pharmaceutical-industry-institutional-corruption-and-public-health
Lies and Deception How the FDA Does Not Protect Your Best Interests. … https://smart-publications.com/articles/lies-and-deception-how-the-fda-does-not-protect-your-best-interests/
newreport from two researchers at the Oregon Health and Science University, published in the journal The BMJ, suggests many of these medical reviewers go on to work for the drug companies they oversaw while working for the government. https://time.com/4510025/fda-drug-companies-pharmaceutical-industry-medical-reviewers/
More than a quarter of the Food and Drug Administration employees who approved cancer and hematology drugs from 2001 through 2010 left the agency and now work or consult for pharmaceutical industry https://www.npr.org/sections/health-shots/2016/09/28/495694559/a-look-at-how-the-revolving-door-spins-from-fda-to-industry
The agency, whose responsibilities include making sure that prescription drugs sold in the United States are safe and effective, receives almost three-quarters of its funding for that work from drug makers. https://www.pogo.org/investigation/2016/12/fda-depends-on-industry-funding-money-comes-with-strings-attached/
If drug companies merely wrote the checks, there might be less cause for concern. Indeed, many federal agencies collect user fees. However, at the FDA, as a study by the Institute of Medicine has observed, the corporate money comes with “strings that are attached.”
Drug and Medical Device Companies Have Outsized Influence on FDA. $700 million in lobbying https://www.ucsusa.org/resources/drug-and-medical-device-com