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Quotes about Drug Approval process from the world's top natural health / natural living authors

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"He feared Graham's views concerning the lack of safety of Bextra, SSRI antidepressants, Lotronex, and Rezulin would invite a general congressional inquiry into FDA's new drug approval process, revealing for the first time details long kept from public view through a combination of intimidation and character assassination. When efforts by Graham's supervisors at intimidating him into not testifying before the Senate Finance Committee proved unsuccessful, new efforts were undertaken to disparage him with Senator Grassley's office and with others." - Jonathan W. Emord, The Rise of Tyranny (Get the book.) "It does so through prior restraint on the right to market, the costly and politically sensitive FDA pre-market drug approval process. Pharmaceutical companies also enjoy statutorily extended patents that provide between 13.9 and 15.4 years of monopoly protection for their FDA-approved drugs.43 Pharmaceutical companies also benefit from FDA enforcement against parties that make identical drug products but sell them illegally without FDA approval and against parties that make competitive therapeutic claims unlawfully without FDA approval." - Jonathan W. Emord, The Rise of Tyranny (Get the book.) "In the case of the drug industry, the FDA has ceded so much control over the drug approval process to the industry that FDA regularly approves drugs that its own medical reviewers have defined as unsafe and as likely to cause significant loss of life or permanent disability. Thus, Vioxx entered the market and killed some 55,000 Americans (comparable to the number that were killed in the Vietnam war); Ketek, Serevent, Rezulin, Redux, and a dozen others have entered the market causing scores to die and many more to suffer serious debilitating injuries." - Jonathan W. Emord, The Rise of Tyranny (Get the book.) "By statutory design, the new drug approval process prevents any company from marketing a drug unless that company has obtained FDA approval.180 Unlike the system for over-the-counter drugs, in the case of prescription drugs first approved by FDA and still under patent protection, no other party is permitted to produce a competing compound and market it without submitting and prose- cuting to FDA approval a new drug application." - Jonathan W. Emord, The Rise of Tyranny (Get the book.)

"The drug companies agreed to pay a $300,000 fee for each new drug application; in return, the FDA's Center for Drug Evaluation and Research promised to adhere to a speedier timetable for the new drug approval process. According to a 2002 GAO report, a little more than half the cost of reviewing new drug applications was funded by user fees from the drug industry. New-drug approval certainly became quicker." - John Abramson, Overdosed America: The Broken Promise of American Medicine (P.S.) (Get the book.)

"He liked to talk about how he might speed up the drug approval process, but he was a stickler for details. And there was one thing that most seemed to preoccupy Hayes: the subject of "patient information." Ever since coming to the FDA, he had gotten an earful from the Reagan cabinet about new regulations, promulgated under Hayes's liberal predecessor, Dr. Jere Goyan, requiring drug makers to provide a "patient information insert" with every prescription. Reagan's deregulation-minded cabinet hated the idea, and saw it as one more example of too much government." - Greg Critser, Generation Rx: How Prescription Drugs are Altering American Lives, Minds, and Bodies (Get the book.)

"This brings us to the drug approval process. The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics and products that emit radiation.5 The key words in this description of the agency's mission are "protecting the public" and "assuring safety." After celebrating 100 years of service to our country, the FDA cannot predict the long-term effect of any drug, nor can the agency guarantee the safety of the drugs they approve." - Craig Pepin-Donat, The Big Fat Health and Fitness Lie (Get the book.) "Does this mean that there need to be more resources for the FDA drug approval process? Generally, expanded resources in the form of personnel and money are wasted on systems that are broken. Unfortunately, it is a moot point. No matter how much money we throw at the approval process, we still are not addressing the real issue, which is prevention. Regardless of what changes may be implemented in the future, prescription drugs will always be toxic and will continue to cause health problems beyond the original disease being treated." - Craig Pepin-Donat, The Big Fat Health and Fitness Lie (Get the book.)

"The result of prescribing thalidomide to pregnant women19 was truly a tragedy, but that tragedy also brought large amounts of funding to pregnancy research and changed the drug approval process. Many countries began demanding various animal studies that had not been required before thalidomide. The FDA further tightened its requirements. It was this very conservative approach that caused many to believe that if a drug was approved in America, it must be quite safe." - Dr. Timothy Scott, America Fooled: The Truth About Antidepressants, Antipsychotics and How We've Been Deceived (Get the book.) "Typically I learn these facts after one of my lectures on depression, mind drugs or the drug approval process. The students who approach me often express anger that their physician would put them on Zoloft, Paxil or another mind drug in view of the research. I want you to know what I routinely say to these students. The following dialogue is reflective of those conversations and includes my standard response. My response: I don't think you should get angry at your physician. She is probably very conscientious and works very hard to provide you good medical care." - Dr. Timothy Scott, America Fooled: The Truth About Antidepressants, Antipsychotics and How We've Been Deceived (Get the book.)

"Take Responsibility for Your Body and Health A s convenient as it would be to place sole responsibility for these problems on the physicians, the pharmaceutical industry, the FDA and the drug approval process, or on our health care system, it would not solve the problem. Only you can take responsibility for your own body and your health. You must be active and vigilant. Our bodies are composed of 11 extremely complicated systems that include the skeletal, muscular, integumentary, circulatory, nervous, respiratory, digestive, excretory, reproductive, endocrine and immune systems." - Craig Pepin-Donat, The Big Fat Health and Fitness Lie (Get the book.)

"I believe few could imagine how dramatically the legislation would transform the FDA and the drug approval process in ways unforeseen by Congress or the FDA. Money Influences Drug Research and Drug Approval Merck's arthritis drug Vioxx made front page news in 2004 when Merck announced it was going to remove the drug from the market because of concerns over increased cardiovascular risks. Most of the public still believes that the Vioxx-heart problem link was only discovered in 2004." - Dr. Timothy Scott, America Fooled: The Truth About Antidepressants, Antipsychotics and How We've Been Deceived (Get the book.)

"His original plans were to continue with the drug approval process but found it to be very time consuming and eventually introduced his product to Waiora's scientific advisory board. They soon found this product could be available to the market much sooner as a natural supplement and at a much lower price. Zeolites were first discovered in 1756 by Axel Fredrick Cronstedt, a Swedish mineralogist. He discovered a form of this mineral called stilbite and noticed it lost water when heated. He gave this mineral the name zeolite, which is Greek for boiling water." - Gregory, A. Gore, Defeat Cancer (Get the book.)

"They could also have a voice in the drug approval process," mainly through testifying at scientific advisory meetings, which often give the key thumbs-up or -down on a new drug. Mossinghoff encouraged the trend. He realized that such testimony would be effective and forthcoming at the right time — when any given NDA was in trouble — if and only if he built strong relations with patient groups early in the approval process. If he didn't, he would leave himself open to the charge of opportunism." - Greg Critser, Generation Rx: How Prescription Drugs are Altering American Lives, Minds, and Bodies (Get the book.) "Gilbert McMahon, the Commission on the Federal drug approval process was originally created as an evenhanded, fact-finding mission to discern whether many of the industry's complaints about the FDA were justified. Undei Reagan, it essentially became an industry organ, funded not by the government but — under the guise of budgetary efficiency — by private interests and philanthropists in tune with the president's deregu-latory impulses." - Greg Critser, Generation Rx: How Prescription Drugs are Altering American Lives, Minds, and Bodies (Get the book.)

"The FDA must depend on the drug companies to provide all the positive and negative information about the safety and efficacy of a particular drug, and it is not completely clear whether the FDA has been provided all the information needed in the drug approval process or whether it simply ignores it. And, worse still, much to its detriment, it appears that the consuming public is the last to know. Then again, if Dr." - Kelly Patricia O'Meara, Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills That Kill (Get the book.) "Department of Medicine, Division of Gastroenterology and Hepatology at Stanford University School of Medicine, before the House Energy and Commerce subcommittee on Health, provides interesting insight into the drug approval process at the FDA (in part): "In the current system of drug approval, trials designed to assess the safety of a drug are often performed after its approval—the so-called post-marketing studies. But these are rarely completed. A drug is considered 'safe' unless proven otherwise." - Kelly Patricia O'Meara, Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills That Kill (Get the book.)

"David Graham, MD FDA Drug Scientist INTRODUCTION Every semester I surprise many students (perhaps shock or anger are even more accurate terms) as I share facts related to the FDA's drug approval process. Most students, like most Americans, assume that if a drug has been approved by the FDA, it is both safe and effective. That was an assumption I also presumed to be true at one time. However, the research on many FDA-approved drugs led me to realize that I, too, had been fooled." - Dr. Timothy Scott, America Fooled: The Truth About Antidepressants, Antipsychotics and How We've Been Deceived (Get the book.)

"There is a simple answer to this question, and it has nothing to do with objective, confirmable biological or neurological tests and, in fact, whether or not a "chemical imbalance" is the cause of any alleged mental illness isn't even a consideration during the FDA drug approval process." - Kelly Patricia O'Meara, Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills That Kill (Get the book.)

"He ignored that risk and instead had the courage to come forward in the public interest to try to effect positive change in the drug approval process. If you would like to read this damning testimony for yourself, visit the Fit Advocate Web site at www.FitAdvocate.com where you will find a link that will enable you to review it in its entirety. If I have not yet effectively conveyed the risks involved with prescription drugs and the FDA approval process, this document will. One Person's Tonic, Another One's Toxin Each human being is different." - Craig Pepin-Donat, The Big Fat Health and Fitness Lie (Get the book.)

"The Wall Street Journal reported on September 27, 2005, that von Eschenbach wants to "streamline and accelerate" the drug approval process. On September 25,2005, he was interviewed by Robert Pear and Andrew Pollack of the New York Times: Dr. Andrew C. von Eschenbach said he had a "100 percent commitment" to both jobs. As director of the cancer institute since January 2002, Dr. von Eschenbach has worked closely with patients and their advocates. At the FDA, he said, he would use that experience to ensure that patients gain swift access to the fruits of biomedical research." - Byron J. Richards, Fight for Your Health: Exposing the FDA's Betrayal of America (Get the book.) "The FDA will need your personal medical data, as it plans to use this database as the cornerstone in its new fast-track drug approval process. In essence, by virtue of being in the database, you will become part of a nationwide clinical trial on all drugs in use. The intention is to replace the existing drug approval system with this new database. As individuals are injured trying new drugs, the database will flag the emerging risk. While this plan may sound ludicrous, it is the plan." - Byron J. Richards, Fight for Your Health: Exposing the FDA's Betrayal of America (Get the book.) "This AEI Newsletter quotes Gottlieb as highly critical of the FDA's drug approval process. Ambitious goals for the Food and Drug Administration. 1/1/2003 Available here: http://www.aei.org/publications/pubID. 14775,filter.all/pub_detail.asp 4. The top FDA position is now assigned to another person seeking to get drugs approved quickly. Pear, Robert and Pollack, Andrew. Bush's Choice for F.D.A. Chief to Keep Other Job The New York Times 9/25/2005 5." - Byron J. Richards, Fight for Your Health: Exposing the FDA's Betrayal of America (Get the book.)

"A major problem is regarding the drug approval process. First, most studies done to determine the safety of a particular drug, are normally conducted by the company that created the drug. The results of the study would be expectedly biased in favor of the drug's approval. Secondly, the company is required to pay a huge sum to the FDA for the drugs' approval. The FDA often evaluates drugs similar to drugs already approved in the past. According to Dr. Glenmullen {Prozac Backlash, 2000, p." - Dr. David W. Tanton; Ph.D., A Drug-Free Approach To Healthcare, Revised Edition (Get the book.)

"We are also beginning to discover just how dangerous and unpredictable the many "FDA approved" drugs really are, and how little safety our current drug approval process actually provides. I cover this issue in considerable detail in my book, A Drug-Free Approach To Healthcare, (now available in a new Revised Edition, 2007). I not only discuss the many dangers associated with these drugs, but also the serious nutrient depletion they are responsible for. Most importantly, I explain why they are seldom (if ever) necessary, and how easily then can normally be withdrawn from." - Dr David W Tanton, Ph.D., Antidepressants, Antipsychotics, And Stimulants - Dangerous Drugs on Trial (Get the book.) "There is a major flaw in our current drug approval process, (and has been for quite some time), which is reflected in Merck's study. For instance, companies can now conduct their own studies, and could easily conduct parallel studies, and then choose the one with the most favorable results, for FDA approval, (an all too common practice). Conducting smaller studies in 13 different countries would provide a perfect opportunity for doing just that. And who would be the wiser if they did?" - Dr David W Tanton, Ph.D., Antidepressants, Antipsychotics, And Stimulants - Dangerous Drugs on Trial (Get the book.) "One problem stems from the drug approval process, which is the result of the budget priorities established by the FDA (where most of the funding is allocated). As most studies regarding the safety of a particular drug are actually conducted by the company that created the drug, the results of the study would thus be expectedly biased in favor of the drug's approval." - Dr David W Tanton, Ph.D., Antidepressants, Antipsychotics, And Stimulants - Dangerous Drugs on Trial (Get the book.) "The obvious question is, what authority does the FDA really have, and why would they just stand by and allow any drug manufacturer to totally ignore their normal drug approval process? Especially when it involves our young children who are at the greatest risk, by far, for reactions to dangerous mind-altering drugs. If the FDA is unwilling to assume that responsibility, and instead stand by and totally ignore an issue that serious, then our legislators should step in and see that it's addressed." - Dr David W Tanton, Ph.D., Antidepressants, Antipsychotics, And Stimulants - Dangerous Drugs on Trial (Get the book.)

"The importance of the EMEA will, however, increase rapidly in the near future, and significandy influence the drug approval process within Europe. Phytoequivalency The ever-increasing sophistication of phytopharmaceuticals demanded by both the regulatory agencies and conscientious manufacturers led to the pertinent question of comparability between different preparations. Similar to the bioequivalency of chemically defined substances, attempts were made to define the therapeutic equivalency of phytopharmaceuticals." - Josef A. Brinckmann and Michael P. Lindenmaier, Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis (Get the book.)

"Some of these gaps may arise because of ongoing tensions within the agency, and even conflicts of interest in the drug approval process. The FDA also faces pressures from industry, advocacy groups, and politicians. The agency's major drawbacks, in our view, are that it's underfunded for the volume of work it faces, and that it has no legislative mandate for some of the things we'd like it to do." - Richard A. Deyo M.D. M.P.H., Donald L. Patrick, Hope or Hype: The Obsession with Medical Advances and the High Cost of False Promises (Get the book.)

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