Decision Maker

Janet Woodcock, M.D.

  • FDA Director, Center for Drug Evaluation & Research

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Petitioning Bernie Sanders

FDA Accelerated Approval of Genervon's GM604 for Use In ALS

My name is Nick and I am 54-years old. In October 2011, I was diagnosed with ALS. Today, I am in a wheelchair and cannot walk or stand. My arms grow weaker almost every day and my breathing is starting to be affected. I used to be very active but now I can only leave my home when I have someone with me who's strong enough to lift me into my wheelchair once I'm done scooting down to the bottom of the stairs on my butt. It can feel like I'm a 100-year old man who can't do things for himself anymore. At 54, I should still be a vibrant part of my community, but this disease is kicking me where it hurts. Through the enthusiasm generated by the Ice Bucket Challenge, many people now know that ALS is a degenerative neurological disease that currently affects over 30,000 Americans, and as it stands the disease is always fatal. Most people with ALS are given only 2-5 years to live. When I was diagnosed, I was devastated - it took me months to accept it. Although I am now resolved, I have not lost hope. Currently, there is only one drug available to treat ALS (Riluzole) and it is only able to extend life expectancy by a couple months. That's why the recent news about a small company named Genervon Biopharmaceuticals and their trial drug "GM604" has been so exciting for the Global ALS Community. While most trials have a hard time even finding a positive trend, the GM604 trial data supports the view that this drug could very well be is a game changer in the battle against ALS. There are multiple, statistically significant data. Not only in clinical data and results alone, but also correlated biomarkers data and results as well. (Please see "Files" section on the campaign website: Genervon met with the FDA in February 2015 and made a potentially life-changing request on behalf of the ALS community; they asked the FDA to promote GM604 to the Accelerated Approval Program with Post-Marketing Phase 4 Requirements, so all ALS patients can have legal access to GM604 now. Under the FDA's Accelerated Approval Program, the treatments would be covered by health insurance. Although Genervon knows that this request might complicate their relationship with the FDA, they were willing to take a stand and do everything they can to help the ALS community because it is the right thing to do. If the FDA does not grant Accelerated Approval, it will likely be 3 more years before patients are able to access this drug -- meaning that most people currently living with ALS will not live to see it reach market. While acknowledging the paramount importance of public safety in the FDA’s drug approval process, I believe that ALS presents a compelling case for an exception to the usual process. I am asking you to help me appeal to the FDA through their sense of compassion for those of us with this dreadful illness. People with ALS don't have time to wait for another clinical trial to be completed.  By signing this petition, you'll be helping patients like me request that the FDA expidite the way potentially life-saving treatments are made accessible to people with ALS -- starting right now with GM604. Doing so could very likely mean a change in the course of ALS progression not only for myself, but hundreds of thousands of other patients worldwide. After you sign, please follow this link to tweet and/or email the FDA: Thank you, Nick Like us on Facebook: Please go to the Genervon website for a true understanding of the facts and the science behind GM604:  

Nicholas Grillo
801,494 supporters
Petitioning Food and Drug Administration, ALSA, Brainstorm Cell Therapeutics, Janet Woodcock, M.D., Peter Marks

ALS patient access to Brainstorm's treatment NurOwn

My name is Bobby Forster and I have ALS, also known as Lou Gehrig’s disease. Most people with ALS live 2-5 years after their first signs of disease and our treatment options are limited.Recently, I was a participant in the US trial of a new treatment called NurOwn. After two weeks of treatment I went from barely able to stand for more than ten seconds, to being able to walk with a walker, to being able to walk unassisted. I also saw significant improvements in my forced vital capacity (FVC) and speech. Other participants yielded great results as well.My improvements continued for a month, then my progression plateaued for a month before I began progressing again. This therapy is one that will require multiple treatments every couple months.  Unfortunately, the company that makes NurOwn, Brainstorm, is hesitant to pursue accelerated approval of this treatment with the FDA and has opted to conduct a Phase III trial which could delay approval for another 5 years. Without accelerated approval thousands of ALS patients could die over the next several years waiting for the traditional process for approval to be completed. Another challenge Brainstorm faces is raising enough money to conduct an expensive Phase III trial. If the money is not raised then Brainstorm and NurOwn could be dead in the water and the treatment will never make it patients. This treatment has now been in multiple trials both in the US and Israel. It has been shown to be effective and has no significant side effects. It is time for all ALS patients to gain access to this ground breaking treatment.  Please sign this petition and ask Brainstorm to pursue accelerated approval of NurOwn with the FDA. I am sick and tired of seeing my friends die while there exists a safe and effective treatment.

Robert Forster
170,014 supporters
Petitioning Food and Drug Administration, Lamar Alexander, Patty Murray, Mark Kirk, Dick Durbin, United States Department of Health and Human Services, Janet Woodcock, M.D., Office of New Drugs, FDA Public Aff...

Urge FDA to approve new treatment for Carcinoid Tumors

Hi. My name is Kerry and I’m a zebra. Now, before you think I'm crazy, I hope you'll please let me have a minute of your time to explain. In medical school, doctors-to-be are often taught the adage “If you hear hoof beats, think horse”. In other words, the most obvious answer is usually the right answer. But sometimes the hoof beats come from something rarer: a zebra perhaps. For nearly 5 years, doctors heard hoof beats as they looked at scans of my liver and saw some small “things” taking up residence. And, for nearly 5 years, they thought horse. They did blood tests, colonoscopies, upper endoscopies; all of the tests you would do looking for the “normal” cancers such as colon cancer, but the tests were negative. So they concluded that my liver had some benign growths on it. Nothing to worry about. In January of 2016 a biopsy of my liver resolved the mystery. I was diagnosed with a rare form of cancer called Carcinoid or Neuroendocrine Tumor (NET). The disease is so rare it is referred to as the zebra of cancers and represents only about 2% of cancers treated each year. In honor of its rarity, the zebra has been adopted as the official mascot of those who suffer from it and we, the patients, are called zebras. In my desperate quest for solutions to my problem, I read about a treatment called Peptide Receptor Radionuclide Therapy, or PRRT for short. It has been available in Europe for more than a decade and clinical trials here in the United States have recently concluded. The results have been very promising. According to one of the doctors who participated in the phase 3 clinical trial, “The findings were, in my opinion, extraordinarily impressive, the median progression-free survival improved by nearly 80%, which is fairly unprecedented in oncologic studies. The finding is important because limited therapeutic options exist for such patients, who comprise 20% to 45% of neuroendocrine tumor cases.” (1) As you can imagine, I have been following these trials with great interest as I am their target patient: my tumors are inoperable and are known to respond to the drug being used in the treatment. Earlier this year, there was hope the treatment would be approved by mid-year 2016. Then it was sometime in the fourth quarter of 2016. The latest timeframe for approval is now early 2017. I understand and appreciate the fact that the FDA has to perform their due diligence to insure that new drugs are safe and effective. None of us want unsafe drugs to be hurried to market. In the case of PRRT, it appears to have proven its worth, both in US clinical trials as well as in more than 10 years of use in Europe. I don’t profess to know or understand what the holdup is in obtaining approval. I’m certainly not a doctor. What I do know is that every day that passes without this treatment being approved thousands of us zebras get sicker and closer to the point where treatments won’t matter any longer. Will you please join me in urging the FDA to keep the approval of PRRT at the top of their priority list? I’m only 55 years old and I’m not ready to leave this world yet. I and my fellow zebras thank you. Kerry (1) Full article discussing PRRT can be found online at

Kerry Downing
65,080 supporters
Petitioning John Morgan, President of the United States, Janet Woodcock, M.D., National Organization for the Reform of Marijuana Laws, Michael Hiller, Lauren Rudick, Joseph Bondy, David Holland, New York Canna...

Demand more research for Fibromyalgia sufferer's

We are being left painfully disabled and confused, its unacceptable and should be a crime. Fibromyalgia sufferers are being failed and we need the help of other chronic pain warriors and our healthy friends to get loud and demand the research we deserve! We are being dramatically taken advantage of and failed by the medical community who are pushed to feed us high paying antidepressant pharmaceuticals as the only option for our pain. They are ineffective for the vast majority that I've polled. It also leaves many of us in a continued state of pain and desperate for relief but too tired and lethargic to fight for more medicine in fear of being called a "drug seeker".  We are suffering in silence and pain with nobody to speak on our behalf, too weak to speak up alone as we are put into an even deeper brain fog with the meds they give us. We are getting lost in the medical shuffle and we need your support to demand more research. We know what works for pain and the days of us being silenced have got to come to an end. We are made feel shamed when asking for pain management and that time is OVER! We know pain better than most people will ever comprehend pain and we battle through it on a minute to minute basis. I did not ask for my life to change and become filled with painfully stiff mornings, unmanageable days, and uncomfortably painful broken sleep patterns. This happened to us, we didn't ask for it, and we deserve far more research and pain management than we're getting. I'm tired of being pushed to get on "high paying" anti depressants offered by big pharmaceuticals. I'll add that if you're one of the few managing through this pain by using those medications this is a no judgement zone and I will always encourage and support anyone to do what they feel is best for them and their family. I personally had 3 natural births without medication and postpartum I refused all pain meds that were offered to me. I have a high pain tolerance and as a "hammer and nails kind of girl" I've always been one to "tough it out". Let me tell you, the day I had my first fibromylgia flare was the last day I had those feelings. I was immobilized by the pain and desperate for relief. The pain literally shook me from my head to the bottom of my feet. Without warning I was unable to lift my head off my pillow, I could not lift my hands up and into my jacket while getting ready for the ER visit ahead of me, and all the while was moaning in more intense pain than I had ever felt or imagined. I suffered in pain at the ER for 8 hours until I finally was given the pain relief a Fibromyalgia sufferer deserves. There are some fibromyalgia fighters who have found relief in a combination of fully natural remedies or a mixture of natural and narco pain management. This decision needs to be made on a case by case, doctor and patient basis. The barely effective antidepressant push is not working and doctors are not listening to us! This is why we are so desperate for your help. We need the help of the healthy community to step up and speak beside us. Please invite your friends and family on this journey with us. Just because I get brain fog, overwhelmed easily, and consumed in debilitating pain, doesn't mean that we should be taken advantage of. We have been lost in the big pharma politics and it should be considered a crime to let us suffer like this. We have the right to enjoy a high quality, limited pain lifestyle. We deserve the right to have access to more effective and custom pain management solutions.   We are offering a beautiful, small piece of jewelry, as a thank you gift for donations larger than $50.00. 100% of the proceeds are going to our mission. The days of doctors using our illness for patients that they are unable to diagnose are over. With the accurate blood test offered by Epic Genetics (I have no affiliation with) called Fm/a we will begin to weed out those who don't truly have this illness while making it impossible for doctors to misdiagnose people going forward. This blood test is our only hope at progress. For those of us who's insurance will not cover the Fm/a test we have to come up with close to $1000.00 to prove our illness per person. These donations will go directly to support getting us tested one by one. Please help us on "Our Journey" by donating, sharing, and getting the word out about how we are being neglected and taken advantage of. We deserve to live, not just exist. Visit our Facebook Group - Fibromyalgia: Our Journey  Blog -   

Fibromyalgia: Our Journey
2,966 supporters
Petitioning Janet Woodcock, M.D.

We need more FDA approved treatments for cystic fibrosis. We are running out of time.

Cystic fibrosis (CF) is a horrible and debilitating disease that affects many parts of the body, including the lungs, liver and pancreas, among other organs. It’s also incredibly rare – only 30,000 Americans have it and there are just 1,000 new cases every year.I know this disease all too well. I have two daughters who suffer from cystic fibrosis. Keeping them mentally strong to deal with CF while also keeping them physically healthy has been the challenge of my life. CF is a daily battle with a chronic illness that threatens another bout of pneumonia or a new infection that could threaten my daughters’ lives. My girls, and thousands of other young adults with CF, need the drugs the FDA is currently considering. Time is not on our side.  I always ask those in positions of leadership: If your child was in the position that mine are in, would you make these drugs more easily available?In recent years, the Food & Drug Administration (FDA) has approved groundbreaking new treatments that help patients with specific genetic mutations of the disease. It is truly a new day for many families living with CF, including mine, who are in a race against time. The average lifespan is late 30s to early 40s, but the promise of new medicines will help ensure that people with this disease live longer and healthier lives. The FDA should be commended for its work on past CF treatments, but we can’t stop now. Please sign my petition today to encourage FDA to quickly review and approve precision medicine treatments for CF where strong science and sound data exist.We simply don’t have time to wait! Your support means everything to me and the thousands of others fighting this horrible disease.

Laura Bonnell
2,441 supporters
Petitioning Janet Woodcock, M.D.

A Penny for your thoughts. The push forward for the herpes vaccine.

Ask the FDA to fast track the vaccine for herpes. “Justice will not be served until those who are unaffected are as outraged as those who are.”― Benjamin Franklin "Are you tired of getting outbreaks? Are you tired of being sad, having suicidal thoughts because of your diagnosis? Tired of taking antivirals? Scared of HIV, and the possibility of Alzheimer's when you get older? I don’t blame anyone who feels this way. However, if you never speak up, then how would anyone realize that so many suffer? Remember the phrase 'see something, say something?' If people do not speak up, how can you expect help? Or any real change?"―Asking for a friend Hello, my name is Rich Mancuso and I was a participant in an experimental vaccine for herpes called Theravax, created by Dr. William Halford. Regardless of the past media hype, it doesn't change the fact that this experimental (and therapeutic), vaccine (not FDA approved), showed amazing promise and much more than the last 30 plus years of attempts of creating a viable and sustainable vaccine for herpes. I know, because myself and a few other people have received it and it worked amazingly. Unfortunately, some are begging for more of this therapeutic treatment, but it is not available to them and they continue to suffer in the worst possible ways. Since October of 2016, I have been volunteering my time [1] speaking about the Theravax vaccine. Why? I think it is imperative that people are aware that hope is still alive for them and that I wish for many others to benefit the same way that myself and a few others have. It seems only fair since I know what it was like to suffer for over 25 years of herpes outbreaks but now I am doing amazing. I have found that over the past two years, the attempts of gaining any support for herpes is quite the difficult task. This is due to the stigma on herpes and the simple fact that no one wants others to know they have it. It's true, but the simple fact that herpes virus ( 9 different types) is millions of years old and infects over 90% of human beings, it seems so odd that we just beginning to talk about it. The truth is, close to 5 billion people have been exposed to herpes simplex, HSV type 1 and HSV type 2, commonly known has herpes simplex-cold sores or genital herpes. Fun fact, 80% of people infected don't even know they have it. This is because their immune system is working just fine. The crazy part of herpes is that most of these people do not even know they have been exposed. This is due to the lack of testing and the fact that the CDC does not recommend testing on individuals who are not showing any symptoms, because it doesn't change the patients behavior. Don't believe me? Click here. So why am I making a big deal about herpes? Why create a petition? If most people have it and they are doing just fine, than who cares? The millions of people who are suffering silently, care. The millions of people who suffer from neuralgic pain, care. The millions of people (world wide) who suffer from constant outbreaks, care. Also, there are many people who find that antivirals do not work for them and everything they try often fails. These are the people who care and wish for a better solution. This petition is to let the FDA know that many of us care and we care about our friends and family that suffer. There are many great strides in medicine and medical advances, we hear about them in the news all the time. These are the experimental drugs that get fast tracked so that patients can gain quicker access instead of waiting 15 years to obtain it. My suggestion to you is to sign this petition, write letters or emails and simply ask for help. Send emails and letters to the FDA, the NIH, local Congressman and Senators, and ask for help. If you suffer and want help, tell them. Tell them your story and ask them to contact the FDA and that YOU want this vaccine tested by the FDA, and wish it to be fast tracked.The FDA and the NIH is not a evil monster that simply eats funding. These are very complicated agencies that happen to be filled with people, just like you and me. Just like every other company in the world. Good people who wish to help. Make your voice heard that you want help. That you want a more serious effort towards herpes research and a working viable vaccine. Even if you don’t support my personal experience and the vaccine Theravax, I urge you to make your voice heard. It is just as important and more relevant now, more than ever. Don’t do it for it for yourself and others! Ask for a real sense of urgency. Ask for more funding. Ask to please fast track herpes research or even ask to fast track Theravax. It’s all up to you! Imagine is thousands of emails flooding the FDA and the NIH with simple requests. Imagine them taking herpes more seriously because they see the number of people suffering. Imagine them adding more funding towards herpes research. Imagine 2 minutes of your day sending an email and just asking. Nothing will ever happen by sitting silently and never asking the question. Find your local representative, Click here. If you decide to write your local Congressman or Senator, please mail them your letter, with a penny taped to the bottom asking "A penny for your thoughts" The reason for this, is that any money they receive, they must account for. This will also emphasize the concern for herpes research. :)   Email: OCOD@FDA.HHS.GOV…/Enforc…/CompliancePrograms/default.htm   [1] I do not work for Rational Vaccines or any other vaccine company.

Rich Mancuso
1,860 supporters
Petitioning United States Department of Agriculture (USDA), Donald Trump, Janet Woodcock, M.D., Cory Booker, FOX News, ABC, United States Department of Health and Human Services, Paul Ryan, Rand Paul, John Hic...

Demand that Fibromyalgia sufferers get the Pain Management we require!

Fibromyalgia may affect someone very close to you and you may not even be aware of it. This chronic pain lasts all day long, some minutes worse than the last. You never know when you may "flare up" (a flare up is a pain so intense and widespread that you become immobile until it passes, shoulders tense, extreme tenderness and pain from your collar bone to the thighs and calves and even your heels, it comes with blinding headaches and inability to move your neck). Since there is not much written or documented regarding this illness we don't have a cure, don't know the root cause, and there is not an effective treatment plan. Many doctors will not even attempt to treat a Fibromyalgia patient because of the unknowns and lack of options. Well, us Fibromyalgia sufferers have figured much of it out on our own by forming online groups and sharing personal experiences. We don't want to be put on nerve blockers and anti depressants that cause more side effects than actual treatment.  Anti depressants effect how 1 in 4 fibromyalgia patients receive pain and even when it works for those rare few it comes with a backlash of side effects from depression (which they didn't have prior), to extreme fatigue, shakes, paranoia, and much more. Eventually, it stops working for those rare few that it initially seemed to helped and they are stuck withdrawing from pills they should not have been on in the first place. As a busy wife, mother of 4, with a full time career I do no have the luxury of waiting it out until the doctors figure something out for me. I don't want to become immobile and disabled because they refuse to give us the pain management we deserve, the pain management my family deserves. Many of us end up severely depressed because of the extreme pain we have difficulty accepting and lack of help we receive. The first step to Fibromyalgia is acceptance. You have to accept that the life you lived is over and you will have to live a new life with limitation's on stress and activity. I was an avid hiker in my previous "well" life and a spontaneous 5 mile hike on a Saturday was common for my husband and I. Now, my hips feel like they are grinding and about to pop out of socket after a mild 10 minute walk. The grieving process was intense and the more I cried and resented my new life the more painful my body ached and the less mobile I became. Now that I have accepted a new lifestyle of lessened activity combined with minimal stress with a combination of pain medication for flare up control and cannabis oil/thc for daily sustainability, the pain, although still constant, is more frequently a level 5/6 rather than 7/8 and my flare ups are fewer at 10-14 days per month rather than 20-25 days.  When you live in chronic pain you start to see people and life in a much different light. You begin to empathize in a much deeper way. I recognize other pain sufferers by how they move and look around the room before adjusting their body or squinting from light sensitivity. It's a world I was very blind to previously and has made me realize how LOUD we have to be to make our painful world know to the "well" community because we need your help too. The flare ups are still here, so what do we do when we feel the more intense pain coming? That is when we must rely on pain killers (hydrocodene 5mg as needed) for emerging pain at minimum. If you get ahead of the flare up early enough you have a greater chance of preventing a full blown flare that will leave you in immense, immobile, pain. If you don't, you can at least keep the edge off until that unbearable, immobilizing, tear draining pain, decides to pass. During one of my first flare ups I was in such intense pain that my wrists became limp on their own and I was unable to turn my shower knob. I broke down crying on the floor desperately seeking my old self would return and pick me up to tell me this is just a terrible nightmare. That never happened. Instead, I took a pain pill, got a hot heating pad, lifted my legs, sprayed on some magnesium oil, and let the tides pass. Eventually, the flare passed and I was tricked into thinking I could be somewhat the old Johana, but I was wrong, and a few flare ups later I learned that my super active and constant moving life was over and I'd have to find a new way of living to get my daily tasks accomplished. A way of living that would contain all day pain, weakness, headache's, and body stiffness. Don't lay down too long with fibromyalgia because you will experience the sort of stiffness you had no idea even existed (tin man from Wizard of Oz comes to mind quite literally). So here I am, telling the world my story, because I have spoken to thousands of fibro warriors that suffer the same daily war I struggle with. Its quite a war on my body but was even more so on my mind in the very beginning. Now that my mind has adjusted, I am here to DEMAND better pain management from the medical community. We are being let down by our doctors who are too afraid to treat us because its not "an official form of treatment". Says who, the guy behind the keyboard whose wrists feel just fine when he types? Because mine are about to fall off from typing this up, and just last year I could write you a 20 page paper in less than 2 hours. Life has changed and the medical community needs to recognize that as well. We need your help to get pain management. No, we will not accept anti depressants and nerve blockers as the medical communities safest and most profitable way out! They don't work! Give me daily cannabis oil with a small amount of thc combined with AT LEAST 10 days of hydrocodone. I say 10 ten days, because the cannabis oil may likely control our flare ups at least 2 out of 3 days if taken properly. Unfortunately, without a root cause or cure the flair ups are inevitable and they are too painful to function under. It should be considered a criminal act that doctors allow us to suffer knowing the all over body pain we are forced to manage through, criminal! The main reason they refuse to give pain medicine is because of the opioid crisis. My answer to that is limit us to a set number of days relief with pain meds that, as adults, we can take and control on "as needed" basis. We learn to live with pain and we accept it so we are not requesting pain meds all day, every day. It is impossible to become addicted at 10 days a month and at the very least we have earned the right to be responsible for our own painful emerging pain and flare ups. We are adults and we are in pain! We DEMAND pain relief through a the following at a minimum mix of: thc/cannabis oil for daily sustainability and 10 days worth of pain pills for controlled flare up management. We REFUSE to sit around in pain, becoming disabled one by one, and being fed with ineffective treatments. If anyone understands PAIN it's a fibromyalgia patient!  Please note that this request is "at minimum" since most doctors don't even offer flare up maintenance with pain pills at all for us suffering in tremendous pain. Once a minimum is established on a national level individual dosing should be discussed between patient and doctor, on an individual level, since each person is experiencing different levels of pain. I ask you to stand by us by signing and sharing this petition so that it gets the attention of people who can make it happen. We need it here and we need it now.    

Johana Aveiro
1,641 supporters
Petitioning Janet Woodcock, M.D., Food and Drug Administration, United States Department of Health and Human Services

Urge the FDA to ensure the effectiveness and safety of deadly generic drugs!

I have had PTSD since I lost my 13 month old daughter to a drowning accident Christmas day of 2002. I suffered another trauma in 2009 that only exasperated the PTSD (Post Tramatic Stress Disorder). I also suffer from Bipolar Disorder, which has been well managed for years but, because of the PTSD, Wellbutrin was added to my mood stabilizer to help with the anxiety, flashbacks and depression. So, like so many others, prescription medications have helped me live a somewhat normal life. I have been taking the generic form (Bupropion) of Wellbutrin XL for many years now, only because my insurance won't pay for the brand name, which is $1800 a month. The generic Bupropion XL 300mg pills I take are small and round and made by Par Pharmaceuticals. My pharmacy started getting the drug, that I've taken for years, from a different manufacturer (Cipla USA Inc.) without notifying me. I only noticed because these new pills were oblong and larger. I did not think anything of the switch because I have always been told that the generic is the same as the name brand, just cheaper. I took one of the pills from the new manufacturer and within hours I started experiencing extreme anxiety, rapid heartbeat, muscle cramps, elevated blood pressure, headache, shivering, "brain zaps"! It was a horrible experience, and I truly did feel like I was going crazy! I can easily see where it could send someone that is already unstable over the edge! My doctor and the pharmacist were not surprised at all by this reaction from just switching drug manufacturers! I have to have my pharmacy always make sure to order the original generic brand for me now, while they are still carrying what is obviously an inferior quality drug (and I have since discovered that ALL of the Wellbutrin, and many other generics of brand names are inferior). Since that experience I've read and heard about thousands of people experiencing bad reactions from the generic form! Patients are saying that only the name brand medications work. They say that the name brand drugs do not have the horrible, sometimes life threatening and suicial/homicidal, side effects that the generics do. I have even had more of my own awful experiences (serotonin syndrome) with other generic medications since. This is crazy and dangerous! Patients cannot afford the drugs that can actually help them, and possibly put themselves at greater risk by taking the generic forms. This affects us all! Anyone who buys generic drugs is taking an added risk by not having the option to take the name brand. This is life or death for so many people already suffering from very serious conditions. Generic drug companies are in the supply chain management business, not medical research. They make cheap products that are “close enough” to the originals to be approvable under an ANDA, usually through a network of off-shore manufacturing partners and loosely regulated commodity-type suppliers. The FDA mandates that generic forms of prescription medication contain the same active ingredient as the brand name, but allows the generic product to have as much as 20% less of the active pharmaceutical ingredient. Also the agency allows the generic version to use different inactive ingredients, including binders to hold the pill together and time release agents to disperse it. That dissolution process was important with Wellbutrin XL and its generic forms because they are "extended release" drugs. Every time-release drug has a mechanism to distribute the active ingredient into a patient's system. The generic forms aren't required to have the same mechanism as their brand name. "What we found was shocking," said Dr. Tod Cooperman, the president of "you're getting a burst of medication coming out very early on with the generic that you shouldn't be getting." -ABC News - 2006, The first generic versions of the popular anti-depressant Wellbutrin XL were approved by the FDA. The drug comes in two dosage strengths, 150 milligrams and 300mg. The 300mg dose is generally used for patients with more severe depression and anxiety and patients who don’t respond to the lower dose. Almost immediately, the FDA started receiving reports from patients that claimed the 300mg dose was being associated with side effects and reduced efficacy. - 2007, According to The Associated Press, an analysis of Wellbutrin XL and Budeprion XL 300 by ConsumerLab in 2007 first indicated the generic released its active ingredient much more quickly than the brand-name drug. - 2012, The FDA finally admitted that the generic of the popular antidepressant Wellbutrin XL is not as effective as GlaxoSmithKline’s original drug. New data showed that Budeprion XL 300 does not release its key ingredient correctly. The 300 mg dose of generic bupropion, sold under the name Budeprion XL and made by Impax Laboratories and Teva Pharmaceuticals was removed from the market because it didn't work as it should. The move does not apply to the brand name version of the drug, Wellbutrin XL, or other generic versions of bupropion. But the FDA asked four other drug makers to test the 300 mg strength of their generic versions of bupropion to make sure they work properly. The FDA's action was based on a study it conducted in 24 adults that found generic Budeprion XL 300 mg is not released into the bloodstream at the same rate and in the same amount as branded Wellbutrin XL 300 mg. This means Budeprion XL might not deliver the same antidepressant benefits as Wellbutrin XL. And it could explain reports from people who said their depression symptoms worsened after they switched from Wellbutrin XL to Budeprion XL. -Consumer Reports - 2013, The FDA issued a long-awaited report on the quality of a generic antidepressant. In October 2012, after unceremoniously pulling Teva's generic form of the drug the FDA required all generic forms of the long-acting 300 mg formulation to be tested to see if they were identical to the brand name Wellbutrin. The Watson form was deemed not therapeutically equivalent to Wellbutrin XL 300. The drug was voluntarily withdrawn. - 2013, We get over 80% of our active pharmaceutical ingredients from abroad, much from India and China. A top drug regulator in India makes a statement regarding inspections of drug suppliers: “If I have to follow US standards in inspecting facilities supplying to the Indian market, we will have to shut almost all of those. We are not the US, the infrastructure and resources available there are much different from those in our country. Our priority is to make medicines available and affordable to all.” He also went on to say, “We don’t recognize and are not bound by what the US is doing and is inspecting…the FDA may regulate its country, but it can’t regulate India on how India has to behave or how to deliver.” - 2015, The FDA announced that the 300mg generic version of Wellbutrin XL manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals was being recalled because it did not work. And this wasn’t just a problem with one batch – this is a problem that has been going on with this particular drug for four or five years, and the FDA did everything it could to ignore it. The FDA apparently approved this drug – and others like it – without testing it. The FDA just assumed if one dosage strength the drug companies submitted for approval works, then the other higher dosages work fine also. Forbes - A Drug Recall That Should Frighten Us All About the FDA Janet Woodcock, the director of the Center for Drug Evaluation and Research at the FDA, told ABC News that the 300mg version wasn't tested separately because "there was concern about testing the generics in normal volunteers. We had had seizures reported, and we were worried that we would be unethically exposing volunteers," she said. ABC News - Questions Raised Over Brand Name Rx Drugs vs. Generics -2017, We had hoped that the problems with generic Wellbutrin (bupropion) were behind us. Officials at the FDA seemed more vigilant about approving this generic product. Sadly, we are starting to hear from readers again that they are experiencing problems. We alerted the FDA to problems with generic Wellbutrin (bupropion) back in 2007. It took five years for the agency to acknowledge there was a serious problem with some slow-release bupropion formulations. Although these drugs were removed from the market, we have continued to receive complaints about certain generic products. The FDA doesn’t test samples submitted by individuals. - -Problems with generic wellbutrin bupropion, not again! Patient experiences: -"I do believe that the antidepressants are responsible for the suicides. I had this happen to me taking Wellbutrin. I was taking Watson 100 SR . I began being sick at my stomach becoming very very scared and fearful. I didn’t realize at first what was happening . The more I took and the longer I took it the more depressed and suicidal I got. Then I got the 75 milligram Apotex brand in the first day I took it I knew something wasn’t right. I was almost hysterical, crying, wanting to die. I finally had it compounded thinking that would be better and the same thing happened. When I went to increase the dose thinking that I wasn’t taking enough that I became much worse. Too scared to leave the house and very very suicidal. Until it happens to you it’s hard to understand. When it is caused from the medication the feelings are so strong. It’s because the medicine changes your brain you become very depressed with no reason to live. These drugs are very very dangerous! That was two months ago and I’m still dealing with the anxiety which I never had before taking these meds and suicidal thoughts. It did something that changed me. This was three different generic brands of Wellbutrin !!! If consumer labs can test these then why can’t the FDA? Every one of the generic wellbutrin should be pulled from the market until the FDA test each one instead of letting the company test them and submit the report." - Helen -“Within the last 2-3 weeks of taking the same dosage, but a new manufacturer, I am having suicidal ideations. These thoughts are persistent. I have never considered thoughts such as these…ever! This manufacturer was just approved. It’s an oblong, white pill.” -John -"Over the years I have taken several different versions/brands of generic wellbutrin xl, none of them was ever 100%. It generally changed when the pharmacy just switched with out letting me know. However I have never had any real issues until about a year ago when I was switched to a white pill apparently made by watson. I began having severe heart issues, high blood pressure, serious anxiety, etc. I didn’t put the two together until 6 months after I had been to the cardiologist several times. I never had any issues and previously wasn’t aware of the “allowances to generic makeup”. After stoping the medicine I felt 80% better within a week and did some research only to find that there are 13 additional inactive ingredients in the current watson version than there are in brand name, 7 additional inactive ingredients than the previous version of watson and 9 additional ingredients than the Teva/Par version!!! - K -“My Wellbutrin XL 300mg was changed to bupropion and within 3 months my family was concerned. I was showing traits of when I first broke down. I called my doctor, went in, took the bottle with me. She cancelled that immediately and put me back on Wellbutrin and told me to always make sure every doctor put “DAW” (dispense as written) on further prescriptions. Within a few weeks I was doing fine. "Since then I question every generic as there is not enough info as to where it is made, what country made it, what was in it, etc. Why should we depend on foreign countries to take care of our basic medical needs when they are not as developed as this country is. That is turning our lives over to questionable facilities.” - Carol -"I found the best generic “FOR ME” is a round, coated tablet with the imprint “A 102” I have gotten friendly with my pharmacist, due to the issues I’ve had over the years, she knows “A102” is the only one I can take. She works hard to make sure I’m taken care of. She tells me there are several different generics on hand in the pharmacy. They typically grab the 1st bottle on the shelf & fill the script.Find a pharmacist you feel comfortable talking to & explain what’s going on. My reactions to another generic was SEVERE! It’s OVAL & it is NOT coated. I don’t recall the imprint.I became severely depressed, almost immediately & extremely suicidal in less than a week. This has happened 3 different times, over many years, before I figured it out. There is definitely a difference when it come to generics!" -"I have tried the Sandoz manufacture brand and its awful. The first night I had ringing in the ears and dry mouth. I also started off with a shocking pain in my knee. I cut it in half and was having these phantom itches on my back and then hair loss. I'm trying to find a pharmacy that carries the Mylan brand. I also started getting huge pimples.. Now my immune system is being compromised with sore throats and cold sores. Not good." - Aluviel This is not just a problem with psychiatric medications, it's all generic forms of the brand name drugs that can be inferior and/or cause alarming side effects: “My daughter started having grand mal seizures at 10 years old in her sleep. Despite many tests, they could never find the cause of her condition. At first she was only having a few seizures in her sleep lasting between 20-60 seconds. When she was around 13 the seizures were happening more frequently, about once a month instead of a few times a year. “At this time I decided to put her on meds. They started her on Keppra 500 mg twice a day. No seizures for 25 mos., not one. We thought we were in the clear. Then the generic came out and the insurance company will only pay for the generic because of course it all comes down to money. “The pharmacy informed me there is no difference between the generic and the brand and just switched her without even notifying or asking the doctor. Since then she has been having relapse seizures. Every month the pills are different shapes, sizes, and colors. My neurologist informed me there are 28 different companies that manufacture this drug and none of them can be 100% identical. The doctor is very adamant about the generics being responsible and he is outraged by this. He has many patients experiencing the exact same thing with the generic form of Keppra." -E.P.      A quick google search will find thousands more of these personal stories. Despite what the big pharm companies and the FDA want you to believe, this is real and it can happen to anyone. *** Please ask the FDA to Protect us from these drug companies and sub par manufacturing standards overseas and assure our safety when taking medications we so desperately need by testing the generic substitutes as stringently as the brand names. There has been no incentive for companies to actually produce bioequivalent drugs or pure pharmaceuticals. Systemic violations have been ignored or undetected for years. Generics should not have less active and different inactive ingredients, including binders and time release agents, than the name brand drugs. If we cannot get the brand name psychiatric medications we need, due to the incredibly high costs, then they should ensure the quality, effectiveness and safety of generic drugs before allowing them to be given to patients who trust the Food and Drug Administration to do it's job.   Notify the FDA of any adverse side effects when using drugs and devices the agency regulates by reporting them online to MedWatch, or by telephone at 1-800-FDA-1088. Please, if you are feeling suicidal call 1-800-273-8255 or 911 immediately  

Amy Lipinski
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