Decision Maker

Federal Drug Administration


Does Federal Drug Administration have the power to decide or influence something you want to change? Start a petition to this decision maker.Start a petition
Petitioning Johnson & Johnson, Federal Drug Administration

Get Johnson & Johnson cancer causing talc products off the shelves

There has been a lot of recent buzz around talc being a major concern with health. In particular, the links between talcum powder and ovarian/lung/uterine cancer are quite alarming! In fact, females who use talcum powder on their genital region, just once per week, are 40% more likely to develop ovarian cancer than someone who does not use talcum powder. HOW IS THIS STILL ON THE SHELVES?! That is my question... This is a product who's consumer target is babies! Can you believe this?! After speaking with Johnson & Johnson on 9/23/16 and listening to them tell me that they have no plans of taking their talc containing  products off the shelves, due to them being "government approved", I knew I had to do something - if for nothing else, to raise awareness!  Where I come in: My mother was diagnosed with ovarian cancer at the young age of 34. She passed away just two months after her 38th birthday. She did not carry the BRCA 1 or BRCA 2 gene which is related to breast and ovarian cancer. So how does someone so young and healthy develop ovarian cancer at such a young age? The average age of developing this cancer is 65 years old, for those who are unaware. I truly believe with all my heart that this was caused by talc. She used Johnson & Johnson baby powder (talc) every day after she got out of the shower as part of her daily hygienic routine. Just like taking a shower or putting moisturizer on - she did this because it was "good for her skin" and "leaves her skin soft, dry and smelling good!" Little did she know she was putting poisons in her body on a daily basis. It's absolutely devastating knowing that we may have prevented her from getting ovarian cancer, dying and leaving behind two daughters and a grand daughter. THIS is why I am fighting- and I won't stop until these products are pulled -- Because I don't want any other person to lose a mother/sister/daughter/wife to such a nasty, potentially preventable disease.  Please, in the name of my mother, Jana Yeager, sign this petition! 

Markesa Kilmartin
41,826 supporters
Petitioning Federal Drug Administration

ALS patients can’t afford the wait. Fast track decision on bring drug to the United States

It’s been over 20 years since a new treatment for ALS, a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord, has been available in the US. That could all change with Radicava, a drug already available in other countries and that extends the lives of those with ALS. The Food and Drug Administration (FDA) is reviewing the drug and say it should make a decision by summer of 2017 -- that is too long. And even if a decision to bring the drug to market is reached, it could take 6 months to get it to pharmacies. People suffering from ALS need this drug, thousands of patients will not make it that long and need access as soon as possible. This isn’t the case of a drug that has never been available to the public and where higher scrutiny would be understandable. Radicava has been available in Japan and South Korea, and hasn’t shown anything that would indicate it is not safe. Sign our petition telling the FDA to expedite their decision. People with ALS should not have to wait for a proven drug until the end of 2017, or possibly not until 2018. It’s been 20 years since any kind of new treatment for this awful disease -- they’ve waited long enough.

Dan Kelleher
26,620 supporters
Petitioning Federal Trade Commission, Federal Drug Administration

Require full disclosure of all ingredients in disposable diapers for babies

We all know that most babies can wear disposable diapers and be just fine. Most babies do wear disposable diapers and are just fine.  Unfortunately, some babies are not just fine.  If you have one of these babies, your heart is probably pounding reading these words.  If you don't, you don't.  That's ok.  You should still keep reading. You'll find this interesting. Product labeling laws generally ensure that you, the consumer, know what you're buying.   Baby clothing is labeled. Baby care items are labeled.  Baby food is labeled.  No matter what, you get to know, before you buy it, if your baby's pants are cotton or polyester. You get to choose what your baby wears. You know, before you buy them, what is in your baby wipes. You know what is in your baby food. You have a choice. By contrast, your baby's disposable diapers are virtually unlabeled.  No textile labels. No ingredient lists. No disclosure. Lots of secrets. Very little regulation. No required testing beyond basic CPSIA tests for lead & phthalates. And when you ask for detailed information about what is in the diapers your baby is wearing, disposable diaper companies don't have to tell you anything. If you ask about your baby's shirt, there are no secrets.If you ask about your baby's pants, there are no secrets.If you ask about your baby's food, there are no secrets.It's on the label.  The law says it has to be.Because your baby is wearing a disposable diaper, there are secrets. Baby diapers are not considered medical devices by the FDA.  Unlike adult disposable diapers, baby diaper companies are not required to go through medical device testing to prove that disposable baby diapers are medically safe for a baby to wear. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=876.5920 Baby diapers are not regulated as cosmetics by the FDA. Baby diapers may contain ingredients (like petrolatum, oils, or other lotions) that are cosmetic ingredients and may be intended to help prevent diaper rash, keep a baby's skin soft, or prevent contact with wetness.  Baby diaper companies generally do not provide parents with a full, detailed, INCI compliant list of ingredients in disposable diapers.  https://www.fda.gov/Cosmetics/Labeling/Regulations/ucm126444.htm Baby diapers are not considered clothing (garments) by the FTC.  Specifically DISPOSABLE baby diapers are nearly the only thing worn by a human, other than a hat or a disposable menstrual pad, where product or package labeling isn't mandated by law to fully disclose the amount and type of materials used in the garment.  Disposable baby diapers are one of the only garments worn by a baby not required by law to include care or content labels.https://www.ftc.gov/tips-advice/business-center/guidance/threading-your-way-through-labeling-requirements-under-textile#textile Why does this matter?Baby diapers are worn by babies, next to their genitals, for two to three years.  Babies are exposed to everything in that diaper.  Every fabric, woven or non-woven.  Every chemical, intended or unintended.  Nearly every other garment in our society has to be fully labeled.  Everything.  Even socks!  Why aren't baby diapers fully labeled?  Why don't we get to know everything our baby is being exposed to in a diaper? As a mom, you should get to know what is in your baby's diapers.  If you want to avoid a certain ingredient, you should be able to avoid that ingredient. A disposable diaper is worn next to the skin and should be considered a garment.  The composition of all textiles, woven or non-woven, should be disclosed on the packaging.  If the diaper includes any chemical ingredients, a full INCI-compliant ingredient list should also be disclosed on the packaging.  Babies are tiny with delicate, sensitive skin.  Parents deserve to be active decision makers in their baby's care. Disposable diaper ingredients should not be kept secret from parents. What now?For your baby's sake, demand, today, that the FTC and the FDA eliminate product labeling exclusions for disposable baby diapers.  Sign this petition. Tell them. #IGetToKnow what is in my baby's diapers.

Jennifer Labit
4,310 supporters
Petitioning U.S. House of Representatives, U.S. Senate, Federal Drug Administration, Centers for Disease Control and Prevention, President of the United States

Make Chronic Pain Patients exempt from CDC Guidelines

The CDC guidelines are causing doctors to leave pain management practice all over the US, for fear of DEA malicious prosecution if they exceed an arbitrary and unscientific “one size fits all” policy while trying to treat their patients effectively and as individuals. Patients are being deserted by their doctors, in some cases without assistance in drug withdrawal,  after they have used opioids as directed, safely and effectively for years to maintain the quality of their lives. Almost certainly some patients have already died and more will commit suicide as a result. Our government is aware of this problem, but chooses to do nothing. The guidelines are also being embedded in State laws that reinforce restrictions on opioids. Major areas of several US States are now without pain management centers, and remaining specialists are seeing ever-heavier patient loads and higher risk of prosecution. The best predictors for people falling into addiction are their age (teens are particularly vulnerable), and their status as unemployed or poor. Restriction of opioid medications to pain patients won’t solve these problems. If anything, we should anticipate increases in deaths due to street drugs, as desperate people are forced to seek them out against their own wishes, just to maintain a marginal quality of life. The CDC needs to withdraw its unscientific and damaging opioid guidelines. Revisions should acknowledge that at the present state of medical knowledge, opioids are an indispensable part of managing agonizing pain, and trained doctors are the best decision makers on how much is needed to relieve pain in each individual patient. Standards of practice and doctor training are needed. But the present CDC guidelines are a poor basis for such standards. Re-writing should be accomplished by professionals who actually understand chronic pain and its management, and not by addiction specialists who have a financial self-interest in diverting limited government resources away from proven pain treatments. For the longer term, the US National Institutes for Health needs to allocate far more research and resources to the study and treatment of chronic pain. At present, less than 1% of NIH research funds are directed to chronic pain – for one quarter of the US population. The percentage of chronic pain patients who abuse their medication is less than 1%. There are well over 100 million people in the US suffering from some for of chronic pain. The only "epidemic" in this country is heroin and illicit fentanyl coming in from China and Mexico. Addicts are being catered to while the chronic pain community is suffering, turning to illicit drugs or committing suicide. It is time to STOP THE WAR AGAINST PAIN PATIENTS! We have rights too!

Erika Meshbesher
1,328 supporters
Petitioning Centers For Disease Control, American Cancer Society, Cure Magazine, Federal Drug Administration, Canadian Cancer Association, American Heart Association, American Diabetes Association, National As...

Stop promoting lung cancer stigma in the media

For years, anti-smoking ads effectively reduced smoking by emphasizing negative images of smokers afflicted with lung cancer. Unfortunately, these ads caused the public to equate smoking and lung cancer, and villianized smokers and lung cancer patients instead of tobacco and tobacco companies.  This "smoking equals lung cancer" meme is persistent, pervasive, and generates lung cancer stigma.   Lung cancer stigma increases depression and blame among patients and their family members, reduces compassion and funding for lung cancer, hinders awareness of other lung cancer risk factors, and discourages those at high risk from seeking lung cancer screening that could save their lives. The "smoking equals lung cancer" meme is unfair and inaccurate. The Centers for Disease Control and Prevention (CDC) and the National Cancer Institute (NCI) state smoking affects every organ in the body and is a risk factor for twelve cancers as well as sixteen other diseases, including heart disease, the biggest killer of all.  In fact, more people die of smoking-related cardiovascular disease than die of lung cancer.  But publications and media usually mention smoking and smoking cessation only in association with lung cancer. This reinforces the stigma.  What do we want?We're asking US and global cancer organizations, media companies, researchers, and professional organizations to help reduce lung cancer stigma by reducing the "smoking equals lung cancer" mindset.  We're asking they do this by using the following tactics in their communications:  avoid using any images of tobacco products in communications about lung cancer refer to smoking as a RISK FACTOR for cancer (instead of a cause) when discussing smoking in association with lung cancer, include references to other known risk factors for lung cancer avoid featuring communications about smoking and smoking cessation in proximity to lung cancer communications whenever possible discuss smoking and smoking cessation in association with EVERY cancer (not just lung cancer) and every disease linked to smoking Why do we care? Lung cancer is the most deadly cancer. In the US alone, a jumbo jet's worth of lung cancer patients die every day.  One in sixteen people in the US will get it in their lifetime, and about 80% of them will be nonsmokers.  Organizations that promote smoking cessation focus on lung cancer patients (most of whom do not smoke) rather than ALL patients whose diseases are linked to smoking. The fact is, smoking cessation cannot cure ANY cancer, nor guarantee a person will not get lung cancer. Because of stigma, many people don't know that anyone with lungs can get lung cancer, and that lung cancer research is funded at a level far less per death that other major cancers. Members of the Lung Cancer Social Media (#LCSM) community want to change these facts in our lifetimes.  You can learn more about lung cancer stigma here https://lcsmchat.com/lung-cancer-stigma-references/Supporters of this petition include [names of lung cancer organizations]

LCSM Chat
596 supporters
Petitioning Donald Trump, Federal Drug Administration, DEA, Bernie Sanders, Barack Obama

Remove the DEA's classification of CBD oil from marijuana as a schedule 1 drug

The DEA has officially announced that it has classified CBD oil specifically from marijuana as a schedule 1 drug. This is an outrageous scheduling of this drug that has helped to save so many lives and CBD continues to do so. CBD is also non-psychoactive. This means it does not get you high. The DEA seems to not take into consideration. The public is screaming out for massive change but this change is a complete 180 in terms of progress in cannabis legalization. I need your signatures to force this change. Its simple but can make the change we desire. For clarification the CBD extracted from Hemp is legal. Let me cite some sources for you. Hemp Products Heal Ben Swan Reality Check What is CBD? So DEA... What is your legitimate reasoning as to why you have scheduled this as a schedule 1 drug with no medicinal benefits and highly addictive? It has been proven time and time again that these are lies. You want to suppress this plant. Your desperate. We see it. You cannot win. Take cannabis off drug scheduling. Hundreds of thousands of people's lives will be saved or dramatically improved with the re-introduction of cannabis and hemp. Please sign this petition.    

levi kaus
225 supporters
Petitioning Federal Drug Administration, Dr. Robert M. Califf, MD

Approve Umbilical Cord Stem Cell treatment for Jacob Gallegos in California

Jacob Gallegos has lived his 32 years of life with a debilitating and deadly disease called Duchenne Muscular Dystrophy (DMD). DMD is a common progressive genetic disorder, which causes aggressive deterioration of the muscles. Patients with this disease typically do not live past the age of 27. Jacob is a fighter but he needs your help. Jacob relies on a tracheostomy tube for breathing and a G.I. tube for eating and fluids. He is not able to drink water or any beverage at this point. He dreams of being able to swallow again one day and enjoy a glass of ice cold water as well as regain the use of his arms. He can only move his fingers and toes. As the disease progresses he won't be able to use his fingers which will leave little hope of connecting to friends on social media or creating his digital artwork. These are the final freedoms he has left in life.   There is a treatment available that has proven to extend the life and quality of life for those granted the right to have this treatment. There have been two DMD patients who have had umbilical cord-derived stem cell treatment for this disease in the United States, Ryan Benton, and the latest patient, a 6 year old boy. Both patients travelled to Panama for the initial treatments, as there are laws restricting adult stem cell therapy in the United States. The FDA has approved subsequent treatments to be administered in the United States, but only for these two patients. Ryan Benton's condition has stabilized and he has suffered no adverse side effects. His prognosis has gone from critical to stable. His quality of life has improved greatly, gaining weight and muscle control back. Jacob cannot travel to Panama to receive this treatment and without it, his prognosis is very poor. His condition is critical and it's imperative that he begin some form of treatment as soon as possible. Imagine what it would be like to be a cancer patient, and the treatment needed was available, but only for two patients, leaving you only one outcome and that is to die. Jacob deserves to live! Jacob deserves treatment! Tell the FDA to make this treatment available for Jacob, in California.

Janet Nielsen
217 supporters
Petitioning Federal Drug Administration, Drug Enforcement Administration

Charge Heroin Dealers With Murder

I am trying to solve the heroin epidemic that has embraced our country. As it is portrayed, heroin users are "sub-human" - not worthy of life itself- that disgusts me- I lost my daughter and she was no way near sub-human. She was your daughter too- your son, mother, cousin, father.. she was a PERSON.. not someone who deserved to die. Heroin dealers are at least 50% responsible- if not more. I have seen first - hand the influence of a dealer, they know they will have an addict for life - a constant flow of money/ a customer. I know first hand how dealers charge their "addicts/customers" double if they can pay "today" because they know that once they are addicted- they got them.  They are pushing and selling for financial gain.. only.   I also know federal statutes exist to charge dealers with murder. Why are some law enforcement charging while others are not ? If these laws were consistent in every state it might eliminate the dealers- right now there is no fear of murder or manslaughter charges. The dealers know they will not be charged and will not do any real time. Only trafficking charges but not murder.  Why cant we change that? These laws exist.. what do we have to do to enforce them?  https://www.dea.gov/druginfo/ftp3.shtml

Donna Thiel
181 supporters
Closed
Petitioning Kevin McCarthy, Nancy Pelosi, Federal Drug Administration, U.S. Food and Drug Administration, Dr. Robert M. Califf, MD

Make Prescription Drugs to Combat Substance Abuse More Affordable

Our country is in the midst of the worst Opioid/Heroin Epidemic in US history. With approximately 129 American citizens overdosing a day we are slowly losing a generation of people. In this country the mentality is treat vs. prevention, profit vs. human life. It is time we stand together, with ONE voice and demand that the pharmaceutical companies STOP price gouging the prescription drugs that could combat this epidemic. Drugs such as Suboxone, Vivitrol,and Methadone. With the monthly average cost to participate in a medically assisted program ranging anywhere from $300.00-$1500.00 many Americans are not utilizing these already underutilized programs. If we want to combat this epidemic and sustain sobriety we must make it affordable for all! #justicesfight

Jennifer Kelly
141 supporters
Petitioning Federal Drug Administration

FDA: Approve Repetitive Transcranial Magnetic Stimulation trials for chronic pain patients

Chronic facial pain is one of the most misdiagnosed and mistreated conditions in the U.S. Many different forms of facial pain are grouped under the term "Trigeminal Neuralgia" because they effect the trigeminal nerve. It is estimated that 14,000 people are diagnosed each year and 140,000 currently have trigeminal neuralgia (TN) of some form in the U.S. Because of misdiagnosis, this number is most likely significantly higher than reported. It is often referred to as the "suicide disease" because of the immense pain that it wreaks on its victim, leading to suicide as sometimes the only way for the pain to stop. Repetetive Transcranial Magnetic Stimulation (rTMS)  is a non-invasive, painless procedure that uses magnets to stimulate the brain. This technology has been in use since 1985 and is being used today all over the world to adequately treat depression and anxiety. Studies done in Europe and Israel have shown impressive results using rTMS in the treatment of chronic pain and found that facial pain responded better than other types of chronic pain. The side effects from rTMS are almost non-existent according to documented medical trials, however the FDA will not approve the use of rTMS for those of us suffering with chronic facial pain because there is not enough data to support the claims. However, without access to the technology to run medical trials there is no conceivable way to obtain data that is satisfactory to the FDA. Those with facial pain are sick of medications. We are sick of needles and scalpels and brain surgeries that offer little to no relief. We need pain relief that for once will not leave us scarred or with side effects that make us regret our decisions. We just want a chance at living a normal life. We urge, no we demand, that the FDA hear our collective cry for pain relief. The technology is already here in the U.S. yet is only being utilized for depression and anxiety when studies show that it can safely do so much more. Allow the physicians and patients who know this pain better than anyone the opportunity for a trial in treating chronic facial pain with Repetative Transcranial Magnetic Stimulation, so that one day this horrific pain will be a thing of the past and possibly pave the way in treating other types of chronic pain and debilitating conditions. 

Danielle Forster
130 supporters