2020 Candidates Are Betting Big On Health - Is That What Voters Really Want?

The one thing we know about health care in the 2020 Democratic presidential primary race is that it’s a top issue for voters.

The latest Tracking Poll from the Kaiser Family Foundation found 24% of Democrats and Democratic-leaning independents said they want to hear the candidates discuss health care. That’s twice the total for the next top issue, climate change; and four times the total for immigration, the No. 3 issue.

The big question, though, is whether that interest will reward a candidate who backs a sweeping, “Medicare for All”-type plan, or a more modest plan like a public option, in which a person can voluntarily join a government health insurance plan.

Polling doesn’t make that clear. On the one hand, Democrats and Democratic-leaning respondents in the KFF poll say when it comes to health care, the candidate they trust most is Sen. Bernie Sanders of Vermont (who initially pushed a Medicare for All plan).


Yet those same people say they prefer a public option (of the sort supported by former Vice President Joe Biden) to Sanders’ Medicare for All plan. That bears out in a separate Quinnipiac poll released last week, in which 36% of respondents say Medicare for All is a good idea while 52% say it is a bad idea. An NBC/Wall Street Journal poll from September found similar results: 67% of respondents said they would support allowing people under age 65 to “buy their health coverage through the Medicare program,” while only 41% favored “adopting Medicare for All, a single payer health care system in which private health insurance would be eliminated.”

So, what the candidates now face is a question of strategy and tactics. Sanders remains all-in on Medicare-for-All. “I wrote the damn bill,” he keeps reminding reporters. Biden and the rising-in-the-polls Pete Buttigieg, the mayor of South Bend, Ind., are firmly in favor of a more moderate approach. “We take a version of Medicare. We let you access it if you want to. And if you prefer to stay on your private plan, you can do that, too,” Buttigieg said at the Democrats’ October debate. “That is what most Americans want.”

Sen. Elizabeth Warren of Massachusetts looks like she is trying to have it both ways. She has unveiled a far more detailed version of Medicare for All than Sanders or other backers of the concept in Congress. And her campaign has unveiled a “first-term” health plan that could be implemented quickly, moving to a broader Medicare for All system later in her first term. (Even Warren’s transitional plan is more expansive than either Biden’s or Buttigieg’s plan.)
Who’s right? There’s no good way to tell until voters go to the polls. But it might surprise people that the last time a health overhaul was a major issue in the Democratic presidential primary race ― in 2008 ― it wasn’t the candidate with the most sweeping plan who emerged as the winner.
Then-Sen. Hillary Clinton had a more sweeping plan for health care than her Senate colleague Barack Obama did. Clinton called for a cap on out-of-pocket medical expenses, and an “individual mandate,” the requirement (repealed by Republicans in 2017) that people either prove they have coverage or pay a fine.

Obama resisted many of those specifics, particularly the mandate. “In order for you to force people to get health insurance, you’ve got to have a very harsh stiff penalty,” he said at a debate in February 2008. Eventually he called for a mandate that all children have coverage. Obama did not fully embrace the mandate that would become part of the Affordable Care Act until mid-2009, during the congressional debate.

But Democratic primary voters have moved significantly to the left since 2008, Medicare for All proponents say.

That is clearly the case. But if Democrats are to keep control of the House of Representatives, they will need to keep the loyalty of those independent voters in districts that are far more moderate than those represented by left-leaning lawmakers like Alexandria Ocasio-Cortez (D-N.Y.) and Ilhan Omar (D-Minn.), who are pressing for major changes including the passage of a Medicare for All plan.
The key to all this, of course, is threading the political needle in a way that keeps the enthusiasm of the Democrats’ Medicare for All base, while not scaring away voters in swing areas who fear such major changes. So far, not one of the presidential candidates has found that perfect spot. The one who does could well be the next president.

HealthBent, a regular feature of Kaiser Health News, offers insight and analysis of policies and politics from KHN’s chief Washington correspondent, Julie Rovner, who has covered health care for more than 30 years.

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Opinions: Canada’s ‘Medicare For All’ Is A Terrible Mess; Lessons On Problems Stemming From Surprise Medical Bills

Selected editorial pages focus on these health care cost issues and others.

Fox News: Sanders, Warren Want ‘Medicare-For-All’ Like Canada – But Canadian Health Care Is Awful Democratic presidential candidates Sens. Bernie Sanders and Elizabeth Warren want you to believe Canada’s health care system is a dream come true. And they want to make the dream even better with their “Medicare-for-all” plans. Don’t believe them. In truth, Canada's system of socialized medicine is actually a nightmare. It has left hospitals overcrowded, understaffed and unable to treat some patients. Americans would face the same dismal reality if Canadian-style "Medicare-for-all" takes root here. (Sally Pipes, 12/8)

Boston Globe: Cutting Through The Clutter On Surprise Billing Understanding and navigating the health care system is more challenging for patients than at any time in history. The complexities and variations among insurance plans on issues of coverage, out-of-pocket costs, and payment for care are extraordinary as compared to other consumer services. One of the most pressing examples is “surprise medical billing.” Such instances occur when a patient receives medical services and is unknowingly cared for by a clinician from outside of the patient’s insurance network. The predictable and understandable result is stress, anger, confusion, and despair.Local and national policymakers are correctly focusing attention on this issue. When surprise billing occurs, patients are unfairly put in the middle of a matter that should be resolved by their health plan and provider. Corrective actions are long overdue. (Maryanne C. Bombaugh, 12/9)

Axios: Surprise Medical Bills Often Follow Heart Attacks The big picture: The new data underscore the importance of a legislative solution to help patients who are powerless to protect themselves. Details: People having surgery or receiving mental health and substance abuse treatment at an in-network hospital are the most likely to experience a surprise bill from an out-of-network provider. Among people with employer-based insurance, out-of-network charges were 50% higher among heart-attack victims than for other diagnoses. 21% of women undergoing mastectomies experienced out-of-network provider charges. My thought bubble: It’s hard to imagine many patients who are so prepared and insurance-savvy that they could protect themselves from an out-of-network bill in the middle of a heart attack. (Drew Altman, 12/9)

Boston Globe: Now That You Have Insurance, How Do You Use It? It’s that time of year — when we enroll in health insurance. Whether you are shopping for individual coverage or have coverage through your employer, there is a good chance you are comparing health plans and getting ready to make one of the biggest financial decisions of the year. (Dania Palanker, 12/9)

The New York Times: Where The Frauds Are All Legal Much of what we accept as legal in medical billing would be regarded as fraud in any other sector. I have been circling around this conclusion for this past five years, as I’ve listened to patients’ stories while covering health care as a journalist and author. Now, after a summer of firsthand experience — my husband was in a bike crash in July — it’s time to call out this fact head-on. Many of the Democratic candidates are talking about practical fixes for our high-priced health care system, and some legislated or regulated solutions to the maddening world of medical billing would be welcome. (Elisabeth Rosenthal, 12/7)

The Wall Street Journal: Congress And The Spending Power James Madison called Congress’s power of the purse “the most complete and effectual weapon” for restraining “the overgrown prerogatives of the other branches of the government.” On Tuesday the Supreme Court will consider in Maine Community Health Options v. U.S. whether Congress can limit the spending discretion it has previously granted to the executive branch. Four health insurers have sued the government for not making payments they say they are entitled to under the Affordable Care Act’s “risk corridors.” (12/8)

Nashville Tennessean: Guideline To Stress-Free Open Enrollment Process Millions of Americans are hunting for health insurance. The Affordable Care Act's open enrollment period ends in just two weeks. Consumers in more than three dozen states are running out of time to log onto HealthCare.gov to shop for coverage for the coming year. The process can be intimidating. Every policy offers a different mix of premiums, deductibles, benefits, and provider networks. (Janet Trautwein, 12/5)

The Oregonian: Oregon Needs A Bold New Health Care Model As a rural business owner, most people assume I am against a single-payer, government-run model. But I am not. I want a bold, new, affordable health care model that takes care of my employees, my business and my family. I know we can accomplish this. The State Accident Insurance Fund is but one example of an efficient and properly-run single payer system for workers compensation right here in Oregon. In July, I co-sponsored with Warren George, who is also a rural Oregon businessman, a poll of Oregon voters that determined most Oregonians feel the same way. According to the poll, conducted by Elway Research: 62% of us would likely support a new health tax to replace insurance and provide universal care. (Ron Loe, 12/8)

The Washington Post: Medicaid Expansion Keeps Breaking Through In Red America. Next Stop: North Carolina? Democrats recently notched big gubernatorial wins in deep red Louisiana and Kentucky, and they took full control of the Virginia state legislature — all of which were driven in no small part by bruising local debates over the Medicaid expansion. Now Democrats are hoping that this momentum for the Medicaid expansion, combined with the growing popularity of the proposal even in Republican territory, could finally produce a breakthrough that they’ve long coveted: in still-reddish North Carolina. (Greg Sargent, 12/6)

 

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

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Community experience of outbreak control during an Ebola outbreak in Luwero District, Uganda

Abstract

BACKGROUND:

A major challenge to outbreak control lies in early detection of viral haemorrhagic fevers (VHFs) in local community contexts during the critical initial stages of an epidemic, when risk of spreading is its highest ("the first mile"). In this paper we document how a major Ebola outbreak control effort in central Uganda in 2012 was experienced from the perspective of the community. We ask to what extent the community became a resource for early detection, and identify problems encountered with community health worker and social mobilization strategies.

METHODS:

Analysis is based on first-hand ethnographic data from the center of a small Ebola outbreak in Luwero Country, Uganda, in 2012. Three of this paper's authors were engaged in an 18 month period of fieldwork on community health resources when the outbreak occurred. In total, 13 respondents from the outbreak site were interviewed, along with 21 key informants and 61 focus group respondents from nearby Kaguugo Parish. All informants were chosen through non-probability sampling sampling.

RESULTS:

Our data illustrate the lack of credibility, from an emic perspective, of biomedical explanations which ignore local understandings. These explanations were undermined by an insensitivity to local culture, a mismatch between information circulated and the local interpretative framework, and the inability of the emergency response team to take the time needed to listen and empathize with community needs. Stigmatization of the local community--in particular its belief in amayembe spirits--fuelled historical distrust of the external health system and engendered community-level resistance to early detection.

CONCLUSIONS:

Given the available anthropological knowledge of a previous outbreak in Northern Uganda, it is surprising that so little serious effort was made this time round to take local sensibilities and culture into account. The "first mile" problem is not only a question of using local resources for early detection, but also of making use of the contextual cultural knowledge that has already been collected and is readily available. Despite remarkable technological innovations, outbreak control remains contingent upon human interaction and openness to cultural difference.

Author information

1

Department of Anthropology, University of Amsterdam, Amsterdam, The Netherlands. d.h.devries@uva.nl.

2

Department of Anthropology, University of Amsterdam, Amsterdam, The Netherlands.

3

Makerere University College of Humanities and Social Sciences, CeSSRA office, Kampala, Uganda.

4

Department of Social Work and Social Administration, Makerere University, Kampala, Uganda.

5

Center for Social Science Research on AIDS (CeSSRA), School of Social Sciences, Makerere University, Kampala, Uganda.

Source:  https://www.ncbi.nlm.nih.gov/pubmed/26883621?dopt=Abstract

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FDA warns 15 companies for illegally selling various products containing cannabidiol

For Immediate Release:

November 25, 2019

Today, the U.S. Food and Drug Administration issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA also published a revised Consumer Update detailing safety concerns about CBD products more broadly. Based on the lack of scientific information supporting the safety of CBD in food, the FDA is also indicating today that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.

Today’s actions come as the FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed. This includes ongoing work to obtain and evaluate information to address outstanding questions related to the safety of CBD products, while maintaining the agency’s rigorous public health standards. The FDA plans to provide an update on its progress regarding the agency’s approach to these products in the coming weeks.

“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns. In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD’s safety – including reports of products containing contaminants, such as pesticides and heavy metals – and there are real risks that need to be considered. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”

Many unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD. The revised Consumer Update outlines specific safety concerns related to CBD products, including potential liver injury, interactions with other drugs, drowsiness, diarrhea, and changes in mood. In addition, studies in animals have shown that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels and impair sexual behavior in males. Questions also remain about cumulative use of CBD and about CBD’s impacts on vulnerable populations such as children and pregnant or breastfeeding women.

CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, food products such as chocolate bars and teas, and topical lotions and creams. As outlined in the warning letters issued today, these particular companies are using product webpages, online stores and social media to market CBD products in interstate commerce in ways that violate the FD&C Act, including marketing CBD products to treat diseases or for other therapeutic uses for humans and/or animals. Other violations include marketing CBD products as dietary supplements and adding CBD to human and animal foods.

The companies receiving warning letters are:

• Koi CBD LLC, of Norwalk, California
• Pink Collections Inc., of Beverly Hills, California
• Noli Oil, of Southlake, Texas
• Natural Native LLC, of Norman, Oklahoma
• Whole Leaf Organics LLC, of Sherman Oaks, California
• Infinite Product Company LLLP, doing business as Infinite CBD, of Lakewood, Colorado
• Apex Hemp Oil LLC, of Redmond, Oregon
• Bella Rose Labs, of Brooklyn, New York
• Sunflora Inc., of Tampa, Florida/Your CBD Store, of Bradenton, Florida
• Healthy Hemp Strategies LLC, doing business as Curapure, of Concord, California
• Private I Salon LLC, of Charlotte, North Carolina
• Organix Industries Inc., doing business as Plant Organix, of San Bernardino, California
• Red Pill Medical Inc., of Phoenix, Arizona
• Sabai Ventures Ltd., of Los Angeles, California
• Daddy Burt LLC, doing business as Daddy Burt Hemp Co., of Lexington, Kentucky

The FDA has previously sent warning letters to other companies illegally selling CBD products in interstate commerce that claimed to prevent, diagnose, mitigate, treat or cure serious diseases, such as cancer, or otherwise violated the FD&C Act. Some of these products were in further violation because CBD was added to food, and some of the products were also marketed as dietary supplements despite products which contain CBD not meeting the definition of a dietary supplement.

Under the FD&C Act, any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy. There is very limited information for other marketed CBD products, which likely differ in composition from the FDA-approved product and have not been evaluated for potential adverse effects on the body.

Unlike drugs approved by the FDA, there has been no FDA evaluation of whether these unapproved products are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns. In addition, the manufacturing process of unapproved CBD drug products has not been subject to FDA review as part of the human or animal drug approval processes. Consumers may also put off getting important medical care, such as proper diagnosis, treatment and supportive care due to unsubstantiated claims associated with CBD products. For that reason, it’s important that consumers talk to a health care professional about the best way to treat diseases or conditions with existing, approved treatment options.

Additionally, some of the products outlined in the warning letters issued today raise other legal and public health concerns:

• Some of the products are marketed for infants and children – a vulnerable population that may be at greater risk for adverse reactions due to differences in the ability to absorb, metabolize, distribute or excrete a substance such as CBD.
• Some of the products are foods to which CBD has been added. Under the FD&C Act, it is illegal to introduce into interstate commerce any human or animal food to which certain drug ingredients, such as CBD, have been added. In addition, the FDA is not aware of any basis to conclude that CBD is GRAS among qualified experts for its use in human or animal food. There also is no food additive regulation which authorizes the use of CBD as an ingredient in human food or animal food, and the agency is not aware of any other exemption from the food additive definition that would apply to CBD. CBD is therefore an unapproved food additive, and its use in human or animal food violates the FD&C Act for reasons that are independent of its status as a drug ingredient.
• Some of the products are marketed as dietary supplements. However, CBD products cannot be dietary supplements because they do not meet the definition of a dietary supplement under the FD&C Act.
• One product outlined in a warning letter to Apex Hemp Oil LLC is intended for food-producing animals. The agency remains concerned about the safety of human food products (e.g. meat, milk, and eggs) from animals that consume CBD, as there is a lack of data establishing safe CBD residue levels.

The FDA has requested responses from the companies within 15 working days stating how the companies will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction.

The FDA encourages human and animal health care professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source:  https://www.fda.gov/news-events/press-announcements/fda-warns-15-companies-illegally-selling-various-products-containing-cannabidiol-agency-details

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FDA approves new treatment for adults with partial-onset seizures

The U.S. Food and Drug Administration today approved XCOPRI (cenobamate tablets) to treat partial-onset seizures in adults.

“XCOPRI is a new option to treat adults with partial-onset seizures, which is an often difficult-to-control condition that can have a significant impact on patient quality of life,” said Billy Dunn, M.D., director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “Patients can have different responses to the various seizure medicines that are available. This approval provides an additional needed treatment option for people with this condition.”

A seizure is a usually short episode of abnormal electrical activity in the brain. Seizures can cause uncontrolled movements,  abnormal thinking or behavior, and abnormal sensations. Movements can be violent, and changes in consciousness can occur. Seizures occur when clusters of nerve cells (neurons) in the brain undergo uncontrolled activation. A partial-onset seizure begins in a limited area of the brain.

The safety and efficacy of XCOPRI to treat partial-onset seizures was established in two randomized, double-blind, placebo-controlled studies that enrolled 655 adults. In these studies, patients had partial-onset seizures with or without secondary generalization for an average of approximately 24 years and median seizure frequency of 8.5 seizures per 28 days during an 8-week baseline period. During the trials, doses of 100, 200, and 400 milligrams (mg) daily of XCOPRI reduced the percent of seizures per 28 days compared with the placebo group. The recommended maintenance dose of XCOPRI, following a titration (medication adjustment) period, is 200 mg daily; however, some patients may need an additional titration to 400 mg daily, the maximum recommended dose, based on their clinical response and tolerability.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has been reported among patients taking XCOPRI. In the clinical trials, some patients experienced DRESS, and one patient died, when XCOPRI was titrated rapidly (weekly or faster titration). No cases of DRESS were reported in an open-label safety study of 1,339 epilepsy patients when XCOPRI was started at 12.5 mg per day and adjusted every two weeks; however, this finding does not show that the risk of DRESS is prevented by a slower titration. A higher percentage of patients who took XCOPRI also had a shortening of the QT interval (an assessment of certain electrical properties of the heart) of greater than twenty milliseconds compared to placebo. XCOPRI should not be used in patients with hypersensitivity to cenobamate or any of the inactive ingredients in XCOPRI or Familial Short QT syndrome. QT shortening can be associated with ventricular fibrillation, a serious heart rhythm problem.

Antiepileptic drugs (AEDs), including XCOPRI, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients taking an AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. XCOPRI may cause neurological adverse reactions, including somnolence (sleepiness) and fatigue, dizziness, trouble with walking and coordination, trouble with thinking, and visual changes. Patients should also be advised not to drive or operate machinery until the effect of XCOPRI is known.

The most common side effects that patients in the clinical trials reported were somnolence (sleepiness), dizziness, fatigue, diplopia (double vision), and headaches.

The FDA granted the approval of XCOPRI to SK Life Science Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source:  https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-adults-partial-onset-seizures

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FDA approves treatment to target abnormality in sickle cell disease

Today, the U.S. Food and Drug Administration granted accelerated approval to Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older.

“Today’s approval provides additional hope to the 100,000 people in the U.S., and the more than 20 million globally, who live with this debilitating blood disorder,” said Acting FDA Commissioner Adm. Brett P. Giroir, M.D. “Our scientific investments have brought us to a point where we have many more tools available in the battle against sickle cell disease, which presents daily challenges for those living with it. We remain committed to raising the profile of this disease as a public health priority and to approving new therapies that are proven to be safe and effective. Together with improved provider education, patient empowerment, and improved care delivery systems, these newly approved drugs have the potential to immediately impact people living with SCD.”
Sickle cell disease is a lifelong, inherited blood disorder in which red blood cells are abnormally shaped (in a crescent, or "sickle" shape), which restricts the flow in blood vessels and limits oxygen delivery to the body’s tissues, leading to severe pain and organ damage. It is also characterized by severe and chronic inflammation that worsens vaso-occlusive crises during which patients experience episodes of extreme pain and organ damage.

“Oxbryta is an inhibitor of deoxygenated sickle hemoglobin polymerization, which is the central abnormality in sickle cell disease,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “With Oxbryta, sickle cells are less likely to bind together and form the sickle shape, which can cause low hemoglobin levels due to red blood cell destruction. This therapy provides a new treatment option for patients with this serious and life-threatening condition.”
Oxbryta’s approval was based on the results of a clinical trial with 274 patients with sickle cell disease. In the study, 90 patients received 1500 mg of Oxbryta, 92 patients received 900 mg of Oxbryta and 92 patients received a placebo. Effectiveness was based on an increase in hemoglobin response rate in patients who received 1500 mg of Oxbryta, which was 51.1% for these patients compared to 6.5% in the placebo group.

Common side effects for patients taking Oxbryta were headache, diarrhea, abdominal pain, nausea, fatigue, rash and pyrexia (fever).

Oxbryta was granted Accelerated Approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need based on a result that is reasonably likely to predict a clinical benefit to patients. Further clinical trials are required to verify and describe Oxbryta’s clinical benefit.

The FDA granted this application Fast Track designation. Oxbryta also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. The FDA granted the approval of Oxbryta to Global Blood Therapeutics.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source:  https://www.fda.gov/news-events/press-announcements/fda-approves-novel-treatment-target-abnormality-sickle-cell-disease


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The Future of Medicine