Posts tagged with "FDA"

Neutrogena recalls Light Therapy Acne Masks, due to risk of eye injuries

July 22, 2019

Many consumers have “seen the light” when it comes to over-the counter acne LED-light therapy masks—and that’s not necessarily a good thing. In fact, earlier this month, Neutrogena issued a recall of its masks, according to The New York Times;  citing a “theoretical risk of eye injury” to a subset of users who have underlying eye conditions or are taking medicine that makes them sensitive to light.

The Times reported that Neutrogena said in a statement that its July 5 recall followed “reports of mild, transient visual adverse events, combined with a growing scientific discussion around the safety of blue light.”

A spokesperson told the news outlet that the “adverse events” had been caused by the Neutrogena masks; although she did not specify how many such events had taken place. She also said that no particular study or expert had informed the company’s decision to recall the masks.

But that is not the only brand that uses visible blue and red lights to treat facial acne. And it may not be the only mask that is causing problems—problems which the Australian Department of Health recently said could cause retinal damage or impair peripheral vision after repeated therapy with the lights.

Among the most popular among these devices are the Lacomri 7 Color LED Light Therapy Acne Mask, Convinsimo Light Therapy Acne Face Treatment, Neutrogena Light Therapy Acne Mask, and Pulsaderm Acne Clearing Mask.

They all use the same treatment technology, explains the American Academy of Dermatology.

And that also may mean that they might share another problem: Such devices kill facial bacteria that could turn into pimples; they are not effective against existing blackhead, whiteheads, acne cysts, or nodules, the academy explains.

Indeed, says the academy, “Most people see clearing, but not 100%”—and “results vary from person to person.”

News of the recalls in the United States and in Australia was for the most part missed by consumers . A spokesperson for the U.S. Food and Drug Administration told the Times that the agency was “aware of the recall” and was looking into it.

The mask was released by Neutrogena in October 2016. Actress Lena Dunham endorsed it on Instagram and said her post was not an advertisement. The product was awarded Best of Beauty in 2017 by Allure magazine..)

Dr. Rachel Nazarian, with Schweiger Dermatology Group in New York City, told the news outlet that only recently had concerns about blue light cropped up, and that they mostly referred to people who had baseline medical conditions that caused their retinas to be more sensitive to light.

But she said that Neutrogena’s mask did not offer enough eye protection. While she planned to continue to use LED treatments in her own practice, she said she used much stronger eyewear than was provided by the company.

“It shouldn’t be used in such a cavalier form,” Dr. Nazarian said. “If you’re using the right eyewear protection, you should be fine.”

Research contact: @nytimes

Last licks: Woman caught on social media licking store ice cream and putting it back faces years in jail

July 8, 2019

A woman who licked more than her lips at a Walmart store may find herself in the “cooler” soon. The “mystery shopper” (who has not yet been identified by authorities) went viral on social media recently for licking a tub of ice cream and returning it to the frozen food display.

Now police say that, when they find her, she faces up to 20 years in prison for the prank, according to a July 4 report by NBC News.

The footage of the escapade—which already has been viewed more than 11 million times— shows the so-far unnamed woman opening a container, running her tongue across the ice cream; then laughing as she places the violated dessert back in the freezer, in a branch of Walmart in the city of Lufkin, eastern Texas.

She could face a second-degree felony charge of tampering with a consumer product, the Lufkin, Texas, Police Department said in an email statement to NBC News. The charge comes with a two- to 20-year prison term and up to $10,000 in fines, according to Texas state penal code.

Police also want to speak to the man she was with, who is thought to have filmed the incident and can be heard encouraging the woman to “Lick it, lick it.”

According to NBC, investigators also are in discussions with the FDA and additional federal charges could be made.

“Our detectives are working to verify the identity of the female suspect before a warrant is issued for her arrest on a charge of second-degree felony tampering with a consumer product,” a police spokesperson said.

“As that portion of the investigation continues, detectives are focusing on identifying the male (in the green shirt) behind the camera seen in images of the two entering the store together.”

Blue Bell Creameries, the local manufacturer of the ice cream brand the woman licked, has called the incident a “malicious act of food tampering.”

All tubs containing the mix of creamy vanilla ice cream with swirls of chocolate fudge and dark-chocolate-covered roasted peanuts have been removed from the store’s shelves as a precaution, the company said. The specific carton believed to be compromised was found among the lot.

In an earlier statement, the company explained that its cartons are frozen upside down in production, which creates a natural, tight seal by freezing the lid to the tub, meaning consumers would notice if any tampering occurred upon opening a fresh tub.

Research contact: @NBCNews

FDA approves another ‘Viagra for women’

July 3, 2019

Late in June, the U.S. Food and Drug Administration approved Vyleesi (bremelanotide)—a libido-booster for premenopausal women.

The drug is injectable, and the manufacturer—Waltham, Massachusetts-based AMAG Pharmaceuticals—says it should be self-administered by placing the needle under the skin of the adbdomen or thigh and pushing the plunger, at least 45 minutes before sexual activity.

But, the pharmaceutical company also advises that patients, themselves, should decide on the “optimal time” ahead of intercourse for the injection because the drug has side effects that can ruin the mood—among them, nausea and vomiting, flushing, injection site reactions, and headaches.

About 40% of patients in the clinical trials experienced nausea, most commonly with the first Vyleesi injection; and 13% needed medications for the treatment of nausea. About 1% of patients treated with Vyleesi in the clinical trials reported darkening of the gums and parts of the skin, including the face and breasts—which did not go away in about half the patients after stopping treatment. Patients with dark skin were more likely to develop this side effect.

How does it work? Vyleesi activates melanocortin receptors, but the mechanism by which it improves sexual desire and related distress is unknown.

Still, the FDA says that this drug represents an advance in treating low sexual desire, for women and their partners affected by this problem.

“There are women who, for no known reason, have reduced sexual desire that causes marked distress, and who can benefit from safe and effective pharmacologic treatment. Today’s approval provides women with another treatment option for this condition,” said Hylton V. Joffe, M.D., M.M.Sc., director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive, and Urologic Products.

The approval of Vyleesi by the FDA follows the agency’s 2015 approval of Addyi, which also was designed to boost libido, but which no one really wanted. (Its sales are currently “tepid,” according to a recent report by The New York Times. Addyi also caused fainting when combined with alcohol.)

Research contact: @US_FDA

Report: Brain health supplements are ‘a massive waste of money’

June 12, 2019

Most of us have seen the TV ads for Prevagen and have heard about the protective effects of ginkgo biloba—and those are just a couple of the dietary aids that Americans swallow in the hope and belief that they will make our brains stronger.

In fact, more than one-quarter (26%) of U.S. adults age 50 and older are taking at least one brain-health supplement, according to the findings of the  2019 AARP Brain Health and Dietary Supplements Survey

And research by the Nutrition Business Journal indicates that fully 69% of U.S. adults age 50 and older are taking a dietary supplement at least three times a week—with 8% saying they’re taking one to “reverse dementia.”

But now we are hearing that those supplements are “a massive waste of money”—and that warning comes from people who should know these things: On June 11, the Global Counsel on Brain Health (GCBH) in partnership with AARP released a report concluding that dietary supplements do not improve brain health or prevent cognitive decline, dementia, or Alzheimer’s disease.

Dietary supplements are not regulated by the FDA, yet 49% of older adults believe otherwise, Prevention magazine reports.

“The GCBH reviewed the scientific evidence on various supplements and determined it could not endorse any ingredient, production, or formulation designed for brain health,” the AARP said in a press release.

Under FDA law, it’s illegal for dietary supplement companies to make any claim that their product can treat, prevent, or cure a disease. If a supplement marketer wants to say their product can reduce the risk of a disease, they must notify the FDA first and get authorization before such a claim can go on a product label, Prevention notes.

Yet, the companies continue to market using misleading claims—among those currently in print or on-air:

  • Clinically shown to be safe and support memory and brain function
  • Clinically proven natural ingredients
  • Supports neurotransmitter development to promote a feeling of mental sharpness
  • Helps your brain maintain healthy neurons to support learning and recall
  • 13 scientifically proven nutrients for a healthier brain
  • Keeps your mind sharp and memory strong
  • Has shown statistically significant improvements in memory and recall in as little as four weeks when taken as directed
  • Designed to help improve memory while increasing focus and concentration
  • Comprehensive blend of vitamins, amino acids, and herbal extracts that support the brain’s structure and function to deliver amazing improvements in memory and concentration!
  • Help lessen the frequency of episodes of forgetfulness and brain fog
  • Improve your ability to retain and recall various kinds of information
  • For cognitive health, memory improvement, memory enhancement
  • These key nutrients have a powerful effect at reducing the inflammatory fires that destroy our brain tissue.

In addition, because dietary supplement companies aren’t regulated by the FDA, neither are their ingredients or dosages. The report warns that supplements “may have too much, too little, or, in some cases, none of the ingredients [consumers] think they’re buying.”

This can have dire consequences. The AARP cites a 2013 report from the U.S. government which found that the FDA received more than 6,000 reports of health problems due to dietary supplements between 2008 and 2011. They included 92 deaths and more than 1,000 series injuries. As part of the FDA’s investigation, the agency’s researchers found “dangerous fungi, pesticides, environmental pollutants, and heavy metals in some products.”

Worse yet, the FDA found that more than 700 dietary supplements contained prescription drugs, including steroids and antidepressants.

“It’s tempting to think you can pop a pill and prevent dementia, but the science says that doesn’t work,” Sarah Lenz Lock, AARP SVP for Policy and Executive Director of the GCBH told Prevention. “We know what will keep your brain healthy: exercise, a healthy diet, plenty of sleep, challenging your thinking skills, and connecting with others.”

Research contact: @AARP

A new way to ‘head off’ allergy symptoms: Immunotherapy is seen as breakthrough treatment

April 12, 2019

If you are one of the 50 million people in America who suffers from seasonal allergies, you probably don’t need anybody to tell you that pollen season is here. You have been sneezing and sniffling and scratching for weeks. But what you might want to hear about is a new immunotherapy treatment in the form of a tablet that has been identified as a promising alternative to over-the-counter medicines and injections.

According to an April 11 report by ABC-TV’s Good Morning America, the new immunotherapy treatment is seen by many professionals as a breakthrough in allergy treatment. A survey by the American College of Allergy, Asthma and Immunology has revealed that 73% of allergists are now offering these tablets as an effective at-home regimen.

There are typically a couple of ways in which allergy sufferers can “head off” their symptoms, according to ABC News’ Chief Medical Correspondent Dr. Jennifer Ashton—either by controlling their environment (reducing the allergens that cause symptoms) or by trying medications that will block allergic responses.

In comparison to these short-term solutions, the new tablets change the immune system’s response to allergens. Patients take increasing doses of the allergens to help build up tolerance.

Indeed, the new tablet immunotherapy could be a good option for those who are already taking the immunotherapy shots, as they offer similar benefits in the form of relieving symptoms, according to Ashton.

The biggest difference between the two is that you can administer the tablets at home rather than having to go to the doctor’s office, although tablets are medication that needs to be prescribed by a doctor.

The only bad news is that, while allergy tablets do not require repeated visits to a doctor’s office, they do require strict compliance and may require up to three years of use to work.

The tablets also cannot be used by all patients, including those with severe or uncontrolled asthma. Additionally, the tablets will only take care of individual allergens, so you would need to take one tablet for each allergen that you react to. By comparison, shots are capable of taking care of multiple allergens at once.

The Food and Drug Administration (FDA) has approved allergy tablets so far for only four allergens.

Research contact: @DrJAshton

Bail on kale: It has too many pesticides!

March 21, 2019

Americans have been nothing short of kale-obsessed for the past few years: In fact—following a flirtation with broccoli in the 1980s and pesto in the 1990s—we have become so fixated on the leafy, green vegetable that it has seen a 400% increase on U.S. restaurant menus since 2008, according to Technomic, a research service for the food and beverage industry.

But foodies should get ready to move on to another “k-food” in the near future—maybe kelp, or kimchi, or kefir or kombucha. An annual study by a nonprofit environmental group has found that—despite its high levels of calcium, iron, and vitamins A and K —kale just might be less healthful than you think.

Interestingly enough, Kale ranked third on the Environmental Working Group’s “2019 Shopper’s Guide to Pesticides in Produce”—a list of the fruits and vegetables with the highest pesticide residues, according to a recent report by Fortune magazine. That was a big jump for the leafy green, which hasn’t appeared at all on the list since 2009.

“More than 92% of kale samples had two or more pesticide residues detected, and a single sample could contain up to 18 different residues,” the report read.

Strawberries and spinach took the number one and two spots, respectively, the business news outlet reported. Kale and spinach samples had, on average, 1.1 to 1.8 times more pesticide residue by weight than any other crop, said the EWG.

Other foods on the Dirty Dozen list, in decreasing order of their pesticide residues, include: nectarines, apples, grapes, peaches, cherries, pears, tomatoes, celery, and potatoes.

The annual study looks at pesticide levels on nearly 41,000 fruits and vegetables that are tested by the Food and Drug Administration and the Department of Agriculture.

Unlike other pesticide-focused studies, this one does not search for a specific brand, such as the weed killer used in Roundup.

Pesticides are regularly used in agriculture, of course, and food service companies say the levels are far below those that have been found to be unsafe for human consumption.

Not all fruits and veggies were denigrated, however. The EWG also put out its “Clean 15” list of the produce with the lowest levels of pesticide residue. Avocados topped that list, followed by sweet corn, pineapples, frozen sweet peas, onions, papayas, eggplants, asparagus, kiwis, cauliflower, cantaloupes, broccoli, mushrooms, and honeydew melons. .

Research contact: @ewg

Food for thought: What is safe to eat during the government shutdown?

January 25, 2019

With the Food and Drug Administration largely out of action for the past month as a result of the partial government shutdown, consumers have been warned that many inspectors are not on the job and they should be careful about the groceries they buy. But questions remain: How careful and what groceries?

The answers are complicated, and it depends on whom you ask, CNN said in a recent report.

“We are very concerned that the shutdown may lead to lapses in food safety, but we don’t know where or when these will happen,” Sarah Sorscher, deputy director of Regulatory Affairs at the Center for Science in the Public Interest, a consumer advocacy group, told the cable news network.

When asked what foods he won’t eat during the shutdown, food safety attorney Bill Marler said, “I would say anything you aren’t controlling yourself—so any fresh, uncooked products,” such as ready-to-eat salads and prepackaged sandwiches, or meals that aren’t cooked.

Specifically, he points to, “Sprouts, leafy greens, ready to eat products like cheese, ice cream. I would be especially suspect if you’re a pregnant woman, children, people with a compromised immune system. I would stay away from it completely.”

“I worry about those foods that are going to institutions—like hospitals, like nursing homes … I worry about our most vulnerable consumers,” Catherine Donnelly, a professor  in the Department of Nutrition and Food Sciences at the University of Vermont told CNN.

However, she said her confidence in the safety of the US food supply is still high, even during the shutdown. The FDA is only one part of the safety system, she said.

“The FDA made it really clear that the responsibility for food safety lies with the companies,” she noted. “They just have responsibility for oversight and determining whether there are violations. To a large extent, the job of food safety is already being done very well I think by the food industry at large.

Consumers should continue to have confidence in those brand names that they trust and the willingness of companies to do the right thing in providing them with safe food.”

Hilary Thesmar, chief food and product safety officer at the Food Marketing Institute, an advocacy organization for food retailers, told the news outlet that supply chain control requirements from grocers help keep the food system safe.

Grocers “have a lot of customer specifications and customer requirements on products that they buy,” she said.

But other consumer groups share Marler’s concern about the safety of the food supply during the shutdown, even with some furloughed inspectors going back to work (without pay).

“Our advice is for people to continue using common sense measures — that they should rinse off their vegetables, rinse off their fruits, cook their meat, don’t eat raw meats, and just do all the normal things that you should do all the time anyway and you should be just fine,” Alex Berezow, vice president of Scientific Affairs of the American Council on Science and Health, a pro-science consumer advocacy organization, said in an email. He added that there really isn’t any particular food that should be avoided and said, “If you have any doubts about food, throw it out.”

Finally, FDA Commissioner Scott Gottlieb, MD,  told CNN that the FDA is taking steps to “expand the scope of food safety surveillance inspections we’re doing during the shutdown to make sure we continue inspecting high risk food facilities.” He noted that “31% of our inventory of domestic inspections are considered high-risk”; those are the inspections the agency is now trying to resume.

This applies to routine domestic surveillance inspections of foods including seafood, bakery products filled with custard, soft and semi-soft ripened cheese and cheese products, unpasteurized juices, fresh and processed fruits and vegetables, sandwiches and infant formula, among other food items.

Research contact: @debgcnn

Beer here?

January 21, 2019

What will fans drink at baseball games next summer? Something tells us that fraternity boys are still buying kegs—but overall, Americans are increasingly laying off the booze; especially, the beer.

In response to the growing trend toward nonalcoholic drinks, the world’s biggest brewers and liquor companies are innovating beyond their traditional inventory and rolling out teas, energy drinks, and nonalcoholic spirits, The Wall Street Journal reports.

According to the Journal, new data show that U.S. alcohol volumes dropped 0.8% last year, slightly up from the 0.7% decline in 2017. Beer got hit the hardest, with volumes down 1.5% in 2018, compared with a 1.1% decline in 2017. Growth in wine and spirits slowed, as well, according to data compiled for the news outlet by drinks market analyst IWSR.

The fall in alcohol volumes reflects “a growing trend toward mindful drinking or complete abstinence, particularly among the Millennial cohort,” Brandy Rand, president of IWSR’s U.S. Region told the newspaper. Wine grew by 0.4%, down from 1% the year before; while spirits climbed 1.9%, compared with 2.2% in 2017. IWSR’s figures are based on products shipped.

And speaking of Millennials, could alcohol (and weed) vaping be a factor? While The Wall Street Journal doesn’t cover this game-changer in its report, the vaping industry is now a multi-billion dollar business, with teens and Millennials among the fastest-growing groups of users.  According to recent research by the FDA, over 1.3 million youths are vaping. 2017 saw the largest spike of any substance use in the United States in the past 50 years. E-cigarettes are now at epidemic level of use in the United States.  

In response to the changing marketplace and the growing disinterest in alcoholic drinks, producers are beginning to diversify:  Molson Coors Brewinghas turned to kombucha, Budweiser brewer Anheuser-Busch InBev  sells a spiked coconut water, and Smirnoff maker Diageo wants teetotalers to start mixing cocktails with a pricey, alcohol-free gin alternative, says the Journal.

IWSR forecasts low- and no-alcohol products in the U.S.—still a small slice of the market—to grow 32.1% between 2018 and 2022, triple the category’s growth over the past five years.

Industry executives say drinkers are increasingly concerned about health and that younger generations socialize differently from their parents, drinking less.

“Twenty years ago we didn’t have coffee shops open late, and pubs and bars open for coffee,” Ben Branson, CEO of nonalcoholic distilled spirit maker Seedlip (which is part owned by Diageo) told the news outlet. “People are favoring experiences over ‘let’s go drink on a night out.’”

AB InBev last year created a new global position, head of nonalcoholic beverages, to lead its efforts to diversify. Nonalcoholic drinks—including energy drinks and nonalcoholic beers—already make up more than 10% of the Bud brewer’s volumes. In 2017, it acquired San Francisco-based Hiball, a producer of organic energy drinks.

What’s more, says the Journal, AB InBev recently began selling Budweiser Prohibition brew—a nonalcoholic version of its flagship beer—in Columbus and Detroit. Nonalcoholic beer volumes nationwide. are expected to climb 9.3% over the next five years, according to research firm Euromonitor.

The beer company also has stepped up its efforts to woo consumers defecting to wine and cocktails. Its craft-style breweries in Oregon, California and New York have served as incubators for new, boozy versions of coconut water, matcha tea and agua fresca, a Mexican fruit-juice drink. And the brewer plans to later this month launch a spiked seltzer brand, Bon & Viv, which it will advertise alongside its beers at the Super Bowl.

“People are looking for something that tastes good but also allows them to live well,” Chelsea Phillips, head of marketing for AB InBev’s Beyond Beer division in the U.S., said in an interview with the Journal.

Research contact: saabira.chaudhuri@wsj.com

Missouri becomes first state to regulate use of the word ‘meat’

August 29, 2018

The last time most of us had “mystery meat” was either in school or in the military. On June 1, Missouri—the “Show-Me State”—made sure that its residents would never have to see mystery meat or eat it again when it became the first state in the nation to pass a law that prohibits food providers from using the word “meat” to refer to anything other than animal flesh.

This  new legislation takes direct aim at manufacturers of what has been dubbed “clean,” or “plant-based, or “nontraditional”meat, according to a report by USA Today. Clean meat—also known as lab-grown meat—comprises cultured animal tissue cells, while plant-based meat is generally made from ingredients such as soy, tempeh and seitan.

The state law forbids “misrepresenting a product as meat that is not derived from harvested production livestock or poultry.” Violators may be fined $1,000 and imprisoned for a year.

What’s more, a similar argument is unfolding on the federal level.

The meat-substitute market is expected to reach $7.5 billion-plus globally by 2025, up from close to $4.2 billion last year, based on findings by Allied Market Research.

The Missouri Cattlemen’s Association, which worked to get the law passed, has cited shopper confusion and protection of local ranchers as reasons for the legislation.

“The big issue was marketing with integrity and … consumers knowing what they’re getting,” Missouri Cattlemen’s Association spokesperson Mike Deering told USA Today. “There’s so much unknown about this.”

On Agusut 27, the company that makes Tofurky filed an injunction in a Missouri federal court to prevent enforcement of the statute, alleging the state has received no complaints about consumers befuddled by the term “plant-based meats” and that preventing manufacturers from using the word is a violation of their First Amendment rights. In addition, the company pointed out, “meat” also refers to the edible part of nuts and fruit.

The statute “prevents the sharing of truthful information and impedes competition,” according to documents filed in U.S. District Court for the Western District of Missouri. “The marketing and packaging of plant-based products reveals that plant-based food producers do not mislead consumers but instead distinguish their products from conventional meat products.”

The co-plaintiff is the Good Food Institute, a Washington, D.C.-based advocacy group.

MCA spokesperson Deering said he was surprised by the suit because the primary target of the law was lab-grown meat.

Tofurky’s main ingredient is the first two syllables of its name-—tofu.

In June, the U.S. Food and Drug Administration announced it would regulate lab-grown meat. Traditional animal proteins are the jurisdiction of the U.S. Department of Agriculture.

Ernest Baskin, an assistant professor of Food Marketing at Saint Joseph’s University in Philadelphia told USA Today that consumers use the word “meat,” when applied to nonanimal protein as a “shortcut” to understand how they eat the food they see on supermarket shelves.

“There’s a segment of consumers that doesn’t have to eat alternative products but wants to,” he said. “In those cases, putting those options together in front of consumers gives them the thought that ‘Hey, maybe these two are similar. Maybe I can substitute.’ ”

Research contact:@ZlatiMeyer

‘Right to Try’ bill heads to White House for signature

May 31, 2018

Nearly 90% of Americans want the chance to try experimental drugs when they are critically ill and “have everything to gain and nothing to lose,” based on findings of a poll conducted in March by CancerHealth.com.

They (and their families and friends) are celebrating the passage of Right to Try legislation by the U.S. House of Representatives—successfully culminating a multi-year campaign by the Goldwater Institute to give such patients access to drugs not yet approved by the Food and Drug Administration (FDA). Specifically, the bill gives terminally ill patients the right to seek drug treatments that remain in clinical trials and “have passed Phase 1 of the Food and Drug Administration’s approval process,” but have not been fully approved by the agency.

The House passed the bill, sponsored by Senator Ron Johnson (R-Wisconsin), on May 29 by a vote of 250 to 169, sending it on to President Donald Trump’s desk for signature. According to coverage by Biopharma Dive, the act covers a much broader population than an earlier House-passed version. The president has been a vocal advocate despite warnings from patient groups and top FDA staffers including Commissioner Scott Gottlieb that it may have unintended effects and potentially hinder FDA’s authority .

On the other hand, Biopharma Dive reported, conservative groups—including Freedom Partners and Americans for Prosperity—backed the effort; calling attention to the fact that 40 states have passed versions of the bill.

“The Administration believes that these patients and their families should be able to seek access to potentially life-saving therapies while those treatments are still under review by the FDA,” an administration policy statement said.

The legislation passed via unanimous consent in the Senate last August.

In a May 21 letter, more than 100 patient advocacy groups—among them, The American Cancer Society, the Alliance of Dedicated Cancer Centers, the Cancer Action Network, Friends of Cancer Research and the National Organization for Rare Disorders—urged House Speaker Paul Ryan (R-Wisconsin) and Minority Leader Nancy Pelosi (D-California) to reject the bill. The groups argued that. while they did not support the previous House-passed bill either, at least it had comprised several safeguards that are missing from the new legislation.

Senior House GOP leadership praised the bill as a leap forward for patients.

Research contact: @SGottliebFDA