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☆ F.D.A. Authorizes New Drug to Protect High-Risk Patients From Covid
▼ + stars: | 2024-03-25 | by ( Dani Blum | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration has greenlit a new medicine to protect some of the people most at risk from Covid. The agency granted emergency use authorization for Pemgarda, a monoclonal antibody infusion, in immunocompromised people ages 12 and older. The drug is intended to protect against Covid for people who are not likely to mount an adequate immune response after vaccination. This includes those who have received stem cell or organ transplants and cancer patients taking medications that suppress the immune system. But, he said, it’s a vital group to protect: the people who most feel left behind at this stage in the pandemic.

Persons: It’s, ”, Michael Mina, Harvard epidemiologist, Ziyad Al, Aly Organizations: Drug Administration, Harvard, Veterans Affairs, Louis Healthcare

☆ Challenging Abortion, Again
▼ + stars: | 2024-03-25 | by ( Emily Bazelon | ) www.nytimes.com time to read: +1 min

How safe is it to take abortion pills? The case could curtail Americans’ access to mifepristone, the first pill taken in a two-drug regimen for a medication abortion. A decision in the plaintiff’s favor would change the landscape of abortion not state by state, like the effects of the 2022 ruling that overturned Roe v. Wade, but across the country. Post-Roe AmericaThe abortion opponents who sued the government in tomorrow’s case, F.D.A. v. Alliance for Hippocratic Medicine, are frustrated by how common abortion has remained.

Persons: Roe, Wade, Margot Sanger, Katz, Claire Cain Miller Organizations: Alliance, Hippocratic Locations: United States

☆ F.D.A. Delays Action on Closely Watched Alzheimer’s Drug
▼ + stars: | 2024-03-08 | by ( Pam Belluck | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration has decided to delay action on a closely watched Alzheimer’s drug, donanemab, which the agency was widely expected to approve this month. will instead require donanemab to undergo the scrutiny of a panel of independent experts, the drug’s maker, Eli Lilly and Company, said Friday. The decision is likely to surprise many Alzheimer’s experts, doctors and patients who had expected the medication would soon be on the market. The F.D.A.’s move was startling to the company, which had been planning for the agency to greenlight the drug during the first quarter of this year. “We were not expecting this,” Anne White, an executive vice president of Lilly and president of its neuroscience division, said in an interview.

Persons: Eli Lilly, “, Lilly, ” Anne White, ” Organizations: Drug Administration Locations: donanemab

☆ Opinion | How America’s Two Abortion Realities Are Clashing
▼ + stars: | 2024-03-08 | by ( The Ezra Klein Show | ) www.nytimes.com time to read: +65 min

mary zieglerWell, I think it’s much easier to ban abortion than it is to enforce a criminal law against abortion. mary zieglerNo, I think that’s right. If our abortion politics don’t reflect our abortion views, what does that tell us about the health of the democracy? We’ve seen upwards of 10 states — I think it’s 14 or 15 that have changed their definition of abortion in abortion restrictive states since Dobbs. So, the idea is that abortions that are presented as life saving either are not abortions or are simply pretexts for abortion that’s elective.

Persons: ezra klein, Ezra Klein, ”, overturns Roe, Wade, we’ve, Dobbs, Mary Ziegler, mary ziegler, Roe, they’ve, they’re, didn’t, isn’t, —, We’ve, ezra klein Let’s, mifepristone, Z, They’re, mary ziegler That’s, Comstock, hasn’t, it’s, ezra klein There’s, Kate Cox, kate cox, mary ziegler —, she’d, there’s, you’ll, don’t, you’re, You’re, That’s, I’ve, I’m, they’ll, Ezra, you’ve, that’s, There’s, what’s, Joe Biden, Bill Clinton, You’ve, It’s, Lindsey Graham, Chuck Schumer, Hakeem Jeffries, Trump, mary ziegler There’s, Glenn Youngkin, Glenn Youngkin’s, mary ziegler It’s, we’re, Donald Trump, Roger Severino, Gene Hamilton, Hamilton isn’t, He’s, Stephen Miller’s, Jonathan Mitchell, Biden, — there’s, Josh Prager’s, Jennifer Holland, Daniel K, Williams, Wade ”, Linda Greenhouse, Reva Siegel, ezra klein Mary Ziegler Organizations: New York, Alabama, Republican, U.S, Supreme, for Life, Environmental Protection Agency, mifepristone, and Drug Administration, Republicans, State, Washington State Patrol, Democratic, Catholic Democrat, Wall Street, Act, Virginia Republicans, Republican Party, Leadership, Heritage Foundation, Health, Human Services Department, Trump, Washington Post, New York Times, HHS, Human Services, Department of Justice, Court Locations: Alabama, America, St, Louis , Missouri, East St, Louis , Illinois, Dobbs, Ohio, United States, Texas, mary ziegler — Texas, Kansas, Austin, Houston, Dallas, Florida, Miami, Jacksonville, Tampa, New York, California, Vermont, New Jersey, Missouri, Idaho, Virginia, Colorado, Roe

☆ A.L.S. Drug Relyvrio Fails Clinical Trial and May Be Withdrawn From the Market
▼ + stars: | 2024-03-08 | by ( Pam Belluck | ) www.nytimes.com time to read: +1 min

One of the few treatments the Food and Drug Administration has approved for amyotrophic lateral sclerosis has failed a large clinical trial, and its manufacturer said Friday that it was considering whether to withdraw it from the market. The medication, called Relyvrio, was approved less than two years ago, despite questions about its effectiveness in treating the severe neurological disorder. At the time, the F.D.A.’s reviewers had concluded there was not yet sufficient evidence that the medication could help patients live longer or slow the rate at which they lose functions like muscle control, speaking or breathing without assistance. But the agency decided to greenlight the medication instead of waiting two years for results of a large clinical trial, citing data showing the treatment to be safe and the desperation of patients with a disease that often causes death within two to five years. Now, results of the 48-week trial of 664 patients are in, and they showed that the treatment did not work better than a placebo.

Persons: ’ Organizations: and Drug Administration Locations: United States

☆ Does Eating Yogurt Reduce Your Diabetes Risk?
▼ + stars: | 2024-03-05 | by ( Alice Callahan | ) www.nytimes.com time to read: +1 min

Nonfat or full-fat, flavored or plain, probiotic or natural — yogurt is already peppered with labels. But you may soon see a new claim on your container: This month, the Food and Drug Administration announced it will allow yogurt makers to say their products may prevent Type 2 diabetes. said it has found “limited scientific evidence” that consuming yogurt may reduce the risk of Type 2 diabetes. The agency’s decision came in response to a petition submitted on behalf of Danone North America, which makes yogurts sold under brands including Activia, Dannon and Oikos. Yogurt can be a nutrient-rich food and part of a healthy diet, and there is some evidence to suggest that people who eat it regularly have a lower risk of Type 2 diabetes, said Dr. Frank Hu, a professor of nutrition and epidemiology at the Harvard T.H.

Persons: Frank Hu, ”, Bonnie Liebman Organizations: Food and Drug Administration, Danone North, Harvard, of Public Health, Center for Science Locations: Danone North America, Chan

☆ First U.S. Over-the-Counter Birth Control Pill Will Be Available Soon
▼ + stars: | 2024-03-04 | by ( Pam Belluck | ) www.nytimes.com time to read: +2 min

Why It MattersThe medication, called Opill, which was approved for over-the-counter sale by the Food and Drug Administration last year, will be the most effective birth control method available without a prescription, research shows — more effective than condoms, spermicides and other nonprescription methods. Some experts said they thought it might be a particularly good option for teenagers, who might otherwise rely on condoms. Reproductive health experts and members of an F.D.A. But long before that, the move to make a nonprescription pill available for all ages had received widespread support from specialists in reproductive and adolescent health and groups. In a survey in 2022 by the health care research organization KFF, more than three-quarters of women of reproductive age said they favored an over-the-counter pill, primarily because of convenience.

Persons: Lupe M, Rodriguez, ” Karen Murry, Opill Organizations: Food and Drug Administration, National Latina Institute, Reproductive

☆ Opinion | Three Mothers’ Plea to the F.D.A.: Save Our Children
▼ + stars: | 2024-02-28 | by ( ) www.nytimes.com time to read: +1 min

To the Editor:Re “Why Can’t More Children Get the Treatment That Saved My Son’s Life?,” by Elizabeth Currid-Halkett (Opinion guest essay, Feb. 24):Our three children, ages 5 and 7, battle a rare, relentless and ultimately fatal disease called cystinosis. We recently found hope in the initial phase of a gene therapy clinical trial that was shown to be safe and yielded very promising results — a therapy that could one day save our children’s lives. Our biggest fear is that it will not be accessible to them or others in desperate need. We applaud Dr. Marks’s wisdom and perspective. reviewers’ initial rejection is a cautionary tale of how patient access to lifesaving therapies could be impeded by a narrow interpretation of efficacy.

Persons: Elizabeth Currid, Currid, Peter Marks, “ Organizations: Biologics

☆ Lead-Tainted Applesauce Sailed Through Gaps in Food-Safety System
▼ + stars: | 2024-02-27 | by ( Christina Jewett | Will Fitzgibbon | ) www.nytimes.com time to read: +1 min

Cinnamon-flavored applesauce pouches sold in grocery and dollar stores last year poisoned hundreds of American children with extremely high doses of lead, leaving anxious parents to watch for signs of brain damage, developmental delays and seizures. The Food and Drug Administration, citing Ecuadorean investigators, said a spice grinder was likely responsible for the contamination and said the quick recall of three million applesauce pouches protected the food supply. Children in 44 states ate the tainted applesauce, some of which contained lead at extraordinarily high levels. and a food-safety law that gives companies, at home and abroad, wide latitude on what toxins to look for and whether to test. “Largely, the food supply regulatory system is based on an honor system.”

Persons: ”, Neal Fortin Organizations: Drug Administration, The New York Times, Institute for Food Laws, Michigan State University, “

☆ N.Y. Attorney General Urges Stricter Warnings for Asthma Drug
▼ + stars: | 2024-02-22 | by ( Christina Jewett | Benjamin Mueller | ) www.nytimes.com time to read: +1 min

The New York attorney general on Thursday urged the Food and Drug Administration to “take immediate action” and renew alerts to doctors and patients about the dangerous effects of Singulair for children, saying that the current warnings about the drug’s psychiatric side effects were not sufficient. In a letter, the attorney general, Letitia James, also called on the federal agency to consider discouraging the prescription of Singulair, an asthma and allergy drug, to children. Thousands of patients and parents have complained to the F.D.A. about symptoms of anxiety, rage, hallucinations and other psychiatric problems that they linked to the drug, which is also known in its generic form as montelukast. in 2020 to order its most stringent warning on instructions for the drug’s usage.

Persons: Letitia James Organizations: New, Food and Drug Administration, New York Times Locations: New York

☆ Biogen Abandons Its Controversial Alzheimer’s Drug Aduhelm
▼ + stars: | 2024-01-31 | by ( Rebecca Robbins | More About Rebecca Robbins | ) www.nytimes.com time to read: +1 min

The drug maker Biogen said on Wednesday it would abandon its ownership rights to Aduhelm, an Alzheimer’s drug that had provoked fierce criticism of the company and regulators after it was approved based on weak evidence that it would help patients. The company will also stop a clinical trial that the Food and Drug Administration had ordered to confirm whether the drug is effective in slowing the progression of Alzheimer’s disease. Biogen’s decision closes out a yearslong saga that generated outrage and eroded trust in the regulatory process for bringing new medicines to market. adviser called the approval of the drug perhaps “the worst approval decision that the F.D.A. has made that I can remember.” A congressional inquiry later found that the F.D.A.’s process for approving Aduhelm was “rife with irregularities” and involved “lapses in protocol,” including unusually close collaboration with Biogen.

Persons: Biogen, Aduhelm Organizations: and Drug Administration

☆ Philips Suspends U.S. Sales of Breathing Machines After Recall
▼ + stars: | 2024-01-29 | by ( Christina Jewett | ) www.nytimes.com time to read: +1 min

Philips Respironics announced on Monday that it would halt sales of all of its breathing machines in the United States after reaching a settlement with the Food and Drug Administration over continuing problems with the devices. Millions of the company’s ventilators and CPAP machines, used to ease breathing at night, were recalled after reports that they blew bits of foam and potentially toxic gases into consumers’ airways. Under the settlement, Philips said it would have to meet a list of standards in a “multiyear” plan before it could resume business in the United States. The company initially began the recall of millions of devices in June 2021 and paused sales of new sleep therapy machines to the United States, according to Steve Klink, a spokesman for Philips. cited the potential for serious injury or permanent impairment from the potentially cancer-causing chemicals emitted from the devices.

Persons: Philips Respironics, Philips, Steve Klink Organizations: Food and Drug Administration, Philips Locations: United States

☆ Innovative Cancer Treatment May Sometimes Cause Cancer, F.D.A. Says
▼ + stars: | 2023-11-28 | by ( Gina Kolata | More About Gina Kolata | ) www.nytimes.com time to read: +3 min

Cancer specialists said the treatments have saved the lives of thousands of patients with blood cancers. And, he said, “I haven’t seen a single one” develop a new T cell cancer. When patients’ T cells are engineered to make proteins that attack cancer cells, a virus helps slip new genes into T cell DNA. Even without chemotherapy or radiation, Dr. Maus added, patients with blood cell cancers are especially susceptible to developing other blood cell cancers. But Dr. DiPersio said, “it is more of a smoking gun.”The F.D.A.

Persons: Marcela V, Maus, John DiPersio, Louis, “, ”, DiPersio, —, . Maus Organizations: Massachusetts General Hospital, Washington University School of Medicine Locations: Massachusetts, St

☆ Opinion | The Quiet Blockbuster at the Supreme Court Could Impact All Americans
▼ + stars: | 2023-11-22 | by ( Kate Shaw | ) www.nytimes.com time to read: +3 min

If embraced in its entirety, the nondelegation doctrine could spell the end of agency power as we know it, turning the clock back to before the New Deal. but would also “invalidate much of the federal budget.” It might also throw into question the constitutionality of other federal agencies, including potentially the Federal Reserve. The Supreme Court has put on hold lower court rulings that invalidated parts of the F.D.A.’s approval, but that’s no guarantee of how the court would ultimately rule in the case. It would furthermore likely destabilize the F.D.A.’s approval process, which has long been seen as the global “gold standard” of drug safety. But embracing these arguments would not result in the court returning power to Congress but claiming enormous and novel powers for itself.

Persons: ’, John Roberts Organizations: Consumer Financial, Federal Reserve, Food

☆ Sickle-Cell Treatment Created With Gene Editing Wins U.K. Approval
▼ + stars: | 2023-11-16 | by ( Gina Kolata | More About Gina Kolata | ) www.nytimes.com time to read: +1 min

Regulators in Britain on Thursday approved the first treatment derived from CRISPR, the revolutionary gene-editing method. Called Casgevy, the treatment is intended to cure sickle-cell disease and a related condition, beta thalassemia. The companies anticipate that the Food and Drug Administration will approve Casgevy for sickle-cell patients in the United States in early December. The agency will decide on approval for beta thalassemia next year. That treatment does not rely on gene editing, insteading using a method that inserts new DNA into the genome.

Organizations: Vertex Pharmaceuticals, CRISPR Therapeutics, and Drug, Bluebird Bio Locations: Britain, Boston, Switzerland, United States, Somerville, Mass

☆ Amazon to Stop Selling Seven Eyedrops After F.D.A. Warning
▼ + stars: | 2023-11-15 | by ( Amanda Holpuch | More About Amanda Holpuch | ) www.nytimes.com time to read: +1 min

Amazon said on Wednesday that it was removing seven eyedrops products from its website after the Food and Drug Administration warned the company that the eyedrops had not been recognized as safe and effective. said in a letter to Andrew Jassy, Amazon’s chief executive, on Monday that Amazon had violated federal regulations by selling the eyedrops, which claimed to help with problems including pink eye, dry eyes, eyestrain and floaters. “These products are especially concerning from a public health perspective,” the F.D.A. letter said. “Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.”The eyedrops named in the letter are: Similasan Pink Eye Relief, The Goodbye Company Pink Eye, Can-C Eye Drops, Optique 1 Eye Drops, OcluMed Eye Drops, TRP Natural Eyes Floaters Relief, and Manzanilla Sophia Chamomile Herbal Eye Drops.

Persons: Andrew Jassy, Manzanilla Sophia Organizations: Food and Drug Administration, Amazon, Eye

☆ F.D.A. Approves New Obesity Drug That Will Compete With Wegovy
▼ + stars: | 2023-11-08 | by ( Gina Kolata | More About Gina Kolata | ) www.nytimes.com time to read: 1 min

The Food and Drug Administration on Wednesday approved an obesity drug from the company Eli Lilly that will be a direct competitor to the wildly popular Wegovy. The drug is called tirzepatide and will be sold under the name Zepbound. Patients who used tirzepatide lost an average of 18 percent of their body weight, according to the F.D.A., when it was taken at its highest dose in a drug trial. That’s compared with Wegovy, manufactured by Novo Nordisk, which produced an average 15 percent weight loss. approved Zepbound for people with obesity and for those who are overweight and have at least one obesity-related condition.

Persons: Eli Lilly, tirzepatide Organizations: Drug Administration, Novo Nordisk

☆ Vaping Declines Among High School Students, Survey Shows
▼ + stars: | 2023-11-02 | by ( Christina Jewett | More About Christina Jewett | ) www.nytimes.com time to read: +4 min

About 90 percent of the students who reported vaping said they used flavored products, citing favorites that tasted like fruit and candy. Public health experts also linked other state and local flavor bans and education campaigns to the falling high school vaping rate, which is the lowest in nearly a decade. In all, about 2.1 million middle and high school students reported using e-cigarettes, down from 2.5 million last year. While the agency has authorized about two dozen vaping products for sale, thousands of illicit candy-colored flavored vapes have flooded the country and are top sellers. Other researchers noted that the combined general use of tobacco products by middle and high school students barely fell, to 10 percent this year from 11 percent last year.

Persons: vaping, Juul, Brian King, There’s, Dr, Neff, “, ” Dr, ”, Karen Knudsen Organizations: Public, ., Food and Drug Administration, Federal, University of Southern, American Cancer Society Locations: California, University of Southern California

☆ Doctors Wrestle With A.I. in Patient Care, Citing Lax Oversight
▼ + stars: | 2023-10-30 | by ( Christina Jewett | More About Christina Jewett | ) www.nytimes.com time to read: +1 min

spokesman, said the agency’s staff members review thousands of pages before clearing A.I. oversight right in medicine, a task that involves several agencies, is critical, said Dr. Ehrenfeld, the A.M.A. in deadly plane crashes to warn about the perils of automated safety systems overriding a pilot’s — or a doctor’s — judgment. He is concerned that doctors might encounter a similar use of A.I. is there should be an obvious place to start,” Dr. Ehrenfeld said.

Persons: James McKinney, ”, Ehrenfeld, weren’t

☆ A New Sickle Cell Treatment Will Change Lives — but How Many? - The New York Times
▼ + stars: | 2023-10-30 | by ( Daniela J. Lamas | ) www.nytimes.com time to read: +3 min

And though comprehensive sickle cell care — at dedicated centers with expert hematologists, social workers and pain management specialists — reduces hospitalizations, and is the standard for diseases like cystic fibrosis and hemophilia, which do not disproportionately affect Black people, these centers are few and far between for sickle cell. Into this complicated landscape enters the possibility of gene therapy. It’s important to note that this isn’t the first cure for sickle cell. is expected to review another gene therapy from the company Bluebird Bio that targets sickle cell disease but does not use CRISPR; this was the therapy Mr. Holmes received as part of the N.I.H. When she was 17 and hospitalized, facing the reality of her chronic illness, she told her mother that she was ready to pursue gene therapy.

Persons: Holmes, Elizabeth Ford, Ford Organizations: Vertex Pharmaceuticals, CRISPR Therapeutics, Bluebird

☆ Fruit Purée Pouches May Contain Lead, F.D.A. Warns Parents
▼ + stars: | 2023-10-30 | by ( Rebecca Carballo | More About Rebecca Carballo | ) www.nytimes.com time to read: +1 min

Federal health officials are warning parents and caregivers not to buy WanaBana apple cinnamon fruit purée pouches or feed them to their children because the product may contain elevated levels of lead. Children who have had the fruit pouches should be taken to a health care provider to get a blood test, the Food and Drug Administration said on Saturday. North Carolina health officials analyzed multiple samples of the fruit purée and detected “extremely high concentrations of lead,” the agency added. reviewed the findings and said that those lead levels “could result in acute toxicity.”The fruit purée pouches are sold nationally and are available through multiple retailers including Sam’s Club, Amazon and Dollar Tree. WanaBana, based in Coral Gables, Fla., agreed to voluntarily recall all WanaBana apple cinnamon fruit purée pouches, regardless of the expiration date.

Organizations: Food and Drug Administration, Sam’s Locations: North Carolina, . North Carolina, Coral Gables, Fla

☆ F.D.A. Experts Will Vote on Safety of a Cure for Sickle Cell Disease
▼ + stars: | 2023-10-30 | by ( Gina Kolata | More About Gina Kolata | ) www.nytimes.com time to read: +4 min

An estimated 100,000 people in the United States have sickle cell disease, most of whom have African ancestry. will decide on another application for sickle cell gene therapy made by Bluebird Bio. Two other companies and an academic center, Boston Children’s Hospital, are testing their own sickle cell gene therapies. While these therapies could reduce the suffering of sickle cell patients in the United States and other wealthy countries, there is an even greater need for them in some developing countries like Nigeria. One company, Beam, is testing a way to provide gene editing that requires nothing more than a single infusion in a doctor’s office.

Persons: “, Mariah Jacqueline Scott, Scott, ”, Stephan Grupp, What’s Organizations: Institute for Clinical, CRISPR Therapeutics, Children’s Hospital of Philadelphia, Bluebird, Boston Children’s Hospital Locations: United States, Highland Park, N.J, Boston, Nigeria

☆ Eyedrops From Major Brands May Cause Infection, F.D.A. Says
▼ + stars: | 2023-10-29 | by ( Rebecca Carballo | More About Rebecca Carballo | ) www.nytimes.com time to read: +1 min

Federal health officials are advising consumers to stop using more than two dozen over-the-counter eyedrops products because of a potential risk of eye infection that may lead to partial vision loss or blindness. The Food and Drug Administration issued an alert on Friday flagging 26 eye care products including eyedrops and gels from CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target up&up and Velocity Pharma. The federal agency recommended on Wednesday that the manufacturer recall all lots of those products after agency investigators found unsanitary conditions in a manufacturing plant, according to the news release from the F.D.A. Bacterial tests came back positive from critical drug production areas in the plant, which the agency did not immediately identify. said that it had not received any reports of infection associated with these products, but it was encouraging health care professionals and patients to report any cases to the agency.

Organizations: Drug Administration, CVS Health, Health, Rugby, Cardinal Health, Rite, Target, Velocity Pharma

In interviews, doctors at several other hospitals said they also used Burst’s products and expressed surprise that the F.D.A. Dr. Sandhu said he had used the product on at least 50 patients, thought it worked well and hadn’t detected any problems. He recalled that for some patients, insurance covered Burst treatment, which typically cost thousands of dollars. He said he would have notified patients had the F.D.A. He said he got off to a good start working for Dr. Härtl, but their standoff over the Burst research soured their relationship.

Persons: Faheem, Sandhu, ”, Gadjradj, Härtl Organizations: Georgetown University Hospital, Weill Cornell Locations: New York

☆ Why the F.D.A. Took So Long to Tackle a Disputed Cold Remedy
▼ + stars: | 2023-09-15 | by ( Christina Jewett | More About Christina Jewett | ) www.nytimes.com time to read: +1 min

Dr. Leslie Hendeles began prodding the Food and Drug Administration to reject a decongestant in cold medicines when he had a mop of curly red hair and Bill Clinton had just become president. By the time opposition to the drug had coalesced, Dr. Hendeles was appearing, at age 80, as an expert to testify before the agency’s advisers, his hair white and his overview of the ingredient spanning 50 years. His advocacy culminated in the advisory panel’s unanimous vote on Tuesday, when it concluded that the decongestant, a common ingredient in cold and flu remedies, is ineffective. Prompted by the news, consumers threw open their medicine cabinets upon learning that the decongestant, phenylephrine, was listed in more than 250 of their go-to drugs for congestion like some versions of DayQuil, Sudafed, Tylenol and Theraflu. And the decision has caused some confusion — experts say the ingredient still works in nasal sprays, just not when taken orally in pill or liquid form.

Persons: Leslie Hendeles, Bill Clinton, Hendeles Organizations: and Drug Administration

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