Food and Drug Administration

WASHINGTON, Sept. 30 (UPI) — The federal government shutdown leaves thousands of federal workers without pay, and an array of public facilities, such as Smithsonian museums and national parks, cite the challenges staying open without much staff.

Smithsonian museums announced on their combined website they have funding set aside to stay open until Oct. 6. The situation with national parks, though, is up in the air. If they don’t close, visitors would not have adequate protection without adequate staffing.

The Library of Congress, another symbol of Washington, announced it will lock its doors to visitors and cancel all events.

Moreover, congressional offices said, the National Institutes of Health will be unable to see new patients to its research hospital, and the Food and Drug Administration will be unable to process applications for new drugs or medical devices.

For those who lived through past shutdowns — the last one came during the first Trump administration in December 2018 and lasted 34 days — the fallout is all too familiar.

David Barna, who served as chief spokesman for the National Park Service from 1995 to 2015, worked during the 34-day shutdown in 2018 and recalled its emotional toll. With roughly 1 million visits to national parks each day, he said closures are “devastating to our visitors.”

“It was heartbreaking for our park visitors,” Barna said. “People who had waited years to visit parks had their plans canceled. I remember talking with a young woman who planned to get married in Yellowstone, and she cried on the phone as she told me about canceling her wedding.”

This time, Barna warned, the situation is likely to be worse. “Rumor is that the parks will be open without staff,” he said. “Last time this happened, the parks were vandalized and trash accumulated everywhere. We need NPS employees to take care of the natural and cultural resources in the parks.”

He added, “Without staff, they are unprotected. The parks are gifts from our grandparents to our grandchildren. Our job is the preserve and protect them,” he said.

Just as Barna fears national treasures will go unprotected without park staff, union leaders representing VA employees warn that the shutdown threatens the people caring for the nation’s veterans.

Robert Malosh, president of a local chapter of the American Federation of Government Employees, said his members fear that a prolonged gridlock will be used to justify further cuts to staff who provide critical care to veterans.

“Since this administration appears to be hell bent on eliminating staff at all costs, there’s plenty of fear that this administration will abuse these emergency powers to further wage war against the heroes who provide care to our veterans,” Malosh said.

“As we speak, some of the best and most qualified personnel are looking for jobs to replace the stability and security they’ve lost in the last eight months,” he said.

While many other federal employees anticipated the shutdown, staffers were already preparing for what has become the reality — working without pay. A spokesperson for Rep. Mike Quigley, D-Ill., said House employees have been declared essential and will report to work regardless of whether funding lapses.

“That means we will be working unpaid for the duration of a shutdown,” the spokesperson said, noting that House staff members are paid on the 30th of each month, providing a brief cushion before the paycheck gap becomes real.

In the 2018 government shutdown, 800,000 federal workers were furloughed and cost the U.S. economy an estimated $11 billion. It was the longest of the 20 shutdowns throughout history, occurring during the first Trump administration.

Each time, political stalemates in Congress continue to leave federal workers, service members and the public caught in the middle.

Uncertainty has also hit the National Guard deployed in Washington. The D.C. National Guard State Public Affairs Office told UPI it had no information on whether troops will continue their deployment or if they will be paid, referring questions to the White House.

That ambiguity underscores how even roles deemed essential by the Trump administration are clouded during a funding lapse.

From Hill staffers to the thousands of others across Washington, the question is how long they can go unpaid. For tourists, consumers, veterans and patients across the country, it remains to be seen what remains open and for how long should the shutdown persist.

Sept. 17 (UPI) — Massachusetts says that all citizens should be vaccinated to protect against the COVID-19 virus as the Bay State will now force insurance providers to cover vaccines approved by the state.

On Wednesday, the Massachusetts Department of Public Health released its COVID-19 vaccine guidelines through 2026 that suggested all state residents get a COVID-19 shot, including children ages 6, and particularly those at higher risk of exposure, with a weakened immune system or pregnant.

“We are not going to let Donald Trump or Robert Kennedy take away your ability to make your own health care decisions,” said Gov. Maura Healey.

The decision by Massachusetts came as the Food and Drug Administration under U.S. Health and Human Services Robert F. Kennedy Jr. approved in August its most recent round of COVID shots but federally limited their use.

Healey said earlier this month that Massachusetts will begin to require health insurance companies to cover state-recommended vaccines and became the first U.S. state to do so, followed by Illinois in an executive order Friday by Gov. JB Pritzker, a Democrat.

Executive actions in Illinois and Massachusetts could be the first in a series of other similar acts by governors to create a coalition to set vaccine policy separate of federal authorities.

“Massachusetts will continue to lead with science and protect access to life-saving vaccines,” Healey, 54, said Wednesday in a statement.

Notably, the Healey administration’s plan was backed by the nonprofit entities Blue Cross Blue Shield of Massachusetts and the Massachusetts Association of Health Plans.

The newly issued state guidelines stand in stark contrast to federal recommendations by the Trump administration and Centers For Disease Control and Prevention.

Massachusetts health officials said the state acted on an “extensive review of current scientific data” consistent with widely respected groups such as the American Academy of Pediatrics.

The commonwealth’s Public Health Commissioner Robbie Goldstein reiterated Wednesday that vaccines remain the “most effective public health intervention of the past century,” adding that vaccine use has “saved millions of lives.”

Goldstein stated its guidelines were “grounded in evidence and science, driven by equity and shaped by the lived experiences” of Massachusetts’ 351 communities.

On Monday, Healey called Kennedy a “walking conspiracy theorist who is denying people vaccines and the healthcare they want and need” during a speech to Massachusetts Democrats as she hailed her administration’s new vaccine coverage mandate for insurance conglomerates.

A recent study indicated that in 2022 and 2023 more than 1.5 million “missing Americans” died due to COVID-19 in excessive deaths that could have been averted.

But on Wednesday Healey said the state was taking this action “so the people of Massachusetts know that you will continue to be able to get the vaccines you want and need — no matter what happens at the federal level.”

Also on Wednesday, ex-CDC Director Susan Minaret appeared on Capitol Hill to testify in front of lawmakers over her termination by Kennedy due to allegations that she refused to allow all decisions to be approved by political staff.

U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., seen here at a hearing at the U.S. Capitol in Washington, D.C. in September. He allegedly pushed now-former Former Centers for Disease Control and Prevention, or CDC, Director Susan Monarez to resign only a month after she was given the job. Photo by Bonnie Cash/UPI | License Photo

Sept. 10 (UPI) — Former Centers for Disease Control and Prevention Director Susan Monarez will testify before the Senate about the organization she briefly ran.

Monarez will appear on Sept. 17 before the Senate Committee on Health, Education, Labor and Pensions, along with Deb Houry, the former Chief Medical Officer and Deputy Director for Program and Science at CDC. Houry resigned her position to protest Monarez’s termination.

The two are slated to discuss their time at the CDC to offer testimony regarding their take on the state of the agency.

“To protect children’s health, Americans need to know what has happened and is happening at the CDC,” said Sen. Bill Cassidy, R-La., chairperson of the HELP Committee, in a press release Tuesday. “They need to be reassured that their child’s health is given priority. Radical transparency is the only way to do that.”

“[Susan Monarez] is a public health expert with unimpeachable scientific credentials,” Kennedy had said of her at the beginning of August after she was sworn into her role. “I have full confidence in her ability to restore the [CDC’s] role as the most trusted authority in public health and to strengthen our nation’s readiness to confront infectious diseases and biosecurity threats.”

However, Monarez only held her position at the CDC for about four weeks, before allegedly being pushed out because she wouldn’t echo the agenda of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr. or remove scientists from the agency because of his plans.

She was fired after refusing to resign.

“Susan Monarez is not aligned with the president’s agenda of Making America Healthy Again,” White House spokesperson Kush Desai said in a statement to media in regard to her being axed.

“Since Susan Monarez refused to resign despite informing HHS leadership of her intent to do so, the White House has terminated Monarez from her position with the CDC,” he added.

“Parents deserve a CDC they can trust to put children above politics, evidence above ideology and facts above fear,” wrote Monarez in an opinion piece in the Wall Street Journal last week. “I was fired for holding that line.”

Dr. Demetre Daskalakis, who formerly led the National Center for Immunization and Respiratory Diseases, and Dr. Daniel Jernigan, who headed the National Center for Emerging and Zoonotic Infectious Diseases, also quit the CDC as Kennedy has worked to reshape the vaccine advisory panel to meet his own vaccine policies.

Kennedy, who cancelled approximately $500 million in contracts for mRNA vaccines last month, changed the recommendations for healthy children and pregnant women to receive COVID-19 vaccinations and led the reduction of approval for updated COVID shots this fall to only cover people over 65, or younger Americans with underlying conditions, via the U.S. Food and Drug Administration, or FDA.

Sept. 5 (UPI) — Massachusetts is the first state to force health insurance companies to cover vaccines recommended by the state’s department of public health.

The law will require that insurance companies not solely follow recommendations by the Centers for Disease Control and Prevention, which has seen recent changes to its vaccine recommendations by Health and Human Services Department Secretary Robert F. Kennedy Jr.

Last week, the Food and Drug Administration narrowed the list of people to whom it recommends the COVID-19 vaccine, drawing criticism from the Senate at Thursday’s hearing questioning Kennedy about that and other decisions.

“Massachusetts has the best health care in the world,” Gov. Maura Healey said in a statement Friday. “We won’t let Donald Trump and Robert Kennedy get between patients and their doctors. When the federal government fails to protect public health, Massachusetts will step up. The actions we are announcing today will make sure people can continue to get the vaccines they need and want in Massachusetts.”

On Wednesday, a group of states with Democrat governors — California, Oregon and Washington — announced plans to form a public health alliance to offer “evidence-based immunization guidance,” The Hill reported.

Healey said earlier this week that her state will join other Northeastern states to create a similar coalition to set vaccine policy.

Blue Cross Blue Shield of Massachusetts and the Massachusetts Association of Health Plans have said they support the action by Healey.

“Today’s action ensures that everyone who should get a vaccine will get one, and their insurance will cover it,” Insurance Commissioner Michael Caljouw said in a statement. “Our collective commitment — state government working with our health insurance companies — is important as we enter the fall season.”

The governor, in the press release, outlined a three-step plan:

The Division of Insurance and Department of Public Health issued a bulletin that requires insurance carriers in Massachusetts to continue to cover vaccines recommended by the Massachusetts Department of Public Health.

The governor has taken steps to ensure that Massachusetts residents who want the COVID vaccine can get it at pharmacies.

Massachusetts is leading efforts to create a public health collaboration with states in New England and across the Northeast committed to safeguarding public health.

Aug. 27 (UPI) — The federal government signed-off on the latest round of COVID-19 vaccines, but new limits were set on which Americans can get them after U.S. Health and Human Services Secretary Robert F. Kennedy Jr. fulfilled many of his promises to reshape U.S. vaccine policy.

The U.S. Food and Drug Administration on Wednesday ended its authorization for the broad use of COVID-19 shots, clearing them only for patients at higher risk of severe illness, and those age 65 and older — or younger adults with at least one underlying health condition who would qualify.

“The emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded,” Kennedy stated early Wednesday afternoon in a post on X.

Kennedy said the American people “demanded science, safety and common sense,” and he claimed this new framework “delivers all three.”

But this new action is likely to complicate access, observers say, and prompts questions on insurance plan coverage.

According to Kennedy, vaccine shots still will be available for patients but only after they consult with a doctor.

On Wednesday, both Moderna and Pfizer confirmed its vaccines were approved for use in adults age 65 and older and those age 5 through 64 with at least one underlying condition.

However, it remains to be seen how easily it can be obtained for patients without higher risk health factors.

Previous U.S. vaccine policy suggested an annual COVID-19 shot for people age 6 months and older.

The American Academy of Pediatrics, the nation’s leading pediatrics association, recently recommended children as young as 6 months old be inoculated against COVID-19 in a departure with Trump administration guidelines.

The COVID-19 vaccine shots must be voted on by a panel of the Centers for Disease Control and Prevention.

Earlier this year Kennedy, a known skeptic of long-used and effective vaccines, gutted the CDC panel and named widely-known vaccine critics to sit in place.

On Wednesday the chief of America’s Frontline Doctors, a right-wing group known to spread false and unsubstantiated claims, cheered Kennedy’s actions on the U.S. coronavirus vaccine policy switch.

“Mandates are dead. Freedom wins,” Dr. Simone Gold, AFD’s president, said on social media.

However, a noted television medical analyst offered advice to those still on the fence on getting another COVID-19 shot.

“If you want to know if you or members of your family should get vaccinated, my recommendation is to solicit advice from your doctor, not the federal government,” Dr. Jonathan Reiner, a professor at the D.C.-based George Washington School of Medicine & Health Sciences and its director of Cardiac Catheterization Laboratories, stated on X.

Aug. 13 (UPI) — The director of the Centers for Disease Control and Prevention told employees about the dangers of misinformation, four days after a suspected gunman shot at the agency’s headquarters in Atlanta, claiming the COVID-19 vaccine made him sick.

On Tuesday, Susan Monarez met with staffers virtually and then sent a note to all 10,000 employees nationwide, obtained by ABC News. Staffers at the headquarters have been working remotely since the attack on Friday.

“The dangers of misinformation and its promulgation has now led to deadly consequences,” she wrote. “I will work to restore trust in public health to those who have lost it — through science, evidence and clarity of purpose. I will need your help.”

The comments were slightly different than those during her staff meeting in which she said: “Public health should never be under attack. We know that misinformation can be dangerous.”

She said the health agency can rebuild trust with “rational evidence-based discourse” with “compassion and understanding.”

Dr. Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Pennsylvania, told NBC News: “The irony is her boss is the biggest spreader of misinformation.”

Robert F. Kennedy Jr. is secretary of the Health and Human Services, which oversees the CDC.

In 2021, during the pandemic, Kennedy described the shot as the “deadliest vaccine ever made” after he filed a citizens’ petition requesting that the Food and Drug Administration end emergency authorization.

Last week, Kennedy announced that HHS was moving to terminate $500 million in contracts to develop vaccines using mRNA technology, which was used to develop the COVID-19 vaccine in 2020.

“After reviewing the science and consulting top experts at NIH [National Institutes of Health] and FDA, HHS has determined that mRNA technology poses more risks than benefits for these respiratory viruses,”

The American Medical Association backs mRNA vaccine research and the CDC still says on its website: “During the COVID-19 pandemic, COVID-19 vaccines underwent the most intensive safety analysis in U.S. history.”

Health officials have denounced skepticism of the research, noting the COVID-19 vaccine saved millions of lives in the United States.

“The Covid pandemic showed us what’s possible when science moves fast,” Rick Bright, who directed the Biomedical Advanced Research and Development from 2016 to 2020, told NBC News. “Dismantling that momentum now is like disbanding the fire department because the fire’s out.”

As head of the HHS, he has updated COVID-19 vaccine recommendations for the fall to be restricted to older adults and those with underlying health conditions. He also doesn’t want children to get the shots.

On Monday, Kennedy toured the CDC campus in Atlanta and met with the widow of the one person slain in the attack, DeKalb County Police Officer David Rose. He toured with Monarez and HHS Deputy Secretary Jim O’Neill.

“He offered his deepest condolences and reaffirmed the agency’s commitment to honoring officer Rose’s bravery, sacrifice and service to the nation,” HHS said.

Since the attack, the union representing CDC workers condemned the lack of support from top officials.

“This leadership is critical in reinforcing public trust and ensuring that accurate, science-based information prevails,” the union said Sunday. “This condemnation is necessary to help prevent violence against scientists that may be incited by such disinformation.”

The American Federation of Government Employees Local 2883, which represents more than 2,000 CDC workers, said in a statement Sunday that the attack “was not random and it compounds months of mistreatment, neglect and vilification that CDC staff have endured.”

The union also said: “The deliberate targeting of CDC through this violent act is deeply disturbing, completely unacceptable and an attack on every public servant.”

The father of the suspected gunman, 30-year-old Patrick Joseph White, reportedly told authorities he targeted the CDC over health problems he blamed on the COVID-19 vaccine. He said the shot made him depressed and suicidal.

He was fatally shot by police after around 200 bullets struck the six buildings. Five firearms were recovered.

“All indications are that this was an isolated event involving one individual,” Jeff Williams, the deputy secretary of the CDC’s Office of Safety, Security and Asset Management, said during the staff meeting Tuesday.

July 19 (UPI) — A man in Long Island, N.Y., is dead after a metal chain he was wearing pulled him toward an MRI machine at a private clinic, police confirmed.

The 61-year-old was inside the Nassau Open MRI clinic this week when he entered an “unauthorized” room while wearing the chain as one of the magnetic resonance imaging machines was operating.

“The male victim was wearing a large metallic chain around his neck causing him to be drawn into the machine which resulted in a medical episode. The Nassau County Police Department responded to assist the aided where he was transported to a local area hospital,” the department said in a statement.

The man was in critical condition when he was transported to the hospital and died the following day, police said in an update.

Nassau Open MRI is located in Westbury, a village in the town of North Hempstead in Nassau County on the North Shore of Long Island, with a population of around 17,000 people.

The company’s website says it has “earned a reputation with our referring physicians and patients for friendly service and clinical accuracy. Our high quality state-of-the-art technology provides the patients and physicians an extra measure of comfort and service.”

As of early Saturday afternoon, the company had not issued a public statement about the incident.

MRI scans are some of the most commonly-done medical scans in the United States.

“The strong magnetic field of an MRI scanner can affect medical implants that contain metal or magnets. When this happens, the implant may move or twist inside of the patient’s body, causing discomfort, pain, or injury,” reads an MRI safety description on the U.S. Food and Drug Administration‘s website.

“Patients with metal-containing implants such as cochlear implants (which also typically contain a magnet) need to be aware of this risk and ensure that health care providers and MR technologists are aware of their implant so that they can take proper precautions when receiving an MRI exam. In addition, the radio waves of an MRI scanner may cause heating of the implant.”

July 15 (UPI) — Dozens of U.S. ice cream manufacturers are pledging to eliminate the use of artificial food colors from their ice cream products made with real milk by the end of 2027, the U.S. dairy manufacturing and marketing trade association said.

Announced Monday by the International Dairy Foods Association, the companies have agreed to remove certified artificial colors Red No. 3, Red No. 40, Green No. 3, Blue No. 1, Blue No. 2, Yellow No. 5 and Yellow No. 6 from their frozen dairy products by 2028.

According to the dairy trade association, the commitment is from companies that together make more than 90% of the ice cream sold in the United States.

“Americans are passionate about their ice cream, and the IDFA Ice Cream Commitment will ensure wholesome, indulgent ice cream products made with real milk from American dairy farmers remain a special part of our lives as state and federal policies evolve,” Michael Dykes, president and CEO of IDFA, said in a statement.

The announcement comes as the Food and Drug Administration has been seeking to remove artificial food colorings from the U.S. market.

During the final days of the previous Biden administration, the FDA announced it had revoked authorization for the use of synthetic food dye Red No. 3 after a linkage to cancer was found in animal studies, with its use to be phased out by 2028.

Under the Trump administration, the FDA announced in April plans to phase out petroleum-based dyes, including those U.S. ice cream makers pledged Monday to eliminate from their products.

“These poisonous compounds offer no nutritional benefit and pose real, measurable dangers to our children’s health and development,” Department of Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement making the announcement. “That era is coming to an end.”

While phasing out artificial color dyes, the FDA has been approving natural color additives, announcing the authorization of galdieria extract blue, butterfly pea flower extract and calcium phosphate, in May.

The FDA also approved the use of a new blue color additive from the gardenia fruit on Monday.

The IDFA said the Monday commitment from U.S. ice cream makers only applies to products made with real milk sold at food retail and does not apply to products made with non-dairy ingredients or those made in-house by small ice cream shops or restaurants.

On Friday, the Consumer Brands Association announced a voluntary commitment to encourage U.S. food and beverage makers to remove certified Food, Drug and Cosmetic colors from products served in schools nationwide by the start of the 2026-27 school year.

June 18 (UPI) — The Food and Drug Administration has approved a new drug that could prevent HIV infections with just two shots every year and possibly eradicate the disease.

The drug’s scientific name is lenacapavir and it will be marketed as Yeztugo, which requires one injection every six months to maintain its effectiveness in preventing HIV infections.

Other drugs exist that also prevent HIV, but they require daily dosages in pill form and have not significantly affected the disease on a global level.

“We’re on the precipice of now being able to deliver the greatest prevention option we’ve had in 44 years of this epidemic,” AVAC executive director Mitchell Warren told the New York Times. AVAC is an anti-HIV organization.

He said recent funding cuts by the Trump administration will make it hard to distribute the drug globally.

“It’s as if that opportunity is being snatched from out of our hands by the policies of the last five months,” Warren said.

Gilead Sciences is producing the drug, which is the second long-lasting HIV prevention drug available.

The other option is cabotegravir, which is sold under the brand name Apretude and requires an injection every two months.

About 21,000 Americans use Apretude, while about 500,000 use daily oral medications to prevent HIV.

Clinical trials showed most participants who received two shots of lenacapavir every year had nearly full protection against HIV.

More than 39,000 people in the United States contracted HIV in 2023, which carries an estimated lifetime treatment cost of $1.1 million per patient, Gilead Chairman and Chief Executive Officer Daniel O’Day told the New York Times.

Lenacapavir already is being prescribed to treat people with HIV infections that resist other medications and at an annual cost of $42,000 per patient, but most patients don’t pay the full cost.

Health insurance coverage and patient-assistance programs would cover the cost for most people using lenacapavir, according to Gilead.

The cost for oral pills taken daily is just $1 per pill, while Apretude carries an annual cost of about $24,000.

Proposed funding reductions for Medicaid and the President’s Emergency Program for AIDs Relief, commonly called PEPFAR, might greatly reduce access to the drug, according to advocacy groups.

The PrEP oral treatment still would be available, but it does not work for many people, Health Gap Executive Director Asia Russell told the New York Times.

June 4 (UPI) — Food and Drug Administration Commissioner Marty Makary said he plans to review the safety of abortion drug mifepristone after a recent study raised concerns about medical side effects.

In a letter to Sen. Josh Hawley, R-Mo., Makary revealed the FDA’s plan on Monday to review the abortion pill after Hawley alerted the commissioner to the study.

“As the Commissioner of Food and Drugs, I am committed to conducting a review of mifepristone and working with the professional career scientists at the agency who review this data,” Makary wrote.

“As with all drugs, FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of early pregnancy,” Makary added.

Hawley referred the FDA commissioner to the recent study, from the Ethics and Public Policy Center, which found 11% of women experienced sepsis, infection or hemorrhaging within 45 days of taking the pill.

While Hawley said that information is listed as a side effect for mifepristone, the numbers are 22 times greater than the label warns. The study was based on insurance claims for 865,727 mifepristone abortions between 2017 and 2023.

“I’m calling on the FDA to reinstate safety regulations on the chemical abortion drug immediately. New data out today show a massive number of severe medical side effects,” Hawley said in April. “The time to act is now.”

Makary told senators during his confirmation hearing in March that he would oversee a review of mifepristone, but did not order it until Hawley alerted him to the EPPC study. The FDA commissioner did express concerns earlier this year about the Biden administration’s policy, which allowed women to access abortion drugs without making in-person appointments.

Last year, the U.S. Supreme Court rejected a challenge to the FDA’s approval of mifepristone, saying the pro-life doctors who brought the case lacked standing. The court said the Alliance for Hippocratic Medicine failed to prove they suffered any harm from the FDA’s policies.

President Donald Trump, who supported the Supreme Court’s decision, was also urged by Hawley to order a mifepristone review over the EPPC’s findings.