(WASHINGTON) — President Joe Biden reminded voters that the fight for women’s reproductive freedom is not over despite the Supreme Court’s decision on regulation of the abortion pill mifepristone on Thursday, which preserved access to the medication nationwide.
“Today’s decision does not change the fact that the fight for reproductive freedom continues,” Biden said in a statement. “It does not change the fact that the Supreme Court overturned Roe v. Wade two years ago, and women lost a fundamental freedom.”
The Supreme Court decision and Biden’s comments come in an election year where abortion is a key issue for many voters. Both Biden and his opponent, former President Donald Trump, have worked to address abortion as they campaign.
Biden said that although the decision means that “women can continue to access” mifepristone, he pointed to other laws to show that the fight for access to reproductive freedoms is ongoing.
“Women are being turned away from emergency rooms, or forced to go to court to plead for care that their doctor recommended or to travel hundreds of miles for care,” Biden said in the statement. “Doctors and nurses are being threatened with jail time, including life in prison, for providing the health care they have been trained to provide.”
He said that this efforts was part of an “extreme and dangerous agenda” from Republican elected officials to “ban abortion nationwide.”
“The stakes could not be higher for women across America,” Biden said.
The Biden campaign stressed that the state of abortion rights in America remains on shaky ground.
“Here’s the reality: this case, brought on by Donald Trump’s allies, was only one tactic in a broader, relentless strategy to strip away access to reproductive freedom everywhere in this country,” campaign manager Julie Chavez Rodriguez told reporters on a press call hours after the Supreme Court’s decision.
Chavez Rodriguez and Mini Timmaraju, president and CEO of Reproductive Freedom for All, stressed that a second Trump presidency would threaten reproductive rights.
“Let me be clear: this attack on medication abortion is only possible because Donald Trump overturned Roe v. Wade,” Timmaraju said, referring to the former president’s appointment of conservative justices who voted in 2022 in favor of striking down the federal protection for abortion.
Trump said in April that abortion should be decided by the states. He has not said if he personally favors a certain number of weeks into pregnancy at which state-level bans should take effect, though he has publicly criticized a six-week ban in Florida and, more recently, talked privately about the idea of a national 16-week ban with exceptions, sources told ABC News in February.
Biden also vowed that he and Vice President Kamala Harris will fight for abortion rights.
“We will continue to fight to ensure that women in every state get the health care they need and we will continue to call on Congress to restore the protections of Roe v. Wade in federal law — that is our commitment,” Biden said.
Harris said a vote for Biden is a vote for reproductive freedom.
“The contrast is stark: While Trump relentlessly attacks reproductive freedoms, President Biden and I will never stop fighting to protect them,” Harris said in a statement. “Americans have repeatedly made it clear they want more freedom, not less, and they will make their voices heard at the ballot box once again this November.”
Mifepristone is the first pill taken in a two-drug regimen for medication abortion, which is the most common method of abortion in the country.
The court’s ruling means mifepristone will remain available under preexisting conditions, which include allowing women to receive the medication by mail and without any in person dispensation requirement.
(CANADA) — A segment of the polar bear population is at risk of extinction should ice-free periods continue to get longer, researchers have determined using analysis of the sea ice as well as the health of the bears themselves.
Ice-free periods in Canada’s Hudson Bay have been lengthening over the past few decades, scientists say. Global warming is projected to extend the ice-free periods even more, reducing the ability for the region’s resident polar bear population to hunt, putting them at risk of extinction if greenhouse gas emissions continue at projected levels, a study published in Communications Earth & Environment on Thursday found.
The Hudson Bay is historically one of the few places in the Arctic where polar bears have routinely come ashore when all of the sea ice has melted, Geoff York, senior director of research and policy of Polar Bears International and co-author of the paper, told ABC News.
What used to be an ice-free period of about four months has now extended far beyond, to the point that the polar bears in the southern and western Hudson Bay have been stretched to the point of genetic adaptation and the length of time they can fast, York said. Today’s Hudson Bay polar bears are spending five weeks or longer on land than their grandparents did, York said.
Collar cameras strapped to Hudson Bay polar bears showed that the longer extents of ice-free periods are putting the Hudson Bay polar bears at risk of starvation, according to a paper published in Nature earlier this year.
Polar bears that were forced to find food on land — by foraging on berries and eating birds — lost about the same amount of weight as the bears that simply fasted, proving that to these bears, food on land had nowhere near the same amount of nutrients as seals, which are full of fat and blubber, the researchers found.
“Their primary food sources require them to be out on the sea ice,” Alex Crawford, assistant professor at the University of Manitoba’s Department of Environment and Geography and co-author of the paper, told ABC News. “So that means that if they are spending [a] longer time on land in the summer, they are spending a longer amount of time effectively fasting.”
The early disappearance of sea ice, now in the late spring and early months, occurs at the same time that pups are being born and when mother bears put on most of their fat that will get them through the winter, York said. Putting them on shore early puts them in a precarious body condition for the upcoming cold months.
“Females are going to be less successful taking a pregnancy to term,” York said. “Even if they do carry it to term, they’ll be less successful in raising those cubs in the first year.”
Between 1.6 degrees Celsius and 2.6 degrees Celsius of warming since pre-Industrial times is the range in which the Hudson Bay polar bears are expected to go extinct, Crawford said.
“That low end, we’re knocking on the door of that already,” Crawford said.
The paper brings together the latest climate models with two components that greatly affect polar bear survivability — snow depth and ice thickness — for the first time, York said. Ringed seals, polar bears’ primary source of prey, need adequate snow depth to successfully den and protect their young in the springtime.
Even when accounting for bias in the climate models, the paper’s findings were still grim, Crawford said.
Predictions made in the early ‘90s about warming impacts on polar bears are happening sooner than expected, York said.
Researchers have observed “dramatic” drops in the Hudson Bay subpopulation of up to 26% in the last decade, York said. There are only about half the number of polar bears in the population than 40 years ago.
“That decline is already kind of in progress, and if anything, I think now we’ll see it likely accelerating,” York said.
There is a chance for the sea ice to recover drastically, Crawford said.
If greenhouse gas emissions were to stop altogether, the extent of the sea ice could reverse in just a matter of years, Crawford said.
(LOS ANGELES) — Family and friends of slain actor Johnny Wactor gathered at the downtown Los Angeles site where Wactor was shot to death to push for arrests in the unsolved case.
“I’m here because one of the best men — if not the best man — I’ve ever known, was tragically and brutally taken from this earth,” Wactor’s friend, Micah Parker, said at Wednesday’s emotional news conference. “He was taken from his mother, his brothers, his extended family, his friends and his fans.”
Wactor, a former “General Hospital” actor, was shot “without provocation” around 3:25 a.m. on May 25, after he ended his shift at a bar and walked to his car, according to the Los Angeles Police Department.
He was confronted by three people who had his car “raised up with a floor jack and were in the process of stealing the catalytic converter,” police said in a statement.
Wactor was with a female co-worker, and he immediately stepped in front of her to try to protect her, according to his family and friends.
“They had a mask on and they pulled out a gun,” Wactor’s friend, Colin Flynn, told ABC News. “And from what I understand, Johnny literally stood in between himself and his colleague. And the shooter just pulled the trigger and ran away.”
In a message to the culprits, Parker vowed, “We are going to find you.”
“You do not get to terrorize our streets, stealing and killing with impunity anymore,” Parker said.
“To the LAPD, who are out there risking their lives every day, who are here with us today, I first want to say thank you,” Parker said. “But I also implore you to please — not rest, do not relent, until these three killers are brought to justice.”
Investigators “have a number of leads” in the case, Joseph Iniguez, the LA district attorney’s chief deputy, said at Wednesday’s news conference.
“We’re working with LAPD. Without commenting on the specific tools, I can tell you that the investigation is very active. We have our best lawyers on the case working with LAPD, and that’s our Major Crimes Division,” he said.
“I loved my brother,” the actor’s soft-spoken brother, Grant Wactor, added at the news conference. “It was something that none of us expected. He was 37 years old. … It hurts.”
Johnny Wactor’s family lives in South Carolina. But his friends are in LA and Grant Wactor said his family wants to make LA a safer city for them.
Parker demanded that city and state leaders protect their residents, and he led a march to LA City Hall after the news conference.
“It could’ve been one of us,” Parker said. “And it will be one of us if public safety is not prioritized in this city now.”
LA City Council member Kevin de León urged anyone with information to come forward.
“Your tip, no matter how small it may seem, could be the key to solving this case and preventing further violence,” he said.
(WASHINGTON) — The U.S. Supreme Court on Thursday ruled a group of doctors lacked legal standing to challenge the Food and Drug Administration’s regulation of the abortion pill mifepristone, preserving access to the medication nationwide.
The unanimous opinion was authored by Justice Brett Kavanaugh.
The case put abortion access back in the spotlight for the court after its conservative majority voted to overrule Roe v. Wade in 2022.
“Plaintiffs are pro-life, oppose elective abortion, and have sincere legal, moral, ideological, and policy objections to mifepristone being prescribed and used by others,” Kavanaugh wrote in the ruling. “Because plaintiffs do not prescribe or use mifepristone, plaintiffs are unregulated parties who seek to challenge FDA’s regulation of others.”
“Plaintiffs advance several complicated causation theories to connect FDA’s actions to the plaintiffs’ alleged injuries in fact. None of these theories suffices to establish Article III standing,” he concluded.
Mifepristone is the first pill taken in a two-drug regimen for medication abortion, which is the most common method of abortion in the country.
The court’s ruling means mifepristone will remain available under preexisting conditions, which include allowing women to receive the medication by mail and without any in person dispensation requirement.
Though President Joe Biden said the decision “does not change the fact that the fight for reproductive freedom continues.”
“Women are being turned away from emergency rooms, or forced to go to court to plead for care that their doctor recommended or to travel hundreds of miles for care,” Biden said in a statement. “Doctors and nurses are being threatened with jail time, including life in prison, for providing the health care they have been trained to provide. And contraception and IVF are under attack.”
The case’s lead plaintiff, the Alliance for Hippocratic Medicine, argued on behalf of anti-abortion rights doctors that those regulations were unsound. The Biden administration defended the FDA’s process in court as being supported by science and decades of safe use.
But much of the March 25 arguments centered on the question of standing, and the court concluded the pill’s challengers “failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact.”
“For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions,” Kavanaugh wrote. “The plaintiffs may present their concerns and objections to the President and FDA in the regulatory process, or to Congress and the President in the legislative process.”
Drug maker Danco, which fought to defend the pill, said the ruling was a huge win for the pharmaceutical industry which had warned against courts overriding the judgment of scientists and experts at FDA.
The court “maintained the stability of the FDA drug approval process, which is based on the agency’s expertise and on which patients, healthcare providers and the US pharmaceutical industry rely,” a Danco spokeswoman Abigail Long, said in a statement.
Abortion opponents decried the decision as “deeply disappointing.”
“It is a sad day for all who value women’s health and unborn children’s lives, but the fight to stop dangerous mail-order abortion drugs is not over,” said Susan B. Anthony Pro-Life America policy director Katie Daniel.
Alliance Defending Freedom Senior Counsel Erin Hawley, who argued before the court on behalf of the doctors, also expressed dismay that the justices did not dive into the merits of the case.
Hawley said the group “will continue to advocate for women and work to restore commonsense safeguards for abortion drugs.”
ABC News’ Alexandra Hutzler contributed to this report.
(FASANO, Italy) — G7 leaders on Thursday agreed to lend Ukraine $50 billion this year — backed by profits from frozen Russian assets — to help the country’s war effort and rebuilding.
This plan has been years in the making. It’s a win for President Joe Biden, who has been pushing allies to agree to the deal, amid hesitation from some European countries.
The agreement will be formalized in the communique at the end of the summit.
But there are still key details of the plan the countries need to work out. The U.S. is willing to make a loan of up to $50 billion, though it’s unclear exactly how much the U.S. will end up lending. Other counties will pitch in to share the risk.
“We’re going to move with urgency,” a senior administration official said on a call with reporters.
“Ukraine is still going to have a large financial need next year and beyond and this summit is our best chance to act collectively to close the gap… This agreement is a signal from the leading democracies of the world, that we’re not going to fatigue and defending Ukraine’s freedom and that Putin is not going to outlast us,” the official said.
Officials said that while it will take time for the funds to be disbursed, they do expect the money to begin to be disbursed this calendar year.
Funds will be used for military, budget, humanitarian, and reconstruction support.
When asked by reporters about the risks associated with the loans, the senior administration official said that it can be thought of as a “secured loan” because of the interest that is generated from the Russian assets. The official added that there are scenarios in which the income stream “may not flow,” but noted that reparations could be a solution.
“How are we going to get repaid? Russia pays…the income comes from the interest stream on the immobilized asset,” the official said. “The principal is untouched for now, but we have full optionality to seize the principal later if the political will is there.”
The official added that “if there is a peace settlement, either the assets stay immobilized. And keep generating interest to repay the loans or Russia pays for the damage it’s caused. Either way, there’s a source of repayment.”
When asked how the U.S. overcame pushback from some allies, the official said that the risks of this agreement outweighed the risk of Ukraine falling short on funding to counter Russia’s offensive.
“What’s the alternative? And if Ukraine was insufficiently financed, to win this war, what would be the chilling effect it would cause across Europe and the rest of the world? What would be the signal to autocrats that they can redraw borders by force? Those are the costs, I think we all agreed were unacceptable, and that’s why we acted,” the administration official said.
Republican presidential candidate former President Donald Trump and Speaker of the House Mike Johnson hold a press conference at Mr. Trump’s Mar-a-Lago estate, April 12, 2024, in Palm Beach, Fla. (Joe Raedle/Getty Images)
(WASHINGTON) — Donald Trump is making a rare appearance in Washington on Thursday to lay out his second-term agenda to Republican lawmakers as he continues to stress party unity in the wake of his historic felony conviction and a month from becoming the party’s official nominee.
The former president is just blocks away from the U.S. Capitol to attend a slate of meetings with GOP allies.
First, he is huddling with House Republicans at the Capitol Hill Club, campaign and House leadership aides confirmed to ABC News. Later, he will meet with Senate Republicans at the National Republican Senatorial Committee headquarters, where he will hold a news conference afterward.
During the meetings, campaign officials say Trump will lay out his policy plans on immigration, entitlement programs and the economy.
“Looking ahead at the policies that will save the nation such as Trump’s commitment to no impact on seniors with any cuts to Social Security or Medicare, policies that actually secure our borders and make our communities safe again, and an America first foreign policy that reclaims peace through strength and world leadership, and economic policies of lower taxes that reignite the vibrant trump economy we had just a few years ago,” a campaign official said.
Trump’s last visit with Republicans happened while he was president in September 2020, when he gave remarks at the same members-only Republican club.
Trump has stayed off the U.S. Capitol campus entirely since he left office shortly after the Jan. 6, 2021, attack. The closest he’s come is when he met the executive board of the International Brotherhood of Teamsters near the Capitol building on Jan. 31.
House Speaker Mike Johnson and Senate Minority Leader Mitch McConnell are both expected to attend the Thursday meetings between their caucuses and Trump.
While Johnson and Trump have worked together on key issues since Johnson’s rise to the speakership last fall, it will be the first time since 2020 that McConnell and Trump meet face-to-face.
McConnell and Trump have a rocky relationship, heightened after McConnell recognized President Joe Biden’s victory in the wake of Trump’s efforts to overturn the 2020 election.
McConnell, asked on Wednesday if he plans to “confront” Trump about their disagreements, dodged the question and repeated his usual support for the Republican “nominee.”
“I said three years ago, right after the Capitol was attacked, that I would support our nominee regardless of who it was — including him,” McConnell told reporters. “I’ve said earlier this year, I support him — he’s earned the nomination by the voters all across the country. And of course, I’ll be at the meeting tomorrow.”
Johnson has openly embraced Trump, who was crucial in supporting him when he faced the threat of being ousted threat by conservative GOP House hard-liners, saying coordination with Trump is important heading into November’s election and a potential second Trump presidency.
“I think it’s important for the country, to have us, to have close coordination,” Johnson said at a news conference on Wednesday. “I believe he’ll have, can be, the most consequential president of the modern era, because we have to fix effectively every area of public policy.”
At that news conference, Johnson also told ABC News he supports a bill that would allow current or former presidents to move state charges against them into federal court — a measure aimed at showing support for Trump after being found guilty in his hush money trial in a New York state court.
“I think that’s an idea that makes sense. It makes sense to most Republicans, and I think almost everyone will be in favor of that. And that’s what we’re talking about and trying to move some of this forward,” Johnson told ABC Senior Congressional Correspondent Rachel Scott.
However, not every Republican is set to fully welcome back Trump when he comes to the nation’s capital.
Sens. Susan Collins, Mitt Romney and Lisa Murkowski, who have been vocal Trump critics, have blamed previous conflicts as a reason for why they couldn’t attend the meeting with Trump.
All three voted with Republicans to impeach Trump for his actions related to Jan. 6.
The group of political meetings comes as Trump is scheduled to be in Washington D.C. to participate in a moderated discussion at a quarterly meeting of the Business Roundtable, a group consisting of more than 200 CEOs. Business Roundtable spokesman Michael Steel said the group invited both presumptive presidential nominees, but with Biden overseas to attend the G7 summit, White House Chief of Staff Jeff Zients is slated to appear.
(NEW YORK) — In a setback to Wall Street Journal reporter Evan Gershkovich, the Russian prosecutor’s office announced Thursday he will stand trial on espionage charges, officially ending any future pre-detention appeals.
“The Prosecutor General’s Office of the Russian Federation has approved an indictment in the criminal case against US citizen Evan Gershkovich,” the office said in a statement. “The criminal case has been sent to the Sverdlovsk Regional Court for consideration on the merits.”
It continued, “The investigation established and documented that the American journalist of The Wall Street Journal, Gershkovich, on the instructions of the CIA in March 2023, collected secret information in the Sverdlovsk region about the activities of the defense enterprise JSC NPK Uralvagonzavod for the production and repair of military equipment.”
Gershkovich has denied he was involved in any espionage and the U.S. State Department has declared him to be wrongfully detained.
The statement Thursday marks the first time prosecutors have publicly accused Gershkovich of working for the CIA, alleging without evidence that he was collecting “secret information” on a tank factory in the Sverdlovsk region. Gershkovich, The Wall Street Journal, the U.S. government and Gershkovich’s many colleagues all vehemently dispute he was working as a spy and say that he was doing his job as a reporter.
Gershkovich was on a reporting trip in Yekaterinburg, the capital of the Sverdlovsk region, when he was arrested in March 2023.
Previously, prosecutors have alleged Gershkovich was working for a foreign intelligence service without specifying which one.
(FORT LAUDERDALE, Fla.) — Over 2 feet of torrential rain is inundating South Florida, flooding neighborhoods, canceling flights, shutting down roads and forcing residents to evacuate their homes.
Rain totals have reached 25 inches in Collier County, 20 inches in North Miami and 19 inches in Hollywood.
Gov. Ron DeSantis declared a state of emergency for Broward, Collier, Lee, Miami-Dade and Sarasota counties.
In Broward County, Fort Lauderdale Mayor Dean Trantalis said high-water vehicles have been deployed throughout the city to respond as needed, and the Florida Fish and Wildlife Commission will be sending boats and buggies, but urged people to stay off the roads if possible.
On Thursday, the flood warnings continue from Miami to Fort Lauderdale, with an additional 4 to 8 inches of rain in the forecast.
A flood watch will last through Thursday evening for Fort Myers, Naples and Sarasota. A flood watch is in effect until Friday evening from Miami to West Palm Beach.
(NEW YORK) — The Food and Drug Administration failed to heed warning signs that there were mounting concerns with one of the nation’s largest infant formula makers, as a series of babies’ severe illnesses and whistleblower complaints began to accumulate ahead of a critical shortage in 2022, the agency’s watchdog has found.
Eventually Abbott, that formula maker, would institute a massive recall and shutdown of their plant — but by that time, the FDA’s lack of communication or sufficient oversight systems had hampered their response, according to the findings of an investigation by the inspector general of the Department of Health and Human Services.
The IG’s findings, scheduled to be released Thursday, were revealed in an exclusive interview with ABC News. The audit, announced in June 2022, assessed how the agency responsible for the safety of the nation’s food and medication supply responded to complaints of infants’ illnesses after eating formula from industry titan Abbott’s plant in Michigan — and strains of the same rare but deadly bacteria had been detected inside that facility.
“If FDA had adequate policies and procedures, it could have identified underlying problems at the Abbott facility and required Abbott to correct them,” the audit concluded. While the agency “took some action” on facility inspections and follow-up, “more could have been done leading up to” Abbott’s formula recall two years ago.
Carla Lewis, the assistant inspector general who led the investigation, told ABC News that time was critical.
“What happens when you don’t immediately address risks is that you can’t mitigate and address them timely. And that’s what we were seeing,” Lewis, Assistant Inspector General for Audit Services, said. “We know that millions of babies each year may rely on infant formula as their sole source of nutrition. So being proactive and ensuring that infant formula is safe, and working with manufacturers to produce safe infant formula, is very critical in the role that FDA plays.”
The IG probe took 17 months of fieldwork and included a review of over 1,600 files consisting of approximately 10,000 pages, Lewis said. The audit team held 19 meetings with FDA officials and made over 60 requests for documentation and information.
There were “gaps and deficiencies” in the FDA’s oversight of infant formula, Lewis said.
“Improvements in [FDA’s] inspection and recall processes are needed to better ensure the safety of the infant formula supply,” the report said, finding the agency “had inadequate policies and procedures,” or had lacked them altogether, “to identify risks to infant formula and respond effectively through its complaint, inspection, and recall processes.”
In response to the findings, the FDA said it “strongly agrees that adequate policies, procedures, and authorities are needed, and delays due to poor procedures are unacceptable and must be corrected.”
“FDA takes seriously its duty to ensure the safety of the infant formula supply, with effective policies and procedures for preventing and timely responding to foodborne illnesses and food contamination events,” noting the IG’s audit “represents a snapshot in time, and the FDA continues to make progress.”
“We are committed to implementing the OIG’s recommendations for strengthening our program,” the FDA said, adding they have already “begun several steps to improve policies and procedures for complaints, recalls, and infant formula inspections.”
Abbott agreed to temporarily shutter their Sturgis, Michigan, facility in mid-February 2022, prompted by contamination concerns and the hospitalization of four infants diagnosed with a rare bacterial infection, Cronobacter sakazakii. Two of the babies ultimately died.
The FDA said it could not conclusively confirm that Abbott products caused the infants’ illnesses or deaths — something the company has also maintained. But the impact of that recall ricocheted from coast to coast, leaving a serious void in the market and forcing families to face empty shelves and scramble for alternatives. The report found that more could have been done ahead of time to potentially soften that impact.
Coming as it did amid other supply chain problems connected with the COVID-19 pandemic, the formula recall plunged many American families into crisis mode and prompted serious questions from policymakers and the public about whether a communication breakdown at the agency had abetted a sluggish response to the growing problem.
The FDA “did not have adequate policies and procedures” for crucial oversight systems, the IG’s report found — mechanisms meant to identify risks to infant formula, such as whistleblower and consumer complaints red-flagging issues.
A whistleblower complaint was sent by email to the FDA in mid-February 2021, alleging Abbott’s facility had violated laws, regulations and other guidance that FDA administered and enforced. But it took “more than 15 months” for the agency to identify that whistleblower’s warning — or forward it to an office that could investigate it, HHS-OIG’s audit found.
At that time, the IG was told by agency officials that there was no one permanently in the role responsible for “identifying and accounting for whistleblower complaints” that came in over email, the report said. Those duties were “covered” by other people who also had “other responsibilities,” and one of them “inadvertently archived the February 2021 whistleblower complaint” without forwarding it for investigation. FDA officials only identified that complaint more than a year later.
“FDA did not have adequate policies and procedures to identify and investigate the February 2021 Abbott facility whistleblower complaint,” the audit determined – even when those complaints came to the “dedicated FDA email inbox” set up to receive them.
And when it came to whistleblower complaints, IG’s report found, FDA “did not develop an organizational structure or assign responsibilities to enable the organization to operate in an efficient and effective manner.”
The FDA “implemented new whistleblower complaint procedures” a few days after the first complaint was finally forwarded in June 2022, the report said, adding, “although we did not audit the effectiveness of the complaint procedures that FDA adopted in June 2022, if effectively implemented they should assist in identifying and accounting for whistleblower complaints.”
A second whistleblower complaint came in October 2021, sent by hardcopy via courier to seven senior FDA employees and additionally emailed to multiple relevant regulatory personnel, including those at the office responsible for investigating complaints, who “acknowledged receipt of the email,” the audit said. But it took nearly four months for that complaint to get to FDA leadership, including the top brass at food policy and response, who were notified in mid-February 2022.
“Without whistleblower complaint escalation policies and procedures, FDA senior leadership was unable to make informed decisions to minimize risks related to the Abbott facility and the infant formula supply chain,” the report said.
Amid scrutiny over their process in May of that year, the FDA released a “timeline of infant formula related activities” which admitted that a second whistleblower complaint wasn’t received by FDA leadership “due to an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues.”
“That whistleblower complaint was sent by Fed-Ex, hard copies, to multiple individuals in multiple offices, so that means it would’ve been lost at multiple offices,” FDA’s former Deputy Commissioner for Food Policy and Response Frank Yiannas said at a March 2023 congressional hearing.
“Some individuals received copies by emails and in hindsight, those should have been escalated to my office very rapidly,” said Yiannas, who just months before, had resigned from the agency.
In an interview with ABC News in April, Yiannas reflected on the lack of communication he grew frustrated with during his FDA tenure.
“I was just surprised that something like that hadn’t been elevated,” Yiannas said of the monthslong mislaid whistleblower report, noting the issues at Abbott had already been brewing for months by the time he “found out about the series of events” ensuing.
“One of the reasons I decided that it was time for me to leave the agency in the current posture that I was in, it was a very decentralized organization with a culture of very siloed mentalities,” Yiannas said. “A culture of silos is always a dangerous culture. There was this idea of accountability without responsibility. And we need some structural change.”
The IG audit stresses the need for clear communication, noting FDA’s own investigators tasked with inspecting formula facilities weren’t always armed with the most current and relevant information — such as new complaints from consumers coming in.
For example, it detailed that the FDA began an inspection at Abbott’s facility on September 20, 2021, and while that investigator had reviewed the plant’s consumer complaint history beforehand, on that very day, a new consumer complaint was entered into the system: “an infant who was diagnosed with a Cronobacter infection after consuming infant formula manufactured at the Abbott facility.”
But the FDA’s personnel “reviewing the new consumer complaint were not aware of the inspection taking place at the Abbott facility and did not communicate the complaint to the investigator” during the week of Abbott’s inspection, the report continued — so “the investigation team conducting the inspection at the Abbott facility was not informed of the new consumer complaint until after the inspection closed.”
The FDA found sanitation issues at Abbott’s Sturgis plant in September 2021, according to an inspection report previously obtained by ABC News. By January 2022, the FDA had received three of what would ultimately grow to four complaints from consumers of infants getting sick with cronobacter “potentially associated” with Abbott’s formula. By mid-February, the FDA had collected samples at the plant confirming the presence of Cronobacter in the environment, according to their timeline. Though the agency has not been able to definitively link the illnesses or deaths to the facility, Abbott agreed to voluntarily recall their products and cease production.
Lewis said they were “very concerned” when they began to realize what their probe was finding.
“Because we were seeing vulnerabilities in FDA carrying out its policies and procedures to oversee infant formula,” Lewis said, “and just overall, their engagement to ensure that risks were being mitigated and addressed.”
In the wake of the 2022 formula debacle, the FDA has overhauled their foods program, aiming to strengthen their oversight and unify the division.
Some of the actions they’ve taken include conducting their own review of their infant formula response; establishing an Office of Critical Foods, like formula; beginning steps to improve their policies for complaints, recalls and infant formula inspections; and developing policies for how and when to conduct timely mission-critical inspections — even during public health emergencies.
Outlining his agency’s overhaul in January 2023, FDA Commissioner Robert Califf told ABC News that “we really believe that with the reorganization, the system of safety and inspections will be much more preemptive.”
“We hope that with the information that we’ve shared with FDA, and the actions that they’re going to take – that the public, the American people, can build trust in terms of the infant formula that they’re buying for their babies,” Lewis said.
“There will always be risks,” Lewis added. “The key is to mitigate those risks.”
Singer songwriter Usher walks through the Rayburn Room outside of House Minority Leader Hakeem Jeffries’ office at the Capitol Building in Washington, D.C., June 12, 2024. (Anna Moneymaker/Getty Images)
(WASHINGTON) — Eight-time Grammy award winner Usher Raymond made a surprise appearance on Capitol Hill Wednesday, urging lawmakers to make Medicare’s Diabetes Prevention Program more accessible to Americans.
“Today, just talking about type 1 diabetes and early screening for type 1 diabetes,” Usher, the Super Bowl LVIII performer, told ABC News after his meetings.
Usher’s son, Cinco, was diagnosed with type 1 diabetes (T1D) in 2014. Before leaving, Usher acknowledged the issue was personal to him.
“Yeah, I’ve been able to share my story today. Hopefully, you’ll get a chance to hear more about it,” he said.
According to the Centers for Disease Control and Prevention, Type 1 diabetes was once called insulin-dependent or juvenile diabetes, and it often develops in children, teens, and young adults, but it can happen at any age.
The CDC said the disease is thought to be caused by an autoimmune reaction.
“This reaction destroys the cells in the pancreas that make insulin, called beta cells,” the agency wrote on its website. “This process can go on for months or years before any symptoms appear.”
Usher was first spotted riding the Senate Subway with Georgia Sen. Raphael Warnock — then the Capitol press corps went on the hunt for the pop icon.
He made his way over to the House side, meeting with House Minority Leader Hakeem Jeffries and other lawmakers as a mix of reporters and staffers congregated outside of the meeting. They patiently waited for a selfie as minutes turned to hours.
At one point, emerging from the meeting in his tan suit, undershirt, and signature shades, Usher said, “I had a great time here in D.C.,” when asked about his conversations with lawmakers.
Throughout the day, the music superstar met with lawmakers in both chambers about the SCREEN for Type 1 Diabetes Act — introduced on Tuesday and led by Reps. Kim Schrier, Diana DeGette, John Joyce, and Gus Bilirakis in the House and Sens. Jeanne Shaheen and Susan Collins in the Senate. The act aims to increase public awareness of the disease, including early detection of type 1 Diabetes.
“He has a family relationship with the issue and he’s decided to speak out to raise awareness and I’m very, very grateful to him for doing that,” Rep. DeGette said after the meeting broke.
Her legislation is supported by the American Diabetes Association, American Heart Association, and the American Medical Association, according to a release from DeGette.
Prior to leaving the Capitol, Usher shared his plan to continue fighting for the cause in the future.
“It was my first time [up here] but it won’t be my last,” he said.
