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FDA chief Scott Gottlieb resigning

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FDA chief Scott Gottlieb resigning

Food and Drug Administration Commissioner Scott Gottlieb is stepping down after nearly two years leading the agency’s response to a host of public health challenges, including the opioid epidemic, rising drug prices and underage vaping.

Gottlieb cited “the challenge of being apart from my family” in Connecticut when announcing his departure Tuesday in a note to FDA staff. He’ll leave next month.

President Donald Trump tapped Gottlieb in 2017 to “cut red tape” at the FDA. But Gottlieb bucked expectations by pushing the agency to expand its authorities in several key ways, including an unprecedented effort to make cigarettes less addictive by requiring lower nicotine levels.

The 46-year-old physician and former conservative pundit advanced his agenda while managing to maintain the support of the president, Republicans and key Democrats in Congress.

Still, he departs with his most sweeping plans unfinished, including the initiative to make cigarettes less addictive.

“Scott deserves very strong credit for his stance on tobacco, I only wish he would have seen some of those efforts through to fruition,” said Dr. David Kessler, who led the FDA from 1990 to 1997. “In the end you have to bring those things home.”

Harvard University professor Daniel Carpenter said Gottlieb benefited from comparisons with more unconventional, anti-regulatory Trump appointees.

“He could govern from a place of moderation and get all the more credit because so many other agencies and positions under the Trump administration were either falling apart or vacant,” said Carpenter, who has written extensively on the FDA.

In recent months, Gottlieb has come under fire for not acting more forcefully to address an explosion in teenage use of electronic cigarettes, especially those with candy and fruit flavors. Under Gottlieb, the FDA has emphasized vaping as a potential tool to wean adult smokers off traditional cigarettes. And in a widely criticized move, Gottlieb delayed key regulations on vaping devices until 2022, in part, to avoid over-regulating the industry.

Anti-smoking groups are now suing the agency to begin reviewing all e-cigarettes. While the FDA has proposed steps to keep e-cigarettes away from teenagers, including tightening restrictions on convenience store sales, it’s unclear whether they will be enough to reverse the trend.

The pushback against FDA’s approach to vaping threatens to overshadow what is by far Gottlieb’s most far-reaching plan. Gottlieb announced in May 2017 the FDA would seek to require tobacco companies to drastically cut nicotine in cigarettes, in a bid to help adult smokers quit. The agency has had the authority to regulate nicotine levels since 2009, though no previous FDA commissioner tried to use it. The agency is still in the early stages of writing regulations that would standardize nicotine in cigarettes.

Dr. Peter Lurie, a former senior FDA official under President Barack Obama, said Gottlieb embraced the agency’s regulatory powers where other Trump appointees tried to weaken their agencies.

“He tried to use its authority in an appropriate fashion,” Lurie said, noting the FDA’s recent announcements on dietary supplements and work to continue food inspections during the government shutdown.

TEXAS SCHOOL CHANGES DRESS CODE TO BATTLE TEEN VAPING EPIDEMIC

Elsewhere, Gottlieb targeted drug industry tactics used to maintain sky-high prices on older drugs, calling them “shenanigans” and “deceptions.” For decades, FDA commissioners steered clear of the issue, noting that the FDA has no direct role in regulating U.S. medicine prices, which are set by drugmakers. But Gottlieb said the agency could help spur competition and reshuffled its review procedures to speed up approvals of lower-cost generic drugs.

Early in his tenure, Gottlieb identified the epidemic of opioid abuse and overdoses as the “biggest crisis facing the nation.” But there have been few clear victories against the problem for either the FDA or the Trump administration.

Drug overdose deaths hit their highest level on record in 2017 — the most recent year for which federal data is available. Fatal overdoses are largely driven by illegal opioids including fentanyl and heroin, though the epidemic was triggered by legal prescription painkillers like OxyContin.

As FDA Commissioner, Gottlieb boosted the agency’s inspectors at U.S. mail facilities to try and intercept illegal opioid shipments from China and other nations. It’s not yet clear whether that effort has reduced drug abuse or overdose rates.

Trump tweeted that Gottlieb “has done an absolutely terrific job,” adding “he and his talents will be greatly missed.”

On FDA’s more day-to-day responsibilities, Gottlieb continued a multi-decade, bipartisan shift toward faster, more streamlined product reviews for drugs and medical devices. That issue has long been the top priority for the powerful pharmaceutical and device industries, which spend millions lobbying Congress and the federal government annually to ensure speedy market access for their products.

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FDA approvals for first-of-a-kind drugs, generic drugs and medical devices hit all-time highs last year.

Gottlieb has long been a favorite of the industry, due to his focus on cutting unnecessary regulations and speeding product approvals. He served in the FDA under George W. Bush and then spent nearly a decade as a conservative commentator at the American Enterprise Institute, while also working as a venture capitalist and industry consultant.

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Bernie Sanders’ hiring of non-American campaign advisers may violate federal election laws, complaint says

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New spokeswoman for Bernie Sanders won't be able to vote for him in 2020 -- she's an illegal immigrant

Bernie Sanders was hit a complaint this week, claiming his presidential campaign violated federal election laws by employing non-Americans in advisery positions.

A new complaint by the Coolidge Reagan Foundation filed with the Federal Election Commission (FEC) notes that three members of the Sanders campaign are foreign nationals, which appears to be a violation of federal election laws that prohibit foreign interference.

NEW SPOKESWOMAN FOR BERNIE SANDERS WON’T BE ABLE TO VOTE FOR HIM IN 2020 — SHE’S AN ILLEGAL IMMIGRANT

Maria Belén Sisa, Sanders’ deputy national press secretary who joined the campaign last month, was among the staffers named in the complaint, as first reported by the Washington Free Beacon. Sisa claims to be an illegal immigrant whose residency is protected under Deferred Action for Childhood Arrivals (DACA), an Obama-era program for assisting illegal immigrants who came to the U.S. as children.

Sisa recently caused an uproar after invoking an anti-Semitic “dual allegiance” trope of Jewish Americans while defending Rep. Ilhan Omar, D-Minn., and questioning whether American Jews, including Sanders, were loyal to the United States.

The complaint notes that Sisa not only got a salary from Sanders’ 2016 presidential campaign, she also contributed money to it and is now serving in “an advisory position” in the 2020 campaign – all of which are “direct and serious violations” of federal election laws.

“Senator Sanders and Bernie 2020 is permitting a foreign national, Ms. Sisa, to serve in an advisory position which allows her to directly or indirectly participate in the decision-making process of persons with regard to election-related activities in violation of FEC regulations,” the complaint reads.

“Senator Sanders and Bernie 2020 is permitting a foreign national, Ms. Sisa, to serve in an advisory position which allows her to directly or indirectly participate in the decision-making process of persons with regard to election-related activities in violation of FEC regulations.”

— The complaint

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According to the FEC rules, foreign nationals, who aren’t lawfully admitted permanent residents, cannot directly or indirectly participate in political campaigns. Such individuals are also barred from making political contributions.

The complaint also names two other foreign nationals on the Sanders’ 2016 campaign, immigration activists Erika Andiola and Cesar Vargas, who worked as the campaign’s national Latino outreach strategist and press secretary for Latino outreach, respectively.

“Due to the high profile of Cesar Vargas, Erika Andiola, and Maria Belén Sisa as leading activists in the undocumented community, there is reason to believe that respondents are ‘foreign nationals’ within the meaning of 52 U.S.C. § 301219b)(2), and in violation of 11 C.F.R. § 110.20 (i) and A.O. 2004-26, directly or indirectly participated in the decision-making process of persons with regard to the election-related activities of Bernie 2016,” the complaint continued.

“There is reason to believe, having previously employed Ms. Sisa, that Bernie 2020 is currently, and knowingly, permitting a ‘foreign national’ … to directly or indirectly participate in the decision-making process of persons with regard to the election-related activities of Bernie 2020.”

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The complaint calls on the FEC to investigate both the 2016 and the current presidential campaigns and take action to curb the violations.

“The Commission should determine and impose appropriate sanctions for any and all violations,” the complaint read. “Further, the Commission should enjoin respondents from any future violations and impose any necessary and appropriate remedies to ensure respondents’ future compliance with the Federal Election Campaign Act.”

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Democrats vow to keep investigating Trump despite Mueller's conclusions, no new indictments

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Congressional Democrats vowed Friday to keep investigating President Trump, his family, and associates despite Special Counsel Robert Mueller wrapping up his Russia investigation with no new indictments.

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‘There needs to be a reckoning’ for those who spread Russia collusion narrative: Mollie Hemingway

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MSNBC’s Chris Matthews livid over Mueller report: ‘How could they let Trump off the hook?’

Those who spent the last two years pushing the narrative that the Trump campaign colluded with Russia during the 2016 presidential election need to be held accountable, the Federalist senior editor Mollie Hemingway argued Friday.

Earlier in the day, the office of Special Counsel Robert Mueller handed in its report on the Russia investigation to the Department of Justice and it was announced that no new indictments would be forthcoming.

During Friday’s All-Star panel segment on Fox News’ “Special Report with Bret Baier,” Hemingway — along with Washington Free Beacon editor-in-chief Matthew Continetti and Reuters White House correspondent Jeff Mason — weighed in on the breaking news that reverberated throughout Washington.

MUELLER SUBMITS LONG-AWAITED RUSSIA PROBE REPORT TO JUSTICE DEPARTMENT

Hemingway began by noting that the “Russia narrative” predates the Mueller probe, having begun circulating during the 2016 election after the creation of the infamous Clinton campaign-funded Steele dossier, which pushed the theory that then-Republican candidate Donald Trump was a “Russian agent.”

“We have, for the last three years … frequently [witnessed] hysteria about treasonous collusion with Russia to steal the 2016 election,” Hemingway told the panel. “The fact [is] that there are no more indictments coming and the fact [is] that all of the indictments that we’ve seen thus far have been for process crimes or things unrelated to what we were told by so many people in the media was ‘treasonous collusion’ to steal the 2016 election.”

“If there is nothing there that matches what we’ve heard from the media for many years, there needs to be a reckoning and the people who spread this theory both inside and outside the government who were not critical and who did not behave appropriately need to be held accountable,” she added.

“The people who spread this theory both inside and outside the government … and who did not behave appropriately need to be held accountable.”

— Mollie Hemingway, senior editor, the Federalist

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Mason told the panel that there’s likely “some relief” in the White House, particularly from Jared Kushner, the president’s son-in-law and top adviser. And while he insisted it was “too early” to draw major conclusions, he later added that those who attacked Mueller’s credibility throughout his investigation will have to walk back their hostility if he concludes that there was no collusion, including President Trump.

Meanwhile, Continetti suggested that the Mueller report could be the “greatest anticlimax in American history,” and that the entire investigation could be “for nothing” because it was “an investigation without a crime.” He did, however, insist that the “battle will continue” as the White House will fight Congress on transparency of the Mueller findings.

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