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WASHINGTON (TIP): The United States will lift restrictions at its land borders with Canada and Mexico for fully vaccinated foreign nationals in early November, ending historic curbs on non-essential travelers in place since March 2020 to address the COVID-19 pandemic, two U.S. officials said on October 12.

Foreign visitors crossing into the United States by land or ferry will need to be vaccinated but will not necessarily need to show proof of vaccination unless they are referred by U.S. Customs and Border Patrol

The rules, which will be formally announced by Homeland Security Secretary Alejandro Mayorkas on October 13, will cover land borders and ferry crossings. They are similar but not identical to planned requirements announced last month for international air travelers, the officials said in a call with reporters.

Lawmakers from New York State praised the move.

“Since the beginning of the pandemic, members of our shared cross-border community have felt the pain and economic hardship of the land border closures. That pain is about to end,” Senate Democratic leader Chuck Schumer said in a statement.

The officials from President Joe Biden’s administration emphasized that the White House would not lift the “Title 42” order put in place by former President Donald Trump’s administration that has essentially cut off access to asylum for hundreds of thousands of migrants seeking to enter from Mexico. The precise date in early November when the restrictions will be lifted will be announced “very soon,” one of the officials said.

Canada on August 9 began allowing fully vaccinated U.S. visitors for non-essential travel.

Once the U.S. curbs are lifted, non-essential foreign visitors crossing U.S. land borders, such as tourists, will be able to visit if they are vaccinated. In early January, the United States will require essential visitors, like truck drivers, to be vaccinated to cross land borders, the officials said.

U.S. lawmakers have been pushing the White House to lift restrictions that have barred non-essential travel by Canadians across the northern U.S. border since March 2020, and many border communities have been hit hard by the closure. Mexico has also pressed the Biden administration to ease restrictions.

The White House announced on September 20 that the United States in early November would lift travel restrictions on air travelers from 33 countries including China, India, Brazil and most of Europe who are fully vaccinated against COVID-19. Foreign visitors crossing into the United States by land or ferry will need to be vaccinated but will not necessarily need to show proof of vaccination unless they are referred by U.S. Customs and Border Patrol for secondary inspections.

By contrast, all non-U.S. air travelers will need to show proof of vaccination before boarding a flight — and will need to show proof of a recent negative COVID-19 test. Foreign visitors crossing a land border will not need to show proof of a recent negative COVID-19 test. On October 8, the U.S. Centers for Disease Control and Prevention said the United States would accept the use by international visitors of COVID-19 vaccines authorized by U.S. regulators or the World Health Organization. The U.S. land border restrictions have not barred U.S. citizens from returning home.

(Agencies)

The new chemicals are called azido impurities and regulatory authorities say they’re mutagenic, meaning they can change someone’s DNA and potentially increase cancer risk

WASHINGTON (TIP): Over the past three years, millions of blood pressure pills that contain a probable carcinogen have been recalled around the world. As pharmaceutical companies have worked on finding a fix, they’ve discovered an entirely new problem: another potentially dangerous chemical is showing up in the same drugs.

The new chemicals are called azido impurities and regulatory authorities say they’re mutagenic, meaning they can change someone’s DNA and potentially increase cancer risk.

The impurities were found in blood pressure drugs which have been recalled in Canada as well as Europe earlier this year. U.S. officials helped lead the way in the 2018 recalls of the same type of drugs tainted with the probable carcinogen N-Nitrosodimethylamine, or NDMA, though they have yet to pull any for containing the azido impurities.

Meanwhile, a U.S. Food and Drug Administration inspector has found at least one large manufacturer in India, Hetero Labs Ltd., has a flawed process for controlling the impurities, according to documents reviewed by Bloomberg. Hetero also hasn’t adequately ensured a residue of impurities aren’t building up on production equipment, which can cross-contaminate subsequent batches, according to the documents.

The FDA inspector visited Hetero Labs Ltd.’s production plant in the Sangareddy district in south central India over 10 days in August. The plant makes the active ingredient for the blood pressure drug called valsartan, which it sells to other pharmaceutical companies to make a finished pill. Valsartan production can form azido impurities. The company did not respond to requests for comment.

Drug regulator Health Canada announced recalls of valsartan, a type of drug called an angiotensin II receptor blocker or ARB, in May for elevated levels of azido impurities. Over the next few months, other drugs in the same class, losartan and irbesartan, were recalled for the same impurities. Companies implicated include Sanofi, Novartis AG’s generic-drug unit Sandoz and generic-drug giant Teva Pharmaceutical Industries Ltd.

Teva also recalled ARBs in the U.K. in June followed by Sanofi in August, according to the country’s Medicines and Healthcare products Regulatory Agency. The MHRA is aware of three potential azido impurities in heart drugs, according to emailed answers to a list of questions from Bloomberg. Other European countries have also recalled ARBs containing azido impurities, including France, Switzerland and Ireland.

Sanofi recalled certain drugs containing irbesartan in Canada in June for elevated levels of azido impurities and sold some of those same drugs in the U.S., a spokesperson said in an email response to Bloomberg. The drugmaker informed the U.S. FDA and didn’t receive any further feedback, the spokesperson said.

Sanofi is close to completing testing of all batches of irbesartan-containing medicine produced between 2018 and 2020. Most have not contained levels of azido impurities above the threshold considered acceptable. The company plans to collaborate with health authorities in mid-October to propose recalls of any non-conforming batches, the spokesperson said. The impurities are a by-product of a previous manufacturing process and Sanofi’s irbesartan tested since January has not contained unacceptable levels of azido impurities, according to the spokesperson.

Sandoz originally recalled 40 batches of ARBs in Canada in May and has since recalled 49 batches of certain losartan pills there. The active ingredient for the drugs was made by another company, according to an emailed statement from a spokesperson for parent company Novartis, though the company wasn’t named.

Sanofi and Sandoz both were involved in another major recall in 2019 related to NDMA-tainted drugs that led the heartburn medication Zantac and its generics to be pulled from the market. The independent testing lab Valisure, based in New Haven, Connecticut, first discovered NDMA in the medication and flagged regulators. The active ingredient in Zantac, ranitidine, was found to form NDMA over time or when stored at high temperatures.

Zantac wasn’t the last recall related to NDMA or chemicals like it, which fall under a class called nitrosamines. Last year, the widely used diabetes drug metformin was recalled for NDMA contamination and Pfizer Inc. recalled all lots of its smoking cessation pill Chantix last month after it was found to contain a nitrosamine.

In 2018, Hetero supplied the active ingredient to some of the companies that had to pull their drugs because they contained NDMA and other similar chemicals. While the recalls started that same year, regulators and industry continued to find additional contamination from chemicals similar to NDMA in the blood pressure pills valsartan, losartan and irbesartan, resulting in recalls that stretched out over almost two years as tainted drugs were identified. The NDMA was likely formed as a part of the manufacturing process for the active ingredients, though drugmakers and regulators didn’t catch the problem for many years.  The FDA declined to address whether it has found drugs that contain azido impurities or if it anticipates any recalls in the U.S.

“We have been closely evaluating this type of impurity, working with manufacturers and foreign authorities, and will continue to investigate and monitor the marketplace and manufacturing efforts to help ensure the availability of safe, quality products for U.S. consumers,” Jeremy Kahn, a spokesman said in an email.

Hetero’s production plant in the Sangareddy district is one of the company’s 10 facilities in India registered with the FDA to help make drugs sold to the United States. It was last inspected in 2018 and received the agency’s worst classification, which means it’s likely the company would have a hard time getting FDA approval to make any new drugs there until it clears up its issues. But the agency typically allows companies with long lists of violations stemming from inspections to continue to make drugs they’re already allowed to produce at substandard plants while they work on fixing their problems. The documents also point out a material used early in the drug-making process plays a role in creating azido impurities. While Hetero’s production guidelines call for keeping that material to a certain level to avoid forming unacceptable impurity levels, the company’s study used to determine that safe level is faulty, according to the FDA documents.

The FDA, spokesman Kahn said, cannot comment on whether it would take any action against Hetero.

(Agencies)

Courts have ruled that former Presidents are afforded executive privilege in some cases

WASHINGTON, DC (TIP) It is a risky move by President Joe Biden that could come back to haunt him — and future Presidents — in the hyperpartisan world of Washington politics, a CNN report says.

Democrat Biden has agreed to a request from the Congress seeking sensitive information on the actions of his predecessor Donald Trump and his aides during the January 6 insurrection, though the former President claims the information is guarded by executive privilege. The move by Mr. Biden isn’t the final word; Republican Trump says he will challenge the requests and a lengthy legal battle is likely to ensue over the information. Courts have ruled that former Presidents are afforded executive privilege in some cases.

But the playbook for the legal world is different from the political world. And in the political world, “every time a President does something controversial, it becomes a building block for future Presidents,” said Saikrishna Prakash, a law professor at the University of Virginia who studies presidential powers. Mr. Biden’s decision not to block the information sought by the Congress challenges a tested norm — one in which Presidents enjoy the secrecy of records of their own terms in office, both mundane and highly sensitive, for a period of at least five years, and often far longer. That means Mr. Biden and future Presidents, as well as Mr. Trump.

While not spelled out in the Constitution, executive privilege has developed to protect a President’s ability to obtain candid counsel from his advisers without fear of immediate public disclosure and to protect his confidential communications relating to official responsibilities.

But that privilege has its limitations in extraordinary situations, as exemplified during the Watergate scandal, when the Supreme Court ruled that it could not be used to shield the release of secret Oval Office tapes sought in a criminal inquiry, and following the Sept. 11 terrorist attacks.

The Jan. 6 insurrection belongs among those ranks, Mr. Biden’s White House counsel wrote to the keeper of records, the Archivist of the United States. An armed mob of Trump supporters stormed the building in an attempt to stop the certification of Mr. Biden’s election victory.

“This committee is investigating a dark day in our democracy — an attempt to undermine our Constitution and democratic processes by the former President — and that context, I think, is important here, too,” White House press secretary Jen Psaki said of the congressional panel seeking the records.

The argument that the special circumstances of the attack justify the extraordinary release should guard against the erosion of executive privilege for presidencies going forward, some experts said.

“By ratcheting up how extraordinary and extreme it is, it limits the precedent going forward,” said Jonathan Shaub, an assistant professor of law at the University of Kentucky J. David Rosenberg College of Law and a former attorney-adviser in the Office of Legal Counsel in the Obama administration. But those other exceptions occurred in a pre-Trump world, where there were clear customs and norms, and generally, one set of facts. Today, a large part of the country believes Mr. Trump’s lies that he is the rightful winner of the 2020 election, even though there is no credible evidence to support his claims of mass fraud, and Mr. Trump and his allies have gone to great lengths to recast the events of Jan. 6 to make the rioters out to be warrior patriots.

If history is any guide, once the door to reviewing past Presidential records is ajar, future Congresses and Presidents could swing it open further as politics warrant.

It’s a path followed by other Washington norms in the increasingly rancorous capital. In 2013, Democrats deployed the so-called nuclear option to eliminate the filibuster that would require 60 votes to approve most Presidential appointments and nominations, but maintained it for legislation and Supreme Court picks. In 2017, when Republicans took control of Washington, they took the tactic further, and during the Trump years, they put three justices on the high court by simple majority votes.

Presidents tend to be protective of their ability to keep White House documents private, both for themselves and their predecessors. But any White House move to deny the congressional request for records on Mr. Trump’s activities could antagonize Democratic legislators just when Mr. Biden needs their support to advance his agenda.

The documents requested by the congressional committee are part of a lengthy and contentious investigation into how the Jan. 6 mob was able to infiltrate the Capitol and disrupt the certification of Mr. Biden’s presidential victory in the most serious assault on the Congress in two centuries. More than 630 people have been charged criminally in the attack, the largest prosecution in U.S. history.

Thousands of documents have been sought from the Trump administration as they try to determine how the insurrection could have happened. Many of those requests went to the National Archives, where Mr. Trump’s correspondence during his time in office is held. According to an executive order on Presidential records, the archivist of the United States “shall abide by any instructions given him by the incumbent President or his designee unless otherwise directed by a final court order”.

“Congress is examining an assault on our Constitution and democratic institutions provoked and fanned by those sworn to protect them,” White House counsel Dana Remus wrote in a letter to the archivist. “The constitutional protections of executive privilege should not be used to shield, from Congress or from the public, information that reflects a clear and apparent effort to subvert the Constitution itself.” Mr. Trump responded with his own letter to the National Archives formally asserting privilege over nearly 50 documents. Referring to the Presidential Records Act, Mr. Trump wrote, “I hereby make a protective assertion of constitutionally based privilege with respect to all additional records.” He said if the committee seeks other information he considers privileged information, “I will take all necessary and appropriate steps to defend the Office of the Presidency.”