Tag Archive for: Food and Drug Administration (FDA)

Texas judge hears case that could ban abortion pills nationwide – National & International News – WED 15Mar2023

Texas judge hears case that could ban abortion pills nationwide.

Ohio sues Norfolk Southern over toxic derailment.

Russian warplane forces down US surveillance drone over Black Sea.

 

NATIONAL NEWS

Texas judge hears case that could ban abortion pills nationwide

A federal judge in Amarillo, TX, heard arguments today in a case brought by anti-abortion groups seeking to ban the sale of the abortion medication mifepristone nationwide. Attorneys for the Texas-based organization Alliance for Hippocratic Medicine contends that the FDA used improperly approved the drug in 2000. The group argues that the FDA and did not adequately assess its use by girls under age 18 to terminate a pregnancy.

Mifepristone is part of a two-drug regimen used to abort a pregnancy, usually before 10 weeks gestation. More than half of all abortions in the US are managed with medication. Mifepristone also has several other approved uses that have nothing to do with abortion. These include treating uterine fibroids and managing symptoms of Cushing’s syndrome.

Department of Justice attorneys defending the FDA said that mifepristone has a proven track record of being safe and effective. The DOJ also argued that the challenge comes much too late as the drug was approved 23 years ago.  The American College of Obstetricians and Gynecologists also filed an amicus brief in support of the FDA, saying mifepristone “has been thoroughly studied and is conclusively safe”.

Women’s health advocates say taking mifepristone off the market would force more women to undergo unnecessary surgical procedures. It would further overwhelm abortion clinics that are already struggling to meet the needs of women who often have to travel several states away.

Trump-appointed judge tried to keep hearing quiet

U.S. District Judge Matthew Kacsmaryk, who presided over the case, asked the attorneys involved early last week not to publicize when and where the hearing would be held. Kacsmaryk hoped to minimize press coverage and protests at the courthouse in this momentous case that could impact over 60 million women of child-bearing age in the US. The judge’s attempt to keep proceedings quiet backfired with women’s rights groups descending on Amarillo. One dressed as a kangaroo with a gavel, implying the hearing was a “kangaroo court”.

Kacsmaryk is a former Christian activist appointed to the federal bench by former Pres. Donald Trump. His court has become a venue of choice for lawsuits from numerous conservative groups. The Alliance for Hippocratic Medicine incorporated in Amarillo just three months before filing suit, which many consider a case of “court shopping”.

Kacsmaryk did not issue a ruling today after four hours of arguments. The groups bringing the suit also asked Kacsmaryk for a preliminary order halting sales of the drug while their lawsuit proceeds. Kacsmaryk ended by saying he would “issue an order and opinion as soon as possible,” possibly suggesting he’s already made up his mind about the preliminary order. In anticipation of mifepristone becoming unavailable, healthcare providers are busy lining up viable alternatives.

The next stop for the losers in Kacsmaryk’s court would be the conservative 5th Circuit Court of Appeals in New Orleans. It’s possible the case could wind up before the Supreme Court. Even if the FDA ultimately prevails, an order from Kacsmaryk halting sales of mifepristone could complicate the lives of millions of women for months (not to mention people who use mifepristone to manage other medical conditions). 

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Ohio sues Norfolk Southern over toxic derailment

The state of Ohio has filed a civil suit against the rail company Norfolk Southern over the derailment in East Palestine last month that was responsible for releasing more than a million gallons of toxic chemicals. The state is hoping to recoup the cost of the state’s costs from the disaster. The suit wants to hold the rail company financially responsible for damage to the state’s natural resources, the cost of state emergency response and economic harm to residents.

The suit refers to the East Palestine disaster as just one of a “long string” of derailments and hazardous material incidents for which Norfolk Southern is responsible. Norfolk Southern has been responsible for at least 20 derailments since 2015 involving the release of toxic chemicals, according to the filing. The state accuses Norfolk Southern of “recklessly endangering” residents and the environment, alleging multiple violations of state and federal laws regarding hazardous waste, water pollution, air pollution and common law negligence.

Communities in western Pennsylvania were also affected by the disaster which took place less than a mile the other side of their border with Ohio. Last month, Pennsylvania Gov. Josh Shapiro issued a criminal referral to his state attorney general regarding the disaster. The attorney general’s office is still investigating whether there was any criminal conduct on the part of Norfolk Southern, but no charges have been filed.

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INTERNATIONAL NEWS

Russian warplane forces down US surveillance drone over Black Sea

Yesterday, an American MQ-9 Reaper drone crashed into the Black Sea near the Crimean Peninsula, a Ukrainian territory Russia has occupied since 2014. US officials say that the crash was the result of an encounter with two Russian fighter jets. The drone became “unflyable” when one of the jets clipped its propeller. Prior to this, the jets had been dumping fuel over the drone to try to force it down. The Kremlin denies this version of events.

The US says the drone was in international airspace when the Russian jets attacked it, but Russia insists the the drone violated their (or Ukraine’s) air space. Russia claims that the presence of the drone is further evidence of direct involvement in the Ukraine war by the US military.

Both Russia and the US have announced that they’ll attempt to recover the drone. There’s a worrisome possibility of confrontation as the two sides try to get to the drone first. Joint Chiefs chair Gen. Mark Milley says he’s not sure if the drone is recoverable, claiming it sank under 4000-5000 feet of water. Milley also stressed the US has taken “mitigating measures” that would thwart Russia’s attempts to recover useful intelligence from the drone should they recover it. Defense Secretary Lloyd Austin confirmed he has communicated with his Russian counterpart Sergei Shoigu regarding the incident.

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“I earned this job”: Behind-the-scenes drama in Speaker vote – National & International News – WED 4Jan2022

 

“I earned this job”: Behind-the-scenes drama in Speaker vote.

New FDA, DOJ rules will make abortion medication more widely available.

More signs of US normalizing relations with Venezuela.

 

NATIONAL NEWS

“I earned this job”: Behind-the-scenes drama in Speaker vote

When Rep. Kevin McCarthy (R-CA) attended the first official session of the new Congress yesterday, he knew his fight to take the podium as Speaker of the House wouldn’t be an easy one. Since the November 2022 elections 8 weeks ago, McCarthy and his allies have been horse-trading and cat-herding to win over a small number of far-right Republican holdouts. He’s made several concessions, most notably a change to the rules that would allow just 5 lawmakers to call for a new Speaker vote.

In an attempt to rally the troops before the first vote, McCarthy held a closed-door meeting with Republican lawmakers. Lawmakers in the room told reporters that McCarthy told the assembly, “I earned this job. We earned this majority, and Goddammit we are going to win it today”. While McCarthy received a standing ovation, not all present were impressed. Rep. Lauren Boebert (R-CO), one of the holdouts, reportedly responded, “Bullshit!“.

There were three votes yesterday, in which each member of the narrowly-divided House was called by name and asked who they were voting for. McCarthy’s supporters seem to have gone in accepting they would lose the first vote. But surely, they thought, by the third vote, McCarthy’s opposition would have lost steam and he would prevail. Not only were they wrong about that, as the voting went on, McCarthy’s numbers got worse. 

No breakthrough

Frustrated at his losses, McCarthy led more frantic closed door meetings overnight. Speaking to NPR this morning, Rep. Dusty Johnson (R-SD) reported there were was “no breakthrough overnight” and no new concessions to the holdouts. The House will vote again at noon today.

NPR’s Steve Inskeep asked Johnson about the possibility of striking a deal with Democrats to get past the impasse. If some Democrats don’t vote, McCarthy could theoretically squeak through with a majority. But Johnson said he wasn’t eager to ask Democrats for help with this issue. The resistance to compromise or collaboration doesn’t bode well either for today’s vote or for the prospects for the next two years of this Congress.

 

FDA, DOJ set rules that will make abortion medication more widely available

The Food and Drug Administration (FDA) will now allow commercial pharmacies to carry the drug mifepristone, commonly used for medication abortions. The use of mifepristone must be followed up with misoprostol. Currently, people wishing to mifepristone drug can only do so through a healthcare provider. It will now be possible to get a prescription either in-person or through telehealth and purchase mifepristone from a pharmacy.

The change will make it easier for women living in states with abortion bans to obtain the pills from another state. However, in states (including Mississippi) which have passed abortion bans that specifically target medication abortions, the pictures is more complicated. It’s questionable whether any state can legally ban an FDA-approved medication. Despite this, many pharmacies in states that have enacted bans have stopped carrying the drugs, even though both mifepristone and misoprostol have uses that have nothing to do with abortion or even pregnancy. 

In a separate development, the Department of Justice says that the US Postal Service can legally deliver abortion pills, even in jurisdictions where medication abortion is banned. There are already pharmacies all over the country that will mail the pills anywhere in the country as long as the purchaser has a prescription. Some overseas medication providers have reported that women who weren’t pregnant were stocking up on the pills as a precaution.

Legally, the situation remains messy and complicated, and many women still have a difficult time in accessing the medication. These moves by the FDA and DOJ should at least help to remove some logistical barriers for women seeking a medication abortion.

 

INTERNATIONAL NEWS

More signs of US normalizing relations with Venezuela

During the Trump administration, the US and many of its allies adopted a preposterous diplomatic fiction regarding Venezuela. Trump declared that Venezuelan opposition leader Juan Guaidó was in fact the president of Venezuela. This was despite the fact that Venezuela already had an elected president, Nicolas Maduro. Guaidó hadn’t even run in the last congressional election. 

As ludicrous as it was, this diplomatic fiction had wide-ranging implications for Venezuela’s government and its people. For example, at the height of the pandemic, Maduro’s government wanted to sell off some of his country’s gold to purchase needed medical supplies. The National Bank of England, which was holding the gold, refused to release. This was because the British government had recognized Guaidó as Venezuela’s president.

Recently, the war in Ukraine and sanctions on Russia have force the Biden administration to look elsewhere for oil. This led to a thaw in US relations with oil-rich Venezuela. After a series of meetings between US officials as well as representatives of the Maduro government and opposition, the US allowed oil giant Chevron to resume work in Venezuela. 

Now, Venezuela’s opposition coalition has voted to dissolve its parallel government and remove Juan Guaidó as its leader. Maduro’s government and the opposition coalition recently signed a preliminary agreement to find a resolution to Venezuela’s political crisis. Maduro and the coalition also issued a joint statement requesting that foreign institutions holding billions of dollars of Venezuelan assets release them for the benefit of Venezuela’s people.

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FDA approves controversial Alzheimer’s drug – National & International News – MON 7

FDA approves controversial Alzheimer’s drug. Manchin backs watered-down voting rights protections. N Korea declares war on foreign slang, fashion.

NATIONAL NEWS

FDA approves controversial Alzheimer’s drug

The Food and Drug Administration has approved a new drug from Biogen labs for treatment of Alzheimer’s patients. Aducanumab aims to clear harmful protein buildups from the brain. In the past, other drugs have targeted these proteins, but haven’t shown any promise in either reversing or slowing cognitive decline in patients. Despite Aducanumab’s hefty price tag ($30,000-$50,000 per year), experts have criticized that it shows little more promise than its predecessors. In fact, only one study has shown that Aducanumab has any effect on slowing the progress of the disease.

Some patient advocate groups argue that any drug that has any effect on the disease, however miniscule, is worthy of FDA approval. Others fear that the FDA’s approval of Aducanumab will open the way for any drug with dubious efficacy. 

The FDA approved Aducanumab despite the less-than-enthusiastic verdict of one of the agency’s own outside panels. A survey asked the group whether the data showed the drug to be effective. The group answered “no”.

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Manchin throws weight behind watered-down voting rights legislation

Senator Joe Manchin (D-WV), now a well-established thorn in the Democratic side, has announced he will not back the Democrats’ For the People Act to protect voter rights. Instead, Manchin says he will support the competing John Lewis Voting Rights Act, which has broader bipartisan support. 

Both the For the People Act and the John Lewis Act aim to combat new voter restrictions in Republican states. The John Lewis Act would restore some provisions of the 1965 Voting Rights Act. This would include requiring federal clearance for any changes to voting laws in states with a history of racially-motivated voter restrictions. It would also require federal approval for any redistricting decisions. 

What’s the difference?

In the Shelby County v. Holder decision of 2013, the Supreme Court ended many provisions of the 1965 Voting Rights Act. There’s no question among voting rights advocates that many of these provisions need to be restored. They argue that the new laws in Republican states all over the US disproportionately impact voters of color.

However, the John Lewis Act does not include other key provisions in the more expansive For the People Act. Many see the provisions in the For the People Act as necessary steps to improving institutional election integrity.

For example, the For the People Act would require greater transparency for political campaign contributions. It would also match small-dollar donations (typically under $200) to campaigns with federal funds. This would both boost the power of individual donors, and reduce the time Congress people have to spend dialing-for-dollars while in office. By comparison, the John Lewis Act has no provisions regarding campaign finance.

The For the People Act would also direct funds to improving election security, actively curb partisan gerrymandering, and strengthen ethical oversight of elections and election laws. The John Lewis Act does none of these things.

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INTERNATIONAL NEWS

North Korea wages war on blue jeans, foreign slang and movies

Apparently distressed by young people sporting hairstyles and fashions similar to those of South Korean “K-Pop” idols, North Korean dictator Kim Jong-Un is cracking down on anything that smacks of foreign influence. North Korea has long had strict prohibitions against foreign materials, such as books and magazines, entering the country. Anyone violating these restrictions has either suffered the death penalty or incarceration in one of North Korea’s infamous labor camps. 

The restrictions are now extending to other forms of media, including movies, TV shows and music. Anyone caught possessing large amounts of such media from the US, South Korea or Japan now faces the death penalty. Those who are caught merely consuming such media face 15 years in a prison camp.

A recent open letter from Kim called on the country’s youth league to report anyone exhibiting foreign dress, using foreign slang, which Kim called “dangerous poisons”.

Lee Sang Yong, editor-in-Chief of The Daily NK (based in South Korea), says that North Korea has also passed a new law. According to Lee, the law “states that if a worker is caught, the head of the factory can be punished, and if a child is problematic, parents can also be punished. The system of mutual monitoring encouraged by the North Korean regime is aggressively reflected in this law”.

According to observers and defectors from the North, the new laws are a reaction to harder times in the Hermit Kingdom. One recent defector says “the harder the times, the harsher the regulations, laws, punishments become”. 

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First vaping death reported in Mississippi

The Mississippi State Department of Health has confirmed the state’s first vaping-related death. The death was in an individual under the age of 30. To date, Mississippi has four identified cases of serious lung injury related to vaping, all in individuals between 18 and 34 years of age. More than 800 cases have been identified nationally, with 12 deaths.

The Mississippi State Department of Health is investigating an outbreak of severe lung illness related to e-cigarette use. This investigation is part of a national outbreak of vaping-related pulmonary illness whose cause has yet to be determined.

Nation-wide, the number of vaping-related lung injury cases jumped to 805 and the number of deaths to 12, but the specific causes of the illnesses are undetermined, the Centers for Disease Control and Prevention reported Thursday.

The Food and Drug Administration said last week that it launched a criminal probe into the spike in vaping-related illnesses.The inquiry will focus on the products, where they were purchased and how they were used.

About Vaping Outbreak

  • Nationally, all reported cases have a history of e-cigarette product use or vaping.
  • Most of the cases have reported vaping cannabis products, such as tetrahydrocannabinol (THC). Many patients have reported using THC and nicotine. Some have reported the use of e-cigarette products containing only nicotine.
  • The specific cause of these lung injuries remains unknown. No single e-cigarette product, device or ingredient has been consistently identified in all cases.

Symptoms

Symptoms of severe pulmonary disease include:

  • cough
  • shortness of breath
  • chest pain
  • nausea or vomiting
  • diarrhea
  • fever
  • fatigue

Symptoms develop anywhere from over a few days of use to weeks of using e-cigarettes. If you have recently used an e-cigarette or vaping product and you have symptoms like these, see your healthcare provider.

For more information on vaping: https://msdh.ms.gov/msdhsite/_static/14,0,418.html?phr=VapingIllness

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