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Abortion drug advocated for restrictions

Jason Robinson on April 24, 2023

Abortion — An anti-abortion organization petitioned the Supreme Court on Tuesday to keep limits on the abortion drug mifepristone in place while the pill’s legality is debated.

Supreme Court Justice Samuel Alito temporarily relaxed the restrictions on Friday at 11:59 p.m. The date is Wednesday.

The decision was taken as a reaction to an emergency request from the Justice Department and Danco Laboratories, the corporation in charge of distributing mifepristone.

The Justice Department and Danco both requested the Supreme Court to expedite its assessment of the case and make a conclusion before the summer vacation.

The Supreme Court, which has a conservative 6-3 majority, may rule on the issue.

The Comstock Act

If the case is considered, the Alliance Defending Freedom group has petitioned the Supreme Court to examine the Comstock Act of 1873.

Mifepristone mailing is practically prohibited under the Act.

If the complaint is heard, the anti-abortion organization will urge the court to investigate whether the FDA lawfully allowed mifepristone in 2000.

Mifepristone is frequently used with another medication, misoprostol.

In the United States, it is the most prevalent technique of terminating a pregnancy, accounting for more than half of all abortions.

If lower court findings against mifepristone are upheld, abortion access might be restricted, perhaps affecting areas where abortion is still legal.

The ADF

The Alliance Defending Freedom (ADF) is a conservative Christian legal group created in 1994 to promote religious liberty, human life sanctity, and traditional marriage and family values.

ADF has defended individuals who allege their religious liberty has been infringed in a number of high-profile cases in the United States and across the world.

The organization offers legal advice and representation to people and groups and has been involved in abortion, marriage equality, and religious freedom disputes.

Many conservative and religious organizations have lauded the group’s efforts, while detractors accuse it of supporting discriminatory and exclusionary policies.

FDA accusation

Attorneys for Alliance Defending Freedom accused the FDA of improperly decreasing mifepristone limitations over time.

The Alliance for Hippocratic Medicine, a collection of anti-abortion physicians, is represented by the organization.

Former FDA officials, the pharmaceutical industry, 23 states in the United States, hundreds of members of Congress, and major medical organizations have all officially disputed the allegations.

The FDA decided that mifepristone was both efficacious and safe after a rigorous scientific assessment.

When Congress authorized it, the deduction for drug control fell under its purview.

Former FDA officials and large pharmaceutical companies cautioned the Supreme Court in a second brief that lower court verdicts will drastically limit the FDA’s regulatory authority and hamper research, development, and investment in innovative therapies.

Suspension and blockade

Judge Matthew Kacsmaryk of the United States District Court for the Northern District of Texas ruled earlier this month that the FDA’s approval of mifepristone, as well as subsequent FDA attempts to improve access to the medicine, were illegal.

However, the US 5th Circuit Court of Appeals upheld the FDA authorization while rejecting aspects of Kacsmaryk’s judgment.

Instead, they reinstated limitations on mifepristone use and distribution.

The appeals halted the mailing of mifepristone, requiring them to seek medical attention.

It also extended the period during which women may use the medicine, extending it until the seventh week of pregnancy.

Furthermore, in 2019, the Circuit halted the approval of GenBioPro’s generic mifepristone.

Availability

For the time being, Supreme Court Justice Samuel Alito has overruled lower court findings, authorizing the administration of mifepristone.

Others, though, were upset with the choice.

The Alliance Defending Freedom’s attorneys, under Erik Baptist’s leadership, argued:

“Women will still have access to chemical abortion drugs under the same restrictions that existed for the first 16 years of mifepristone’s use.”

“The only effect of the lower court’s order is to restore a modicum of safety for the women and girls who use the drug, including supervision and oversight by a physician.”

Lower court rulings

In their emergency petitions to the Supreme Court, the Justice Department and Danco contended that the lower court rulings would effectively pull mifepristone off the market for months, despite the fact that the FDA would merely change the medication’s labeling to conform with the 5th Circuit’s judgment.

The lawsuit and lower court judgments have been highly disappointing, according to US Solicitor General Elizabeth Prelogar.

It would also have far-reaching consequences for the pharmaceutical business, women’s health, and the FDA’s approval power.

The government also claimed that complying with the appeals court verdict would violate a competing court order issued by Judge Thomas Rice of the United States District Court for the Eastern District of Washington.

Rice has prevented the FDA from limiting mifepristone supplies in 17 states, including Washington, DC.

Drug shortages persist across the US as pharmacy shelves remain empty

Jason Robinson on December 19, 2022

…

Customers are searching pharmacies around the United States as demand surges due to drug shortages.

Due to the shortage of popular prescription drugs like Adderall and amoxicillin, pharmacies are compelled to restrict the number of pills they sell.

Another justification for travel by parents of unwell kids is the quest for over-the-counter medications.

Shortages

Drug shortages, according to experts, are not uncommon.

They assert that although it usually happens more quietly, it occurs regularly in the US.

David Margraf, a pharmaceutical research scientist from the Resilient Drug Supply Project at the University of Minnesota’s Center for Infectious Disease Research and Policy, said:

“Shortages hit a lot of different patient populations with different drugs and whatnot, but many of those don’t get a lot of headline news because they’re very niche.”

The reason for the empty shelves can vary based on the place and the drug at any given time because every shortage has its own unique causes.

“They’re all a different tale,” said Margraf.

“There’s commonalities between them, but each one is a little bit different, and it’s very tedious trying to figure out what’s going on sometimes.”

Factors

Drug shortages are frequently problematic since there aren’t enough economic incentives to develop them.

However, availability may also be impacted by a scarcity of ingredients, labor issues, or production delays.

Despite being a global leader in developing novel therapies, the US nevertheless depends on other countries for the production of its medications.

Bindiya Vakil claims that imports from China and India account for a large portion of the raw ingredients required to make new drugs.

Vakil is the CEO of Resilinc, a company that tracks supply chains and maps them to notify clients as soon as danger arises.

Disruptions in China or India could have a cascading effect on goods supplies (such as a work stoppage at a Chinese firm because of its recently relaxed zero Covid policy).

Despite normal product levels, the current cold and flu season in the US may make it difficult for families to find what they need due to high demand.

Reports

Several groups around the nation are tracking drug shortages.

The nonprofit American Society of Health-Systems Pharmacists represents hospital pharmacists.

It keeps track of claims of drug shortages in the US and verifies the information by getting in touch with manufacturers.

Nonprofit organizations define drug shortages as issues with the supply that affect how a pharmacy prepares or dispenses pharmaceuticals or that have an impact on patient care if doctors are obliged to use alternatives.

Data from the American Society of Health-Systems Pharmacists show that as of late September, there were 260 active drug shortages, down from the 264 shortages reported in the second quarter of 2022.

Two hundred eighty-two active shortages were present in the second quarter of 2019, which was close to the record high.

The FDA keeps an eye on drug shortages and receives information directly from manufacturers.

However, it defines shortages differently.

Pharmaceuticals are said to be in short supply when all commercially available goods are insufficient to meet the current demand.

Additionally, shortages occur when a legitimate alternative producer cannot meet present or future demand, keeping patients in the dark.

According to the FDA, there are currently fewer drugs in limited supply than there were in 2011 when there were 251.

They kept an eye on 41 drug shortages in 2021.

Three hundred seventeen shortages were averted that year.

To address the “persistent problem” of medicine shortages, the FDA formed a task force in 2019.

It could be challenging to resolve when they occur because some situations last for years.

For instance, the demand for Adderall surged considerably between 2020 and 2021.

Leading manufacturer Teva attributed the delays to a lack of laborers.

But the problem has since been resolved.

Because Adderall is a controlled substance, it is governed by tight government laws.

The Drug Enforcement Administration imposes manufacturing limitations to prevent patient misuse.

According to David Margraf, Adderall shortages are anticipated to last until 2023.

Vulnerability

Typically, generic medications that run out are affordable injections.

They have strict production requirements, which makes them expensive to produce.

Additionally, because of their lower profit margins, firms find it less viable to produce them.

Some generics, like antibiotics, are vulnerable to shortages, though.

Researchers claim that the problem recently affected a few amoxicillin formulations.

Companies generally produce generic pharmaceuticals on demand rather than keeping stock on warehouse shelves.

Several manufacturers claim that the 2022 orders did not cover the increased demand.

Even when companies become aware of scarcity, manufacturing and shipping different products takes weeks or months.

Senior Director Vimala Raghavendran works for the US Pharmacopeia (USP), a nonprofit group that sets high standards for the following:

Dietary supplements
Food
Medications

“Really, it comes down to economics,” offered Raghavendran.

USP has tracked pharmaceutical supply chains for the past three years using its Medicine Supply Map to identify and stave off potential shortages.

“Antibiotics are 42% more likely to be in shortage compared to other classes of drugs,” said Raghavendran.

“They have lower price points, so there’s less incentive for manufacturers to invest in excess capacity.”

“And then you throw in an unexpected shock, like a demand increase because of the surge in RSV and the flu and Covid, and the supply chain is not able to absorb that shock.”

Staying ahead

There are systems and backup plans in place to avoid drug shortages.

If there is an interruption in the supply or production of medicine, manufacturers are required to inform the FDA.

It frequently makes it possible for the business to avoid problems.

However, companies are not currently required to alert the FDA to increased demand.

“But that’s something we’re really encouraging companies to do,” said an official.

“Let us know if there’s a spike in demand so that we can work with them early on, just as they can with supply disruptions.”

Drug shortages are a primary priority for the Biden administration, according to the White House.

The government highlighted the executive order on America’s supply chains that President Joe Biden signed in February of the prior year.

It instructed the secretary of the Department of Health and Human Services to identify and record risks in the supply chain for pharmaceuticals and their active ingredients and make recommendations for reducing those risks.

Reference:

Empty pharmacy shelves shine a light on vulnerabilities in US drug supplies

Flavored tobacco banned in California, stores required to add warning signs

Edward Anderson on December 13, 2022

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Flavored tobacco: On Monday, the Supreme Court denied a request by RJ Reynolds to challenge a California law banning the sale of flavored tobacco products.

RJ Reynolds Tobacco Company

RJRT (RJ Reynolds Tobacco Company) is the second-largest tobacco company in the United States.

The company’s cigarette brands account for over a third of the country’s cigarette sales.

RJRT offers products in all segments of the cigarette market and manufactures many of the best sellers in the United States, including:

Newport
Camel
Snus
Pall Mall

The ban

In November, voters overwhelmingly approved Proposition 31.

It bans the sale of most flavored tobacco products, including menthol cigarettes.

Menthol cigarettes are one of the company’s biggest sellers, and RJRT has argued that the new California law conflicts with tobacco control law.

The Tobacco Control Act provides authority for the federal Food and Drug Administration to regulate the sale of cigarettes.

The court first passed the law two years ago.

However, the tobacco companies successfully funded a campaign blocking its implementation and raised the issue in the 2022 statewide vote.

The judges upheld the law without explanation or opinion from the public.

The ban will take effect on December 21.

The law

In November, Californians went to the polls to approve the ballot initiative by a majority of 63.5% to 36.5%.

The law, SB 793, states:

“Proposition 31 (SB 793) prohibits in-person stores and vending machines from selling most flavored tobacco products or tobacco product flavor enhancers.”

“The proposition does not ban shisha (hookah) tobacco sold and used at the store, certain cigars, or loose-leaf tobacco.”

Additionally, the law defines flavors as anything beyond the regular flavor of tobacco., including:

Fruit
Menthol
Honey
Chocolate
Vanilla

The law imposes a $250 fine on store and vending machine owners who violate the requirements.

Arguments

Lawyers for RJ Reynolds argued that the lower court wrongly ignored federal law and allowed states to ban the sale of flavored tobacco products outright because they failed to meet tobacco product standards.

Further, the attorneys noted that in 2009, Congress passed a sweeping regime to divide tobacco product regulatory powers between the FDA and state and local governments.

They also said the law gives the FDA primary authority to regulate tobacco products.

During the legal briefs, California urged the judiciary not to interfere in the dispute.

They argued that states had exercised their authority to protect the health of their citizens for more than a century.

California attorney Rob Bonta said the law was needed, saying:

“Flavored tobacco products are the central cause of unfavorable trends in youth addiction to tobacco.”

Bonta also pointed out that the tobacco industry spent tens of millions of dollars persuading voters to repeal California’s ban, which it did not.

Furthermore, the attorney said that when Congress passed the Tobacco Control Act 13 years ago, it protected established state authority over selling tobacco products.

California ban conclusion

Following the ban on flavored tobacco products, attorney Bonta applauded the Supreme Court for rejecting Big Tobacco’s recent attempt to block California’s common sense ban.

“The voters of California approved this ban by an overwhelming margin in the November election, and now it will finally take effect,” said Bonta.

“I look forward to continuing to defend this important law against any further legal challenges.”

Health warning signs

Last week, the Justice Department announced that cigarette manufacturers would be required to post warning signs at retail locations about the health effects of smoking.

The ordinance will come into effect on July 1, 2023.

It is the latest in a long line of court-ordered actions in a 1999 lawsuit against cigarette manufacturers.

Past lawsuit

The order stems from a 1999 lawsuit filed in the District of Columbia by a coalition of anti-tobacco and public health advocacy groups.

This led to a ruling that cigarette manufacturers were misleading consumers about the health risks of smoking.

Since 2017, similar health warnings have appeared in newspapers, television, cigarette packs, and company websites.

The order

The Justice Department order requires the following brands of cigarettes to show the signs for two years.

Philip Morris USA Inc
RJ Reynolds Tobacco Company
Four cigarette brands under the ITG Brands

Associate Attorney General Vanita Gupta released a statement, writing:

“Justice Department attorneys have worked diligently for over 20 years to hold accountable the tobacco companies that defrauded consumers about the health risks of smoking.”

The signs

The ordinance requires retail signs to have an eye-catching design that includes warnings such as:

“Smoking cigarettes causes numerous diseases, and on average 1,200 American deaths every day.”

“The nicotine in cigarettes is highly addictive, and that cigarettes have been designed to create and sustain addiction.”

According to the Justice Department, the order applies to more than 200,000 outlets in the United States that have merchandising agreements with cigarette manufacturers.

References:

Supreme Court declines to block California’s ban on flavored cigarettes

Supreme Court upholds California ban on flavored tobacco

Cigarette companies ordered to display health warning signs at retailers