DEA Shuts Down Drug Factory Even as Adderall Shortage Persists

“For more than a year, the U.S. has experienced a shortage of Adderall, the medication used to treat attention-deficit/hyperactivity disorder (ADHD). Now, while continuing to deny its own role in the shortage, the federal government is making the problem worse by threatening manufacturers that could help ameliorate the crisis.
In October 2022, the Food and Drug Administration (FDA) announced a shortage of amphetamine mixed salts, Adderall’s primary ingredient. The announcement noted that manufacturers were “experiencing ongoing intermittent manufacturing delays” and it anticipated that the shortage could last until March 2023.

As Reason has reported since the FDA’s first announcement, the Drug Enforcement Administration (DEA) imposes production caps on Schedule I and II narcotics. Each year, drug manufacturers apply for a piece of the overall quotas. Even after a spike in demand during the COVID-19 pandemic, the DEA did not lift the production quotas on the ingredients used to make Adderall or its equivalents.”

“In April 2022, Ascent submitted its annual quota applications for 11 total drugs, but instead of a speedy approval, the company was subjected to a DEA audit.

Investigators pored over Ascent’s books and identified discrepancies that indicated sloppy record keeping. For its part, the company admitted to committing infractions, though the details seem needlessly petty: In one example, “orders struck from [DEA forms] must be crossed out with a line and the word cancel written next to them,” Walsh wrote. “Investigators found two instances in which Ascent employees had drawn the line but failed to write the word.”

The audit forced Ascent to shut down production at its facility on Long Island, near New York City; company officials told New York that this constituted 600 million annual doses that it is unable to produce. It began laying off workers after more than a year in regulatory limbo.

Ascent sued in September 2023, seeking an injunction “compelling DEA to respond, to Ascent’s applications for quotas.” The DEA quickly denied all of Ascent’s quota applications, saying that it “lacks confidence in the data provided by Ascent in its quota requests” but giving no specifics.”

“It’s entirely possible that Ascent did keep shoddy records, and perhaps it did misplace doses of drugs like opioids or stimulants that are ripe for abuse (allegations that the company denies). But the DEA’s policy of artificially constraining the supply of those drugs continues to harm those patients who actually need them.”

https://reason.com/2024/02/26/dea-shuts-down-drug-factory-even-as-adderall-shortage-persists/

The RSV shot shortage isn’t just a supply problem

“It’s more complicated to fix the fragmented US health care system that creates big barriers to Beyfortus access for some kids, O’Leary said. That system is structured such that many pediatricians have to take huge financial risks to keep Beyfortus in stock. For patients who get care at those practices, access will likely be a little touch-and-go until demand also stabilizes and pediatricians can better forecast how much to stock.
Why is it so risky for some pediatricians to stock certain immunization products?

It has to do with who’s paying for the products, and how much they cost. Pediatric vaccines are paid for and distributed in the US through two main mechanisms. About half of American kids get vaccines paid for by the federal government through a program called Vaccines for Children, or VFC. The program’s goal is to ensure cost isn’t a barrier to vaccinating kids, so eligibility is restricted to kids who are Medicaid-eligible, under- or uninsured, or American Indian or Alaska Native.

The other half of American kids get vaccines paid for by private insurance companies, but only after the pediatrician administers it. What insurance companies pay for each vaccine isn’t always enough to cover its full cost, and the pediatrician often doesn’t know how much an insurance company will pay them for a vaccine until after the fact.

This setup means ordering any vaccine is somewhat of a financial risk to pediatric practices. But because most vaccines are relatively cheap, and because their familiarity to most parents makes demand relatively predictable, the risk is relatively small.

The math is totally different for Beyfortus, though: One dose costs a doctor’s office nearly $500 — and as a totally novel immunization, its popularity was hard to forecast. “For a medium-sized practice, they might have to spend $250,000 to cover their patient population,” O’Leary said. “And that is not money they have lying around.””

“A universal vaccination program that made vaccines available across the lifespan, free of charge, would be wonderful, O’Leary said, and it’s what other industrialized countries like Canada and the United Kingdom do. “But that’s not where we are,” he said.”

https://www.vox.com/2023/10/25/23931321/rsv-beyfortus-nirsevimab-shortage-supply-vfc-vaccines-for-children-respiratory-syncytial-virus

Gazans turn on Hamas as food shortage fuels disorder

“Desperate Palestinians have begun attacking Hamas security forces as tensions grow in Gaza over chronic shortages of food, water and medicine.
In rare acts of defiance, Gazans hurled rocks at Hamas police who tried to jump a queue for water”

https://www.yahoo.com/news/gazans-turn-hamas-food-shortage-120846775.html

Tariffs on Baby Formula Returned. So Did the Shortages.

“When supply chain issues caused a baby formula shortage last year, Congress (eventually) cut tariffs to help get more formula onto American store shelves.
It worked! Imports of baby formula soared during the second half of 2022 after tariffs and other regulations were lifted. Stores reported lower out-of-stock rates and news stories about panicked parents being unable to feed their infants abated. In short, the government removed economic barriers and the market solved the problem.

Then, the government put those barriers back in place. On January 1, the tariffs on baby formula returned. Now, so has the crisis.

“It’s getting harder and harder” to find baby formula, pharmacy owner Anil Datwani told Fox News this week. “[Mothers] go from one store to the next store to the next store” looking for baby formula.

Meanwhile, some consumers are complaining on social media that prices for baby formula have suddenly spiked and availability is once again a problem. A Forbes investigation into a recent increase in the price of Enfamil baby formula noted that the increases “follow the expiration of the U.S. government’s suspension of infant formula tariffs in January, which opened the door for formula (both foreign and U.S.-produced) to become more expensive.” (Another contributing factor: Reckitt Benckiser, the British-based company that owns the Enfamil brand, issued a recall in February affecting about 145,000 cans of formula.)

Because that’s what tariffs do, of course. They are import taxes that protect domestic industries at the expense of domestic consumers, who are subjected to limited supply and higher prices as a trade-off for industrial protectionism.”

Why does the WeWork guy get to fail up?

“The housing shortage is certainly a big deal. The US was short nearly 4 million housing units as of late 2020, and the problem is spreading across the country. The inability to buy a home has huge repercussions on everything from Americans’ quality of life to their ability to create wealth. The problem is big enough that venture capital firm Andreessen Horowitz (a16z) is writing its biggest check to date — $350 million, valuing the company at $1 billion — to invest in Flow with the hope that the company can disrupt residential real estate through technology.”

‘Enormous’ fertilizer shortage spells disaster for global food crisis

“A global fertilizer crunch is threatening to further starve a planet that’s already going hungry.
Officials at the United Nations and beyond are stepping up warnings about the mounting crisis for fertilizers — an essential substance to boost soil fertility — as vulnerable countries in areas such as Africa grapple with prices that have soared by 300 percent since Russia’s war in Ukraine began.

The continent, where smallholder farmers feed the majority of people, is already lacking 2 million metric tons of fertilizer, according to the African Development Bank. The high price of fertilizers will mean less food at a time when people need it most, with more frequent bouts of extreme weather and the Ukraine war still leaving import-dependent countries insecure. Farmers in Europe are feeling similar strains, though to a lesser degree.”

“Making fertilizers is an energy-intensive process, especially for nitrogen-based fertilizers, which use natural gas as an essential ingredient. That means the price of fertilizers tends to correspond with energy costs.

“The increased price is [a] burden for all farmers in the world, but the burden is even higher for those farmers in developing countries that have less financial capacities and organisation to purchase the fertilisers than the European ones,” an EU official wrote to POLITICO.”

“Fertilizer prices were high even before Russia invaded Ukraine, which prompted a further 50 percent spike, according to the European Commission.

The war in Ukraine has exacerbated the problem because of Russia’s outsized role in the world fertilizer market. It’s the world’s top exporter of nitrogen fertilizers, the second largest supplier of potassium and the third-largest exporter of phosphorus fertilizers.

Since its invasion of Ukraine in February, shipping costs and energy prices have gone up. Europe’s fertilizer producers now warn of shortages if the Continent’s imports of natural gas from Russia continue to fall.”

Hospitals struggle with staff shortages as federal Covid funds run out

“Hospitals across the country are grappling with widespread staffing shortages, complicating preparations for a potential Covid-19 surge as the BA.5 subvariant drives up cases, hospital admissions and deaths.

Long-standing problems, worker burnout and staff turnover have grown worse as Covid-19 waves have hit health care workers again and again — and as more employees fall sick with Covid-19 themselves.”

San Francisco Legalizes ‘Missing Middle’ Housing in the Worst Way Possible

“There’s a clear lesson emerging from the first cities that have legalized “missing middle” housing. The more rules you lift on the construction of these two-, three-, and four-unit homes, the more you’ll actually see built.
San Francisco politicians have absorbed this information and are now using it for evil. On Tuesday, the San Francisco Board of Supervisors passed an ordinance theoretically legalizing fourplexes in the city’s lowest density neighborhoods, but only under conditions that will ensure almost none of this housing actually gets built.”