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- Revisiting Pharma’s tariff reality
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- Listen: A Federal Agency Is After Workers’ Health Data, and Critics Are Alarmed
- Johnson & Johnson launches ‘Generation Fine’ depression project
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- GSK tees up a Modern Family for meningitis messaging
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- Pennsylvania enacts dental faculty bill
- Payer denials remain elevated, but aren’t accelerating: Tenet
- Dental industry eyes increased payer oversight, transparency: 4 updates
- Dr. Michael Durbin named president of the American Association of Orthodontists
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- Remarks at the 13th Annual Conference on Financial Market Regulation
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- Is dentistry losing its spark?
- Amazon Pharmacy to offer home delivery for Novo Nordisk's Ozempic pill
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- FDA to reconsider shock rejection of cell therapy Ebvallo. Could uniQure be next?
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Every wonder what would happen if government were in charge of healthcare?
For starters, things will go haywire.
And when they do, government predictably will step in to fix things.
According to the longform NBC News report on February 6 (clipped here for length):
... In October 2022, the FDA announced a shortage of Adderall.
Since then, doctors say other ADHD medications, such as Focalin, Ritalin and Vyvanse, have become in short supply.
As of 2022, there were 107 U.S. companies involved in manufacturing ADHD drugs, according to the market research company IBISWorld.
Drugmakers have published estimates of when the medications will be back in stock, but as they struggle with demand, those estimates have been pushed back.
Aurobindo Pharma, which makes a generic version of Adderall, for example, estimated in June that some doses of the drug would be available in December, only for the timeline to be pushed back several months, to September, according to the FDA drug shortage database. Teva Pharmaceuticals, a major manufacturer of ADHD medications, did resolve many of its Adderall shortages. However, certain doses estimated to be available in October or December have been pushed back to February or May, according to the database.
Dr. Lenard Adler, director of the adult ADHD program at NYU Langone Medical Center in New York, said about 30% to 40% of the prescriptions he writes for ADHD medications have to be rewritten because pharmacies may not have them in stock.
<clip>
Drugmakers and the Drug Enforcement Administration, which regulates controlled substances, are pointing fingers at one another for the problem, said Erin Fox, senior pharmacy director at the University of Utah Health.
Makers of ADHD drugs say they don’t have enough ingredients to make the drugs and need permission from the DEA to make more. The DEA is insisting that drugmakers have not met their quota for production and could make more of the drugs if they wanted. Adderall is a controlled substance regulated by DEA, which sets limits on how much of the active ingredient drugmakers are allowed to produce in a given time frame. Drugmakers must get approval from the DEA before they go over their quotas.
In August, the DEA and FDA issued a joint statement calling on drugmakers that do not wish to increase production to relinquish their allotment so that other drugmakers may produce more of the ADHD medications. The FDA said it was also taking steps to provide alternative treatment options.
In a bid to boost the availability of the medications, in August the FDA approved several generic versions of Vyvanse.
NBC News reached out to five of the major ADHD drug manufacturers for updates on their supplies. They didn’t respond. In addition, the DEA did not immediately respond to requests for comment.
There doesn’t appear too much else the FDA can do in the near term, experts say. In a statement, Chanapa Tantibanchachai, a spokesperson for the FDA, said the agency is working with "numerous manufacturers" and others in the supply chain to "understand, mitigate and prevent" shortages.
"The FDA recognizes the potential impact that lack of availability of certain products may have on health care providers and patients," she said.
Certain formulations of Adderall are also now more widely available, according to the FDA’s drug shortage database, however, the agency still lists the drug as being in shortage.
Dr. Sarah Cheyette, a pediatric neurologist who treats both children and adults with ADHD at the Palo Alto Medical Foundation, said January was a bad month for her patients.
Vyvanse, even with generic versions recently approved, is still hard to come by, she said; so is Ritalin and Focalin.
Patients have to go to multiple pharmacies to find their prescriptions, she said, and many pharmacies tell them they have the drugs on back order.
Dr. David Goodman, director of the Adult Attention Deficit Disorder Center of Maryland, said that for his patients, the shortage is not as “problematic” as it was several months ago, but it's not alleviated yet.
He said he has noticed that the brand name version of Adderall is more readily available, but not its generic versions.
The reason for that, he said, could be because many insurance companies exclusively cover generic versions, prompting patients to quickly get these versions as soon as they hit the market, leading to increased demand and short supply. Some insurance companies, he said, have recently started paying for the brand-name drug if patients are unable to get their hands on the generic versions....
`
Berkeley Lovelace Jr. is a health and medical reporter for NBC News. He covers the Food and Drug Administration, with a special focus on Covid vaccines, prescription drug pricing and health care. He previously covered the biotech and pharmaceutical industry with CNBC.
This week, the State of Michigan Department of Insurance and Financial Services entered the fray.
DIFS Urges Health Insurers to Support Michiganders Impacted by Ongoing ADHD Medication Shortage
FOR IMMEDIATE RELEASE: March 20, 2024
(LANSING, MICH) Michigan Department of Insurance and Financial Services (DIFS) Director Anita Fox today urged state-regulated health plans to take steps to support Michigan families impacted by the ongoing national shortage of medications used to treat attention-deficit/hyperactivity disorder (ADHD).
“Michigan families are grappling with a widespread and ongoing shortage of medications that treat ADHD, and today we are urging health insurers to take steps to assist these families,” said DIFS Director Anita Fox. “Some insurers have reduced copays or adjusted coverage tiers, and today’s bulletin urges all Michigan health insurers to exercise flexibility to help Michigan families impacted by this shortage, for example by covering alternative medications or lowering out-of-pocket costs for name brand drugs when generic options are unavailable. Additionally, insurers should take steps to ensure that pharmacies and consumers are aware of these options. Michigan families impacted by the shortage should contact their health insurer for assistance in accessing these needed medications.”
In a bulletin issued today, the Department urged insurers to exercise flexibility with coverage and cost-sharing requirements for the duration of this shortage. The bulletin applies to fully insured Michigan health insurance plans in the individual, small group, and large group markets, which includes plans sold on the Health Insurance Marketplace. Michiganders with self-funded group health plans offered by some large employers should contact their insurer or employer to understand any accommodations available to assist with this medication shortage.
Michiganders impacted by this medication shortage should first contact their insurer for assistance. For concerns that cannot be resolved directly with the health insurer, call DIFS at 877-999-6442 Monday through Friday from 8 a.m. to 5 p.m. or file a complaint online at Michigan.gov/DIFScomplaints....
And just think: they haven't even started yet on the cause of so much ADD/ADHD.
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