2001, Drugs and Pharmacy - Drug Discovery Digest

State Boards of Pharmacy Missing in Action During Opioid Crisis

Policy Prescription

JANUARY 31, 2022

state boards of pharmacy to properly regulate pharmacies that irresponsibly and too often illegally profited from opioid drug sales to patients. West Virginia, sadly, is the poster child of the opioid drug crisis in the United States. Last year, the state ranked 5th in the rate of drug overdose deaths.

Pharmacy

Pharmacy Regulations Doctors Drugs

Join Us for an HPM Webinar: Recent Hospital Controlled Substance Diversion Cases — Cautionary Tales; Tuesday, October 3, 2023: 12:00-12:45

FDA Law Blog: Biosimilars

SEPTEMBER 12, 2023

More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing.

Hospitals

Hospitals Pharmacy Compliance Government

Reminder: HP&M Webinar on Recent Hospital Controlled Substance Diversion Cases — Cautionary Tales; Tuesday, October 3, 2023: 12:00-12:45

FDA Law Blog: Biosimilars

SEPTEMBER 26, 2023

More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing.

Hospitals

Hospitals Pharmacy Compliance Government

The Gig Economy, Nightwork, and Stimulant Use

Common Sense for Drug Policy Blog

JANUARY 5, 2024

Historians trace the use of coffee back to the fifth century, in the Sufi monasteries of Mocha, now known as Yemen (Weinberg and Bealer 2001 ). Studies in sports medicine attest to caffeine’s positive effects in adults, including increased endurance and strength, improved reaction time, and delayed fatigue (Graham 2001 ; Sökmen et al.

Pharmacy

Pharmacy Regulations Production Marketing

Manitoba Judge’s Opinion Reveals Different Side of the CanadaDrugs Case

Policy Prescription

MARCH 11, 2022

A recent opinion from an appeals court in Manitoba, Canada sheds new and more favorable light about the CanadaDrugs-related wholesale drug importation case that was first covered a decade ago in the Wall Street Journal. for sales of mostly misbranded (but not counterfeit drugs) and two batches of counterfeit drugs. supply chain.

Online Pharmacies

Online Pharmacies Pharmacy FDA International

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. First, nearly all psychedelics are Schedule I drugs under the Controlled Substances Act (CSA).

FDA

FDA Trials Therapies Regulations

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Agency IQ

JANUARY 26, 2024

The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste As drug shortages have made headlines over the past few years, the FDA has announced the extension of expiration dates on a variety of drug products.

Science

Science FDA Production Packaging

Article EMA Thank You New EC report dives deep to better understand shortages of critical medicines

Agency IQ

JULY 12, 2024

In response to even more acute drug shortages during the Covid-19 pandemic, the European Commission issued proposals to set up a “European Health Union” meant to address drug shortages in several ways. The non-paper also suggested three potential actions to address drug shortages.

Regulations

Regulations Production Packaging FDA

Another RICOdiculous Decision

Drug & Device Law

JULY 24, 2023

2019) (“ PATDC82 I ”), because the third-party payor (“TPP”) plaintiffs were allowed to misuse RICO to pursue what was essentially a garden variety inadequate warning case – that the drug Actos increased the risk of bladder cancer. 341 (2001). Takeda Pharmaceuticals Co. , 3d 1243 (9th Cir. Indeed, that’s what the label says.

Testimonials

Testimonials Pharmacy FDA Doctors

The FDA and Feasible Alternative Designs

Drug & Device Law

FEBRUARY 20, 2023

Drug manufacturers often could trade a little less efficacy for a little more safety, but the safest design is not always the best one. to determine whether a proposed alternative drug would have received FDA approval.” For physicians to prescribe such a safer drug, it must reach the market. Wyeth LLC , 562 U.S. 2d 506 (N.Y.

FDA

FDA FDA Approval Testimonials Vaccine

A Texas Mess

Drug & Device Law

JANUARY 4, 2024

Alabama State Board of Pharmacy , 61 F.4th Okuley’s Pharmacy & Home Medical , N.E.3d 341 (2001), and the exclusivity Buckman recognized of FDA authority over approval of the products it regulates also provide grounds for implied conflict preemption those the Complaint’s allegations. 247d-6d(b)(8). 4th 902, 905 (11th Cir.

Vaccine

Vaccine FDA FDA Approval Production

Beating FDCA-Based Negligence Per Se Claims on Non-Preemption Grounds

Drug & Device Law

OCTOBER 26, 2023

Recently, within the course of a couple of weeks, two different courts reached the same conclusion – that a plaintiff’s negligence per se claims, largely based on purported violations of the Food, Drug & Cosmetic Act (“FDCA”), failed to state a claim. 341 (2001) (a Bone Screw case). See Disarro v. 11, 2023), and Alcozar v.

Regulations

Regulations Doctors FDA Drugs

FDA’s Rules are FDA’s to Enforce

Drug & Device Law

OCTOBER 10, 2023

Plaintiff has listed its patches on the FDA’s National Drug Code (“NDC”) database. Doing so comes with obligations to comply with FDA’s labeling requirements for such OTC drugs, which Plaintiff alleges they do. The Food, Drug, and Cosmetic Act (“FDCA”) does not contain a private right of action. 341 (2001).

FDA Approval

FDA Approval FDA Pharmacy Regulations

Drug Manufacturer’s Claims Against Compounding Pharmacy Held Impliedly Preempted by S.D. Tex. Notwithstanding Fifth Circuit’s Spano Decision

Drug & Device Law

NOVEMBER 2, 2023

A court within the Fifth Circuit has held that the FDCA impliedly preempts unfair-competition and consumer-protection claims asserted by a drug manufacturer against a compounding pharmacy. Despite generally rooting for drug manufacturers, we are okay with the decision, Zyla Life Scis., Pharmacy v. 21 U.S.C. §

Compounding Pharmacies

Compounding Pharmacies Pharmacy FDA Approval FDA

Drug Discovery Digest

State Boards of Pharmacy Missing in Action During Opioid Crisis

Join Us for an HPM Webinar: Recent Hospital Controlled Substance Diversion Cases — Cautionary Tales; Tuesday, October 3, 2023: 12:00-12:45

Trending Sources

Reminder: HP&M Webinar on Recent Hospital Controlled Substance Diversion Cases — Cautionary Tales; Tuesday, October 3, 2023: 12:00-12:45

The Gig Economy, Nightwork, and Stimulant Use

Manitoba Judge’s Opinion Reveals Different Side of the CanadaDrugs Case

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Article EMA Thank You New EC report dives deep to better understand shortages of critical medicines

Another RICOdiculous Decision

The FDA and Feasible Alternative Designs

A Texas Mess

Beating FDCA-Based Negligence Per Se Claims on Non-Preemption Grounds

FDA’s Rules are FDA’s to Enforce

Drug Manufacturer’s Claims Against Compounding Pharmacy Held Impliedly Preempted by S.D. Tex. Notwithstanding Fifth Circuit’s Spano Decision

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