STAT

MAY 1, 2023

WASHINGTON — Two hospitals that refused to provide an emergency abortion  to a pregnant woman who was experiencing premature labor put her life in jeopardy and violated federal law, a first-of-its-kind investigation by the federal government has found.

Hospitals 222

Hospitals Documentation 222

STAT

AUGUST 28, 2023

Food and Drug Administration has postponed its plans to enforce a law designed to thwart counterfeit or diverted medicines passing through the pharmaceutical supply chain. The law was supposed to be fully enforced in late November, but the agency now says it will not take action until November 2024. distribution network.

Pharmaceutical Manufacturing 206

Pharmaceutical Manufacturing 206

STAT

APRIL 10, 2023

Abortion is banned in Idaho at all stages of pregnancy, but the governor on Wednesday signed another law making it illegal to provide help within the state’s boundaries to minors seeking an abortion without parental consent. Read the rest…

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STAT

JULY 6, 2023

The trade group for generic drug companies has filed a lawsuit alleging a Minnesota law that is designed to provide transparency into prescription drug pricing is unconstitutional, the latest effort to push back against states attempting to lower the cost of medicines.

Drug Pricing 188

Drug Pricing 188

STAT

MARCH 22, 2024

The Texas Medical Board, responding to pressure from the state Supreme Court and widespread uncertainty among physicians, proposed draft guidance Friday in an attempt to clarify what constitutes emergency grounds for a legal abortion.

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231

Pharmaceutical Commerce

JANUARY 29, 2024

In an interview with Pharma Commerce Associate Editor Don Tracy, Ron Lanton, Partner, Lanton Law PLLC, discusses recent moves by CVS and Express Scripts to follow Mark Cuban's drug plus model.

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STAT

SEPTEMBER 6, 2022

There is a federal law that prohibits drug companies from directly covering out-of-pocket spending by Medicare beneficiaries. But these companies are allowed to donate to independent charities that provide assistance to patients — and they can earmark donations for a condition treated by their drugs.

Drug Pricing 230

Drug Pricing 230

Pharmaceutical Commerce

MARCH 27, 2024

A study investigates how a New Mexico law can impact patients’ out-of-pocket costs surrounding mental health and substance use disorder medications.

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FDA Law Blog: Biosimilars

NOVEMBER 15, 2023

(“HP&M”) is proud to announce the firm has been selected to the 2 024 edition of Best Law Firms. Firms included in the 2024 Best Law Firms ranking are recognized for professional excellence with persistently impressive ratings from clients and peers.

Drug Development 52

Drug Development 52

FDA Law Blog: Biosimilars

MARCH 24, 2024

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. 23-92-604(c)(1), (2) (Act 1103).

Drug Pricing 59

Drug Pricing 59

STAT

JANUARY 13, 2023

law gives biologics more time before becoming subject to government price limits , Reuters explains.  The law sets a nine-year exemption period for drugs that are mainly pills, while biologics, generally injections or infusions, are protected from negotiation for 13 years. Continue to STAT+ to read the full story…

Drug Pricing 205

Drug Pricing 205

STAT

NOVEMBER 6, 2023

As weather starts to cool in much of the country, the heat-baked cement and sweaty afternoons from this summer fade from collective memory. But activists and labor groups representing outdoor workers haven’t forgotten. They are pushing lawmakers and regulators to keep facing the heat.

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PharmaState Academy

NOVEMBER 30, 2023

Laws in Pharma Marketing Quiz Learn more about “Pharma Marketing Laws ” and its pivotal role in the pharmaceutical landscape by participating in this quiz. The winner will be announced after profile verification. Once you're a winner, you will not be considered for the prizes for another two months. How to Participate?

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STAT

OCTOBER 20, 2022

After years of stops and starts, a law was finally passed in Congress this summer to address the rising cost of prescription medicines. The Inflation Reduction Act allows the federal government to negotiate prices for some costly drugs, but only a small number that cost the government the most money.

Drug Pricing 184

Drug Pricing 184

PhRMA

MAY 8, 2023

This week, Governor Holcomb signed into law Senate Bill 8 recently passed by the Indiana legislature. This new law will ensure that Indiana patients aren’t paying more for their medicines than their health insurance company or the middlemen known as pharmacy benefit managers (PBMs).

Health Insurance Companies 92

Health Insurance Companies Pharmaceutical Companies Pharmaceutical Companies 92

STAT

OCTOBER 6, 2022

Buried deep within the Inflation Reduction Act’s drug-price negotiation provisions is language that could open the way to a new era of biomedical breakthroughs and smarter health spending. This language does something Medicare hasn’t tried before: It ties payment for treatments to how well they work. Doing so used to be illegal.

Drug Pricing 240

Drug Pricing Drug Development 240

STAT

MARCH 26, 2024

It’s time to acknowledge when a law intended to right an egregious wrong has become harmful — and change it. That’s the case for a law that requires people covered by Medicaid to wait at least 30 days after signing a consent to sterilization form to actually undergo the procedure.

Hospitals 253

Hospitals 253

PharmaState Academy

DECEMBER 12, 2023

Summary for Masterclass: Applicable Laws Regarding Promotional Materials in Pharma Marketing held on 7th Dec 2023. They emphasized the importance of understanding all applicable laws and regulations to guide the development of promotional materials. NDA also discussed the amendments proposed to the DMRA and the ASCI Code.

Communication 52

Communication Hospitals Labelling 52

STAT

MAY 7, 2024

appeals court must weigh how far FDA regulations for an abortion pill go in preempting state laws that regulate the practice of medicine — a largely untested area that legal analysts say will shape abortion access , Bloomberg Law explains. On April 30, a U.S. Legal analysts predict both sides are likely to appeal the ruling.

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PharmaState Academy

NOVEMBER 27, 2023

Pharmaceutical marketing and promotion is governed under a medley of general and industry-specific laws in India. Therefore, keeping a track of legal developments, regulatory actions, and judicial precedents is key for the industry. Who should attend? Pharma Marketing, Medical, Legal, Compliance & Sales teams.

Pharmaceutical Companies 59

Pharmaceutical Companies Pharmaceutical Companies 59

STAT

APRIL 3, 2023

The patient arrived in the trauma bay with gunshot wounds to his chest and abdo­men. “Doctor, please don’t let me die today,” he begged me.

Hospitals 241

Hospitals 241

STAT

MARCH 14, 2024

Currently, Medicare is prohibited by law from covering medications for obesity treatment alone. WASHINGTON — Novo Nordisk’s newly won permission to market the heart benefits of its obesity drug Wegovy could provide a backdoor way to expand access to the drug for people on Medicare, experts told STAT.

Labelling 350

Labelling 350

STAT

MARCH 27, 2024

AstraZeneca filed a lawsuit seeking to block an Arkansas law that requires the company to ship its medicines to any pharmacy working with hospitals participating in a controversial federal discount program. As a result, AstraZeneca argued the law is illegal because it is preempted by federal law and also violates the U.S.

Hospitals 199

Hospitals Pharmaceutical Companies Pharmaceutical Companies 199

FDA Law Blog: Biosimilars

APRIL 25, 2023

Since section 524B(b) of the FD&C Act on its face does not apply to IDEs, it would seem that these recommendations are likely to remain unaltered by the new law. The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Special 510(k)s.

Documentation 105

Documentation Labelling Communication 105

STAT

MARCH 28, 2024

“Is there anybody who can sue and get a judicial ruling on whether what FDA did was lawful? And maybe what they did was perfectly lawful, but shouldn’t somebody be able to challenge that in court?” ” Alito asked the government’s lawyer. Read the rest…

Labelling 258

Labelling Drug Development 258

STAT

NOVEMBER 30, 2023

The federal law requires employers to give pregnant employees reasonable accommodations, such as getting appropriately sized uniforms or having closer parking. While pregnancy discrimination is illegal under federal and state laws, it remains an omnipresent and pernicious force in U.S.

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PioneerRx

FEBRUARY 27, 2023

The implementation of these laws can. With the opioid epidemic continuing to rage, the state of Illinois has passed legislation to combat the rise of overdoses.

Independent Pharmacies 52

Independent Pharmacies 52

STAT

NOVEMBER 28, 2023

WASHINGTON — President Biden is using a Cold War-era law to stem drug shortages by boosting domestic pharmaceutical manufacturing. Biden announced the initiative at the first meeting of his supply chain resilience council.

Pharmaceutical Manufacturing 329

Pharmaceutical Manufacturing Hospitals 329

National Association of Boards of Pharmacy

NOVEMBER 4, 2022

Of the examinations that NABP offers to gauge candidates’ readiness for pharmacy practice, the MPJE is the only one that assesses knowledge of state and federal laws and the ability to apply that knowledge in practice. However, NABP assures its members and stakeholders that law exams are here to stay. MPJE Plays a Vital Safety Role.

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FDA Law Blog: Biosimilars

MARCH 6, 2024

FDA Law Blog readers can use discount code S10-866-866L24.S As the co-founder of HP&M’s FDA Law Blog , Kurt often leads the response to new rules and regulations, sharing his interpretation with the broader legal community. More information about the conference can be found here. S for reduced registration fees.

Pharmaceutical Manufacturing 59

Pharmaceutical Manufacturing Drug Development Pharmaceutical Companies Pharmaceutical Companies 59

PharmExec

JANUARY 29, 2024

In an interview with Pharm Exec Associate Editor Don Tracy, Ron Lanton, Partner, Lanton Law PLLC, discusses recent moves by CVS and Express Scripts to follow Mark Cuban's drug plus model.

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40

STAT

MARCH 28, 2024

While the chemical is almost entirely removed during the decaffeination process, advocates say that a little-known nearly 66-year-old federal law mandates the agency ban the additive because it has been proven to cause cancer in rodents. Read the rest…

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PhRMA

APRIL 4, 2023

Recently, Arkansas became the latest state to enact a law so that many patients aren’t paying more for their medicines than their insurance company or pharmacy benefit manager (PBM).

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59

STAT

MARCH 5, 2024

Wade, declaring a Texas law prohibiting abortion, and similar laws in other states, to be unconstitutional. 22, 1973, the U.S. Supreme Court handed down its decision in Roe v. Not quite 50 years later, on June 24, 2022, the Supreme Court overturned the Roe decision. In Dobbs v.

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PharmaState Academy

SEPTEMBER 29, 2023

Can Krulak’s Law of Leadership be applied to Pharma Bangladesh and India? “ The future of a pharma company is in the hands of the medical representatives in the field, not the General Managers, the Vice Presidents, the CEOs back home.” How do you interpret Krulak’s Law to Pharma Bangladesh and India? Warding of external competition.

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STAT

FEBRUARY 23, 2024

The cyberattack and subsequent system outage within UnitedHealth’s Change Healthcare has caught the attention of federal law enforcement agencies. The severity of the attack started to become more apparent Thursday after UnitedHealth disclosed a “suspected nation-state” is behind the cyberattack, which began on Wednesday.

Hospitals 360

Hospitals 360

STAT

APRIL 30, 2024

A controversial provision of a federal law designed to speed copycat drugs to market and foster competition saved Medicare Part D nearly $15 billion from 2015 to 2021 on just 15 medicines during that period, according to a new analysis. In short, this is a so-called carve-out.

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Labelling Generic Medicine Biosimilars 222