Health Care Counsel

Arent Fox's health care law blog offers news, analysis, and insights for the health care industry.

Health Care Counsel
Prescription Drug Pricing & Government Price Reporting
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FDA issued a final version of Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements

Last week, FDA issued a final version of Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements, which is available here. In this document, FDA sets forth the Agency’s expectations for parties involved in contract drug manufacturing, specifically that they delineate—in written quality agreements—each party’s roles and responsibilities to ensure compliance with FDA’s current good manufacturing practice (CGMP) requirements. The guidance applies to commercial manufacturing of human and veterinary drugs, certain combination products, biological and biotechnology products, finished products, active pharmaceutical ingredients, excipients, in-process materials and drug constituents of combination drug/device products.

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California Approves First-In-The-Nation Regulation Specifically Addressing the Threat of Workplace Violence in Healthcare Facilities

Recently, the California Division of Occupational Safety & Health Standards Board approved a new safety standard designed to provide comprehensive regulatory protections for workers exposed to workplace violence in healthcare settings. The standard, which was sponsored by several labor unions, will require covered healthcare providers to develop workplace violence prevention plans, training programs, and recordkeeping procedures to track certain incidents of workplace violence. 
 

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Prescription Drug Pricing & Government Price Reporting
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FDA Announcement on Guidance for Industry, Generic Drug User Fee Amendments of 2012

On November 17, FDA announced that it had revised, and finalized in part, Guidance for Industry, Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments, available here

The revised guidance finalizes the section of the document that pertains to user fees. (Note that FDA announced GDUFA user fees for fiscal year 2017 for Abbreviated New Drug Applications, Prior Approval Supplements, Drug Master Files, and facilities earlier this year (81 Fed. Reg. 49,225, July 27, 2016).) Questions and answers related to self-identification, review of generic drug submissions, and inspections and compliance, which appeared in earlier versions of this GDUFA Q&A guidance, will be updated and addressed in a separately issued final guidance.  

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Affordable Care Act
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Podcast: What's Next For Obamacare (Part 2)

With President-elect Donald Trump and a new Congress ready to take office in January, the US health care system has reached a pivotal moment. In particular, the overarching question facing the industry and employers across the country is what will become of President Barack Obama's signature legislation, the Affordable Care Act?

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Affordable Care Act
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Podcast: What's Next For Obamacare (Part 1)

With President-Elect Donald Trump and a new Congress ready to take office in January, the US health care system has reached a pivotal moment. In particular, the overarching question facing the industry and employers across the country is what will become of President Barack Obama's signature legislation, the Affordable Care Act?

In Part One of this Health Care Counsel podcast series, Arent Fox counsel Lanhee J. Chen, a senior appointee at the US Department of Health and Human Services during the George W. Bush administration, and Senior Government Relations Director Sonja L. Nesbit, a former Obama Administration appointee who served at HHS, discussed how they expect a Trump Administration to handle Obamacare.

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Key Issues for the California Cannabis Industry

In the wake of the legalization of cannabis in the state of California following last week’s election, it is important for businesses to take stock of several legal issues as opportunities within this burgeoning market continue to grow. Outlined below are just a few of the areas cannabis businesses in California need to be aware of to avoid legal problems down the road.

Real Estate & Land Use

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Weeding Through California's Prop 64: Employer Takeaways

This alert was originally published on Law360

On Nov. 8, 2016, California voters passed Proposition 64, the Control, Regulate and Tax Adult Use of Marijuana Act. The initiative legalizes recreational marijuana for individuals over the age of 21. It allows adults to possess, carry, share, transport and purchase up to one ounce of marijuana. The basic thrust of Proposition 64 is to decriminalize the adult use of marijuana for recreational purposes, as well as to regulate marijuana cultivation, distribution, sale and use.

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Prescription Drug Pricing & Government Price Reporting
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CMS Published the Covered Outpatient Drug Final Rule

On Monday, CMS issued a notice that, in effect, gives drug manufacturers a three-year reprieve to updating their systems to include sales in US territories in the AMP and Best Price. The government’s release about the changes that were published to Medicaid.gov can be found here.

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Affordable Care Act
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The GOP's ObamaCare Strategy Pays Off

Arent Fox’s health care counsel Lanhee Chen co-authored an article titled, “The GOP's ObamaCare Strategy Pays Off,” published in The Wall Street Journal. To read this WSJ article, click here

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Affordable Care Act, Prescription Drug Pricing & Government Price Reporting
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What the 2016 Election Means for Health Care
We expect substantial activity on issues related to health care, both in terms of individual medical insurance, entitlement programs such as Medicaid, drug pricing, stimulation of medical innovation, and possibly marijuana reforms.
 
It is not easy to predict with much certainty what Donald Trump's health care policy would look like now that he has been elected, but his statements and issue papers released by his campaign offer some insight as to his main priorities.
 
Read the full analysis here.
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ABOUT ARENT FOX LLP

Arent Fox LLP, founded in 1942, is internationally recognized in core practice areas where business and government intersect. With more than 350 lawyers, the firm provides strategic legal counsel and multidisciplinary solutions to clients that range from Fortune 500 corporations to trade associations. The firm has offices in Los Angeles, New York, San Francisco, and Washington, DC.