News & Analysis as of

Pharmaceutical Industry Suppliers

Quarles & Brady LLP

New Year, New CMS Pharmacy/DMEPOS Regulations on Refill, Deactivation, Revocation & Revalidation

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It pays to look closely. Buried deep within a 205-page and 1230-page Federal Register final rules publication, the Centers for Medicare & Medicaid Services (“CMS”) initiated impactful changes for pharmacies and Durable...more

Quarles & Brady LLP

Amidst Ongoing Manufacturer Restrictions, 340B Covered Entities and Contract Pharmacies Get Creative

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Although 340B-participating covered entities likely don’t need the reminder, numerous manufacturers continue to significantly restrict 340B pricing available via traditional “bill to/ship to” contract pharmacy models, with...more

Quarles & Brady LLP

FDA Announces Guidance for DSCSA Process to Request a Waiver, Exception, or Exemption

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On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q1 2023

On February 7, the Department of Justice (DOJ) issued a press release indicating that settlements and judgments under the False Claims Act (FCA) exceeded $2.2 billion in the fiscal year ending September 30, 2022. Of this...more

BCLP

Differentiated general terms and conditions of sale

BCLP on

Distribution: In two rulings issued on 28 September 2022, the French Supreme Court clarified the conditions under which suppliers can be held liable for failure to comply with their duty to communicate - Article L.441-1...more

Arnall Golden Gregory LLP

There Is Never a Bad Time To Audit Your Supply Chain

In late December 2021, the United States banned imports of disposable gloves produced in Malaysia by manufacturer Brightway Holdings over allegations of forced labor....more

Goodwin

Field Alert Reporting: Supplier Contracting Implications for Drug Developers

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For emerging companies establishing their first supply chains, ensuring notification requirements in supply agreements for when commercial-stage manufacturing issues arise may not be top of mind. However, it is important for...more

Knobbe Martens

Affordable Healthcare Solutions Pleads Guilty to Dealing in Non-FDA Approved Devices

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The United States Department of Justice announced that Affordable Healthcare Solutions, LLC has pleaded guilty and was sentenced to Receiving Adulterated Devices in Interstate Commerce and Delivery for Pay with Intent to...more

Hogan Lovells

FDA explains how EUA medical devices can electronically comply with AE reporting requirements

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On September 9, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance...more

Searcy Denney Scarola Barnhart & Shipley

Compounding Pharmacies -- Are Users of Finasteride for Hair Loss in Danger?

WHAT ARE THEY? Sometimes the needs of a patient are so unique that prescription medications readily available at retail drug stores are not sufficient to combat the illness or treat the condition. An example of such a...more

Troutman Pepper

Temporary FDA Policy for Compounding COVID-19 Drugs Poses Opportunities and Risks for Hospitals and Pharmacies

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With COVID-19 cases on the rise in the United States, some hospitals have faced shortages of FDA-approved drug products used to treat the disease. ...more

Hogan Lovells

Russian regulatory trends in the pharma industry in light of the outbreak of COVID-19

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The COVID-19 pandemic has impacted every industry, causing global economic changes and, consequently, extensive legislative amendments. There are no doubts that the pharmaceutical industry is the most affected. Since the...more

Morgan Lewis

CARES Act Provisions Impact Drug, Device, and Food Manufacturers and Suppliers

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The $2 trillion economic stimulus package laid out in the Coronavirus Aid, Relief, and Economic Security (CARES) Act includes $11 billion in appropriations for vaccines, therapeutics, and other medical needs, and $34.9...more

Hogan Lovells

FDA moves to increase ventilator supply

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Amid reported shortages of ventilators, accessories, and other respiratory devices resulting from the spread of novel coronavirus COVID-19, FDA issued a letter to health care providers and new guidance on 22 March 2020,...more

Hogan Lovells

COVID-19 block exemption for the healthcare sector - South Africa

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Acting swiftly to try to contain the spread of Covid-19 in South Africa, on 15 March 2020 President Cyril Ramaphosa declared a National State of Disaster. Now the government has gone further - on 19 March 2020 regulations...more

Goulston & Storrs PC

An Unintended Interruption to the Global Supply Chain

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The current outbreak of COVID-19 (the coronoavirus) will be a test of the global supply chain’s strength in the face of unintended interruptions, and can be a lesson on building-in supply-chain contingency plans.  As a result...more

Hogan Lovells

NHS medicine and device suppliers urged to carry out supply chain coronavirus risk assessment

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At the end of last week, the World Health Organisation (WHO) upgraded the global risk assessment of the novel coronavirus to "very high." This comes shortly after the United Kingdom saw its first fatality as a result of...more

K2 Integrity

Deterring the Counterfeits: Finding an Antidote for Global Businesses

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When thinking of counterfeit products, minds may wander to a person on the street selling near-authentic looking bags, sunglasses, and watches, for a fraction of the price of what would be paid at a store. But what if there...more

Robins Kaplan LLP

Financial Daily Dose 8.26.2019 | Top Story: Amgen to Pay More Than $13 Billion for Otezla

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Amgen will pay $13.4 billion in cash to buy psoriasis treatment Otezla, a deal that will “pave the way for Bristol-Myers Squibb to complete its acquisition of Celgene” by addressing “regulatory concerns over their union”....more

Carlton Fields

Court Refuses to Treat Unopposed Petition to Confirm Arbitration Award as a Motion for Default Judgment, Reviews the Merits of the...

Carlton Fields on

The case involved an AAA arbitration centering on the lack of performance under an exclusive distributorship agreement (EDA) that a medical supplier signed with a product manufacturer. The supplier failed to order sufficient...more

Holland & Knight LLP

FDA Guidance on DSCSA Product Identifier Requirements

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Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more

Hogan Lovells

USTR Requests Input on Impact of Trade Agreements on Government Procurement

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On August 21, 2017, the Department of Commerce (Commerce) and the Office of the United States Trade Representative (USTR) issued a request for public comment on the impact of government procurement provisions of U.S. trade...more

Sheppard Mullin Richter & Hampton LLP

En Banc: Federal Circuit Provides Guidance on Application of On-Sale Bar to Contract Manufacturers

Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented...more

Troutman Pepper

Federal Circuit Finds That Use of a Contract Manufacturer Does Not Trigger the On-Sale Bar Provision

Troutman Pepper on

The court’s decision provides insight into which activities trigger the on-sale bar provision. On July 11, in The Medicines Co. v. Hospira, Inc., No. 14-1469 (Fed. Cir. July 11, 2016), the U.S. Court of Appeals for the...more

Ballard Spahr LLP

Federal Circuit Limits On-Sale Bar’s Reach

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If you were concerned that outsourcing the manufacture of your invention before you filed your patent application triggered a "sale" that could put your patent at risk, you can rest easy. In The Medicines Company v....more

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