Fashion Counsel: Pricing Strategies and Antitrust Considerations
Pricing Strategies and Antitrust Considerations
From Business Viability and Cashflow Analysis to First Payment Rights — Restructuring and Bankruptcy Considerations for the Food, Beverage and Agribusiness Industry
In December 2023, the Food and Drug Administration (FDA) issued a final guidance, “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs,” explaining the agency’s interpretation of the...more
The U.S. Food and Drug Administration (FDA) recently published a guidance for immediate implementation, Enhanced Drug Distribution Security Requirements Under Section 582(g)(1), that provides a one-year reprieve from certain...more
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
On June 27, 2023 the FDA published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. In this draft guidance, FDA provides examples of activities prohibited...more
Ten years in the making, and full implementation is finally coming. In about a year—beginning on November 27, 2023—prescription drug manufacturers and their supply chain partners will be required to fully trace and verify...more
In one year (plus a few days, as of this writing), regulation of the U.S. drug supply chain will be historically changed. On November 27, 2023, the final phase of the Drug Supply Chain Security Act (DSCSA) goes into effect....more
The US Food and Drug Administration (FDA) has issued a proposed rule—“National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers” (Proposed Rule)—pursuant to FDA’s obligations...more
On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay...more
The US Food and Drug Administration (FDA) published its proposed rule National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers on February 4, 2022. The proposed rule sets...more
New federal regulations have been proposed that will affect licensure of wholesale drug distributors and third-party logistics providers (3PLs). The Drug Supply Chain Security Act became law in 2013. The U.S. Food and Drug...more
The Federal Trade Commission (“FTC”) issued orders under Section 6(b) of the FTC Act to nine large retailers, wholesalers, and consumer good suppliers requiring them to provide information for a study examining recent...more
Earlier in the summer, the FDA issued a quartet of guidance documents setting forth the Agency’s plan for implementing requirements under the Drug Supply Chain Security Act (DSCSA). The DSCSA directs FDA to build an...more
Host Kermit Nash, co-chair of Saul Ewing Arnstein & Lehr’s Food, Beverage and Agribusiness (FBA) Practice, speaks with Barry Chatz, a partner in the Firm’s Bankruptcy and Restructuring Practice, on a variety of financial...more
Part One - As the 2020 election nears, the Democratic campaign has begun to talk policy specifics regarding energy and climate change. Although the Trump administration undertook to dismantle many Obama-era policies and...more
During the pandemic, businesses are asking about their potential price gouging liability in states that they do not sell into directly but where their products might end up. At least one federal circuit court addressed this...more
Unchartered Waters - State price-gouging laws have come into focus in recent weeks as all 50 states have declared an emergency in the wake of the COVID-19 crisis. There is a relatively underdeveloped body of...more
Like other industries, the fashion, apparel & beauty businesses have been, and continue to be hit hard by the COVID-19 pandemic. The $400 billion dollar American fashion industry employs over four million people, excluding...more
Within the first week of the confinement measures in Europe, the Hellenic Competition Commission (HCC) was one of the first EU competition authorities to announce a more lenient approach towards certain vertical agreements,...more
During the current COVID-19 pandemic, antitrust/competition law in the EU and UK has focused primarily on competitor cooperation and price increases of certain products, such as face masks, hand sanitizer, paracetamol,...more
In a win for alcohol beverage suppliers, on Wednesday the Oklahoma Supreme Court issued an opinion in The Institute For Responsible Alcohol Policy v. State ex rel. Alcohol Beverage Laws Enforcement Comm’n. In a 5-4 ruling,...more
Missouri tied-house law, which restricts dealings between suppliers, wholesalers and retailers, is currently in flux following a recent ruling by the US District Court for the Western District, which held that several of...more
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
The FCA has outlined the current trends, risks and its overall assessment of the General Insurance sector in its 2017 Sector Views, published last week. ...more
Manufacturers must begin to comply with the Drug Supply Chain Security Act (DSCSA) serialization and verification requirements on November 27, 2017 (Compliance Date). Serialization and verification are intended to enable...more
Last week FDA published a notice of public meeting and a request for comments regarding certain aspects of the Drug Supply Chain Security Act (DSCSA). The meeting will take place on October 14, 2016 at the Agency’s campus in...more