News & Analysis as of

Pharmaceutical Industry Manufacturers

Continuous Manufacturing of Pharmaceuticals: FDA Wants to Hear from Industry

by Hogan Lovells on

Continuous manufacturing has often been highlighted by FDA as an exciting technology in the area of pharmaceutical manufacturing, but one that the Agency is still wrapping its head around. Accordingly, on June 22, 2017, FDA...more

Outsourcing in the Pharmaceutical and Life Sciences Sectors – A UK Perspective

Pharmaceutical and Life Sciences companies operate in a demanding environment and face diverse challenges such as pricing pressure, increased regulatory requirements and mounting costs. With this backdrop, they have, starting...more

Targeting Generic Drug Prices

by Blank Rome LLP on

For years, states and the federal government focused their drug pricing enforcement efforts on higher priced and more expensive branded drugs. Not surprisingly, private qui tam lawyers followed on the coattails of these...more

Fourth Circuit Punts West Virginia Innovator Liability Issue

by Reed Smith on

We have two posts on innovator liability that we update on a consistent basis: our innovator liability scorecard, and our “Innovator Liability at 100” state-by-state collection of materials that we originally compiled when...more

Filling in the Gaps on Medical Device Cybersecurity

by Hogan Lovells on

Cybersecurity has become a hot button topic for many in the medical device industry following the announcement of several high-profile medical device vulnerabilities and in light of the recent WannaCry ransomware attack that...more

Medical devices – South Africa's changing landscape

by Hogan Lovells on

Subject to certain exceptions, medical devices have historically not been heavily regulated in South Africa.  Prescriptive requirements for medical devices were not in force and advertisers and marketers of medical devices...more

Things That Make You Go Hmmm, Part II: Drug Company Plays Games With FDA To Delay Facility Inspection

by Arnall Golden Gregory LLP on

More than ten years ago, I wrote an article about a company action that invoked a memory of my then-3-year old son’s playful “The Thinker” pose. (I continue to have this picture hanging in my office now.) He would frequently...more

French ANSM Clarifies Guidance Related to Raw Materials for Pharmaceutical Use

by Jones Day on

On January 31, 2017, the French National Drug and Health Product Agency ("ANSM") issued an updated FAQ related to the authorization and declaration procedures of manufacturing, import, and distribution of raw materials for...more

Health Care Provider Insights - Introductory Edition

by Wilson Elser on

Welcome to the introductory edition of Health Care Provider Insights. We are practice management consultants, providing legal and business management advice and assistance to physicians and dentists (health care...more

EU-U.S. Agreement for Mutual Recognition of GMP Inspections Entered Into Force

by Jones Day on

On March 4, 2017, the "Decision No 1/2017 of March 1, 2017, of the Joint Committee established under Article 14 of the Agreement on Mutual Recognition between the European Community and the United States of America, amending...more

The Continuing Story of Manufacturers' Off-Label Promotion of Approved or Cleared Medical Products

by Jones Day on

Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products. On January 18, 2017, FDA published two...more

HHS Further Delays Effective Date of Final Rule for 340B Drug Pricing Program’s Drug Ceiling Prices and Civil Monetary Penalties

by King & Spalding on

On March 20, 2017, HHS issued an interim final rule further delaying until May 22, 2017, the effective date of a January 5, 2017, final rule for the 340B Drug Pricing Program that addresses the calculation of drug ceiling...more

Non-Existent Duty to Warn of Mensing Not Enough to Get Around Mensing Preemption

by Reed Smith on

Earlier this week, we discussed how the presentation of the federal question of express preemption from the face of a complaint can lead to removal. Part of why the defendant drug or device manufacturer may prefer federal...more

Blog: Compliance Date for Drug Supply Chain’s Security Act’s Serialization and Verification Requirements Quickly Approaching

by Cooley LLP on

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

Medicinal Products: the EU and the US Mutually Recognize Manufacturing Standards

by K&L Gates LLP on

The European Union (“EU”) and the United States (“US”) have reached a sectoral agreement (the “Agreement”) that will greatly ease the administrative burden when proving compliance with Pharmaceutical Good Manufacturing...more

EU - US mutual recognition of GMP inspections: agreement published

by Hogan Lovells on

On 4 March 2017, the agreement between the EU and the US governing the reciprocal recognition of GMP inspections of manufacturing sites for medicinal products for human use was published in the Official Journal of the EU:...more

FDA Is Cold As Ice As It Steps Up Foreign Inspection Enforcement

by Arnall Golden Gregory LLP on

So far, in 2017, the Food and Drug Administration’s Office of Manufacturing Quality in the Center for Drug Evaluation and Research has released fourteen Warning Letters. Of these, 100% involved manufacturing facilities...more

JPML Refuses MDL for Proton Pump Inhibitor Kidney Injury Cases

by Reed Smith on

A multidistrict litigation (MDL) can be a sound way of managing a mass tort. Efficiencies are available (e.g., deposing company witnesses only once) and the U. of Chicago part of us dreams of economies of scale. Then again,...more

U.S. FDA and EU Regulators Announce Enhanced Mutual Recognition for Pharmaceutical Manufacturing Inspections; Allows FDA to...

by Hogan Lovells on

In an effort to avoid the duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other parts of the world where there may be greater risk, the U.S. Food and Drug...more

Sixth Circuit Affirms Branded Drug Preemption and Trial Win

by Reed Smith on

In the aftermath of Levine, with its generous interpretation of the CBE regulation and its novel “clear evidence” standard, we wondered how long it would be until we saw a court holding that a failure to warn claim with a...more

Expanding Duties and Eroding Protections for Medical Device Manufacturers

Earlier this month, the Washington Supreme Court saddled medical device manufacturers with a new duty to warn under Washington law—the duty to warn hospitals about potential risks their products may pose—and eroded exemptions...more

Non-Physician Learned Intermediaries

by Reed Smith on

One of us was asked a question the other day that we couldn’t answer immediately. “Does the learned intermediary rule apply to a physician’s assistant?” We didn’t remember any cases actually deciding that issue. So we did...more

What Is “Product Liability”?

by Reed Smith on

We’re serious – we’re not planning to give a flip answer like “an extortion racket.” No, it’s more like law school, where a first-year contracts professor began with the question “What is Chicken?” (Hint – that’s discussed...more

Form Drug Distribution Services Agreements May Not Be Formulaic

by Arnall Golden Gregory LLP on

Vanilla-looking form agreements may contain or omit terms that are important to one or both parties. We were recently reminded of the danger of entering into form pharmaceutical distribution services agreements. Although...more

International Product Liability Review - Issue 65

by Hogan Lovells on

The International Product Liability Review provides quality updates and comment from around the world on legal developments in the field of product liability and product safety. Please see full Publication below for more...more

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