News & Analysis as of

PHRMA

Mayo at Five: Eligibility of Diagnostic Method Claims

by Fish & Richardson on

Just over five years ago, the Supreme Court began reshaping the concept of patent-eligible subject matter in the life sciences with its decision in Mayo v Prometheus. Decisions following Mayo – from the Supreme Court to the...more

PhRMA Comment on the FDA’s Proposed Off-label Rule: The Rule of Law is the Best Medicine

by Reed Smith on

The FDA cannot get out of its own way on the issue of off-label communications. Its power to punish off-label promotion comes from an odd regulatory two-step, whereby off-label promotions are said to prove an indicated use...more

Part III: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars

This post, Part III, of a three-part series on FDA’s interchangeability draft guidance highlights a number of open issues that stakeholders have identified in their comments to FDA....more

Chicago Proposes Pharma Rep Licensing Rules and Ethical Standards

by Dechert LLP on

The City of Chicago Commissioner of Public Health on Friday, March 17, published proposed Rules to implement the highly-publicized pharmaceutical representative licensing ordinance enacted in November 2016....more

Blog: FDA Delays “Intended Use” Final Rule until March 2018

by Cooley LLP on

Late last week, the U.S. Food and Drug Administration (FDA) announced that it was once again delaying implementation of the final rule issued January 9, 2017 related to amendments to its regulations regarding intended use...more

What a Trump Administration Could Mean for the 340B Drug Program

by K&L Gates LLP on

A Republican White House and a Republican-run Congress could bring significant changes to the 340B Drug Pricing Program (“the 340B program”). Many in Washington believe that the new administration and Republicans in Congress...more

Amicus Briefs Not So Friendly to California Supreme Court’s Dreadful BMS Personal Jurisdiction Decision

by Reed Smith on

We do a lot of grousing on this blog, but we acknowledge that there is much for which we should be thankful. This legal business permits us to keep our minds lively and our fingernails clean. Even the rotten decisions...more

FDA Will Hold Hearing on Communications Regarding Unapproved Uses

by Knobbe Martens on

The Food and Drug Administration has issued a notice announcing a public hearing on November 9 & 10, 2016 to gather input relating to companies’ communications about their medical products, with a particular focus on...more

Blog: FDA Announces Critical Off-Label Forum for Drugs and Devices

by Cooley LLP on

A notice was published today in the Federal Register regarding a two day public hearing that will be held on November 9-10, 2016 by the U.S. Food and Drug Administration (FDA) to obtain input from a wide range of stakeholders...more

Health Update - August 2016

Section 1332 Waivers: Will We See More State Innovation? - Editor's Note: In a new essay for the National Institute of Health Care Management (NIHCM), summarized below, Manatt Health examines Section 1332 waivers and the...more

Health Law Insights - Issue 12

by McCarter & English, LLP on

CMS Proposes Bundled Payments for Cardiac Care - In its most recent effort to hasten Medicare’s transformation from a fee-for-service payment model to a value-based payment model, the Centers for Medicare & Medicaid...more

Off-Label Marketing – Industry Groups Step into the Breach

by Reed Smith on

We have been waiting, literally for years, for the FDA to revise, clarify, update, or simply pay attention to, its off-label promotion regulatory position in light of repeated governmental First Amendment losses in Sorrell v....more

States’ Efforts for Drug Price Transparency Stymied by the Pharmaceutical Industry

As we previously reported, in 2015 and early 2016, bills and voter initiatives were introduced in several states that would impose drug pricing controls and transparency requirements on pharmaceutical manufacturers. Of...more

BREAKING NEWS: FDA Denies Citizen Petitions Regarding Biosimilar Labeling

by Goodwin on

FDA denied citizen’s petitions from Abbvie, the UAW Retiree Medical Benefits Trust, and the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Industry Organization (“BIO”) trade associations...more

Senate Judiciary Introduces CREATES Act To Expedite Access To Affordable Drugs

by Foley & Lardner LLP on

Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of...more

FDA Issues Interim Response to PhRMA/BIO Joint Citizen Petition on Biosimilar Labeling

by Goodwin on

As we previously reported, late last year the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Industry Organization (BIO) trade associations jointly submitted a Citizen Petition asking the FDA...more

GPhA Responds to PhRMA/BIO’s Joint Citizen Petition Regarding Biosimilar Labeling

by Goodwin on

As we previously reported, in late 2015, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Industry Organization (“BIO”) trade associations jointly submitted a Citizen Petition asking the...more

Tackling Drug Prices: CMS and PhRMA Propose Steps to Promote Value-Based Purchasing

Last week, the Centers for Medicare & Medicaid Services (CMS) and the Pharmaceutical Research and Manufacturers of America (PhRMA) released proposals to address recent criticism over rising drug prices. CMS proposed to...more

The US Biosimilars Pathway: Key Questions

In 2015, FDA issued a number of final guidance documents for biosimilars. But many fundamental questions remain unsettled and the industry awaits FDA’s guidance on labeling of biosimilars, the requirements for...more

As Urged by PhRMA and BIO, Supreme Court Agrees to Review Claim Construction Standard Used in Patent Office Trials

by BakerHostetler on

Pharmaceutical companies have reason to be pleased with the Supreme Court’s recent decision to grant a petition for a writ of certiorari in Cuozzo Speed Technologies, LLC v. Michelle K. Lee, Under Secretary of Commerce for...more

Washington Healthcare Update

by McGuireWoods LLP on

This Week: Congress unable to come to agreement on funding the government past Dec. 11 so a short-term funding bill was passed to give more time for negotiations... Tax extenders still being discussed as a vehicle for a...more

District Court in D.C. Vacates HHS’ Interpretive Rule Regarding Orphan Drug Exclusion from 340B Discount Pricing

by Arnall Golden Gregory LLP on

In what amounts to a victory for the pharmaceutical industry, on October 14, 2015, the U.S. District Court for the District of Columbia vacated the interpretive rule issued by the U.S. Department of Health and Human Services...more

340B Orphan Drug Interpretive Rule Struck Down by D.C. District Court: HHS and HRSA Lose In Second Round of Litigation Over 340B...

by K&L Gates LLP on

In an Opinion issued October 14, 2015, D.C. District Court Judge Rudolph Contreras granted Pharmaceutical Research and Manufacturers of America’s (“PhRMA”) motion for summary judgment against the U.S. Department of Health and...more

D.C. District Court Deals Blow to HHS 340B Program Interpretive Rule

by BakerHostetler on

Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more

First Amendment Notes: Amicus Briefs In Pacira & Application of IMS v. Sorrell

by Reed Smith on

Here we discuss a couple of developments involving (actually or potentially) the application of the First Amendment to the FDA’s increasingly battered prohibition against truthful promotion of off-label use....more

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