PHRMA

News & Analysis as of

Health Law Insights - Issue 12

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

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

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

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

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

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

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

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

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...

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

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

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

Does Invalidation of 340B Orphan Drug Rule Doom HRSA’s Guidance?

Our recent post on HRSA’s Omnibus Proposed Guidance for the 340B Drug Discount Program (Proposed Guidance) noted that since the DC District Court had yet to rule on the validity of HRSA’s “interpretive” 340B orphan drug rule,...more

Federal Court Rejects HHS Interpretation of 340B Program’s Orphan Drug Rule

On October 14, 2015, the United States District Court for the District of Columbia (the Court) issued a decision in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human...more

Updates Regarding the Pacira Pharmaceutical Inc. v. FDA Lawsuit Regarding First Amendment and Off-Label Promotion Issues

As readers of this blog know, following Amarin’s success in obtaining a preliminary injunction limiting FDA enforcement action against it for truthful, non-misleading off-label promotion of its prescription drug Vascepa,...more

Court Strikes Down 340B Orphan Drug Rule Again: Will This Impact the “Mega Guidance”?

A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Drug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when...more

Orphan Drug Ruling Disrupts the 340B Program

On Wednesday, the United States District Court for the District of Columbia issued its highly anticipated opinion regarding the 340B orphan drug litigation. The Court ruled in favor of PhRMA, a trade association that...more

Victory for Pharmaceutical Manufacturers Challenging HHS’s Interpretive Rule Covering Orphan Drugs Under 340B Program

On October 14, 2015, the United States District Court for the District of Columbia struck down an interpretive rule from HHS that limited the prices pharmaceutical manufacturers could charge for orphan drugs sold to certain...more

Trans-Pacific Partnership: Compromise on Biologics Exclusivity Unclear

Earlier this month, a final agreement was reached on the Trans-Pacific Partnership that could provide for as little as five years of exclusivity for biologics. In recent months, it was reported that the biologics exclusivity...more

Breaking News - Arizona Supreme Court to Review Watts Learned Intermediary decision

We've posted previously about the awful learned intermediary decision by the Arizona Court of Appeals in Watts v. Medicis Pharmaceutical Corp., 342 P.3d 847 (Ariz App. 2015). Well, that's not the last word anymore. Today...more

Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: BIO and PhRMA

Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted...more

Clinical Trial Data: The New Regime

The European Medicines Agency moves to increase EU clinical trial transparency. The last five years have seen a sea change in the attitude of EU authorities regarding the disclosure of clinical trial results, moving from...more

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