Pharmaceutical Industry

News & Analysis as of

FDA Unveils Action Plan to Combat Opioid Abuse

The U.S. Food and Drug Administration (“FDA”) recently announced a “far-reaching action plan” to evaluate and improve the agency’s prescription opioid policies. The announcement came amidst public criticism and mounting...more

What the Administration Actually Can Do on Drug Pricing

The President’s budget makes clear for all to see that the Administration wants to do something related to drug pricing. Unfortunately for the Administration, most of their proposals require Congressional authority that have...more

Alert: 340B Self-Audits: The Best Defense Is A Good Defense

Federally qualified health centers (FQHCs) participating in the 340B Drug Pricing Program (the “340B Program”) are subject to audits by Health Resources and Services Administration (HRSA) and the drug manufacturers who...more

FDA Panel Shows Strong Support for a Remicade Biosimilar

The Food and Drug Administration’s (FDAs) Arthritis Advisory Committee gave a thumbs up to a biosimilar copy of Johnson & Johnson’s Remicade product, an inflammation blocker used in the treatment of rheumatoid arthritis, on...more

Deciphering the Final AMP Rule – Key Provisions Impacting Pharmacies, PBMs, and Manufacturers

In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”). The rule creates the regulatory definition for...more

Health Alert (Australia) - February 8, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: South Australia 28 January 2016 - Inquest into the death of Ebony Simone Napier The South Australian Coroner has...more

Pharmaceutical Life Cycle Management: Navigating the New IP, FDA and Antitrust Terrain

Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of administration and treatment indications. In addition, negotiation of...more

District Court Refuses to Enjoin State From Pursuing Claims That Fell Within Terms of Prior Class Settlement Agreement and Release

The court in In re Flonase Antitrust Litigation, No. 08-3301, 2015 WL 9273274 (E.D. Pa. Dec. 21, 2015) recently held that it could not enjoin the state of Louisiana from pursuing claims that, on their face, fell within the...more

Seventh Circuit Knocks Out Claims Against Generic Manufacturer on Preemption Grounds

It is not often that we get the opportunity to discuss an opinion from a panel of judges including two former professors from our law school. Diane Wood is the Chief Judge of the 7th Circuit and taught us Civil Procedure at...more

Competition/antitrust law

Focus on the US - Cartel enforcement activity and stiffer criminal penalties against price fixing - The Department of Justice (DOJ) continues to investigate and seek criminal charges against worldwide cartels. This...more

Blog: Heath Provisions in President’s Budget Take Aim at Drug Prices and Opioid Abuse

Today, the President sent Congress the $4 trillion Fiscal Year 2017 Budget Proposal – his last while in office. While the Budget on the whole is dead on arrival in the Republican-controlled Congress, there are provisions...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

Injunctive Relief Claims Lead to Defense Opportunities

It’s not all that common, but every now and then our opponents feel their oats and seek injunctive relief – usually against the continued marketing of an FDA-approved product. A state-law plaintiff seeking such injunctive...more

AbbVie Submits Citizen Petition on Interchangeable Biosimilars

AbbVie, Inc., a biopharmaceutical company, has submitted a citizen petition to the FDA regarding determinations of interchangeability under the BPCIA. An interchangeable biological product is biosimilar to a reference...more

Disneyland Bingo – SEC FCPA Settlement Points to Disneyland (Again)

In planning that trip to promote your products and to qualify under the FCPA affirmative defense of reasonable and bona fide expenditures, whatever you do, DO NOT take any foreign officials to Disneyland. On February 4, 2016,...more

Catching up on developments posted on the blog

Some quick updates on stories I have been following: SENTENCING FOR DEADLY PAIN-MEDS DOC: An Orange County, CA., physician has been sentenced to 30 years to life imprisonment. She was convicted of murder for her...more

Blood on the Tracks Hits No. 1 and the Lessons Learned from SciClone

On this week in 1975, Bob Dylan’s 15th studio album, Blood on the Tracks, reached the Number 1 album slot on the Billboard charts. This was in spite of no song rising above the 31st slot on the single charts. It came out in...more

Arizona Supreme Court Adopts Learned Intermediary Doctrine

The Arizona Supreme Court has issued an opinion adopting the learned intermediary doctrine in Arizona. The Supreme Court rejected the Arizona Court of Appeals’ earlier decision holding that the learned intermediary doctrine...more

The US Biosimilar Pathway: What’s Ahead

2015 was a landmark year for biosimilars. It began with the approval of the first US biosimilar, Sandoz’s Zarxio, in March 2015 under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Zarxio entered the US...more

CMS Finalizes Long-Awaited Covered Outpatient Drug Rule

The Centers for Medicare & Medicaid Services (“CMS”) recently issued a final rule implementing provisions of the Patient Protection and Affordable Care Act of 2010 (“ACA”) that pertain to Medicaid reimbursement for covered...more

California-Based Pharmaceutical Company Settles with SEC Regarding FCPA Offenses in China

On February 4, the SEC settled FCPA allegations with a California-based pharmaceutical company with a cease and desist order finding that the company violated the FCPA’s anti-bribery, books and records, and internal controls...more

SciClone Pharmaceuticals: A Textbook Case of FCPA Violations for Gifts, Meals, Entertainment and Travel

The Securities and Exchange Commission continues its steady march as the prominent FCPA enforcement agency against corporations.  The Justice Department has not brought any enforcement actions this year and continues to...more

Behind the Curtain: Shkreli was NOT the Big Story on the Hill Today

Congress’s complex relationship with prescription drugs was on display today in the House of Representatives. In the House Committee on Oversight and Government Reform (OGR), Martin Shkreli pleaded the 5th at a hearing...more

Final WHO Biosimilar Naming Proposal Resembles FDA Approach

On January 26, 2016, the World Health Organization (WHO) unveiled the final version of its proposal for a worldwide biosimilar naming convention. The WHO proposes to add a “biologic qualifier” (BQ), which consists of four...more

Drug Manufacturer Discount Cards: Accept With Caution

Pharmaceutical manufacturer discount card usage by government program beneficiaries has been an active area for government action in recent years. In a September 2014 Special Advisory Bulletin, the U.S. Department of Health...more

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