Prescription Drugs Pharmaceutical Industry

News & Analysis as of

Chinese Legislature Adopts Amendments to Drug Administration Law

China’s top legislature, the Standing Committee of National People’s Congress, recently approved the amendments (the “Amendments”) to the Drug Administration Law. The Amendments, effective as of April 24, 2015, cover the...more

Massachusetts Legislation Proposes Cost Disclosures and Price Caps for Prescription Drugs

The Massachusetts Legislature is currently considering Senate Bill 1048, “An Act to Promote Transparency and Cost Control of Pharmaceutical Drug Prices.” The bill, sponsored by State Senator Mark Montigny, Vice Chair of the...more

States Move to Impose Limits on Biosimilar Drug Substitution

In early April, Colorado joined multiple other states in passing a biosimilar substitution law that addresses the circumstances under which an FDA-approved interchangeable biosimilar product may be substituted for the...more

Still No Duty To Supply Drugs - In 22 States

Since the inception of the blog we’ve taken interest in “flip side” lawsuits in which a plaintiff sues one of our manufacturer clients making allegations diametrically opposed to what we usually see in product liability...more

OMB Reviewing HRSA Proposed Rule For Civil Monetary Penalties And Ceiling Price Regulations For 340B Drug Discount Program

The agency that oversees the 340B Drug Discount Program (340B program) is seeking review by the White House Office of Management and Budget (OMB) of a proposed rule that would use civil monetary penalties to enforce ceiling...more

Health Alert (Australia) - March 23, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Reports: New South Wales (NSW). Ministry of Health - Media Releases - 18 March 2015 - NSW says protect against mosquitoes after huge...more

Notes From The Off-Label Underground

Keeping track of litigation over off-label use/promotion frequently sends us off on tangents. We’ve wandered into abortion cases, securities law cases, criminal cases – even cases brought by criminals....more

A Change of Pace for Product Liability Class Actions: Certification Denied in Two Recent Cases

Oft-referred to as “quintessential class actions”, the majority of product liability actions that have sought certification as class proceedings in the last 10 years have been granted certification. However, two recent...more

FDA Establishes Docket for Public Comments on Drug Compounding

The Food and Drug Administration (FDA) recently announced a new docket for public comments on the compounding of human drug products under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FFDCA). The FDA...more

New FDA Guidance Opens the Door for Electronic Consent Forms That Come with Significant Advantages and Raise Privacy and Secure...

On March 9, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance that allows for the use of electronic informed consent (eIC) in human clinical trials. eICs have the potential to...more

Prescriptions for the Headache of High Cost Drugs

A March 11 policy conference in Washington produced some creative thinking about the problem of high-cost specialty drugs. And on the same day, the RAND Corp. think tank released a study on the subject, “Borrowing for the...more

Advertising Law - March 2015

NAD: A Product Can’t be The “#1 Prescribed Brand” Without Other Prescribed Brands - A “#1 brand prescribed” claim implies that professionals have a choice in prescribing brands, the National Advertising Division...more

State Medicaid Programs May Be Leaving Revenue From Drug Rebates on the Table

The recent release of a New York State Office of the State Comptroller audit report serves as an example of state Medicaid programs that may not be maximizing their collection of revenue from drug rebates for Medicaid managed...more

340B in the Spotlight This Thursday: Congress Offers Webcast of Upcoming Hearing Regarding the 340B Drug Pricing Program

Thursday, March 5th at 10:00 a.m. EST, the House Energy & Commerce Health Subcommittee on Health will hold a hearing entitled, “Examining the 340B Drug Pricing Program.” The purpose of the hearing is to review the...more

PTAB Update -- Biopharmaceutical Edition

Earlier this week, the Patent Trial and Appeal Board ("PTAB" or "Board") handed down what is thought to be the first set of inter partes review ("IPR") Final Written Decisions ("FWDs") in the biopharmaceutical industry. And...more

The Iron Law of Unintended Consequences - (with apologies to Robert Michels)

It is a certainty that no matter what action is taken (by an individual, a group, or especially a legislative body) that there will be unintended consequences. It is also true that those unintended consequences, like the...more

Pharmaceutical Patent Score a Win - Amneal Pharms., LLC v. Supernus Pharms., Inc.

In three separate but related final written decisions in the first successful defense of a pharmaceutical patent in an inter partes review (IPR), the U.S. Patent and Trademark Office’s (PTO) Patent Trial and Appeal Board...more

Free Speech & Pharmaceutical Promotion — U.S. ex rel. Solis v. Millennium Pharmaceuticals, Inc.

Off-label prescription drug use — using drugs to treat ailments not indicated on FDA-approved labeling — is among the thorniest legal issues facing the pharmaceutical sector. On one hand, off-label prescriptions are lawful...more

CMS Takes a Measured Approach to Medicare Advantage and Part D Plan Payment Rates and Policy Changes for 2016

Increased Part D Drug Costs Set the Stage for Higher Beneficiary Premiums - The Advance Notice (“Advance Notice”) of Methodological Changes for Calendar Year (“CY”) 2016 for Medicare Advantage (“MA”) Capitation Rates,...more

FDA Revisits Its Proposed Rule Regarding Generic Drug Labeling

On February 18, 2015, the FDA announced that it is reopening the comment period for its proposed rule that would allow ANDA holders to unilaterally update their generic drug product labels prior to the NDA holder doing so....more

False Claims Act – 2014 Year in Review

The False Claims Act (FCA) imposes liability on individuals and companies who defraud or submit false claims to the federal government. The FCA allows the federal government to seek treble damages, civil penalties and...more

Court Report - February 2015 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Vaccines and Diagnostics, Inc. et al. v. Pfizer, Inc. 2:15-cv-01283; filed February 18, 2015 in the District...more

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

FDA Issues Additional Guidance Documents for Compounding Pharmacies and Outsourcing Facilities; Addresses Repackaging

The U.S. Food and Drug Administration (FDA) announced the availability of four new Draft Guidance documents and a draft Memorandum of Understanding (MOU) between the FDA and individual states. The Draft Guidance documents...more

Clinical Trial and Medicare Provider Quality Improvement Provisions in House Committee 21st Century Cures Discussion Draft

On January 27, 2015, the House Energy & Commerce Committee (“Committee”) released a discussion draft of comprehensive medical innovation reform legislation as part of its 21st Century Cures Initiative. According to supporting...more

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