Drug Manufacturers

News & Analysis as of

FDA Releases Compounding Policy Documents

The U.S. Food and Drug Administration (FDA) has released five policy documents regarding compounded human drug products in connection with its continued implementation of the compounding provisions of the Drug Quality and...more

Drug Compounding: Manufacturing Standards Announced for Outsourcing Facilities

In late 2013, Congress passed the Drug Quality and Security Act (DQSA) in response to a deadly fungal meningitis outbreak linked to a sterile compounded injectable drug shipped across the country and responsible for more than...more

FDA Offers Guidance for Choosing Prescription Drug Names

If you've seen your share of prescription drug commercials, you've likely marveled at the odd drug names: Moexipril. Oxcarbazepine. Zafirlukast. You might think pharmaceutical companies just prefer complex, new combinations...more

Federal Judge Puts Narcolepsy Drug Horizontal Conspiracy Claims to Bed

On Monday, June 23, 2014, a Federal Judge in the Eastern District of Pennsylvania granted summary judgment for five pharmaceutical companies on horizontal conspiracy claims brought by Apotex Inc. and direct purchaser and end...more

FDA Issues Two Draft Guidance Documents Relating to Internet and Social Media Use by Drug and Device Manufacturers

On June 17, 2014, the Food and Drug Administration (“FDA”) released two draft guidance documents related to manufacturer communications on the Internet and social media platforms. The two documents are (1) “Internet/Social...more

Judicial Efficiencies and Economy Support Bifurcation of Liability and Damages at Trial

Endo Pharmaceuticals, Inc. v. Actavis, Inc., et al. Case Number: 1:12-cv-08985-TPG (Dkt.55) - Endo brought suit against Actavis, as well as over a dozen other pharmaceutical manufacturers, for allegedly...more

HRSA “Interprets” Its Enjoined 340 Orphan Drug Rule into Effect

In January, I predicted that 2014 would be a game-changer for the 340B Drug Discount Program, in part because of HRSA’s announcement that, in June 2014, it would for the first time publish an omnibus rule governing 340B...more

FDA Issues Distribution of Risk Information Draft Guidance Amid Asserted Push to Release Guidance on Manufacturer Communications

The U.S. Food and Drug Administration (FDA or the Agency) issued the June 6, 2014, draft guidance (Draft Guidance) in response to stakeholder inquiries into the Agency’s views on disseminating new scientific or medical...more

Genzyme First Circuit Decision

In a huge victory for Massachusetts-based biologics manufacturer Genzyme Corporation, the First Circuit Court of Appeals on June 5, 2014 affirmed the District Court’s dismissal of a multi-million dollar shareholder class...more

The Orphan Drug Wars: HHS’s Recent Loss to PhRMA

On May 27, 2014, almost a year following the promulgation of its final rule, the U.S. Department of Health and Human Services (HHS) had its rule vacated by the U.S. District Court for the District of Columbia under an...more

Recent Court Decision Limits HRSA's Authority Under the 340B Drug Discount Program - Will It Change the Impact of the Anticipated...

In the rapidly evolving landscape of the 340B Drug Discount Program, a recent court decision is the first to limit the rulemaking authority of the Health Resource and Services Administration (HRSA). This decision may...more

FDA Issues Draft Guidance Relating to Distribution of New Risk Information for Approved Drugs and Biologics and Grants Two Citizen...

On June 6, 2014, the Food and Drug Administration (“FDA”) issued two documents that reflect the agency’s ongoing effort to clarify its regulatory approach regarding manufacturer communication of scientific and medical...more

Establishing Personal Jurisdiction Over Foreign Corporations in ANDA Cases

In this BNA Insight, attorney Paul Ragusa examines the impact of a recent U.S. Supreme Court decision on litigation involving foreign corporations and abbreviated new drug applications. He says it may become more challenging...more

DC District Court Strikes Down 340B Orphan Drug Rule

On May 23, Judge Contreras of the U.S. District Court for the District of Columbia (DC District Court) ruled that the Health Resources and Services Administration (HRSA) did not have the statutory authority to promulgate its...more

Cloudy Skies Ahead for Providers? CMS’ Release of Medicare Billing Data Combined with Physician Payment Sunshine Act Data May...

In February 2013, we reported (on our Healthcare Law Blog) that the Centers for Medicare and Medicaid Services (CMS) announced the final rule for the Physician Payments Sunshine Act. In the interest of providing more...more

Summary of FDA’s Final Guidance on Dear Health Care Provider Letters

At the beginning of this year, the Food and Drug Administration (FDA) issued its final guidance on the content and format of Dear Health Care Provider (DHCP) letters. DHCP letters are correspondence, often in the form of a...more

FDA Ups the Ante on Inspections with New Administrative Detention Authority

New authority allows FDA inspectors to quickly detain products during inspections if they believe the products are misbranded or adulterated....more

OIG Issues Advisory Bulletin Impacting Independent Charity Patient Assistance Programs

On May 21, 2014, the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) issued its “Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs” (SSAB) to...more

OIG Proposes Rule to Implement Expanded Civil Monetary Penalty Authority under the ACA

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published a proposed rule that would amend the health care program civil monetary penalty (CMP) regulations (Proposed Rule)....more

False Claims Act Litigation Update: Bayer Decision Sheds Light on Pleading in False Claims Act Cases

A recent win for a large company in a False Claims Act suit (a seeming rarity as of late) alleging illegal off-label promotion could provide some helpful insight to similarly situated manufacturers and support dismissals of...more

Federal Testosterone Drug Lawsuits Consolidation on the Horizon as More Studies Link Low-T Drugs to Significant Risk of Heart...

A growing number of testosterone drug lawsuits have recently been filed in U.S. federal courts against various manufacturers of testosterone replacement therapies (or low-T therapies), like testosterone gels, patches and...more

FDA Plays Catch Up in the Digital Age

Part of JD Supra's series on innovation and the law. A look at how, as pharmaceutical manufacturers increasingly turn to social media to exchange information, laws and regulations that are decades old struggle to keep pace...more

In re Lamictal Direct Purchaser Antitrust Litigation

Case Name: In re Lamictal Direct Purchaser Antitrust Litigation, Case No. 12-cv-995 (WHW), 2014 U.S. Dist. LEXIS 9257 (D.N.J. Jan. 24, 2014) (Walls, J.) - Drug Product and Patent(s)-in-Suit: Lamictal® (lamotrigine);...more

CMS To Publish Financial Relationships Between Physicians and Drug Manufacturers Beginning September 2014

Beginning in September 2014, the Centers for Medicare and Medicaid Services (“CMS”) will publish a list of all payments and transfers of value paid by drug manufacturers to physicians and teaching hospitals on a publicly...more

Hoffman-La Roche Inc. v. Apotex Inc. (Fed. Cir. 2014)

Last Friday, the Federal Circuit issued an opinion in Hoffman La-Roche Inc. v. Apotex Inc. that is a cautionary tale of patent lifecycle and the difficulties those seeking to extend patent protection face -- namely the...more

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