News & Analysis as of

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

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

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The U.S. Food and Drug Administration (FDA) announced the availability of four new Draft Guidance documents and a draft Memorandum of Understanding (MOU) between the FDA and individual states. The Draft Guidance documents...more

Five Lessons From OPDP's First Enforcement of 2015: (Lack of) Precision Carries the Day

The first Untitled Letter of 2015 from the Office of Prescription Drug Promotion (OPDP) provides valuable lessons on drug promotion. OPDP issued its first Untitled Letter of 2015, after a 2014 relatively light on...more

Warner Chilcott Co, LLC v. Teva Pharms. USA, Inc

Case Name: Warner Chilcott Co, LLC v. Teva Pharms. USA, Inc., Nos. 2014-1439, 2014-1441, 2014-1444, 2014-1445, 2014-1446, 2014 U.S. App. LEXIS 21946 (Fed. Cir. Nov. 18, 2014) (Circuit Judges Lourie, Reyna and Taranto...more

GPhA Annual Meeting 2015: GDUFA, Quality, and Industry Trends – Part Two of Two

Day Two of the open GPhA Annual Meeting featured a panel on FDA and industry perspectives on a quality culture. Janet Woodcock, M.D., Center Director, Center for Drug Evaluation and Research (CDER) provided the agency’s new...more

GPhA Annual Meeting 2015: GDUFA, Quality, and Industry Trends: Part One of Two

On February 9-11, 2015, a record 765 attendees descended on Miami Beach for the Generic Pharmaceutical Association (GPhA’s) Annual Meeting. Craig Wheeler, President, Momenta Pharmaceuticals, Inc. delivered the welcoming...more

Blog: Congress Eyes Pharmaceutical Company Settlement Agreements as Source for Additional FDA & NIH Funding

Senator Elizabeth Warren (D-MA) recently introduced legislation that, if passed, would require certain pharmaceutical companies that enter into settlement agreements with the Department of Justice or other governmental...more

Proposed FDA Overhaul to Improve Biomedical Discovery and Development

The House of Representatives and the Senate are assessing significant reforms to the Food, Drug and Cosmetic Act. The reforms are aimed at accelerating the approval of new drugs, medical devices and other products regulated...more

Sandoz Inc. v. Amgen Inc.,

Case Name: Sandoz Inc. v. Amgen Inc., No. 2014-1693, 2014 U.S. App. LEXIS 22903 (Fed. Cir. Dec. 5, 2014) (Circuit Judges Dyk, Taranto, and Chen presiding; Opinion by Taranto, J.) (appeal from N.D. Cal, Chesney, J.) (A...more

FDA Simplifying Physician Application Process for Compassionate Use of Unapproved Drugs

On February 4, 2015, FDA released draft guidance around its “Expanded Access” program, also known as “compassionate use.” The guidance proposes a greatly streamlined application form that physicians may use on behalf of...more

Citizen Petitions Aimed at Delaying Generic Competition Remain a Concern

Despite Congress enacting legislation in 2007 to curb misuse, citizen petitions submitted by pharmaceutical companies to the Food and Drug Administration (FDA) may still provide a mechanism for competitors to delay the...more

FDA Revises Approach to Presentation of Risk Information in Brief Summary

On February 6, 2015, the U.S. Food and Drug Administration (FDA) issued a revised draft guidance titled Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and...more

Biosimilars Update

Novartis came one step closer to becoming the first company to offer a biosimilar drug for sale in the United States. Last month, an independent panel voted 14-0 to recommend FDA approval of Sandoz’s (Novartis’ generics...more

Washington Healthcare Update

This Week: President’s FY2016 Budget Request... FDA Commissioner Hamburg to step down... Tennessee Medicaid expansion plan rejected by legislature. 1. Congress House House Ways and Means Committee Hosts Hearing...more

U.S. Congressional Committees Address Drug And Device Approval

As mentioned on our Health Industry Washington Watch blog, committees in both the House of Representatives and Senate last week addressed the speed at which medical innovations are approved and available for patient use. ...more

FDA Regulatory and Compliance Monthly Recap - January 2015

In This Issue: - FDA’s CDER, CDRH and CBER put out 2015 guidance agendas - FDA to study limiting major risk statements in direct-toconsumer TV ads amid concern that information is getting lost on consumers...more

The Cure for the Common FDA Reform Legislation? House Committee Releases 21st Century Cures Discussion Draft

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

Supreme Court Takes a Pass on Generic Drug Labeling Appeal

In the watershed case of PLIVA, Inc. v. Mensing, the United States Supreme Court determined that federal law preempts state law failure-to-warn claims against generic pharmaceutical manufacturers. More specifically, Mensing...more

Actavis Amici Briefs Don’t Support Injunction

The expedited appeal to the Second Circuit pits New York State’s arguments for facilitating competition in a “molecule market” (a product market defined by the active ingredient of a prescription drug) against the brand name...more

Generic Drug Cos. Face Failure-To-Warn Claims In Calif.

On Jan. 20, 2015, the U.S. Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956 (U.S. Jan. 20, 2015). This...more

FDA Proposes Electronic Distribution of Prescribing Information

Drug manufacturers may no longer be required to distribute prescribing information on paper—with limited exceptions—and instead may have to distribute that same information electronically. The FDA recently issued a proposed...more

Product Liability Alert: Failure-To-Warn Suit Against Generic Drug Maker Proceeds Despite Argument of Federal Preemption

On January 20, 2015, the U.S Supreme Court denied cert in Teva v. Superior Court of California, Orange County, refusing to review a California state court ruling allowing patients to proceed with claims that Teva...more

FDA Clarifies Orphan Drug Exclusivity Policy Following Court Defeat

On the heels of a loss in federal court last fall, the FDA recently announced a clarification of its policy concerning orphan drug exclusivity. In short, despite a court ruling requiring the FDA to grant orphan drug...more

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