Drug Manufacturers

Jury Buys Plaintiff’s Argument That Drug Manufacturer Should Have Distributed Dear Doctor Letter Sooner, Without Prior FDA...

by Ellen Adler, James W. Huston, Joanna Simon | Morrison & Foerster LLP on 5/16/2013

Dear Doctor letters were front and center in the just-tried case of Tietz v. Abbott Laboratories, Inc., et al., No. 12-L-002715. On Thursday, May 9, 2013, a Chicago jury returned a $2.2 million verdict in favor of the...more

Generic Drugs: A Closely Watched Case

by Phillips Law Offices on 5/8/2013

In 2005, Karen Bartlett visited her doctor complaining of shoulder pain. Her doctor prescribed Sulindac, a nonsteroidal anti-inflammatory drug used to relieve pain and address symptoms of arthritis. Ms. Bartlett was dispensed...more

Congress Drafts Compounding Legislation -- Defines Compounded Drugs as "New Drugs" Under the FFDCA and Creates Bright Line Between...

by Elinor Hart, Rachael G. Pontikes | Duane Morris LLP on 4/30/2013

In the wake of the New England Compounding Center meningitis outbreak, the federal government has actively pushed for greater legislative oversight over compounding pharmacies. On April 26, 2013, the U.S. Senate Committee on...more

Court Report - April 28, 2013

by Sherri Oslick | McDonnell Boehnen Hulbert & Berghoff LLP on 4/29/2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Mayo Foundation for Medical Education and Research v. ARUP Laboratories, Inc. - Infringement of U.S. Patent Nos....more

HHS Office of Inspector General Issues Updated Self-Disclosure Protocol

by Ropes & Gray LLP on 4/19/2013

On April 17, 2013, the Office of Inspector General of the Department of Health and Human Services (“OIG”) released an Updated Provider Self-Disclosure Protocol (“SDP”). The Updated SDP replaces OIG’s original Provider...more

Business Litigation Report -- April 2013

by Quinn Emanuel Urquhart & Sullivan, LLP on 4/15/2013

In This Issue: - Firm News: DoJ Star Healthcare Fraud Prosecutor Joins Washington, D.C. Office; and Quinn Emanuel Wins Top Honors at the Inaugural U.S. Benchmark Annual Awards - Main...more

Intellectual Property Bulletin - Winter 2013

by Ewa Davison, R.J. Heher, David Marty, David Tellekson, Jedediah Wakefield, Elizabeth White, Lauren Whittemore, Sean Wikner | Fenwick & West LLP on 4/4/2013

In This Bulletin: - Just Moot It: Supreme Court in Already v. Nike Clarifies When a Covenant Not to Sue Can Kill a Declaratory Judgment Case - Murky Waters: Post-Approval Regulatory Activities and the §...more

Mind the Gap: Sixth Circuit Finds Room for Suit Against Generic Manufacturers After Mensing

by Erin M. Bosman, Jeffrey M. David, James W. Huston, Julie Y. Park | Morrison & Foerster LLP on 3/15/2013

Yesterday, the Sixth Circuit issued its decision in Fulgenzi v. PLIVA, Inc., a case involving a state law claim for failure to warn against a generic drug manufacturer. Case No. 12-3504 (6th Cir. March 13, 2013). The court...more

Senators Introduce Another Bill to Ban Reverse Payment Settlement Agreements

by Kevin E. Noonan | McDonnell Boehnen Hulbert & Berghoff LLP on 3/15/2013

Last week, Senator Al Franken (D-MN) was joined by Senators David Vitter (R-LA), Dick Durbin (D-IL), Jeanne Shaheen (D-NH), and Bernie Sanders (I-VT) in introducing S. 204, the "Fair and Immediate Release of Generic Drugs...more

CMS Publishes Final Sunshine Act Rule Creating New Regulatory Landscape for Physician-Manufacturer Interactions

by Tom Crane, Brian P. Dunphy, Kimberly J. Gold, Karen S. Lovitch, Kate Stewart | Mintz Levin - Health Law on 3/7/2013

Originally published in the Health Care Fraud Report, 17 HFRA 219, on 03/06/2013. The final rule (the ‘‘Final Rule’’) implementing the Physician Payments Sunshine Act (‘‘Sunshine Act’’), published in the Federal...more

China SFDA Creates New Regulatory Pathways for Transfer of Drug Licenses

by Katherine Wang | Ropes & Gray LLP on 3/4/2013

To accelerate GMP compliance by domestic pharmaceutical companies, the Chinese State Food and Drug Administration (“SFDA”) published a notice on February 22, 2013 (the “Notice”) clarifying the regulatory pathways for...more

In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation (Fed. Cir. 2013)

by Andrew Williams | McDonnell Boehnen Hulbert & Berghoff LLP on 3/1/2013

On the first day of February, the Federal Circuit rejected Impax's efforts to get out from under a preliminary injunction in a case captioned In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation. ...more

Court Report -- February 24, 2013

by Sherri Oslick | McDonnell Boehnen Hulbert & Berghoff LLP on 2/25/2013

In This Issue: Novartis Pharmaceuticals Corp. v. Actavis LLC et al.; Precision Biosciences Inc. et al. v. Cellectis S.A. et al.; Bayer Pharma AG v. Warner Chilcott Co., LLC et al.; Promega Corp. et al. v. Life...more

CMS Publishes Physician Payment Sunshine Rules; Manufacturers and Group Purchasing Organizations Are Required to Submit Detailed...

by Frederick Ball, Elinor Hart | Duane Morris LLP on 2/25/2013

On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited rules (the "Rules") detailing manufacturers' and group purchasing organizations' reporting requirements under Section 6002...more

The Sunshine Act Final Rule: CMS Sheds Light on Reporting Physician and Teaching Hospital Payments

by Tripp Haston, Amy Leopard, Amanda Nichols, Whitt Steineker | Bradley Arant Boult Cummings LLP on 2/22/2013

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released a final rule implementing the Physician Payment Sunshine Act (the “Act”). The Act requires certain manufacturers of covered drugs, devices, and...more

China Life Sciences Health Industry Client Briefing – January 2013 (February 21, 2013)

by Vicki Lung, Mao Rong, Gordon B. Schatz, John Tan, May Ling Wong, Jay J. Yan, Katherine Yang, Amy Yin | Reed Smith on 2/22/2013

In This Issue: Li Keqiang Comments from the 12th Plenary Meeting of the Medical Reform Leading Group (USCBC 2012-01-06) – January 6, 2013; MOH Announces Roadmap for Medical Reform (USCBC 2012-01-10) – January 10, 2013;...more

China Amended Good Supply Practices for Pharmaceuticals

by Katherine Wang | Ropes & Gray LLP on 2/21/2013

The Chinese Ministry of Health (“MOH”) published the long-awaited amendment of Good Supply Practices for Pharmaceuticals (the “Amended GSP”) on January 22, 2013, to be effective as of June 1, 2013. After three rounds of...more

Looking Ahead: Forthcoming 2013 Securities and Corporate Governance Litigation Developments

by Douglas W. Greene | Lane Powell PC - Securities / D&O Discourse on 2/21/2013

This promises to be an eventful year in securities and corporate governance litigation. A number of looming developments have the potential to change the landscape for many years to come. This is the first of two posts – or...more

Here Comes the Sun: Final Rules Implementing the Federal Sunshine Law

by Ropes & Gray LLP on 2/20/2013

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited final rule implementing the Federal Sunshine Law (42 U.S.C. 1320a-7h). (The rule was subsequently published in the Federal...more

Drug Manufacturing Through the Eyes of Breaking Bad

by Law Offices of Adrian H. Altshuler &... on 2/20/2013

If you watch the mega hit Breaking Bad, you know that the main characters Walter White (a former high school teacher) and his former student/sidekick punk Jesse Pinkman manufacture methamphetamine in part to pay for Walt’s...more

Physician Payment Sunshine Rule is Finalized

by Christopher P. Dean, Joshua Freemire, William Mathias | Ober|Kaler on 2/15/2013

The Final Rule implementing the Physician Payment Sunshine Act was announced on February 1st and published in the Federal Register on February 8th. The Final Rule establishes procedures for drug and device manufacturers to...more

Pending Bill Would Expand FTC Powers Over Drug Patent Settlements and Alter the Legal Test

by Irene Ayzenberg-Lyman, MIke Cowie, George Gordan | Dechert LLP on 2/14/2013

Key Points: - This month several U.S. Senators introduced the Preserve Access to Affordable Generics Act. There is no similar bill pending in the U.S. House. - The Act revives legislative efforts to wipe out the...more

CMS Issues Final Rule for Implementing Sunshine Act

by Wilson Sonsini Goodrich & Rosati on 2/14/2013

On February 8, 2013, 16 months after the statutory deadline, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register the final regulation implementing the physician payment transparency...more

CMS Issues Final Physician Payment Sunshine Act Regulations

by Joel R. Levin, Jeffrey Miller, Jerica L. Peters | Perkins Coie on 2/13/2013

On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations implementing the Physician Payment Sunshine Act (Act or Sunshine Act). The Sunshine Act requires drug,...more

Physician Payment Sunshine Rule Finalized; Let The Sun Shine In; Payment Reports Flow

by BakerHostetler on 2/11/2013

The Centers for Medicare and Medicaid Services (CMS) recently published the final rule implementing the Physician Payment Sunshine Act (Sunshine Act) that requires most manufacturers of drugs, devices, biologics or medical...more

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