Pharmacies

US Sues Novartis for Alleged Pharmacy Kickback Scheme

by Josh Crank | Lawyers.com on 4/30/2013

Swiss drug maker Novartis has been sued by a U.S. Attorney for allegedly paying kickbacks to pharmacies that converted thousands of patients to one of its drugs. The civil fraud suit accuses the company of disguising the...more

2014 Final Call Letter: CMS Raises Medicare Advantage Rates but Foreshadows Other Significant Program Changes

by Roy M. Albert, Theresa C. Carnegie, Tara Swenson | Mintz Levin - Health Law on 4/17/2013

After receiving many comments on its Draft Call Letter, CMS published its Contract Year 2014 Final Call Letter on April 1, 2013. The Final Call Letter addresses a wide variety of issues that will affect all parties involved...more

Franchising in the Courts - April 2013

by Gillian Scott | Osler, Hoskin & Harcourt LLP on 4/8/2013

Robert Moore Pharmacy Ltd. v. Shoppers Drug Mart Inc.: The Applicability and Limits of the Duty of Good Faith - Robert Moore Pharmacy Ltd. v. Shoppers Drug Mart Inc. 2012 ONSC 73511 (Moore Case) reaffirms key...more

CMS Announces CY 2014 MA and Part D Rates with Change to Growth Rate Estimates

by Jeremy Earl, Anne W. Hance | McDermott Will & Emery on 4/5/2013

The Centers for Medicare & Medicaid Services (CMS) released the announcement of CY 2014 payment rates on April 1, which included its change in position regarding the assumption of the "doc fix" in estimates of Medicare...more

Virginia Enacts the First State Law Regulating Interchangeable Biosimilar Products

by Vincent Capuano, L. . Norwood Jameson, Alan Klein, Vicki Norton, Siegfried Ruppert | Duane Morris LLP on 3/28/2013

On March 16, 2013, Virginia became the first state to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug. ...more

Virginia Enacts Nation’s First Biosimilar Substitution Law

by Joy Liu | Ropes & Gray LLP on 3/26/2013

On March 21, 2013, Virginia governor Bob McDonnell signed into law the nation’s first state law concerning substitution of biosimilars. The law’s requirements that pharmacists keep records of substitutions, give notice of...more

Pro Te Solutio - Vol. 5 No. 4 November 2012

by Butler, Snow, O'Mara, Stevens and Cannada,... on 3/4/2013

In This Issue: - Forecast for the Physician Payments Sunshine Act: Partly Cloudy - Document Preservation Notices and the Lists of Who Receive Them: Are They Discoverable? - FDA Warning Letters Through...more

New Tennessee Law Aims To Reduce Prescription Pill Abuse

by Law Offices of Adrian H. Altshuler &... on 2/27/2013

Accidental drug overdoses are huge problem in this country, and last year more than 1,000 people died from drug overdoses in Tennessee. A new Tennessee law seeks to reduce this problem by reducing prescription drug abuse and...more

Legislative Update Report No. 2013-04 -- Feb 22, 2013

by Osler, Hoskin & Harcourt LLP on 2/26/2013

In This Article: Federal Government; Alberta; British Columbia; Manitoba; New Brunswick; Newfoundland; Northwest Territories; Nova Scotia; Nunavut; Ontario; Prince Edward Island; Québec/Quebec; Saskatchewan; and Yukon....more

Chinese FDA Imposes Mandatory Electronic Barcoding on Imported Drugs

by Katherine Wang | Ropes & Gray LLP on 2/5/2013

The State Food and Drug Administration (“SFDA”) issued a Notice on Relevant Issues Concerning Imposing Electronic Barcoding on Imported Drugs (“Notice”) on January 29, 2013 with immediate effect. Pursuant to the Notice,...more

Bill on Bankruptcy: AMR Make-Whole Opinion Vulnerable on Appeal [Video]

by Bloomberg Law on 1/23/2013

Jan. 23 (Bloomberg) -- The case of the week on the Bloomberg bankruptcy video is the decision by Bankruptcy Judge Sean Lane who concluded that American Airlines isn't obliged to pay several hundred million dollars in...more

Court Report -- January 20, 2013

by Sherri Oslick | McDonnell Boehnen Hulbert & Berghoff LLP on 1/21/2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Cadence Pharmaceuticals, Inc. et al. v. Fresenius Kabi USA, LLC - 3:13-cv-00139; filed January 17, 2013 in the...more

Compounding Pharmacy Implicated in Deaths

by Janet Raasch | Lawyers.com on 1/17/2013

A compounding pharmacy in Massachusetts has been linked to the outbreak of a rare form of fungal meningitis caused by contamination of steroid injections commonly used for back and neck pain...more

Uncertainty Regarding the Future Regulation of Compounding Pharmacies

by Fuerst Ittleman David & Joseph, PL on 1/14/2013

As we previously reported, the nationwide outbreak of fungal meningitis linked to contaminated injections produced by New England Compounding Center (“NECC”), a compounding pharmacy in Framingham, Massachusetts, prompted...more

Massachusetts 2013 – 2014 Legislative Session Preview

by George Atanasov, Julie Cox | Mintz Levin on 1/11/2013

The 188th Massachusetts Legislature began the 2013 – 2014 legislative session on January 2. This alert identifies the key public policy issues that will likely emerge in the current session and offers insight into their...more

U.S. Government’s Use of the "Park Doctrine" to Police Pharmacies

by Frederick Ball, Rachael G. Pontikes | Duane Morris LLP on 1/7/2013

The U.S. government may be resurrecting the "Park Doctrine" as a tool to prosecute the owners of pharmacies for federal Food, Drug, and Cosmetic Act (FDCA) violations. In United States v. Park, 421 U.S. 658 (1975), the U.S....more

Alabama District Court Grants Pharmacy’s Motion To Dismiss, Holding Plaintiff’s Claim Barred Because She Provided Her Cell Phone...

by Joshua Threadcraft | Burr & Forman on 1/2/2013

After dropping off a prescription with Defendant, Plaintiff was asked for several pieces of information, including her cell phone number. According to Defendant, the number was needed “in case there were any questions that...more

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

by Michael M. Gaba, Shannon Hartsfield Salimone | Holland & Knight LLP on 12/27/2012

On December 19, 2012, the U.S. Food and Drug Administration (FDA) held a public meeting, broadcast live on the Internet, to discuss the respective roles of the federal and state governments in regulating pharmacy compounding....more

Could the Recent Meningitis Outbreak Lead to Litigation?

by Phillips Law Offices on 12/21/2012

Pharmaceutical litigation most frequently occurs when drug companies fail to adequately test medications prior to release or fail to properly inform consumers of the potential side effects. In these cases, the drugs are...more

FDA and State Pharmacy Boards Discuss Regulating Compounding Pharmacies

by Rachael G. Pontikes | Duane Morris LLP on 12/21/2012

On December 19, 2012, the U.S. Food and Drug Administration (FDA) and officials from all 50 states' boards of pharmacy met to discuss their views on state and federal roles in regulating compounding pharmacies. The meeting...more

OIG Approves Pharmacy’s Provision of Free or Below Market Value Items in Limited Circumstances

by Theresa C. Carnegie, Carrie Roll | Mintz Levin - Health Law on 12/13/2012

Last Friday, the Office of Inspector General (OIG) issued Advisory Opinion No. 12-19 approving three of four proposed arrangements involving a pharmacy’s provision of free or below market items and services to community homes...more

Can I Sue if a Pharmacy Gives Me the Wrong Drug?

by Barasch McGarry Salzman & Penson PC on 12/12/2012

Medical malpractice law applies to all health care providers, including pharmacies. Individuals who suffer injury due to medication errors made by doctors or pharmacies may have grounds to file a lawsuit, typically based on...more

Birmingham Medical News: Compounding Pharmacies Coming Under Greater Scrutiny

by James A. Hoover | Burr & Forman on 12/6/2012

With as many as 13,000 patients possibly exposed to fungal meningitis from tainted spinal steroid injections traced to a New England compounding pharmacy, the regulation of compounding pharmacies is once againheating up. The...more

Massachusetts Board of Pharmacy Enacts Emergency Regulations Targeting Compounding Activities and Impacting All Registered and...

by Jonathan E. Anderman, Jeffrey W. Mittleman, Melissa A. Wong | Holland & Knight LLP on 11/6/2012

The Massachusetts Board of Pharmacy (BOP) enacted emergency regulations effective November 1, 2012, in response to the deadly fungal meningitis outbreak caused by drug contamination at a Massachusetts compounding pharmacy....more

Contaminated Medication Believed to Be Cause of National Fungal Meningitis Outbreak, Including Over Twenty Florida Cases

by Law Offices of Cohn & Smith, P.A. on 10/23/2012

Federal and state officials believe that a contaminated medication from a Massachusetts pharmacy is responsible for an outbreak of fungal meningitis that has killed at least twenty-four people and sickened more than three...more

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US Sues Novartis for Alleged Pharmacy Kickback Scheme

2014 Final Call Letter: CMS Raises Medicare Advantage Rates but Foreshadows Other Significant Program Changes

Franchising in the Courts - April 2013

CMS Announces CY 2014 MA and Part D Rates with Change to Growth Rate Estimates

Virginia Enacts the First State Law Regulating Interchangeable Biosimilar Products

Virginia Enacts Nation’s First Biosimilar Substitution Law

Pro Te Solutio - Vol. 5 No. 4 November 2012

New Tennessee Law Aims To Reduce Prescription Pill Abuse

Legislative Update Report No. 2013-04 -- Feb 22, 2013

Chinese FDA Imposes Mandatory Electronic Barcoding on Imported Drugs

Bill on Bankruptcy: AMR Make-Whole Opinion Vulnerable on Appeal [Video]

Court Report -- January 20, 2013

Compounding Pharmacy Implicated in Deaths

Uncertainty Regarding the Future Regulation of Compounding Pharmacies

Massachusetts 2013 – 2014 Legislative Session Preview

U.S. Government’s Use of the "Park Doctrine" to Police Pharmacies

Alabama District Court Grants Pharmacy’s Motion To Dismiss, Holding Plaintiff’s Claim Barred Because She Provided Her Cell Phone...

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

Could the Recent Meningitis Outbreak Lead to Litigation?

FDA and State Pharmacy Boards Discuss Regulating Compounding Pharmacies

OIG Approves Pharmacy’s Provision of Free or Below Market Value Items in Limited Circumstances

Can I Sue if a Pharmacy Gives Me the Wrong Drug?

Birmingham Medical News: Compounding Pharmacies Coming Under Greater Scrutiny

Massachusetts Board of Pharmacy Enacts Emergency Regulations Targeting Compounding Activities and Impacting All Registered and...

Contaminated Medication Believed to Be Cause of National Fungal Meningitis Outbreak, Including Over Twenty Florida Cases

Bill on Bankruptcy: AMR Make-Whole Opinion Vulnerable on Appeal [Video]

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