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New Reprint Guidance Maintains Bipartisan Status Quo

On February 28, 2014, the FDA issued its most recent unofficial guidance on distribution by manufacturers of research concerning off-label uses. With minor textual revisions, this new Guidance essentially restates the safe...more

Health Reform + Related Health Policy News - January 2014, Issue 1

In This Issue: - Top News ..Congress Approves Budget Deal with Short-Term ‘Doc Fix' ..CMS “Two-Midnight” Rule delayed until March 31, 2014 ..Individuals with Canceled Insurance Policies May Apply for...more

False Claim Act: 2013 Year in Review

Last year continued the trend of robust False Claims Act (FCA) enforcement by the U.S. Department of Justice (DOJ) and proliferating qui tam lawsuits brought by whistleblowers on behalf of the United States. In 2012, DOJ...more

New Jersey Federal Court Applies Supreme Court’s Clapper Decision and Dismisses Data Breach Class Action

Relying in part on the recent United States Supreme Court’s ruling in Clapper v. Amnesty International, a federal judge in New Jersey dismissed a putative data breach class action against three healthcare entities and a...more

Drug Quality and Security Act Creates New Laws for Compounding Pharmacies

On November 27, 2013, the Drug Quality and Security Act was signed into law. This new law provides clarity to the existing pharmacy compounding laws within Section 503A of the Food, Drug & Cosmetic Act (FDCA) and creates new...more

Medical Device Company Files First Amendment Lawsuit Challenging OIG’s Criticism of Physician-Owned Distributors (PODs)

On October 8, 2013, Reliance Medical Systems, LLC (“Reliance”) filed a Complaint against the HHS OIG in the United States District Court for the Central District of California. The Complaint alleges that OIG’s assertion in a...more

Federal Court Upholds California County’s Safe Drug Disposal Ordinance

On August 28, 2013, the U.S. District Court for the Northern District of California issued an order upholding Alameda County's Safe Drug Disposal Ordinance as constitutional. The ordinance, passed in July 2012 by the Alameda...more

D.A.R.E. to Market Off-Label Uses of Prescription Drugs? Make Sure You are in the Second Circuit: United States v. Caronia and the...

Truthful, non-misleading off-label promotion of prescription drugs is not illegal. At least, not in the Second Circuit. This, despite the billions of dollars in civil and criminal penalties assessed against pharmaceutical...more

HHS States That It Will Issue Guidance On HIPAA Regulation For Prescription Refill Reminders

On September 11, 2013, HHS stated in a joint motion filed in the case of Adheris, Inc. v. Sebelius, No. 1:13-cv-1342 (D.D.C.), that it plans to issue guidance on a HIPAA regulation related to prescription drug refill...more

Health Reform + Related Health Policy News - July 2013

In This Issue: - Top News ..Obama Administration Delays Employer Mandate One Year ..House Energy and Commerce Committee Releases Draft Legislation for SGR Fix ..CMS Proposes Payment Changes for Medicare...more

Association for Molecular Pathology v. Myriad Genetics

Supreme Court Ruling that Human Genes May Not Be Patented

Full text copy of the unanimous U.S. Supreme Court ruling in Association for Molecular Pathology v. Myriad Genetics that human genes may not be patented because they occur naturally in nature. From Greg Stohr writing for...more

Getting Over the Goal Line: Congress Shows Strong Support for Medical Device Tax Repeal, but Issues Remain

Introduction - The Patient Protection and Affordable Care Act (“ACA”) generates very few areas of agreement. However, in recent months, proposals to repeal one of the most visible and controversial provisions of the...more

Federal Court Orders FDA to Approve OTC Sales of “Morning-After Pill,” Finds Current Age and Point-of-Sale Restrictions to be...

On April 5, 2013, Judge Edward R. Korman of the United States District Court for the Eastern District of New York found that the Secretary of Health and Human Service’s (“HHS”) decision to limit over-the-counter (“OTC”)...more

FDA Emphasizes Patient-Specific Prescriptions

On March 7, 2013, the United States Food and Drug Administration (FDA) issued a warning letter to compounding pharmacy Medi-Fare Drug & Home Health Center (Medi-Fare Drug), taking the FDA's most aggressive position to date...more

Two New Developments in First Amendment Challenges to Off-Label Promotion: What's Next?

Following the Second Circuit’s marquee First Amendment ruling in the Caronia case, two recent developments demonstrate a shift in the battleground for First Amendment challenges to the prohibition on off-label promotion under...more

WLF Submits Comments on Abbott's Citizen Petition on Biosimilars

Last April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act...more

False Press Release Leads To Exclusion From Federal Programs

Dr. Harkonen was the CEO of InterMune, Inc, a pharmaceutical company that developed, marketed and sold drugs for lung and liver diseases, including Actimmune. In 2002, the FDA had approved Actimmune to treat only two...more

Health Reform + Related Health Policy News Update - February 6, 2013

In This Issue: - Top News ..CMS Announces Round 2 Competitive Bidding Single Payment Amounts ..CBO Lowers SGR Repeal Cost by $100 Billion ..Republicans Press HRSA on 340B Audits ..HHS Proposes...more

Second Circuit Jettisons Criminal Conviction for Pharma Rep Convicted for Off-Label Promotion

On December 3, 2012, the United States Court of Appeals for the Second Circuit overturned the conviction of a pharmaceutical sales representative convicted for misbranding in violation of the federal Food, Drug and Cosmetic...more

United States v. Caronia: Second Circuit Rules Manufacturers Cannot Be Criminally Prosecuted for Off-Label Promotion of Drugs...

On December 3, 2012, the United States Court of Appeals for the Second Circuit issued a landmark decision in United States v. Caronia, holding that “the government cannot prosecute pharmaceutical manufacturers and their...more

Second Circuit Rules Off-Label Marketing is Protected by First Amendment

On December 3, 2012, the United States Court of Appeals for the Second Circuit, in a 2-1 opinion, vacated the criminal conviction of a pharmaceutical sales representative for promoting off-label uses of a particular drug....more

Second Circuit Vacates Misbranding Conviction for Pharmaceutical Representative on First Amendment Grounds

In United States v. Caronia, No. 09-5006-cr, slip op. (2d Cir. Dec. 3, 2012), the U.S. Court of Appeals for the Second Circuit held that "the government cannot prosecute pharmaceutical manufacturers and their representatives...more

Palo Alto Boy Returns To School After DNA Flap

A Palo Alto 6th grade boy was allowed to return to his middle school after his family convinced the school officials that they did not need to worry about his genes....more

Boy In School Flap Over Cystic Fibrosis

A Palo Alto middle school ordered an 11 year old boy to move to another middle school 3 miles away because it believed that his genetic makeup was a health risk to some of its other students....more

Affordable Care Act Survives Supreme Court Review Largely Unscathed, Clearing Way for Biosimilars

In a history-making decision, the Supreme Court today in National Federation of Independent Business v. Sebelius upheld the Patient Protection and Affordable Care Act (PPACA) as constitutional under the taxation clause of the...more

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