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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

Pathway for Follow-on Biologics Survives the Supreme Court

The Supreme Court of the United States delivered its much-anticipated and historic ruling in National Federation of Independent Business v. Sebelius today, holding the major provisions of the Patient Protection and Affordable...more

U.S. Supreme Court Upholds Patient Protection and Affordable Care Act Under Taxation Clause in Nat'l. Fed'n. of Independent...

In a history-making decision, the Supreme Court today ruled that the Patient Protection and Affordable Care Act (PPACA) is constitutional under the taxation clause of the Constitution. The most controversial provision was the...more

A Look At Abbott’s Citizen Petition Against The Biologics Price Competition And Innovation Act

When the Supreme Court upheld the constitutionality of the Patient Protection and Affordable Care Act, those hoping to benefit from the portion of the law known as the Biologics Price Competition and Innovation Act (the...more

Will Thursday Be the End of Biosimilars?

It is expected that the Supreme Court will hand down its decision on Health Care Reform this Thursday. As we discussed in a previous post, there is a real possibility that the Court will strike down the entire Affordable...more

Will the BPCIA go down with Health Care Reform?

As the Supreme Court’s week of arguments on the constitutionality of the individual mandate provisions of the 2010 health care reform act progressed, the pundits have seemed more and more certain that the Court will find...more

Supreme Court Strikes Vermont Data Mining Law and Protects Pharmaceutical Marketing

On June 23, the U.S. Supreme Court issued a 6-3 decision in Sorrell v. IMS Health Inc., declaring a Vermont law designed to prevent data mining unconstitutional. The Vermont Prescription Confidentiality Law at issue...more

Healthcare Legal News - July 27, 2011 • Volume 1, Number 1

In This Issue: - ENFORCEMENT ACTIONS AGAINST MANAGEMENT OF HEALTHCARE PROVIDERS By Ralph Levy, Jr. - HEALTHCARE IT NEWS A PARTIAL MEANINGFUL USE REPRIEVE By Tatiana Melnik - CMS ANNOUNCES CHANGES IN...more

Supreme Court Strikes Down Vermont Prescriber Data-Restriction Law

On June 23, 2011, the United States Supreme Court struck down Vermont’s law restricting the sale, disclosure, and use of pharmacy records that reveal the prescribing patterns of individual physicians. Vermont and other states...more

Health Headlines - June 27, 2011

In This issue: - United States Supreme Court Strikes Down Vermont Prescription Confidentiality Law - “Fighting Fraud To Protect Taxpayers Act Of 2011” Would, If Enacted, Change The Dynamic Of False Claims Act...more

Increased FDA Regulatory Action: The Current Landscape and Its Impact on Drug and Medical Device Litigation

The Food and Drug Administration (FDA) has a number of tools to enforce its laws and regulations. From warning and untitled letters to seizures, recalls, injunctions, monetary penalties and criminal prosecutions, its options...more

Electronic Privacy Information Center, et al., v. Janet Napolitano, et al.,

Initial Brief For Respondents

DHS Files Brief in EPIC Airport Body Scanner Case The Department of Homeland Security has filed its answer brief in EPIC's suit to suspend the agency's controversial airport body scanner program. EPIC filed its opening...more

Mary Scott Doe et al. v. President Barack Hussein Obama et al.

Reply Brief of Appellants

In the consolidated appeal of two judgments dismissing the plaintiffs' complaints for lack of standing, plaintiffs-appellants argue that the plaintiff human embryos have standing, as human beings,to challenge the...more