Health Constitutional Law

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FDA Holds Hearing on Off-Label Communications

After several high-profile defeats in both district and circuit courts involving the off-label promotion of regulated products and the First Amendment, the U.S. Food and Drug Administration (FDA) is now engaged in a...more

Five Important Themes to Watch in the Reform of FDA’s Off-Label Communications Policy

As we’ve previously reported, FDA has recently been forced to reexamine its legal position and enforcement policies related to drug and device manufacturers’ off-label communications. Although the Agency has for years...more

Guest Post – The FDA’s Two-Day Meeting on Manufacturer Off-Label Communications

Today’s guest post is by Liz Minerd, a Reed Smith associate, who closely followed the online feed of the recent FDA meeting that the Agency called to discuss what changes would be appropriate in its off-label promotion...more

Ninth Circuit Considers Limits to DEA Access to Oregon PDMP

On November 7, 2016, the US Court of Appeals for the Ninth Circuit heard arguments in Oregon Prescription Drug Monitoring Program v. United States DEA, No. 14-35402 (9th Cir. 2016). Here, the Drug Enforcement Administration...more

FDA Says BPCIA Poses No Fifth Amendment Taking for Innovator Biologics Submitted Prior to Its Enactment

On the same day that FDA approved the first biosimilar of Humira, the fourth biosimilar to be approved in the U.S., it also denied a citizen petition filed by Abbott Laboratories (now AbbVie) requesting that FDA not accept...more

TCPA Update - October 2016

We are pleased to present the latest edition of Monthly TCPA Digest, bringing you insights on TCPA regulatory and legislative updates, class action developments, and trends. If you have suggestions for content you would like...more

Religious Institutions Update: October 2016

Timely Topics - The final rule implementing Section 1557 of the Patient Protection and Affordable Care Act (ACA) was issued by the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) on May...more

Requiring A Flu Shot Over Religious Objections: Risky Business

It’s flu season and many employers, particularly those in healthcare, want to require employees to be vaccinated to minimize the spread of illness. But what happens when an employee refuses on religious grounds?...more

Upcoming FDA Public Meeting on Speech and Medical Products

As a reminder, the Food and Drug Administration (FDA) is holding a two-day public meeting on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” ...more

Update on Prosecution for Truthful Off-Label Promotion

We have been following issues related to the interplay of off-label use, manufacturer statements about off-label use, the First Amendment, and FDA enforcement for a long time. (Like here, here, and here, among many posts.) ...more

Watching SCOTUS – ERISA Church-Plan Exemption Revisited

Seyfarth Synopsis: Currently before the Supreme Court are two petitions regarding the thorny legal question of which organizations can qualify for ERISA’s Church-plan exemption. If the Supreme Court grants certiorari and...more

Off-Label Promotion And The First Amendment Updates

Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and whether it comports with First Amendment free speech principles—persist....more

South Carolina Court Decides Key Health Care Case - Physical therapists win in employment lawsuit

The South Carolina Supreme Court has decided a case with great significance in the health care industry. The court overturned a ban on physicians employing physical therapists and gave guidance regarding how state agencies...more

FDA Announces Public Hearing on Off-Label Communications; Registration Deadline October 19, 2016

The US Food and Drug Administration (FDA) will hold a public hearing on November 9 and 10, 2016, to obtain input on manufacturer communications regarding unapproved uses of approved or cleared medical products (off-label...more

California Ballot 2016: Pros and Cons of Props 57-61

This is the second post in our California Ballot 2016 series – providing the “nutshell” versions of each of the 17 state-wide measures voters must decide in November. Please refer to our first post in the series: Props 51-56,...more

FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more

"Privacy & Cybersecurity Update - August 2016"

In this edition of our Privacy & Cybersecurity Update, we highlight guidance issued by the Irish data protection authority regarding the use of location data, as well as the FTC's request for comment on its Standards for...more

HHS Wins Summary Judgment Against Hospitals Disputing CMS’s Treatment of Part C Days as Days “Entitled to Part A” for Purposes of...

On August 17, 2016 the United States District Court for the District of Columbia granted summary judgment in favor of HHS in a dispute over whether Part C days can be treated as “days entitled to benefits under Part A” for...more

Texas Medical Board’s Appeal Must Proceed Under Existing Jurisdiction Arguments

In another procedural defeat for the Texas Medical Board (the “Board”) over its embattled telemedicine rule, last week, a federal judge held that the Board waited too long to request certification of appeal to the Fifth...more

Plaintiffs Cannot Bring Data Breach Lawsuits Without Evidence That Information Will Be Used To Harm

The latest development in how American courts will handle the standing question for data breach class actions came last week when the U.S. District Court for the District of Columbia dismissed for lack of standing a putative...more

A Favorable, New Climate for Challenging Medicare Appeals

Over the past decade, health care providers seeking to challenge Medicare claim denials have faced increasing delays in reaching what many consider the most important step in the Medicare appeals process - a hearing before an...more

Off-Label Marketing – Industry Groups Step into the Breach

We have been waiting, literally for years, for the FDA to revise, clarify, update, or simply pay attention to, its off-label promotion regulatory position in light of repeated governmental First Amendment losses in Sorrell v....more

Health Update - July 2016

The Vulnerability of Healthcare Information - According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more

Department of Justice Imposes Almost 100% Increase in Minimum and Maximum Monetary Penalties Under FCA

On June 30, 2016, the U.S. Department of Justice (“DOJ”) announced an interim final rule almost doubling per-claim penalties under the False Claims Act (“FCA”). The FCA still imposes treble damages for government losses in...more

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