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FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

"FDA Publications Double Down on Agency’s Ability to Prohibit Off-Label Communications, but Narrow Scope of Debate"

On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more

FDA Issues Three Key Documents Relating to Medical Product Manufacturer Communications

On January 18, 2017, the Food and Drug Administration (“FDA”) released three key documents outlining the agency’s current thinking regarding drug and device manufacturers’ communication of information not contained in...more

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

FDA Off-Label Promotion Memo Should Affect §510k Preemption & Evidence

Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k “substantially equivalence” medical device clearance as non-preemptive because it was supposedly “focused on equivalence, not safety”? Id. at...more

Guest Post – Midnight Madness - The FDA Continues To Discount First Amendment Implications Of Restrictions On Off-Label Promotion

This guest post is from Liz Minerd, an associate at Reed Smith. She previously wrote the post on the FDA’s off-label promotion meeting last November, so when she indicated that she’d like to write about the FDA’s “Midnight...more

FDA Defends Its First Amendment Position in “Memorandum”

On January 18, 2017, the Food and Drug Administration (FDA or the Agency) released for public comment a Memorandum, Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding...more

Data Breach Class Action Reinstated Against Horizon Healthcare Services Inc.

The U.S. Court of Appeals for the Third Circuit has vacated a district court's dismissal of a data breach class action filed against Horizon Healthcare Services Inc., in the wake of the 2013 theft of two computer laptops...more

Breaking News – Supreme Court Takes BMS Personal Jurisdiction Case

The United States Supreme Court today granted certiorari in Bristol-Myers Squibb Co. v. Superior Court. Here is a link to the order. The California Supreme Court decision in this case was our worst case for all of 2016. ...more

Obama FDA’s Parting Shot On Off-Label Promotion And The First Amendment

We haven’t digested it yet, so this isn’t a substantive post, but we wanted to make our readers aware that today the FDA made an announcement, which states in pertinent part...more

The Anthem Breach – A Retrospective

Many people and news outlets have opined, weighed in, and informed the public about the 2015 Anthem breach. It is still a hot topic in January 2017, because it currently lines up with other hot stories about hacking ordered...more

The First Amendment Does Not Protect All Off-Label Drug Promotion

FDA is considering making off-label promotion easier, consistent with recent case law. The drug and biologics industry is also proposing an ease up of FDA regulation, which would allow it to “responsibly” promote new drug...more

3D Printing of Manufactured Goods: An Updated Analysis

(NEW YORK) December 15, 2016 – Reed Smith LLP today released “3D Printing of Manufactured Goods: An Updated Analysis,” a comprehensive new white paper that provides in-house counsel and industry leaders with an in-depth look...more

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

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

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

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

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

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

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