Newest FDA Newsletter from AGG

Once a month, AGG’s terrific FDA team publishes a newsletter updating readers on the latest regulatory news affecting food/drug companies–including those from Ireland and Northern Ireland. The August newsletter is here and has several updates of interest for Irish and Northern Ireland life sciences companies operating, or looking to operate, in the US: (i) additional discussion of the Amarin off-label promotion case; (ii) guidance for data-driven medical device companies on implementing effective data security and privacy measures; and (iii) potential changes that could streamline 510(k) medical device reviews at FDA.

PHARMACEUTICALS

Another One Bites the Dust: FDA Doesn’t Like the Fishy Smell of the Latest Court Decision on Off-Label Dissemination
By: Alan G. Minsk and William H. Kitchens

The Food and Drug Administration has lost yet another court decision challenging its ability to restrict a company’s commercial free speech rights. To quote the rock band Queen, Another One Bites the Dust. In the most recent court decision, a U.S. District Court granted a drug company’s preliminary injunction to prohibit FDA from taking enforcement action against the company’s distribution of information about an unapproved use of its FDA-approved product. We have summarized the facts of the case, highlighted key elements of the 70-page decision, and offered several observations. More >

MEDICAL DEVICES

Six Ways for Data-Driven Medical Device Companies to Implement Effective Privacy and Security Measures
By: Kevin Coy and Andrew B. Flake 

The increasing amounts of health information being generated, stored and collected have heightened the special risks medical device manufacturers have long faced. In addition to the nexus to patient health and safety, if a manufacturer does not address data privacy and security, it could face a wide range of regulatory consequences from multiple agencies. Hacks are a major risk, as is intellectual property theft. So what should a medical device manufacturer take into account when it comes to privacy and security safeguards? This article offers some best practices and insights for the medical device manufacture who is handling health information. More >

NEWS FROM WASHINGTON

FDA Issues Guidance to Streamline Review of 510(k) Submissions. A Clear Path Forward?
By: Alan K. Parver  


On August 4, 2015, the Food and Drug Administration’s Center for Devices and Radiological Health released a new guidance document intended to provide applicants with clear and consistent guidance in the submission and initial intake evaluation process of 510(k) submissions. It explains the procedures and criteria that FDA will use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and whether it will be accepted for substantive review. More >

OTHER NEWS

Key Ruling In False Claims Act Case Could Have Important Implications For Defendants
By: Aaron M. Danzig and J. Ryan Hood

A recent decision of a United States District Court in Alabama may signal that the playing field traditionally dominated by the government will no longer be so one-sided against providers defending against False Claim Act (“FCA”) claims. In United States v. AseraCare Inc., No. 2:12-CV-00245-KOB (N.D. Ala. June 25, 2015) (the “Reconsideration Order”), the Northern District of Alabama affirmed its previous grant of AseraCare’s request for bifurcation, ordering the trial to be conducted in two phases: one phase on the falsity element of the government’s FCA claim, and a second phase on the other elements of the FCA claim and all other claims. That is, the government must first prove an “objective falsehood” in the claims submitted by the defendant before being able to present evidence that the defendant acted knowingly. See Reconsideration Order, pg. 1. In bifurcating the trial, the district court acknowledged the inherent prejudice, jury confusion, and waste of resources caused by allowing the government to present evidence of general corporate practices unrelated to specific patients before a determination has been made as to whether the claims in question are, in fact, false claims. Id. at 5. More >

Necessary Ingredients for Sound Legal Holds
By: Scott A. Wandstrat

Whenever e-discovery and healthcare litigation and investigations come up, you can almost always count on the topic to include a discussion of sanctions. That’s not an accident. There has been an uptick in both the volume of filings asking for discovery sanctions and orders granting those requests. And, for better or for worse, these trends don’t seem to be at risk of abating. More >

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Arnall Golden Gregory LLP | Attorney Advertising

Written by:

Arnall Golden Gregory LLP
Contact
more
less

Arnall Golden Gregory LLP on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide