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MAY 2017

 

Montreux Summer 2017:  On Wednesday, July 26, 2017 at 7:45 a.m. we will hold the joint DD&B/Transportation/Class Actions entitled: From Farm to Table or Felon to Table: FSMA - What is it and what it means for foreign suppliers. An Update on Implementation, Compliance, Litigation and Enforcement.  We will have a dynamic panel to address the new compliance requirements for the rules being implemented and enforced beginning 2016-17.  With a new administration at the helm, it is unclear how the agencies will enforce the new requirements but what is clear is that over 4,000 pages of new rules provide a lot for this multi-section panel to cover.

DD&B Webcast: We are closer to having a date for the webcast on opioids entitled: Opioids – and the Fifth Vital Sign.  This liability issues surrounding this product continue to evolve and our panel will have representatives of industry and FDCC lawyers to outline where we are today, how we got here and what to expect going forward. The so-called “opioid epidemic” has unique enforcement and litigation risks, some of which are playing out in the courts and agencies today and some which are simmering beneath the surface.

On May 9, 2017 the Senate confirmed President Trump’s appointment of Scott Gottlieb, M.D. by a vote of 57 to 42. There are a number of initiatives FDA has underway that might, at long last, see some positive progress.  Not the least of which is FDA’s docket on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products” aka off-label promotion.

 

 

 

 

APRIL 2017


Charleston Winter 2017
: For those unable to attend the Charleston meeting, the Drug Device and Biotech Section had an outstanding panel on off-label promotion that Michael Hurvitz moderated and included FDCC member and former DD&B Chair, Marisa Trasatti, and Jonathan Kahan of Hogan Lovells. The topic and speakers brought us up to date on the more challenging aspects of compliance, enforcement and private litigation related to new uses for medical products. This is a hot topic in our practice area and will remain on the front burner for the foreseeable future.  Among the things to follow include, the effective date for the FDA final rule on Intended Use is extended until March 2018 and April 19, 2017 is the deadline to submit written comments to the FDA on the docket for Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”


Montreux Summer 2017:  DD&B is running a joint program with Transportation and Class Actions entitled: FSMA - What is it and what does it mean for foreign suppliers? An Update on Implementation, Compliance, Litigation and Enforcement.  We have a dynamic panel of speakers and industry representatives to address the new compliance requirements for the rules being implemented and enforced beginning 2016-17. With a new administration at the helm, it is unclear how the agencies will enforce the new requirements. What is clear is that over 4,000 pages of new rules provide a lot for this multi-section panel to cover.

DD&B Webcast: We are in the final planning stages for a webcast on opioids entitled: Opioids – and the Fifth Vital Sign.  This program will have representatives of industry and FDCC lawyers and will outline where we are today,  how we got here and what to expect going forward. The so-called “opioid epidemic” has unique enforcement and litigation risks, some of which are playing out in the courts and agencies today and some which are simmering beneath the surface.

The AMA and the Plaintiff’s Bar:
  In response to the recent DD&B request for members to submit important issues for the DD&B section members to consider, Tim Pratt forwarded letters to the ABA from the House Committee on the Judiciary and the ABA’s response  Both are attached here.

As you can see from the letter we attach to this newsletter, the Judiciary Committee expressed the concern raised in the recent American Medical Association resolution supporting a legislative or regulatory remedy to “[t]he onslaught of attorney ads” that has resulted in “some patients …stopping prescribed medications without speaking to a physician.” The ABA’s response reads like a plaintiffs brief. First, the ABA claims that drugs injure and kill many people each year. Second, the ABA takes the position that it is barred by the First Amendment from imposing rules regulating lawyer advertisements. Third, the ABA already regulates “false and misleading ads” and the attorney advertising is not false or misleading. If the one-sided and fallacious analysis of the First Amendment didn’t convince you of the ABA’s plaintiff oriented agenda, this third issue certainly should.

This is an important issue for the DD&B industry as these ads are directly focusing on our clients. As leaders in the defense bar, we might give serious consideration to lending our voice in response. Please respond to the Section Chair and Vice Chairs with any thoughts, suggestions or recommendations.

more Calendar

6/4/2017 » 6/8/2017
23rd Annual Litigation Management College

6/4/2017 » 6/8/2017
14th Annual LMC Graduate Program

6/12/2017 » 6/13/2017
Deposition Boot Camp

7/24/2017 » 7/29/2017
2017 FDCC Annual Meeting/ Bridging The Gap Insurance Summit

9/17/2017 » 9/19/2017
Corporate Counsel Symposium

Featured Members
Marjorie J. BergerMarjorie is with American Nuclear Insurers in CT
Bradford D. BoxBrad Box is with Rainey, Kizer, Reviere & Bell in TN

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