For The Defense, November 2012 - DRI Today
For The Defense, November 2012 - DRI Today
For The Defense, November 2012 - DRI Today
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son, 535 U.S. at 375. Furthermore, since<br />
the FDA probably could achieve the narrowly<br />
stated goal of encouraging manufacturers<br />
to seek approval for all indications<br />
through less restrictive means, the regulation<br />
and policies articulated in the FDA<br />
draft guidance may only await a constitutional<br />
challenge by a manufacturer on First<br />
Amendment grounds.<br />
Conclusion<br />
<strong>The</strong> FDA’s stated mission is to ensure that<br />
all drugs and devices are safe and effective.<br />
This is a noble goal which no drug manufacturer,<br />
physician, or patient could find<br />
fault with. However, the FDA’s prohibition<br />
on off- label marketing and the recent Guidance<br />
clarifying its policy on responding to<br />
unsolicited requests for off- label information<br />
do little to advance that goal. <strong>The</strong> net<br />
result of recent policy announcements will<br />
be that drug manufacturers are too constrained<br />
and fearful to provide truthful<br />
and valuable information about off- label<br />
uses, even in the limited instances when<br />
the Guidance provides an opportunity to<br />
do so. Consequently, doctors may not be<br />
fully informed and patients may not receive<br />
the latest innovative therapies. It is time for<br />
the FDA to rethink their policy towards offlabel<br />
marketing, and recent First Amendment<br />
jurisprudence suggests the courts<br />
may be willing to do it for them upon the<br />
appropriate challenge.<br />
Greater, from page 29<br />
and volunteer to get involved. I think that<br />
you will find this committee to be one of<br />
the most energized committees in <strong>DRI</strong>. I<br />
have known some of these people for 27<br />
years, and consider many of them to be<br />
close friends.<br />
Every committee chair should have a<br />
vice chair as fantastic as Patrick Sweeney.<br />
Pat is great to work with. Our Law Institute<br />
representative is Paul Lavelle. I have<br />
known Paul for decades. Paul takes his<br />
job with the Law Institute extremely seriously<br />
and really encourages this committee<br />
to improve with each year. When you<br />
see the programs and the quality of the<br />
speakers that we have, think of all the hard<br />
work that Paul Lavelle put into the programming,<br />
and understand that Anne Talcott<br />
and James Weatherholtz have worked<br />
nights and weekends to put this next seminar<br />
together.<br />
I have a great committee. I want to make<br />
it greater. If you ever think of anything that<br />
we can do to improve the committee, please<br />
shoot me an email or give me a call. I look<br />
forward to seeing everyone in April!<br />
2013<br />
Seminar<br />
Schedule<br />
January 24–25<br />
January 31–<br />
February 1<br />
February 28–<br />
March 1<br />
March 13–15<br />
March 20–22<br />
March 21–22<br />
April 3–5<br />
April 10–12<br />
April 24–26<br />
Fire Science and Litigation<br />
FireSky Resort, Scottsdale, AZ<br />
Civil Rights and Governmental Tort Liability<br />
Arizona Biltmore, Phoenix, AZ<br />
Toxic Torts and Environmental Law<br />
<strong>The</strong> Ritz-Carlton, New Orleans, New Orleans, LA<br />
Women in the Law<br />
Eden Roc Renaissance Miami Beach, Miami Beach, FL<br />
Trial Tactics<br />
Paris Las Vegas, Las Vegas, NV<br />
Medical Liability and Health Care Law<br />
Eden Roc Renaissance Miami Beach, Miami Beach, FL<br />
Product Liability Conference<br />
Gaylord National, National Harbor, MD<br />
Insurance Coverage and Claims Institute<br />
Swissôtel Chicago, Chicago, IL<br />
Life, Health, Disability and ERISA Claims<br />
Westin Copley Place, Boston, MA<br />
82 ■ <strong>For</strong> <strong>The</strong> <strong>Defense</strong> ■ <strong>November</strong> <strong>2012</strong>