GLG News by Pharmaceutical Regulation and FDA Experts: Lawyers

James O'ReillyVolunteer Professor of LawUniversity of Cincinnati - CC

Getting a New Food Additive to Market

September 15, 2010

1. Food ingredient companies face substantial exposure for new direct additive materials because of a weakness in FDA's food materials review process.2. After marketing, if the food material is challenged, FDA will walk away and say that the food supplier was told "you're on your own".3. Ultimately food industry efforts will have to be devoted to getting a permanent and workable solution in place.

James O'ReillyVolunteer Professor of LawUniversity of Cincinnati - CC

No Company is Bullet-Proof Against Federal Contractor Risks

June 10, 2008

Analysis of:U.S. sues Honeywell over bullet-proof vests | www.latimes.com

Product liability exposure of new materials makers can be severe, especially with fatal consequences of failures Internal memos re product problems can shoot company in the foot; prudent firms have a plan for controlling open-ended speculative memos in an instant-message environment Major PR and govt. contract risk of "getting it wrong" with new materials under expected stressful conditions makes this a good warning to upstream materials suppliers.

James O'ReillyVolunteer Professor of LawUniversity of Cincinnati - CC

Controversy Bred By Under-Regulation: Are Genes Too Casual?

February 4, 2008

Analysis of:Growth of Genetic Tests Concerns Federal Panel | www.nytimes.com

Recent reports by a federal study panel, addressed in stories in the NY Times and other sources, highlight one more gap between expectations and reality in the resource-starved federal safety net for consumers. Much less is being done to oversee Gene Test kits than consumers may expect; eventually there will be a public outcry when some real harm is documented. This Administration has prided itself on responsiveness to industry's preferences, yet choices to not regulate leave open the federal agencies as well as the industry to a backlash when future harms occur.

Thomas SaundersOf CounselRISSMAN HENDRICKS & OLIVERIO, LLP

RIPENING INHIBITORS: ROSY FUTURE OR BRUISED FRUIT?

December 21, 2007

Analysis of:Current and Potential Commercial Applicationsof the Suppression of Ethylene Action by 1-MCP in Plants | www.rohmhaas.com

    Product shelf-life is a major economic concern for the agricultural industry.   The biological mechanism for regulating the ripening of fruits is mediated by ethylene.     Ethylene  management is addressed in three ways: 1) Ethylene absorption 2) Inhibition of ethylene biosynthesis and 3) Prevention of ethylene receptor signaling.     In the ripening control patent landscape novel cyclopropene compounds function as ethylene receptor blockers.  Of the 60 U.S. patents that have issued, approximately 15 are related to cyclopropenes, while the remaining 45 are more or less evenly distributed between about 20 different ethylene management technologies. AgroFresh Inc., a Rohm and Haas subsidiary, has staked out a significant position in ethylene receptor blocking technology by claiming a wide range of cyclopropene derivatives

James O'ReillyVolunteer Professor of LawUniversity of Cincinnati - CC

Paint Industry Needs Global Lead Settlement Quickly

May 9, 2007

Analysis of:Lead paint industry on the defensive | www.lawyersweeklyusa.com

"Son of Asbestos" claims may sound extreme; but the lead paint makers would be prudent to collectively negotiate and fund a 50-state settlement that follow the tobacco companies' model and avoids the bankruptcy model of the asbestos-using firms. Lead injury awareness has increased and demands for public protection will escalate. Paint and related product industries knew of risks long before the warnings and bans, so their parallels to asbestos defendants are likely to bring juries to similar sized awards. Lobbyists can buy time but not buy peaceful continued business operations. As author of studies on building safety, toxic torts and on product warnings liabilities, I see only a matter of a few years before asbestos-like liabilities will inevitably crush those who don't choose a global settlement of the lead legacy.

Thomas SaundersOf CounselRISSMAN HENDRICKS & OLIVERIO, LLP

Defending Knock-Offs: Head-to-head With Brand Names in Trademark, Copyright, and Internet Marketing

March 1, 2007

Analysis of:Defending Knock-Offs: Head-to-head With Brand Names in Trademark, Copyright, and Internet Marketing | www.iptoday.com

-Name Brands vs, Knock-Offs: Strategies and Counter-Strategies

-Vulnerabilities of Name Brand Copyrights

-Why the internet Knock-Off market will always exist

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