FDA On GM Process

For animals and plant based pharmaceuticals-
something to compare with official attitudes towards Marijuana and other herbs

FDA pledges openness on gene-altered products

By RICARDO ALONSO-ZALDIVAR – 9 hours ago

WASHINGTON (AP) — Federal health officials Thursday pledged a new, open process for approving drugs and foods from genetically engineered animals.

Consumer groups complained the policy won't do enough to tell people if they're eating gene-altered animals and fails to protect the environment. They urged the incoming Obama administration to reconsider it.

Genetic engineering, already widely used for crops, is on the threshold of producing animals that can grow faster or even yield drugs that treat human illnesses. Although the potential benefits — and profits — are huge, many individuals have qualms about manipulating the genetic code of other living creatures.

In issuing its long-awaited final policy, the Food and Drug Administration said it will not allow any products from genetically engineered animals to be sold without first submitting them to scrutiny by independent advisers at a public meeting. The government will allow exceptions for research animals, such as lab rats, and the FDA will post those on its Web site.

Genetically engineered — or GE — animals are not clones, which the FDA has already said are safe to eat. Clones are exact copies of an animal. With GE animals, their DNA has been altered to produce a desirable characteristic.

"We will not approve any application until we are convinced of the safety and effectiveness," said FDA biotechnology expert Larisa Rudenko, who has been working on the complex issue since 1989. "The public should rest assured that we are not going to be rushing any decisions."

But consumer groups said the FDA's policy will not require all genetically engineered foods to be labeled as such. And they said the government has not done enough to examine the potential impact of genetically engineered animals on the environment, particularly if some escape and begin to mate with animals in nature.

"They are completely ignoring consumers' overwhelming desire for labeling," said Michael Hansen, a senior scientist with Consumers Union, publisher of Consumer Reports. FDA officials said genetically engineered foods will be labeled if they are different in some important way from natural foods, for example, no-fat filet mignon.

The FDA also failed to require a cradle-to-grave tracking system for genetically engineered animals, said Gregory Jaffe, who heads the biotechnology project at the Center for Science in the Public Interest. He's particularly concerned about animals that are not supposed to enter the food supply chain.

"The FDA has made some small but important changes to increase the transparency of this process," said Jaffe. "It helps, but the devil is in the details."

While not calling for a repeal of the FDA policy, Jaffe urged the incoming Obama administration to work with Congress on a new law that specifically addresses the genetic engineering issue. The FDA based its policy on older laws that apply to animal drugs.

Drugs and foods from GE animals will become increasingly common in the next five to ten years. For example, an FDA advisory committee last week considered approval of an anti-clotting drug produced from the milk of GE goats. The scientific advisers concluded that the drug — ATryn — appears to be safe and effective. A final FDA decision is pending. And a Massachusetts company hopes to win FDA approval this year for a faster-growing salmon.

The biotechnology industry welcomed the FDA's announcement.

"This system will ensure the products made available through this science will go through a rigorous and transparent review process before being approved for the marketplace," said Barbara Glenn, a senior scientific adviser with the Biotechnology Industry Organization.

On the Net:

• FDA policy -: http://tinyurl.com/9l37n9

Criminal Mercantilism For GM - Monsanto

U.S. occupation rule 81 mandating monopoly for GM seeds
over traditional Iraqi seeds

http://thepanelist.com/Opinions/Opinions/The_Real_Victor_in_Iraq%3A_Monsanto_200810281252/

Written by Jeanne Roberts
Tuesday, 28 October 2008

Five years of occupation, more than $558 billion spent, 4,182 U.S. soldiers and 655,000 Iraqi civilians dead, and it now looks like Monsanto (NYSE.MON - $71.95) is going to be the real victor in Iraq thanks to a postwar document known as Order 81.

Part of the infamous 100 Orders, Order 81 mandates that Iraq's commercial-scale farmers must now purchase "registered" seeds. These are available through agribusiness giants like Monsanto, Cargill Corporation (a private company) and the World Wide Wheat Company (also private), but Monsanto is far and away the most significant player in the registered seed market.

Monsanto's seeds are "terminator" seeds. This means they are inherently sterile, and any seed they produce does not give birth to more plants.

The technology behind registered seed is called genetic modification, and genetically modified (GM) seeds supposedly can't reproduce, though "drift," via wind currents and bird consumption, has resulted in a great many instances where GM crops ended up in fields where they were not planted.

A classic example is Canadian farmer Percy Schmeiser, whose canola fields inexplicably sprouted GM varieties from Monsanto. Monsanto promptly sued Schmeiser for patent infringement.

Originally developed to avert world hunger (at least according to Monsanto), these GM crops not only do not produce more than their non-modified cousins, but the herbicide Roundup, developed in tandem by Monsanto to treat GM fields, is becoming increasingly ineffective. This has led to more herbicide purchases among farmers, greater profits for Monsanto, increasingly smaller yields, and greater environmental pollution overall.

Roundup, a glyphosate, is the direct descendant of Agent Orange (also produced by Monsanto), and is especially toxic to marine animals. Glyphosates, known as endocrine disruptors, are being increasingly implicated in neurological disorders, DNA damage and even death. However, as often (and mistakenly) reported, Roundup does not contain pesticide. Pest control is part of the genetic modification of seeds.

In the U.S., these GM varieties of corn, soy and rapeseed may have cost the U.S. economy $12 billion since 1999 in rising farm subsidies, lower crop prices, loss of major export orders and product recalls, according to Britain's premiere organic food
association, the Soil Association.

Contrary to popular belief, farm subsides do not protect small American farmers. They do drive down the profit on crops. In the US, 10 percent of farms receive 75 percent of subsidies, and all these farms are run by agribusiness giants like Monsanto. Exporting GM crops is hampered by the fact that many countries refuse to buy genetically modified crops, including Australia, the EU (except Spain), and Japan. Product recalls, involving the use of GM crops in food products sold to countries where GM food is forbidden, is not only costly but represents an ongoing bone of contention on the world market which hampers international trade relations.

In India, where regional governmental studies show Monsanto's GM cotton producing seven times less than an indigenous variety of cotton, farmers are drinking the toxic chemicals they formerly used to treat their fields in an effort to escape rising debt and poverty. This so-called "suicide by pesticide" is the final solution
for farmers locked into Monsanto contracts that benefit no one but Monsanto.

In Columbia, where Monsanto's RoundUp Ultra has been deployed in the war against drugs (under the name Plan Columbia), local communities and human rights organizations are charging that Ultra is destroying indigenous food crops, water sources and indeed entire protected ecologies in the Andes. Ironically, cocaine production has jumped almost 10 percent since the plan's inception, moving higher
into the mountains and decimating even more remote ecologies.

Monsanto's share of this American taxpayer-funded drug eradication enterprise ($1.3 billion) is more than $25 million. Ultra, a concentrated version of Roundup with added surfactants to increase its toxicity, has been implicated in the deaths of a number of children. DynCorp International (NYSE.DCP - $10.83), the company
doing the spraying, is under contract to the U.S. government.

Order 81, by first forcing Iraq's farmers to use GM seeds, and then by declaring natural seeds an infringement on Monsanto technology, will result in the sorts of tragedies seen elsewhere in the developing world, reducing Iraq's farmers to drinking field-grade herbicides to escape financial catastrophe.

Nor will the Iraqi people benefit in terms of more food. Order 81, mandated under the dystopian title "Plant Variety Protection," turns the agricultural world on its head by defining indigenous crops as invasive and GM crops as uniform and stable. Moreover, the six varieties of wheat developed for Iraq are primarily used in pasta.
Since the Iraqis don't eat pasta, one can only assume these food crops are destined for Western nations, leaving the average Iraqi that much closer to starvation.

Order 81, carefully crafted to look like humanitarian legislation aimed at rescuing a country decimated by half a decade of war, is in fact a Monsanto power play under U.S. government sponsorship. Farmers who do not comply will have seeds, farm implements and even land seized.

The infamous 100 Orders, of which 81 is only an instance, are clearly a ploy to allow multinationals like Monsanto to take over an entire nation. As Iraqi resentment over this privatization grows, expect continued resistance, more deaths, and ultimately a failure of democracy.

And that is perhaps the greatest tragedy of all.
--

Monsanto is a client of the Washington, D.C. law firm of Covington & Burling.

Covington & Burling
1201 Pennsylvania Avenue, Washington, D.C.

1904 - 2004 U.S.D.A.

United States Department of Agriculture:
From Plant Based Drugs
to GMO Plant Made Pharmaceuticals

I have searched in vein for the cir 1904 USDA paper on growing Coca and other drug crops at the USDA library in Greenbelt, Maryland. Apparantly they do not have a copy.

Below is a USDA conference one century later with a panel about the recent development of Genetically Modified Plants for growing patentable pharmaceuticals, and the paper of one of the panel speakers- a food, drug and insurance attorney from the law firm of Covington & Burling, who, according to a letter dated March 1990 by Dr. Arnold Trebach and Kevin Zeese of the Drug Policy Foundation, was "assigned to take primary responsibility for advising the Foundation", as reported here.

“The (U.S.) Food Industry’s View About the Development of Plant-made Pharmaceuticals and Industrials” by Marialuisa S. Gallozzi

Covington & Burling - Bio - Marialuisa Gallozzi

Agricultural Politics of Drug Policy Plenary Panel Proposal

Drug Policy Foundation Was Advised by Covington & Burling Food and Drug Attorney

From my unpublished manuscript "Coca- Forgotten Medicine"

"... We have received valuable advice from Marialuisa Gallozzi, the Covington and Burling associate assigned to take primary responsibility for advising the Foundation. Having Covington and Burling in our corner is a source of great comfort.”

Arnold Trebach and Kevin Zeese, letter dated March 1990

Marialuisa S. Gallozzi (“M.L.”) -- born December 22, 1961[1] – “the Covington and Burling associate assigned to take primary responsibility for advising the [Drug Policy] Foundation” is a partner in the insurance and food and drug practices, admitted to the bar in the New York,1987, and the District of Columbia, 1988 (graduated Harvard University, A.B. cum laude, National Merit Scholar, 1982, and N.Y.U. Law School, J.D. 1986; clerked for Judge Robert G. Doumar E.D. Virginia; subsequently hired at Covington and Burling), according to Covington & Burling’s web site in 2005.

In the insurance area, Marialuisa assists policyholders in settling and mediating coverage disputes and designing insurance portfolios. She works with Bermuda, London Market, U.S. and captive insurers and with a range of traditional and new insurance products. She has extensive experience in asbestos, silica, pharmaceutical and medical device and other coverage claims as well as in insurer insolvencies. Her recent presentations include "Settlement Credits and Excess Insurers" (Mealey's Allocation and Settlement Credits Conference, Nov. 2005) and "Solvent Schemes: Running Off or Running Out?" (Mealey's Advanced Insurance Coverage Conference, Jan. 2006).

Marialuisa is listed in the Guide to the World's Leading Insurance and Reinsurance Lawyers (Euromoney 2004) and The International Who's Who of Insurance & Reinsurance Lawyers. She has co-chaired several Mealey's insurance conferences. In the food and drug area, Marialuisa advises corporations and trade associations on FDA regulation of products including OTC drugs, food, dietary supplements, and medical devices. Her work has involved federal regulation of agricultural biotechnology and plant-based pharmaceuticals.

Her article, "Inactive Ingredients in Over-The-Counter Drug Products", appeared in Regulatory Affairs FOCUS in August 2002. Marialuisa serves as a civil case and child protection mediator in the Superior Court of the District of Columbia. The National Head Start Association named her a 25th Anniversary Star Honoree for her long service to that organization.

The 2004 version, ended with the following line that would be dropped from later versions: “She likes travel, bicycling, photography and cooking”.

Lexis-Nexis lists her practices in these areas of law: Food and Drug Law; Insurance Coverage; Mediation, though without indicating when she entered each.

This 2005 Covington & Burling Marialuisa Gallozzi biography fails to mention her recent paper with regards to agricultural biotechnology and plant-based pharmaceuticals regulation about GMO plants for growing patentable drugs that she is listed as presenting at the U.S.D.A. February 2004 Annual Conference “Ensuring a Healthy Food Supply". She was listed as one of three presenters in a panel “Promise and Pitfalls of Plant-Made Pharmaceuticals And Industrial Compounds,” moderated by Neil E. Hoffman, Director, Regulatory Programs, Biotechnology Regulatory Services, Animal and Plant Health Inspection Service, USDA. Her paper was titled “The (U.S.) Food Industry’s View About the Development of Plant-made Pharmaceuticals and Industrials.” [2] It was only available on the internet briefly in 2004, and of the more then 75 speaker presentations at that 2004 USDA conference, is the only one where both paper and its author are deleted from the later html version of the conference schedule, without replacements.

The firm’s website makes no mention if she has worked in drug policy reform issues, nor the pro bono publico client relationship with the Drug Policy Foundation. The various reports by the Drug Policy Foundation subsequent to 1988-89 report’s March 1990 letter omit any mention of this pro bono publico Covington & Burling/Marialuisa Gallozzi/Drug Policy Foundation connection, nor any other such relationship with any other attorneys or law firms. The description that she was “…assigned to take primary responsibility for advising the [Drug Policy] Foundation” would suggest that any such advice from Covington & Burling to the Drug Policy Foundation, regardless of the physical parties, would be filtered and conceivably decided by her.

The Covington and Burling website (Health page, early 2005) acknowledged that the law firm has worked closely with the Drug Policy Foundation and other organizations involved with drug policy reform:

Commonwealth v. Hutchins. We represent Mr. Hutchins and the interests of similarly situated patients for whom the medical use of marijuana is necessary, in a variety of state and national initiatives aimed at decriminalizing such use. We work closely with the Drug Policy Foundation, the Marijuana Policy Project and sympathetic members of Congress and selected state legislatures. American Civil Liberties Union - Drug Policy Litigation Project. We were asked to assist the ACLU in preparing a letter to the Drug Enforcement Agency in support of an application by a professor at the University of Massachusetts for registration to manufacture or distribute controlled substances for the purposes of a scientific study on medical marijuana. Specifically, they requested that we opine on the consistency of the application with the United States' treaty requirements pursuant to the 1961 Single Convention on Narcotic Drugs. We have continued to provide advice on related aspects of this matter.

[1] Lexis-Nexis search: http://www.lawyers.com/find_a_lawyer/search/atty_profile.php?attyindex=0&firmlid=355425&attylid=355474&attylids=355474&lids=&country=&firmname=&firstname=Marialuisa&lastname=Gallozzi&searchtype=N&termtype=2&personalaop=&personalterm=&businessaop=&businessterm=&language=&pagenum=1&city=&county=&state=&country=&resultcount=&displaycount=&sorttype=&sed=&ts=0 [2]“U.S. Food Industry’s View on the Development of plant-made Pharmaceuticals and Industrials” by Marialuisa Gallozzi is listed in PDF http://www.usda.gov/oce/forum/Archives/2004/Program/2-10final.pdf and other fixed format versions of that conference’s published schedule, with its author’s name appearing with two other panelists, Barry Holtz, CEO, Inflexion Therapeutics, who gave a presentation “Moving Products into the Clinic: The Next Stage of Development for the Plant-made Pharmaceuticals Sector” and Rachel G. Lattimore, Attorney, Arent Fox Kintner Plotkin & Kahn, PLLC, who gave the presentation “Plant-Made Pharmaceuticals Confinement Systems”.

However, later html achieves

http://www.usda.gov/oce/forum/Archives/2004/speeches/speeches.htm#promisepitfall
delete both this paper regarding the topic GMO plants for growing patentable drugs, otherwise known as "Plant Based Pharmaceuticals" or "Plant Made Pharmaceuticals"and its author’s name on the list of panelists- apparently purged, according to a USDA research librarian who could find no way to access this paper. (Other such papers that are not available are nonetheless otherwise still listed along with their authors’ appearance upon their respective panels).

From “The (U.S.) Food Industry’s View About the Development of Plant-made Pharmaceuticals and Industrials” by Marialuisa Gallozzi, viewable here

Mention of this paper was subsequently added in her Covington & Burling biography which appears in the following 2008 version:

Marialuisa ("ML") Gallozzi is a partner in the insurance coverage and food and drug practices.
Her insurance advisory practice focuses on: negotiating settlements of insurance coverage disputes; advising policyholders on the insurance aspects of transactions; negotiating and analyzing terms of policies, including clinical trials, patent and other specialty coverages; and representing policyholders in claims against insolvent and runoff insurers in the United States and abroad, and state guaranty funds. She also provides food and drug advice to manufacturers of medical devices, over-the-counter drugs, and dietary supplements.

Ms. Gallozzi is a managing partner for Legal Personnel at the firm, with responsibility for associate issues. She served as an Associate Ombudsperson and co-chaired the summer associate program from 2004 to 2006.

Representative Matters

• Advised Sotheby's on placement of its E&O coverage.
• Represented a major American food supplier in complex novation transaction involving workers compensation policies.
• Advised a clinical trials organization on coverage under its clinical trials policy.
• Represented a multinational corporation seeking coverage for an employee dishonesty claim involving a foreign subsidiary.
• Represented a medical device manufacturer in dealings with FDA concerning a product recall and subsequent investigation.
• Represented a financial services company in recovering for its property and business interruption losses caused by the September 11 terrorist attacks.
• Negotiated numerous settlements with domestic and foreign insurance carriers securing coverage for silicone breast implant, IUD, heart-valve, asbestos, and environmental claims.

Honors and Rankings

• Chambers USA, leading Insurance - Policyholder lawyer (2007-2008)
• Guide to the World’s Leading Insurance and Reinsurance Lawyers, Legal Media Group/Euromoney (2006)
• The International Who’s Who of Business Lawyers (2007)

Pro Bono

• District of Columbia Superior Court Multi-Door Dispute Resolution Division, Civil Mediator (since 1997) and Child Protection Mediator (since 2004).
• Representation of the National Head Start Association since 1988, 25th Anniversary Star Honoree in 1998.

Publications

• "Climate Change: D&O Issues for Policyholders," The Insurance Coverage Law Bulletin (February 2008), Co-Author
• "Insuring Against Disaster: Coverage for Product Recalls," The Insurance Coverage Law Bulletin (October 2007), Co-Author
• "Climate Change: Issues for Policyholders," The Insurance Coverage Law Bulletin (May 2007), Author
• "Policyholder Alert," Covington E-Alert (1/11/2007), Co-Author
• "London Market Issues: The Formation, Funding and Future of Equitas," Journal of Insurance Coverage (Autumn 2002), Co-Author
• "Representations and Warranties," Environmental Claims Journal (Autumn 2002), Co-Author
• "Inactive Ingredients in Over-the-Counter Drug Products," Regulatory Affairs FOCUS magazine (August 2002), Author
• "Introduction to Environmental Risk Policies," Environmental Claims Journal (Winter 2001), Co-Author

Presentations and Speeches

• "Settlement Credits and Excess Insurers," Mealey’s “All Sums: Reallocation & Settlement Credits” Conference (November 2005)
• "The Food Industry’s View About the Development of Plant-Made Pharmaceutical and Industrials," USDA’s Agricultural Outlook Forum: Ensuring a Healthy Food Supply (February 2004)
• "Insuring Biotech Risks," American Bar Association, Section of Litigation, Insurance Coverage Litigation Committee CLE Seminar (March 2003)

Practices

	Insurance Coverage - Policyholders
	Litigation – Arbitration Mediation & Non-Binding ADR
	Food & Drug

Industries

Life Sciences

Education

• New York University School of Law, J.D., 1986
  • Journal of International Law and Politics, Articles Editor
• Harvard University, A.B., 1982
  • cum laude

Judicial Clerkship

• Hon. Robert G. Doumar, U.S. District Court, Eastern District of Virginia, 1986-1987

Bar Admissions

• District of Columbia
• New York

Languages

• French
• Italian

Covington & Burling - Bio - Marialuisa Gallozzi


http://freedomofmedicineanddiet.blogspot.com/2012/04/about-drug-policy-covington-and-burling.html

http://freedomofmedicineanddiet.blogspot.com/2013/04/more-about-drug-policy-covington.html