Public Policy

U.S. Congress — Both Chambers are controlled by Republicans: What now?

What now?  The answer is quite a lot. It remains to be seen whether the change-over in the U.S. Senate, putting both chambers of Congress in the hands of Republicans, will do anything to alter the modus operandi of the Obama presidency — which means the President’s willingness, or unwillingness, to roll up his sleeves,

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Anticipating Committee Changes in the 114th Congress

Every new Congress brings changes in committee membership and sometimes in committee leadership.  The 114th Congress will follow this pattern, and will bring very significant changes as a result of the new Republican majority in the Senate.   Republicans will have more seats on every Senate Committee, and Democrats fewer.  Newly elected Senate and House members

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HIPAA Comes of Age… Thanks to HITECH, D.D.S.

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part II) In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to share some highlights from throughout the years.  Part I focused on Hatch-Waxman.  Today’s blog focuses on the development

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Climate Smart, Sustainable Agriculture

By Marshall L. Matz and Peter B. Matz, as published in Agri-Pulse On September 29, the United Nations’ Food and Agriculture Organization (FAO) Director-General José Graziano da Silva issued a call for climate smart agriculture and a “paradigm shift towards sustainable agriculture and family farming.”  It is a theme we have seen in a number of recent reports by leading organizations, including:

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Thirty Years of Hatch Waxman

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part I) Since its inception in 1979, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practices have focused on myriad regulatory issues arising under FDA and broader HHS jurisdiction.  We advise clients on matters ranging from Hatch-Waxman and generic drug marketing exclusivity

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John Block Reports: Dietary Guidelines for Americans 2015 Edition – Losing It’s Way on Caffeine (Part I)

This week, OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block. There are a variety of disturbing questions surrounding the Dietary Guidelines for Americans now being drafted for release in 2015. The questions relate to whether the Dietary Guidelines Advisory Committee should focus its review and recommendations on scientific advances in

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What to Do After I Filed My Comment on FDA’s Proposed “Nutrition Facts” Labeling Regulations

Don’t sit back and wait: Be proactive! The comment period for FDA’s proposed regulations revising the “Nutrition Facts” label has closed.  The comment period has also closed for FDA’s proposed rule that would lead to more than 30 new serving sizes for foods.  This is a big deal because the nutrient content information that appears

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White House U.S.-Africa Leaders Summit: Agriculture Prospective

“…agriculture development is critical, because it’s the best way to boost incomes for the majority of the Africans who are farmers, especially as they deal with the impacts of climate change…”  President Obama, August 5, 2014 What is the White House U.S.-Africa Leaders Summit? The first ever U.S.-Africa Leaders Summit took place on Monday, August

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Salt

What should we be eating? We are getting hammered from every angle about what is good for us versus what is bad. Too many carbs, stay away from red meat, don’t trust GE foods, sugar will make you fat. The government wants to regulate. We have been through this before but never with the intensity

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OFW Law Celebrates 35 Years of Successes: Food/Dietary Supplements Practice Team

Thirty-five (35) years ago, the Washington, DC law firm presently known as Olsson Frank Weeda Terman Matz PC, or simply “OFW Law,” originated as Olsson and Frank, P.C.  It was comprised of two (2) founding attorneys, Philip C. (Phil) Olsson and Richard L. (Rick) Frank, who left another DC law firm to start their own. 

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Supreme Court Holds FD&C Act Does Not Bar Competitor Food Label Challenges under the Lanham Act

By Michael J. O’Flaherty and Stewart D. Fried In a recent opinion delivered by Justice Kennedy (with Justice Breyer recused), the U.S. Supreme Court unanimously held that competitors may bring Lanham Act claims challenging food labels, even if such labels technically comply with regulations promulgated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and

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The Next Dietary Guidelines Debate

By Marshall L. Matz and Nathaniel B. Fretz, as published by Agri-Pulse There is a new question surrounding the Dietary Guidelines for Americans now being drafted for release in 2015. The question is whether the Dietary Guidelines Advisory Committee should continue to focus their review and recommendations on scientific advances in nutrition and diet or should they venture

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Following the Money: House And Senate Appropriations Release Draft Bills & Reports Funding FDA For FY 2015

The House and Senate Appropriations Committees with oversight of FDA have been very busy. Both voted out draft bills for FY 2015 that include appropriations for FDA and released draft reports.  Roger Szemraj and the rest of our government relations practice have scoured the draft bills and reports looking for insight into what FDA drug-related activities

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Organic Confusion

By Marshall L. Matz, as published in Agri-Pulse Organic foods are “in.”  Analysts estimate that U.S. organic food sales have reached $35 billion, or over 4% of all the foods consumed at home.  While that means 96% of the foods we consume are not “USDA Organic,” 4% is statistically significant.   Produce and dairy are the top two

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Senate Ag Appropriations Subcommittee Reports FY 2015 Bill Without Amendments–Discretionary Spending Allocation Lower than Amount Provided to House

The Senate Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Subcommittee also voted today by voice vote to approve its draft FY 2015 bill and report it to the full Senate Appropriations Committee.  The full Committee is scheduled to consider this bill on Thursday, May 22.  Neither the bill text nor the

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Fishy Fishy – MOU between FSIS and FDA to Improve Interagency Cooperation

There have been on-going questions regarding the regulatory oversight of catfish inspection.  To address this concern, the 2014 Farm Bill required the Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) to create a Memorandum of Understanding (MOU) to “improve interagency cooperation on food safety and fraud prevention and to maximize

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House Agriculture Appropriations Subcommittee Reports FY 2015 Bill Without Any Amendments

The House Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Subcommittee today voted  by voice vote to approve its draft FY 2015 bill and report it to the full House Appropriations Committee.  The full Committee is expected to consider this bill on Thursday, May 29, with the goal of having the bill

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For Drought-Hit Farmers, USDA’s Federal Crop Insurance Can Help, But Only If You Understand the Rules

The severe drought that had plagued the American Southwest over the past three years – the worst in modern memory – has taken a toll on many local businesses, taxpayers, and homeowners, but among its worst casualties have been American farm producers. USDA’s Federal crop insurance program, run by the Federal Crop Insurance Corporation (FCIC),

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As Vermont Goes….? GMO Labeling Becomes the Law in Vermont

Vermont has become the first state in the nation to enact a law requiring labeling of genetically engineered foods.  (Connecticut and Maine has enacted labeling laws, but their laws do not go into effect unless a critical mass of neighboring states enact similar requirements.)  On April 23, 2014, the Vermont state legislature passed H.112 requiring

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Food Stamp Vendors Face Increased Eligibility Requirements and Oversight Following Implementation of Farm Bill’s SNAP Provisions

The 2014 Farm Bill contains several important provisions which will impact retail stores that participate in the USDA Food and Nutrition Service’s (FNS) Supplemental Nutrition Assistance Program (SNAP).  The key changes for food stamp vendors include an increase in the minimum number of staple food items that stores must carry on a continuous basis, that

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FDA/ONC/FCC Health IT Report Signals Possible Deregulation of Certain Software Medical Devices

Has the U.S. Food and Drug Administration (FDA) opened the door to deregulation of certain software medical devices?  Its recently issued Health IT Report seems to indicate so, and FDA is seeking comments on the report.  Now is the time to weigh in on what FDA ultimately should do. Federal law enacted by Congress in

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Global Food Security

By Marshall L. Matz, as published in Agri-Pulse Agriculture is a business, a very big business.  Whether you look at net farm income, agriculture exports or the number of people employed in the farm and food value chain, agriculture is big business by any criteria. As the Old Testament tells us, however, agriculture is more than just

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U.S. Supreme Court Extends Sarbanes-Oxley Whistleblower Protection to Employees of Privately-Held Companies

On March 4, 2014, the U.S. Supreme Court ruled in Lawson v. FMR LLC, No. 12-3 that “whistleblower” protection under the Sarbanes-Oxley Act of 2002 extends to the employees of a public company’s private contractors and subcontractors. The Sarbanes-Oxley Act was enacted in the wake of the Enron scandal largely to protect investors in public companies

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GE To The Rescue

It’s not new news to report that genetically engineered (GE) products are under assault. We are in free trade talks with Europe. The EU public is adamantly opposed to GE food. There are bills in 23 of our state legislatures to label foods that contain GE products. The naysayers have a loud voice. However, you

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