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Public Policy

The Drones are Coming! FAA Releases Proposed Rule on Small Unmanned Aircraft Systems

OFW Law News, Public Policy, USDA /

Mention the word “drone” and most people think of our nation’s military activities in the Middle East. However, over the last few years, unmanned aircraft is finding its way into new civilian applications. Small drones, which are also known as unmanned aerial vehicles (UAVs) or small Unmanned Aircraft Systems (sUAS), when equipped with sophisticated cameras, can […]

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Privacy Update: White House Drops Draft Consumer Privacy Bill . . . Splat!

Health Care, Public Policy /

The White House (via the Department of Commerce) has released a “discussion draft” of consumer privacy legislation intended to codify President Obama’s 2012 Consumer Data Privacy In A Networked World: A Framework For Protecting Privacy And Promoting Innovation In The Global Digital Economy.  The 2012 Framework included a Consumer Privacy Bill of Rights and called

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Drug Supply Chain Security Act – What’s Next? A whole lot.

FDA, Health Care, Public Policy /

The passage of the Drug Supply Chain Security Act (DSCSA) in November 2013 led to a very busy 2014 as FDA and manufacturers, wholesale distributors, and dispensers began the statute’s complex 10-year implementation.  2015 promises to be equally busy. A Surge Of Activity At Year-End In 2014 2014 closed in a flurry of DSCSA action. 

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Statement by Senator Bob Dole on Nutrition Report

Health Care, Public Policy, USDA /

Contact: Marshall Matz (202) 789-1212; mmatz@ofwlaw.com or Marion Watkins (202) 654-4863; marion.watkins@alston.com “As co-author with Senator George McGovern of the original 1977 ‘Dietary Goals for the United States’ report, I commend the USDA, HHS and its Dietary Guidelines Advisory Committee for continuing to focus attention on human nutrition.  The Committee’s recently-released report notes the staggering numbers of

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Global Child Nutrition Foundation to Honor Secretary Vilsack on April 16th

Public Policy, USDA /

The Global Child Nutrition Foundation is proud to announce Secretary of Agriculture Tom Vilsack as the recipient of the 2015 Gene White Lifetime Achievement Award for Child Nutrition. Please join the Global Child Nutrition Foundation (GCNF) and its partners in honoring Secretary Vilsack for his remarkable achievements in child nutrition at GCNF’s Annual Gala Reception. Now

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Dr. Nina Fedoroff Joins OFW Law as Senior Science Advisor

FDA, OFW Law News, Public Policy, USDA /

We are pleased to announce that Dr. Nina Fedoroff, a renowned plant molecular biologist, has joined OFW Law as Senior Science Advisor focusing on agriculture policy, global food security and government affairs.  The former Science and Technology Adviser to the Secretary of State, Dr. Fedoroff has long been involved in regulatory issues surrounding genetic modification of organisms (GMOs)

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Gas Tax

Public Policy, USDA /

How many of you out there think that we would be well-advised to spend some money repairing our roads and bridges? What about our locks and dams and seaports that carry our grain to countries around the world? Are you aware that our Federal Highways Trust Fund will be running out of money this spring?

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114th Congress – What to Expect in Ag and Food

EPA, FDA, Public Policy, USDA /

As the 114th Congress begins in earnest, there is rough sledding ahead this winter over the gulf between the governing philosophies of the President and the new Congress. Not to belabor the obvious, but early indications are that Republican victories have altered the President’s willingness to deal only very modestly, if at all.  With just

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A Flurry of End-of-Year Activity from FDA on Food

FDA, Public Policy /

In what seemed like a bit of end-of-year housekeeping, FDA issued a series of minor guidance documents, notices, and other regulatory paraphernalia related to food.  Coming in under the wire in 2014 were: A notice requesting nominations for non-voting industry representatives to the Food Advisory Committee. Nominations are due by January 7, 2015.  FDA is

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2014 And 2015

FDA, Public Policy, USDA /

As we say goodbye to 2014 and welcome 2015, it’s time for a little backward and forward looking. Here’s what we saw in the 2014 rear view mirror in our little corner of the Universe devoted to the regulatory aspects of foods, drugs, medical devices, agriculture, and the like. In January, the Food and Drug

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Fred Branding headshot

FDA’s Draft Guidance On DSCSA Preemption Misses The Mark

FDA, Health Care, Public Policy /

In a flurry of end-of-year activity, FDA recently issued a Draft Guidance on the express preemption provisions in §585 of the FDC Act, added last year by the Drug Supply Chain Security Act (or DSCSA). FDA, the pharmaceutical supply chain, and other stakeholders have been working very hard to implement the DSCSA as quickly as

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Congress Approves Agriculture, FDA Funding as Part of Consolidated Appropriations Act of 2015

FDA, Public Policy, USDA /

Congress has completed action on the Consolidated Appropriations Act of 2015 (the Act), which funds eleven of the twelve regular Appropriation bills through September 30, 2015, the balance of fiscal 2015.  Funding for the Homeland Security bill is provided under a Continuing Resolution through February 27.  The House approved the Act on Thursday, December 11,

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GMO Hearing

FDA, Public Policy /

Yesterday, the House Energy and Commerce Subcommittee on Health held a hearing to examine FDA’s role in the regulation of genetically engineered foods (commonly, but inaccurately, referred to as “genetically modified organisms” or “GMOs”).  Congressman Mike Pompeo’s (R-KS) Safe and Affordable Food Act (H.R. 4432), which would preempt state GMO labeling laws and require labeling only

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Free Webinar on Big Data and Unmanned Aerial Vehicles

EPA, Public Policy, USDA /

OFW Law’s John Dillard will be kicking off this year’s Ohio Food, Agriculture and Environmental Law Webinar Series with a discussion on two cutting-edge topics affecting agriculture: agricultural drones and “big data.” Mr. Dillard’s webinar will provide a brief primer on the current and potential applications for drone technology in agriculture. He will also discuss

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Webinar Tomorrow: What Dispensers Need to Know About the Drug Supply Chain Security Act

FDA, Health Care, Public Policy /

A Complimentary Webinar Presented by OFW Law’s Tish Pahl and the Food Marketing Institute Thursday, December 4th, 2014 3:00 pm – 4:00 pm US/Eastern Please join FMI on a webinar with Tish Pahl —Under the Drug Supply Chain Security Act (DSCSA), beginning January 1, 2015, manufacturers, wholesaler drug distributors, and repackagers, must provide transaction data

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The DSCSA Standards Guidance is here!

1 Comment / FDA, Health Care, Public Policy /

This morning, FDA met another of its milestones in implementing the Drug Supply Chain Security Act (DSCSA) and posted a Draft Guidance, DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information.  FDA is to be commended for both getting the Draft Guidance

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FDA Shares the Pain in Final Rules on Menu Labeling and Vending Machine Food Labeling

1 Comment / FDA, Public Policy /

Citing the obesity epidemic and the fact that Americans consume about one-third of total calories in the form of foods prepared outside the home, FDA yesterday issued two sweeping  final rules on nutrition labeling of foods sold in chain restaurants and similar retail food establishments and vending machines. There had been considerable controversy over how

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Stewart Fried headshot

Celebrating 35 Years of Success: USDA Practice Team

OFW Law News, Public Policy, USDA /

Recently, Olsson Frank Weeda Terman Matz, P.C., otherwise known as “OFW Law,” celebrated 35 years of business with colleagues, family, friends and clients.  We were extremely proud to share this milestone with those who have helped make OFW Law one of the leading firms practicing USDA and FDA law today. Although OFW Law has expanded

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Consumer-Directed Promotions About Prescription Drugs: A Look Back at Print and TV Communications

FDA, Health Care, OFW Law News, Public Policy /

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part VI) By Tish Eggleston Pahl 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 throughout the years.  Parts I, II, III, IV and V focus on

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Feed the Future: A Bipartisan Opportunity

Public Policy, USDA /

By Marshall L. Matz, as published in Agri-Pulse The “Feed the Future” initiative is aimed at improving agriculture productivity and economic development around the world. Bipartisan legislation has been introduced in the both the House and Senate to make this discretionary program permanent. The legislation (H.R. 5656; S.2909) has the support of private sector corporations as well

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GMPs Have Long History That Precedes Application In Medical Products

1 Comment / FDA, Health Care, OFW Law News, Public Policy /

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part V) By Neil P. Di Spirito 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 throughout the years.  Parts I, II, III, and IV focused on

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26 Years, With 9 To Go…. 35 Years to Prescription Drug Traceability

2 Comments / FDA, Health Care, OFW Law News, Public Policy /

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part IV) By Tish Eggleston Pahl 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 throughout the years.  Parts I, II, and III focused on Hatch-Waxman, medical

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

FDA, Public Policy, USDA /

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 the current science on nutrition

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John Block headshot

The Realized Benefits of User Fees

3 Comments / FDA, Health Care, OFW Law News, Public Policy /

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part III) 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 throughout the years. Parts I and II focused on Hatch-Waxman and medical privacy laws, while

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