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
The Realized Benefits of User Fees Read More »
Phil: Rick, it’s hard to believe that 35 years have passed since we started this firm as a two-lawyer shop in 1979. Rick: It sure is. I remember working with you at the law firm I joined fresh out of the University of Michigan Law School, and which you had joined several years earlier out
Phil Olsson and Rick Frank on 35 Years of Life at OFW Read More »
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,
U.S. Congress — Both Chambers are controlled by Republicans: What now? Read More »
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
Anticipating Committee Changes in the 114th Congress Read More »
At last – the mid-term election is behind us. President Obama had said that although he was not on the ballot, his policies were. The nation’s voters repudiated those policies. Republicans were voted in and Democrats voted out. Some races are still in dispute, but Republicans have already secured more than enough new Senate seats
John Block: Mid-Term Elections Read More »
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
HIPAA Comes of Age… Thanks to HITECH, D.D.S. Read More »
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:
Climate Smart, Sustainable Agriculture Read More »
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
Thirty Years of Hatch Waxman Read More »
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
By John R. Block, as published in the Des Moines Register Every day millions of shoppers are paying out as much as 50 or 100 percent more to buy organic foods for themselves and their families. I have friends who make these choices because they have no reason to question claims on labels, in advertising and
Consumers are Misled About Organic Safety Read More »
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
Happy Birthday, Hatch-Waxman! You’re a mature 30-year old now, a regular adult. Some personal musings on my stroll down the Hatch-Waxman Memory Lane over the past 30-plus years follow. A small background digression: For those of you in the FDA regulatory arena who are real newbies or who have been in a Rip Van Winkleoid
Hatch-Waxman Turns 30 – A Stroll Down Memory Lane Read More »
“…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
White House U.S.-Africa Leaders Summit: Agriculture Prospective Read More »
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
By Marshall Matz, as published in the Des Moines Register Next month President Barack Obama is hosting an Africa summit with heads of state and corporate chief executive officers. The timing is excellent. Africa’s unique green revolution, with its focus on smallholder farmers, is now moving beyond the tipping point. And as smallholder farmers make
Farming’s transformation starts to change Africa Read More »
Today, I want to talk to you about the deficit – not the dollar deficit. That’s for another day. I want to talk about the deficit of action, the deficit of responsibility. The U.S. Congress and the President have failed the people. The end of this fiscal year is fast approaching and the Congress (once
John Block: Getting Nothing Done Read More »
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.
OFW Law Celebrates 35 Years of Successes: Food/Dietary Supplements Practice Team Read More »
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
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
The Next Dietary Guidelines Debate Read More »
The great battle for the 2014 Farm Bill is thankfully over, but that hasn’t stopped the U.S. Congress from continuing to tinker with Federal Crop Insurance. Most recently, in late May, the House and Senate Appropriations Committees each voted to report their versions of bills to fund USDA in fiscal 2015, and each took the
Crop Insurance Appropriations – A Clue for the next SRA? Read More »
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
On behalf of OFW Law’s Agriculture practice group, here is a copy of our new newsletter. We hope you find it useful. To receive this periodic newsletter by e-mail, please contact Carrie Morgan at [email protected].
Regulatory Round-Up Newsletter, Spring 2014 Read More »
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
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
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
Fishy Fishy – MOU between FSIS and FDA to Improve Interagency Cooperation Read More »
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
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),
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
As Vermont Goes….? GMO Labeling Becomes the Law in Vermont Read More »
We are pleased to announce that Edward J. Farrell, Esq., an expert on international trade, customs and agriculture matters, has joined OFW Law as a Principal. Please click the announcement, below, to enlarge it.
Edward Farrell, Esq., Joins OFW Law Read More »
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
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
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
Global Food Security Read More »
Last week’s headlines announced the arrival of higher food prices with more increases to come because of widespread drought in California and Texas. Talk of climate change and its effect on food production in some circles has taken on a new sense of urgency. But among all the handwringers, one common characteristic stands out. They
Food Security from the Tractor Seat Read More »
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
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
