How to Legally Import and Market Medical Devices in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP

October 1, 2014, 1:00 p.m. EST

During this webinar, the first of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to successfully and legally import and market a medical device in the U.S. and Canada. Topics will include, among others:

  • Device classification schemes in the U.S. and Canada
  • Marketing authorization mechanisms in Canada and the U.S.
  • Manufacturing controls in both countries
  • Canadian and U.S. labeling and promotional requirements and restrictions
  • Reporting of adverse events in both countries
  • Recordkeeping and reporting requirements imposed by both countries

The webinar will be approximately 40 minutes long with a Q and A session at the end. There is no cost to attend this webinar, but space is limited.

To register for the webinar, please visit www.cvent.com/d/14qf66.

To view or share this information as a PDF, please click here.

About the presenters:

Neil O’Flaherty is a principal at OFW Law, a Washington, D.C.-based law firm, where he has been practicing as a member of the firm’s Medical Device Practice Group for more than 23 years. Neil advises clients from around the world on a wide range of matters relating to the U.S. Food and Drug Administration’s (FDA) regulation of medical devices. Of particular relevance, Neil assists clients with labeling and promotional issues, the development of strategies to bring medical devices to market, pre-submission advocacy, adverse event reporting compliance and other postmarket requirements, and preparation of necessary regulatory filings.

Sara Zborovski is a partner in Davis LLP’s Toronto office and is a member of firm’s Life Sciences and Intellectual Property Groups. Sara assists companies in navigating the regulatory landscape imposed by Canada’s Food and Drugs Act, its related regulations, and their intersection with intellectual property issues. She advocates before all branches of Health Canada on behalf of the medical device, pharmaceutical, biotech, food and beverage, natural health product, and cosmetic industries. Sara works with clients to get products from idea to market while providing advice on approval and marketing strategies.

Hatch-Waxman Turns 30 – A Stroll Down Memory Lane

By Arthur Y. Tsien

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 state in recent times, the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (formally known as the Drug Price Competition and Patent Term Restoration Act of 1984) are the statutory basis for generic drug products sold in the United States today.  FDA can approve a generic drug based on an “abbreviated application” that demonstrates that the generic product is equivalent to the brand or innovator drug product being copied, without repetition of laboratory animal safety studies and human clinical trials that support the approval of the brand drug.  Before Hatch-Waxman, FDA would consider an abbreviated application only for a copy of a brand drug product first approved before 1962.  As a result, very few “generic” versions of most newer brand name prescription drugs were available.

I was working in FDA’s Office of Chief Counsel as a young attorney during the latter part of Hatch-Waxman’s long gestation period.  Although not designated a “drugs” attorney, I was quite familiar with the pre-Hatch-Waxman regulatory landscape by virtue of having worked on several court cases involving “generic” drugs.  This included United States v. Generix Drug Corporation, 460 U.S. 453 (1983), where the Supreme Court in essence upheld FDA’s policy that each “generic” copy of a brand drug had to be approved in its own drug application, rather than being able to take advantage of “old” drug status based on “general recognition” of the active ingredient’s safety and effectiveness.

I joined OFW Law not long after Hatch-Waxman became law.  Our first generic drug client of any consequence appeared soon thereafter.  It was a true shoestring startup operation with perhaps 50 employees, financed by credit card cash advances and operating out of a set of very modest, adjacent buildings of a type typically associated with, say, independent car repair shops.

Despite its limitations and seemingly tenuous hold on life, our erstwhile client had remarkable success in getting its generic drug applications reviewed and approved by FDA very quickly.  It all seemed too good to be true, and it was.  Subsequent FDA investigation revealed that our client (and others of similar mindset) had given items of substantial value to key FDA staff to have their applications reviewed out of sequence.  Some less-than-honorable firms also submitted fraudulent data to FDA in their applications, helping ensure approval in the first review cycle.

Suffice to say, both such practices are highly disfavored under federal criminal and regulatory law.  These activities, often called the “generic drug scandal” of the late 1980s and early 1990s, were a sad chapter in the histories of both the generic drug industry and FDA.  Hatch-Waxman, let’s just attribute that to the growing-up process during your early years.

In the days before the 1995 Oklahoma City Federal Building bombing and 9/11, the Parklawn Building, FDA’s then-headquarters in Rockville, Maryland, was wide open to all members of the public, just like most other federal buildings.  It was a common practice for pharmaceutical company (whether brand, generic, human, or animal) regulatory affairs personnel to make periodic visits to FDA, roaming the halls and visiting with reviewers of their firm’s applications.  In that climate, it was relatively easy for unscrupulous company personnel to surreptitiously offer unlawful things of value (like a wad of cash sticking out of a drug application that a company rep was personally delivering to an FDA staffer).  The old days of open federal buildings are gone forever, needless to say.

As FDA’s investigation of our former client unfolded, FDA summarily “rescinded” its recent approval of one of our client’s drug applications.  Patently illegal, I thought, because FDA has to follow the statutory procedure for withdrawing approval.  So, we sued FDA over its purported rescission.  We lost, soundly.  See American Therapeutics, Inc. v. Sullivan, 755 F. Supp. 1 (D.D.C. 1990).  That experience gave personal meaning to the often-heard lawyers’ adage, “bad facts make bad law.”  It was also my first (and last) experience with moving for judgment on the pleadings, a procedure resurrected from my inactive memory of first year law school civil procedure class.  Never again!

In response to the “scandal,” debarment, civil penalty, and additional withdrawal of approval provisions were added to the FDC Act in 1993.  In its wisdom, Congress decided that, for the most part, these additional provisions would apply only to abbreviated applications for generic drugs, not to full drug applications for brand drug products.

Following the “scandal,” a number of waves of administrative and judicial activity regarding the approval of generic drug products washed ashore during Hatch-Waxman’s teenage and young adulthood years.  In the 1990s, most activity centered on the substantive conditions of FDA approval, such as whether the generic product and its brand counterpart have the “same” active ingredient, dosage form, or labeling or whether the generic is bioequivalent to its brand counterpart.  Hatch-Waxman provides for 180-day exclusivity, under which the first generic drug applicant to challenge a patent on the brand product being copied gets a statutory 180-day “head start” over its generic competition.  Until 1998, 180-day exclusivity was very seldom rewarded.  In that year, however, the D.C. Circuit rejected FDA’s former “successful defense” regulation, under which a “first” generic applicant had to have prevailed in patent litigation to be eligible for 180-day exclusivity.  See Mova Pharmaceutical Corp. v. Shalala, 162 F.3d 1201 (D.C. Cir. 1998).  Post-Mova, a 180-day exclusivity period was likely to be associated with generic versions of every brand drug product for which there was an associated patent challenge.  Thus, after Mova opened the flood gates, the generic drug regulatory world was awash with 180-day exclusivity disputes and litigation during much of the first decade of this century.  Congress made fundamental changes to 180-day exclusivity in the Medicare Modernization Act of 2003, but that only led to more disputes and litigation.

I am pleased and honored to have represented a number of different clients in these administrative and judicial battles that helped shaped the current regulatory landscape for generic drugs, although I wish my win-loss record were better.

Today, the generic drug industry has grown and matured from its humble beginnings.  For example, the five largest suppliers of generic drugs in the United States (by prescription volume, according to the internet) – Teva, Mylan, Actavis (nee Watson), Sandoz, and Lupin – are all global, publicly traded companies with tens of thousands of employees.  Generic drugs account for the substantial majority of all prescriptions filled, but only a much smaller portion of total prescription drug spending.  Annual U.S. savings from generic prescription drugs are many billions of dollars.

Hatch-Waxman also provides countervailing benefits for brand drug companies, such as non-patent data exclusivity and patent term restoration to compensate for patent life lost during product development and FDA review.  Nothing indicates to me that brand drug companies have suffered as a result of Hatch-Waxman.

The current frontier for “generic” pharmaceutical competition is drug products of biological, rather than synthetic chemical, origin.  The Biologics Price Competition and Innovation Act, modeled loosely on Hatch-Waxman in many respects, became federal law in 2010 and created a regulatory pathway for FDA approval of “biosimilars.”  The top two selling prescription drugs in the world are AbbVie’s Humira (adalimumab) and Johnson & Johnson’s Remicade (infliximab), both of which are very expensive drugs indicated for the treatment of Crohn’s Disease, arthritis, and similar conditions.  A biosimilar version of Remicade has been approved in Europe, and biosimilar versions of Humira appear to be the subject of substantial effort by a number of companies.  According to public reports, the first biosimilar applications were submitted to FDA last month, including one for a biosimilar version of Remicade.  Scientific, medical, and legal arguments in opposition to the approval of specific biosimilars have been raised in the U.S., similar to arguments that were raised in opposition to the approval of generic drugs under Hatch-Waxman.  Perhaps the first biosimilar will be approved in the U.S. soon.  If so, only time will tell whether it will gain widespread marketplace and prescriber acceptance.  Stay tuned as history unfolds!  Hatch-Waxman, we will be watching to see if your progeny does at least as well as you have as it grows up.

Hatch-Waxman, it’s been a good 30 years.  May the next 30 be even better.

Export Certificates for FDA-Regulated Foods Containing Egg Products as an Ingredient

By Michael J. O’Flaherty

The USDA’s Food Safety and Inspection Service (FSIS) plans, effective November 10, 2014, to halt issuing export certificates for FDA-regulated foods that contain an egg product(s) as an ingredient because USDA’s Agricultural Marketing Service (AMS) now provides this service.

FDA regulates the safe production, sanitary processing, and labeling of food products containing egg products.  Nevertheless, since it assumed responsibility for conducting the federal egg products inspection program from AMS on May 28, 1995, FSIS has been issuing export certificates of wholesomeness for prepared or manufactured food products that contain egg products as an ingredient.

On April 3, 2013, AMS announced the establishment of the Processed Egg and Egg Products Export Program.  The AMS program pertains to FDA-regulated, further processed eggs and egg products and composite foods containing egg products.  Pursuant to a Letter of Agreement between USDA’s Foreign Agricultural Service and the Office of International Affairs at FDA, AMS was provided with the authority to perform onsite verification of public health certification statements and issue export certificates on a fee for service basis.  The extent of the onsite verification process is directly related to the complexity of the certification statements required by the foreign country of destination for the food product.

Establishment of the export certification program is intended to allow U.S. processors access to expanding global markets, supporting AMS’ goal of promoting the marketing of U.S. agricultural products.  Companies interested in requesting the service should file an application with AMS.  Once the application is submitted, AMS will determine the import requirements of the foreign authority(s) for the food product(s) identified in the application.  AMS has established a program for verification of the source of the eggs and egg products used in the production of the food products identified for certification.  Additionally, AMS will verify that the product was produced in a processing facility in accordance with good manufacturing practices under sanitary conditions to certify that the products are fit for human consumption, as well as that the product meets the foreign government import requirements.  The verification of a product will require a minimum of two onsite visits per year.  If AMS determines that a company meets the established certification requirements, the company will be listed as eligible for export by product and country.  An eligible company then may contact AMS for an export certificate covering an accepted product(s) and identifying the foreign country.

Prior to shipping certified food products, exporters should have their importers confirm that the foreign country will accept AMS’ certification statements.  Additional packaging and labeling requirements also may need to be addressed with the importer before the food product will be allowed into the foreign country.

If you are an exporter of a FDA-regulated food that contains an egg product as an ingredient and need an export certificate(s), you should engage the AMS soon.  Please feel free to come to us with any questions related to AMS’ new verification and export certification program.

Africa Rising

By Marshall L. Matz, as published in the St. Louis Post-Dispatch

According to Forbes Magazine, Mr. Strive Masiyiwa is the Bill Gates of Africa. The Econet Wireless Group headed by Masiyiwa and based in South Africa now operates in 17 countries, employs 6,000 and generates $3 billion a year. Yet Masiyiwa believes it is agriculture development that will drive the African economy.

It is a belief shared by the African Union, the organization that represents Africa’s 54 nations. In the United States we are all fed by the 1 percent who farm; in Africa some 65 percent of the population farms. While Americans spend less than 10 percent of our disposable income on food, Africans must devote the vast majority of their income to food. It is common for our farmers to get yields of 200 bushels of corn per acre; in Africa 20 bushels an acre is common.

Most African farmers are smallholder farmers, tilling less than two hectares (around 5 acres).  “Smallholder farmers are at the heart of African agriculture and they must have access to the resources needed,” said Kofi Annan, the former secretary general of the United Nations and the father of the African Green Revolution.

The recent White House-African Summit and African Green Revolution Forum held in Ethiopia each emphasized the importance of the African smallholder farmer as the key to economic development. The goal, according to Annan, is to double production in the next five years. This would not only reduce hunger but it would catapult the African economy.

The good news is that Africa is well on its way to achieving this goal. The Bill and Melinda Gates Foundation and the Rockefeller Foundation have created the Alliance for a Green Revolution in Africa, AGRA, to coordinate a public-private effort.

The seed program has now released over 450 new varieties carefully selected for their compatibility with the African environment. The seeds include locally adapted varieties of maize, rice, cassava, sweet potatoes, soybeans, bananas and other African staples.

Other AGRA programs focus on soil health, markets, capacity building, financing and public policy in those countries that make up Africa’s two “breadbaskets.”

“Africa has the resources necessary to feed its population and to help feed the world as well,” said Akin Adesina, the minister of agriculture in Nigeria. It is a rich continent with poor people. Agriculture already accounts for over one-third of Africa’s combined gross national products. Further, agriculture has strong multiplier effects on employment and is critical to achieving broad-based economic growth, reducing poverty and addressing youth unemployment.

While continuing to expand seed production, markets and the other building blocks of modern agriculture, there are two major challenges.

The first challenge is to get the modern seeds and other inputs needed to boost production to the smallholder farmers who are the backbone of African agriculture. There are now some 20,000 local agro-dealers in rural Africa. They are privately owned businesses: mom-and-pop agriculture stores reaching smallholder farmers in the local villages. Africa needs 200,000.

The agro-dealer network has provided farmers with over 400,000 metric tons of seed and 1 million metric tons of fertilizers. Farmers in Kenya, Nigeria, Mozambique, Uganda and Ghana are reporting that improved hybrid seed varieties along with other inputs have doubled harvests. Further, agro-dealers can provide extension services to educate smallholder farmers on best practices and tractors to help mechanization. It is clearly time to replace hoes with tractors.

The other major challenge in Africa is government policy. While many African countries are responding to the African Union’s call to allocate at least 10 percent of their national budgets to agriculture, more attention must be paid to consistent and reliable government regulatory policies. Trade among African nations must be eased. Governments can also help with guaranteed financing for smallholder farmers and other creative initiatives. In Kenya, for example, Governor Mutua in Mackakos County has purchased tractors and is lending them to farmers for one day at a time.

In the United States, we take agriculture and food production for granted. We are the most efficient country in the history of the world when it comes to food production. Most of our political leaders, including President Obama and those in Congress, come from our big cities. But if we want to help Africa and its emerging private sector economy, we must give more time and thought to agriculture. The African Growth and Opportunity Act, AGOA, should be amended to provide technical assistance for agriculture. Feed the Future should be made permanent by legislation with a focus on economic development.

Africa is on the cusp of great change with six of the 10 fastest-growing economies in the world. It is agriculture that is going to drive the next stage of Africa’s economic development, as it did in the United States after President Lincoln created the Department of Agriculture and the land grant universities.

Marshall Matz was counsel to the Senate Committee on Agriculture. He serves on the board of the World Food Program-USA and the Congressional Hunger Center.

GMA Announces Initiative to Address Criticisms of GRAS Exemption

By Mark L. Itzkoff

We have previously reported on criticism of the so-called “GRAS Exemption” and FDA’s GRAS Notification Program by the Pew Charitable Trusts, the Natural Resources Defense Council, and the Center for Science in the Public Interest.  In response to these criticisms, the Grocery Manufacturers Association (GMA) recently announced a 5-part initiative to improve the procedures used by the food industry to determine if a food ingredient is generally recognized as safe (GRAS) and to assure the public that ingredients used in processed foods are safe.  While the GMA initiative is focused on self determinations, rather than GRAS Notifications, it will likely have a significant impact on all companies producing or using GRAS ingredients.

The initiative is comprised of 5 separate projects:  (1) a Publicly Available Standard (PAS) that will establish guidelines for conducting a GRAS assessment; (2) a GMA-sponsored database that will contain information on GRAS substances; (3) a Code of Practice (COP) that requires that any GRAS ingredient purchased by a GMA member has been evaluated in accordance with the PAS; (4) expansion of GMA’s current educational programs, including GMA support of the Center for Research and Ingredient Safety at Michigan State University; and (5) an expanded communications plan to inform the public “of the steps being taken by industry to increase the integrity of procedures used to assess ingredient safety.”

During a recent presentation describing the initiative, GMA representatives stated that the PAS will be developed by an independent standard setting agency, such as the American National Standards Institute (ANSI), and that GMA has issued a Request for Proposal (RFP) for this project to three groups.  GMA estimates that the standard will take about two years to develop.  GMA also stated that while details of the PAS will be determined independently, the standard will require 3rd party certification of all companies, toxicologists or consultants conducting GRAS determinations.  To receive certification, the company or consultant will need to establish a standard operating procedure (SOP) for GRAS evaluations and have the procedure approved before performing a certified review. The standard would only apply to “self determinations” that are based on scientific procedures, i.e., would not apply to determinations based on common use in food prior to January 1, 1958.  While the PAS would not apply to determinations submitted to FDA as part of GRAS Notifications, it is likely that it will indirectly become a requirement for these determinations, as well.  GMA also stated that ingredients currently used in compliance with a self-determination would be exempt from the PAS for the current applications, but new uses would not be exempt.  Substances that are the subject of GRAS review by the Flavorings and Extracts Manufacturers Association (FEMA) would also be exempt from the PAS.

All companies preparing GRAS determinations in compliance with the PAS will be required to submit the supporting information, including a list of the safety studies reviewed and the exposure data used, to the GMA-sponsored database.  The database will reportedly include three classes of information, including information that will be made available to the public, information that will be submitted to FDA, and information that will be available to GMA members.  GMA is asking for input on how to delineate the three categories.  It is not clear whether other trade associations will be permitted to participate in the database and gain access to the information for their members.

GMA’s Board of Directors has approved a new COP regarding the use of GRAS ingredients and reportedly all GMA members have agreed to abide by the COP.  GMA has not yet released the COP, but has said that it requires all members to purchase only GRAS ingredients that have been certified for compliance with the PAS.  The COP will become effective January 5, 2015.  GMA did not discuss how the COP will address the use of ingredients deemed to be GRAS after the COP goes into effect, but before the PAS is adopted.

While compliance with the GMA PAS will not be required under the Federal Food, Drug and Cosmetic Act or FDA regulations, its impact may be similar to a new FDA regulation.  GMA membership includes many of the largest food processing companies in the United States, including The Hershey Company, The Campbell Soup Company, and McCormick and Company.  It is our understanding that once the GMA-sponsored PAS is adopted, any company opting not to have its GRAS determinations conducted by certified specialists will be precluded from a large percentage of the possible market.  Thus, as a practical matter, suppliers will need to comply with the PAS.

FDA Updates 4 Proposed Rules Implementing FSMA

By Michael J. O’Flaherty

The Food and Drug Administration (FDA) today made available proposed revisions to four (of seven) proposed rules implementing the FDA Food Safety Modernization Act (FSMA).  The proposed revisions address:

  1. Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (for a summary, click here);
  2. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (for a summary, click here);
  3. Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (for a summary, click here); and
  4. Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (for a summary, click here).

The proposed revisions derive from feedback received by FDA from the public during meetings and in tens of thousands of comments submitted on the proposed rules.

The proposed revisions will be published in the Federal Register on September 29, 2014.  FDA will accept comments on the proposed revisions of the four proposed rules for 75 days, while continuing to review comments already received on the portions of the proposed rules that are staying the same.  It has stated that it will not consider comments outside of the scope of the revisions to the original proposed rules.  The agency will consider both sets of comments before issuing final rules in 2015.

Webinar Series: Regulatory Requirements for the Import of Medical Products and Foods Into the U.S. and Canada

Announcing OFW Law and Davis LLP’s New Four-Part Webinar Series:

REGULATORY REQUIREMENTS FOR THE IMPORT OF MEDICAL PRODUCTS AND FOODS INTO THE U.S. AND CANADA

OFW Law and Davis LLP have joined together to present a new webinar series to provide attendees with an overview of laws with which a firm must comply when importing medical products and foods into the U.S and Canada.  The webinars will include the following topics:

  1. How to Legally Import and Market Medical Devices in the U.S. and Canada

October 1, 2013, 1:00 p.m. EST

  1. How to Legally Import and Market Pharmaceuticals in the U.S. and Canada

October 15, 2014, 1:00 p.m. EST

  1. How to Legally Import and Market Foods and Beverages in the U.S. and Canada

October 29, 2014, 1:00 p.m. EST

  1. Medical Devices, Pharmaceuticals and Food Products as Consumer Products — Additional U.S. and Canadian Regulatory Considerations

November 12, 2014, 1:00 p.m. EST

Each webinar will be approximately 40 minutes long with a Q and A session at the end.  There is no cost to attend the webinars, but space is limited.

To register for one or more of the webinars, please visit http://www.cvent.com/d/14qf66.

To view or share this information as a PDF, please click here

Webinar presenters are attorneys of OFW Law and Davis, LLP.

ofw logoWith over 400 years of combined legal experience and more than 30 attorneys and Senior Policy Advisors, OFW Law uses its background in government, medicine, and industry to create innovative solutions for clients in the food, pharmaceutical, medical device, and agricultural industries. OFW Law represents clients from around the world in FDA, USDA, and health care matters before federal agencies, courts, and the U.S. Congress.

Davis LLP logoDavis, LLP is a full service law firm that provides advice and efficient service in over 50 practice areas, including Life Sciences, Food & Beverage, Regulatory & Administrative Law, and Health Law.  Davis LLP works with clients to get products from idea to market, providing strategic advice on approval and marketing, and managing global product portfolios.

How to Legally Import and Market Pharmaceuticals in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP

October 15, 2014, 1:00 p.m. EST

During this webinar, the first of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to successfully and legally import and market pharmaceuticals in the U.S. and Canada. Topics will include, among others:

  • Requirements for drug importation into the U.S. and Canada
  • Pharmaceutical market approval pathways in both countries
  • Pharmaceutical manufacturing controls in both countries
  • Pricing of brand and generic pharmaceuticals in Canada
  • Labeling and promotional requirements and restrictions for drugs in the U.S. and Canada
  • Post-market requirements in both countries including recordkeeping and adverse event reporting in the U.S.
  • Inspections and enforcement

The webinar will be approximately 40 minutes long with a Q and A session at the end. There is no cost to attend this webinar, but space is limited.

To register for the webinar, please visit www.cvent.com/d/14qf66.

To view or share this information as a PDF, please click here.

About the presenters:

Tish Pahl is a principal at the Washington, D.C.-based firm OFW Law where she has been practicing as a member of the firm’s Pharmaceutical Practice Group for nearly 20 years. In this capacity, she has counseled clients on the lawful marketing of their drugs, cosmetics, and dietary supplements under the Federal Food, Drug, and Cosmetic Act.  She has particular expertise in health care communications, advertising, labeling, and commercial distribution of products regulated by the U.S. Food and Drug Administration (FDA).  Tish frequently provides strategic advice to healthcare entrepreneurs and inventors on pathways into the U.S. market.  She has been a frequent speaker on numerous topics, including drug regulation, advertising and labeling compliance.

Sara Zborovski is a partner in Davis LLP’s Toronto office and is a member of firm’s Life Sciences and Intellectual Property Groups. Sara assists companies in navigating the regulatory landscape imposed by the Food and Drugs Act and its related regulations. She advocates before all branches of Health Canada on behalf of the pharmaceutical and biotech industries. Sara works with clients to get products from idea to market, providing advice on approval and marketing strategies and intellectual property issues. Sara has particular experience navigating Canada’s Patented Medicines (Notice of Compliance) Regulations (the equivalent of Hatch-Waxman litigation in the U.S.) and with the Federal Court review of regulatory decisions.  She also works with clients in matters relating to product safety, including Health Canada inspections and enforcement, crisis management and product recalls.

Big Data and Your Privacy

By John G. Dillard

Note: John authors a regular column in Farm Journal magazine, the most widely-circulated farm publication in the United States.

Agriculture is officially entering the era of big data. Prescriptive planting relies on historical weather trends and satellite mapping coupled with soil sampling, yield monitoring and soon whatever a drone can glean from flying over a field. Using these tools, data flows from a farmer’s equipment to a central database, along with terabytes of information from farms all across the country. While this data transfer is necessary to feed the algorithms that will compute an individual farmer’s planting prescription, it also has value that extends well beyond its use for prescriptive planting.

One of the primary concerns many producers have about prescriptive planting programs is the ownership of the data. Most farmers view the information about their farm as personal. Although you might brag or complain about yields in the truck line at the grain elevator, you do not necessarily feel comfortable with a computer jockey who is five states away sharing your yield data. If this data can be sold, many farmers want to know how it will be used.

Click here to read the rest of John’s Farm Journal column.

2014 Global Child Nutrition Forum, Sept. 29-Oct. 3

By Peter B. Matz

The 2014 Global Child Nutrition Forum is fast approaching and, while space is limited, there is still opportunity to attend, exhibit and/or sponsor the Forum.  This year’s event is being held by the Global Child Nutrition Foundation and World Food Program outside Johannesburg, South Africa, from September 29-October 3.

This conference is held annually to support countries in the development and implementation of sustainable school feeding programs, i.e. programs that can be maintained long-term with a connection to local agriculture.  This year’s theme is “Nutrition and School Feeding: Improving Nutrition by Strengthening School Feeding Programs,” with a focus on the multi-sector benefits of sustainable school feeding programs and the United Nations Post-2015 Agenda.

Who’s invited?  Representatives of government offices, companies, international organizations, NGOs, academic institutions, and others interested in school feeding and child nutrition programs, as well as the link between agriculture and school feeding programs in Africa.

In particular, participation is encouraged among the sectors which gain the most benefit from investing in nutritious school meal programs with a connection to local farm production: Education, Agriculture, Finance, Health, Industry and Trade, and Budget and Planning.

Why attend?  The Forum is an opportunity to share your experience, successes, and challenges in school feeding and to learn what others are doing, as well as to interact with experts from around the world, see school feeding in action in South Africa and exhibit your programs and products in the Market Place.  Further, the Forum provides the ideal opportunity to contribute to the discussions on the UN Post-2015 Agenda on the development of partnerships among smallholder farmers, governments, the private sector and stakeholders in adding value across the supply chain through school feeding programs.

For further information about the event and/or to register, please visit www.gcnf2014.orgPlease note that registration is being handled exclusively through this website.