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.

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.

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

By Marshall L. Matz and Eden Shiferaw

“…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 4th through Wednesday, August 6th. The Summit involved the United States, over 50 African heads of state, and the African Union. The Summit was organized around the theme “Investing in the Next Generation.” Summit participants discussed investment issues, peace and security, governance, and other topics. The Summit and associated events highlighted key goals in the White House Administration’s 2012 Africa Strategy, which focuses on U.S. efforts to help African countries to foster:

  • good governance;
  • food security;
  • increased economic growth, trade, and investment, in partnership with U.S. firms;
  • durable peace and security; and
  • greater socio-economic opportunity and development.

Initiatives and Partnerships Related to Agriculture

  • Global Resilience Partnership, a $100 million partnership launched by United States Agency for International Development (USAID) and The Rockefeller Foundation was announced at the Summit. The Global Resilience Partnership will institute a new model for solving the complex and interrelated challenges of the 21st century such as persistent and often extreme poverty, food insecurity, and climate shocks through public-private partnerships.
  • Through the Feed the Future initiative, the U.S. Government stands alongside its partners in Africa to promote agricultural development as a means to catalyze broad-based economic growth that can make a significant impact against hunger, poverty and undernutrition. The U.S. reiterated its commitment to enable smallholder farmers and producers with access to agricultural insurance so that they can feel comfortable adopting and using new tools, technologies and practices that can help increase yields and, ultimately, economic outcomes.
  • The New Alliance for Food Security and Nutrition report was released at the Summit, announcing that, under the effort, private sector companies have collectively committed more than $8 billion in responsible agriculture investments in Africa, African governments have made progress or completed 95 percent of their policy-related commitments, and 3 million smallholder farmers have been reached.
  • The Global Open Data for Agriculture and Nutrition (GODAN) initiative will now have four new partners and up to $1 billion in export credit guarantees that will enhance trade between the U.S. and Africa.
  • The United States intends to join the global Alliance for Climate Smart Agriculture (ACSA) slated for launch at the United Nations Secretary General’s Climate Summit in New York in September 2014. At the Summit, the African Union Commission shared its plans for a roadmap to implement the Malabo Declaration’s commitments, including actions to build resilience to climate and weather-related risks through Climate-Smart Agriculture (CSA).

Administration’s Comments on Agriculture

  • Secretary of State John Kerry: “When you talk about food security, it doesn’t take very long to have the name, Norman Borlaug, come up. Norman would have been 100 years old this year, and he dedicated his entire life and career to feeding the world’s hungry. He won a Nobel Prize for his work. And he pursued that path for one reason. As he put it, ‘You can’t build a peaceful world on empty stomachs and human misery,’ pretty simple.

But on top of that, the growing impacts of climate change are going to put extraordinary stress on our ability to be able to produce the amount of food that we need to be able to feed those increasing numbers, and, I might add, to feed from increasing numbers from increasingly – from agricultural locations that are increasingly under greater stress and duress…

We need more governments, more businesses, more research institutions, more civil society, more people all over the world focused on improving agricultural productivity, on investing in innovation and technology like seeds that withstand drought and floods, and on ensuring the world’s agricultural sector is operating as sustainably as possible…”

  • Secretary of Agriculture (USDA), Tom Vilsack: As a panelist during the “Resilience and Food Security in a Changing Climate” event, Secretary Tom Vilsack discussed the three goals USDA is focused on, including advancing sustainable agricultural practices, building greater resiliency in agriculture, and reducing greenhouse gas emissions related to agriculture. Secretary Vilsack said USDA can share research data on crop genomes, pest and disease control, as well as monitoring and addressing drought conditions.

Overview

The Administration considers global food security a top foreign policy priority. It is not just Africans and African leaders recognizing the importance of agriculture, the Summit demonstrated the Administration’s understanding that agriculture is the key to Africa’s economic prosperity. Furthermore, the Administration accepts that a “green revolution” in Africa cannot take place without Climate-Smart Agriculture (CSA) technology. The Administration repeatedly alluded to biotechnology by advocating for smart, sound science in order to combat the effects of climate change.

The Administration purposely refrained from offering a set of deliverables from the Summit, however, it should be noted that the Administration is enthusiastic about Africa Growth Opportunity Act (AGOA) and Feed the Future. Throughout the Summit, the Administration reiterated that AGOA and Feed the Future are top legislative priorities.

Despite the Administration refraining from deliverables, the Summit was a successful bipartisan effort. “Congress has played an enormous role on a bipartisan basis in supporting Africa policy,” said Ben Rhodes, the deputy national security adviser for strategic communications. “It is important to note that in an environment in Washington where there’s not a lot of bipartisan agreement, Africa has been the true exception.”

Links

Webinar Series: Regulatory Requirements for the Import of Medical Products and Foods Into the U.S. and Canada 1

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 Would an FDA Standard of Identity for Honey Benefit Consumers, the Honey Industry, and U.S. Agriculture? USDA Wants to Know.

By Robert A. Hahn

The U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) has published a Federal Register notice requesting comments on a possible federal standard of identity for honey.

Although the Food and Drug Administration (FDA) is the agency that would be responsible for developing a standard of identity for honey, the 2014 Farm Bill charged the Secretary of Agriculture with developing a report describing how a standard of identity would be in the interest of consumers, the honey industry, and U.S. agriculture.  Section 10012 of the Agricultural Act of 2014 specifically requires USDA to consider a March 2006 citizens petition to establish a standard of identity for honey submitted by the American Beekeepers Federation and several other honey-related trade associations.  The 2006 petition asked FDA to establish a standard of identity similar to the Codex Standard for Honey (CODEX STAN 12-1981, Rev. 2 (2001)).  FDA denied the petition in 2011, claiming that it did not demonstrate the need for an FDA standard of identity for honey and that existing law is sufficient to protect the integrity of honey.  The petition and FDA’s denial can be found here and here.

FDA recently issued a draft guidance document on proper labeling of honey and honey products, Draft Guidance for Industry: Proper Labeling of Honey and Honey Products (see our post dated April 8, 2014).  According to the draft guidance, “honey” is the common or usual name for “a thick, sweet, syrupy substance that bees make as food from the nectar of flowers and store in honeycombs.”  Only products made exclusively from honey may be called “honey.”  In the absence of a federal standard of identity, a number of states have adopted, or proposed to adopt, their own state standards of identity for honey, creating the potential for a patchwork of differing state standards of identity that could impede interstate commerce.   In addition, USDA/AMS has voluntary grading standards for honey: U.S. Standards for Grades of Comb Honey and U.S. Standards for Grades of Extracted Honey.

USDA/AMS is requesting comments on the 2006 petition to establish a standard of identity for “honey,” and specifically on the adoption of certain deviations from the Codex standard proposed by the petitioner.  Comments are due September 19, 2014.

Even if the Secretary of Agriculture’s report supports creation of an FDA standard of identity for honey, that recommendation would not be binding on FDA.  However, FDA might be persuaded to reconsider its conclusion that a federal standard of identity is unnecessary if there are conflicting state standards.  If FDA does adopt a federal standard of identity for “honey,” it would preempt any state standards that are not identical to the federal standard.

Salt

By John R. Block

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 that we face today. I remember when they said, “Butter is bad for you. Eat margarine.” Now, it is the other way around. At one time, some critics advised to not eat bacon because when you fry it, it is a carcinogen. How can the average consumer know what to do?

The World Health Organization, following the advice of a Tufts University research study, advised that we cut our salt consumption in half. The salt we eat leads to 1.65 million deaths annually. Excessive sodium results in high blood pressure, stroke, and heart disease. Our Food and Drug Administration plans to work with our food companies to get them to cut back the salt. FDA argues that we should consume less than 2,300 milligrams of sodium per day. High levels are associated with high blood pressure. The average U.S. sodium daily consumption is 3,400 milligrams. Simply put – we are consuming too much salt.

However, we have a new study published in the New England Journal of Medicine which tells us that if we cut back on our salt we will have a heart attack. The new study involved 100,000 people in 17 countries over 3 years. They found that individuals that consumed the low level of sodium recommended by the FDA had a 27% higher risk of death.

The new study suggesting that we aren’t consuming too much sodium today contradicts the position of the American Heart Association, the World Health Organization, and FDA.

Perhaps USDA’s Dietary Guidelines Advisory Committee should consider making some adjustment in their recommendations – that is, if “they are worth their salt.”

As for me, I’ll still salt my steak and eggs and, to be safe, I’ll have another piece of bacon and a glass of red wine.

John Block was Secretary of the U.S. Department of Agriculture from 1981-1985, where he played a key role in the development of the 1985 Farm Bill.

Lupin, A Legume Becoming More Popular In The US, May Cause Allergic Reactions

By Robert A. Hahn

FDA has issued a Consumer Update (Allergies to a Legume Called Lupin: What You Need to Know) and FAQs (Frequently Asked Questions on Lupin and Allergenicity) on lupin, a legume belonging to the same plant family as peanuts.  According to the agency, lupin can cause severe allergic reactions, including life-threatening anaphylaxis, in allergic individuals.  While some individuals develop an allergy to lupin over time, others may have an allergic reaction on their very first exposure.  Persons with peanut allergies are at greater risk of being allergic to lupin.

Because lupin is relatively new in the U.S. food supply, many Americans are not familiar with it.  It is becoming more popular, however, because of its use in gluten-free foods.  Lupin and ingredients derived from lupin, such as lupin flour and lupin protein, are good substitutes for gluten-containing flours in baked goods and pasta.  Lupin is also found as a whole bean (called “lupini beans”) sold in Italian and other ethnic specialty stores.  Lupin or lupini beans are a traditional food in Mediterranean and some Asian cuisines.

Lupin and ingredients derived from lupin are required to be listed in the ingredients declaration on food labels.  FDA advises consumers, particularly those with peanut allergies, to look for “lupin” or “lupine” on the label.

While lupin is not a “major food allergen,” it seems possible that FDA might consider undeclared lupin to be a food safety hazard that could trigger the need for a recall.  The term “major food allergen” is defined as the “Big 8” (i.e., peanuts, tree nuts, milk, eggs, soy, wheat, fish, and crustacean shellfish) and any ingredient that contains protein derived from the Big 8, except for: (a) highly refined oils and ingredients derived from highly refined oils, and (b) ingredients that FDA has exempted from the definition of “major food allergen” under Federal Food, Drug, and Cosmetic Act § 403(w)(7) (21 U.S.C. § 343(w)(7)).  Although not a major food allergen, lupin might fall into the category of foods (which includes sulfites, Yellow No. 5 and 6, and MSG) that, although not major food allergens, will typically trigger a recall if present in a food but not declared on the label.

FDA is “actively monitoring” complaints of allergic reactions to lupin.

FDA’s “Gluten-Free” Labeling Rule Takes Effect

By Robert A. Hahn

On August 5th, FDA’s regulation defining the claim “gluten-free” for voluntary use in food labeling became effective.  FDA cautions consumers that there may still be some products on store shelves labeled “gluten-free” that do not comply with the new definition, but all foods entering commerce on or after August 5, 2014 must comply.

Here are the key features of the FDA rule:

Definitions

  • “Gluten” refers to certain proteins (e.g., prolamins and glutelines) in gluten-containing grains that cause adverse health effects in persons with celiac disease.
  • “Gluten-containing grains” are wheat, rye, and barley, as well as hybrids of those grains (e.g., triticale).
  • “Gluten-free” means either: (1) the food and its ingredients are inherently free of gluten, and any gluten present in the food is <20 parts per million (ppm); or (2) the food contains an ingredient derived from a gluten-containing grain that was processed to remove gluten (e.g., wheat starch), and any gluten present in the food is <20 ppm. The bottom line is that the food must contain <20 ppm gluten.

Labeling

  • FDA prefers the term “gluten-free” and discourages use of other terms, but will accept use of certain equivalent terms (e.g., “no gluten,” “without gluten”). Other truthful and non-misleading statements about gluten content are also permitted including: a statement of the amount (or maximum amount) of gluten in the food; a statement such as “not made with gluten-containing ingredients”; and/or a gluten-free certifying organizations seal or logo.
  • If a food label includes both a “gluten-free” claim and the word “wheat” (e.g., it lists a wheat ingredient that has been processed to remove gluten in its ingredients list), the word “wheat” must be followed by an asterisk that refers to the following statement in close proximity: “The wheat has been processed to allow this food to meet the Food and Drug Administration (FDA) requirements for gluten-free foods.”
  • If a food is labeled “gluten-free,” FDA encourages manufacturers to identify any oat-derived ingredients in the food that do not use the word “oats” in their name (e.g., “beta glucan (from oats)”).
  • FDA notes that oats and other (non-gluten-containing) grains, legumes, and seeds may come into contact with “gluten-containing grains” during harvesting, storage, transportation, and manufacturing. Therefore, manufacturers of “gluten-free” foods containing other grains, legumes, or seeds need to be careful such foods contain <20 ppm gluten.

Scope

  • Use of the claim “gluten-free” is strictly voluntary.
  • The regulation applies only to packaged foods, including packaged foods sold in restaurants and other foodservice establishments. FDA encourages restaurants to comply with the definition of “gluten-free” for non-packaged foods as well.
  • The regulation applies to FDA-regulated human foods, including dietary supplements. It does not apply to food for animals.  It also does not apply to meat and poultry products regulated by the U.S. Department of Agriculture (USDA) or alcoholic beverages regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB), but FDA is seeking to harmonize with those agencies.

Compliance and Enforcement

  • Manufacturers making “gluten-free” claims are not required to test their ingredients or finished products for gluten. However, manufacturers are responsible for ensuring that “gluten-free” foods comply with the FDA definition.  Therefore, FDA encourages use of effective measures, such as:
    • Testing ingredients or finished foods for gluten;
    • Requiring certificates of analysis from ingredient suppliers; or
    • Participating in a third-party gluten-free certification program
  • If manufacturers of “gluten-free” products do test for gluten, they are not required to use any particular analytical method. However, FDA recommends use of scientifically valid methods, and identifies two ELISA methods that the agency will use in tandem for compliance purposes; they are the R5-Mendez Method (test kit available from R-Biopharm) and the “Morinaga method” (test kit available from Morinaga Institute for Biological Science, Inc.).
  • FDA acknowledges there is currently no scientifically valid method to test for gluten in fermented or hydrolyzed foods. FDA intends to publish a proposed rule explaining how it will evaluate compliance in “gluten-free” fermented and hydrolyzed foods.

FDA has issued a Small Entity Compliance Guide and Q&As on the “gluten-free” rule.