Topic: FDA & Food Safety

FDA releases new guidance on off-label promotion

By Benjamin Wallfisch (US) on June 19, 2018 Posted in FDA & Food Safety

Last week, the U.S. Food and Drug Administration (“FDA”) released two guidance documents that relate to sharing of certain information about drugs and medical devices, including economic information about unapproved products and unapproved uses, as well as information not included in a product’s FDA-approved labeling. These guidance documents are part of broader blueprint published by … Continue reading

Recent effort to regulate pharmaceutical pricing deemed unconstitutional by Fourth Circuit

By Robin Adelstein (US) and Krishna Kavi (US) on April 17, 2018 Posted in Enforcement, FDA & Food Safety, News from DC, Regulatory

In the absence of federal action, states have attempted to rein in high pharmaceutical pricing by enacting laws aimed at regulating drug pricing. Following what now has become a trend, on March 13, 2018, Oregon became the newest state to enact such legislation, The Prescription Drug Price Transparency Act, H.B. 4005. But many of these … Continue reading

FDA relaxes FSMA enforcement

By Cori Goldberg (US) and Krishna Kavi (US) on January 9, 2018 Posted in FDA & Food Safety

On January 5, 2018, the U.S. Food and Drug Administration (“FDA”) released guidance entitled Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs: Guidance for Industry. The guidance states that FDA will exercise enforcement discretion for certain parts of the Food Safety Modernization … Continue reading

FDA commissioner discusses key policy goals for 2018

By Cori Goldberg (US) on December 19, 2017 Posted in FDA & Food Safety

On December 14, 2017, the Commissioner of the U.S. Food and Drug Administration (“FDA”), Dr. Scott Gottlieb, posted Looking ahead: Some of FDA’s major policy goals for 2018 on FDA’s blog, FDA Voice, and discussed FDA’s policy agenda published on the Unified Agenda of Federal Regulatory and Deregulatory Actions (“Unified Agenda”), which provides the public … Continue reading

FDA commissioner discusses upcoming guidance to modernize its framework for medical device review

By Cori Goldberg (US) on December 13, 2017 Posted in FDA & Food Safety

On December 11, 2017, the U.S. Food and Drug Administration (“FDA”) Commissioner, Scott Gottlieb, posted Advancing Policies to Promote Safe, Effective MedTech Innovation on FDA’s blog, FDA Voice and discussed FDA’s plans to modernize its policy framework for the review of new medical devices. These changes will require FDA to make the review process more … Continue reading

FDA embraces medical innovation in 2017

By Frederick Robinson (US) and Andrew Lu (US)* on November 27, 2017 Posted in FDA & Food Safety

On November 16, 2017, the US Food & Drug Administration (“FDA”) unveiled a comprehensive policy framework – a suite of four guidance documents – to oversee regenerative medicine products. Regenerative medicine is the science of restoring structure and function to damaged or diseased cells, tissues, or organs. The two final guidance documents outline when cell … Continue reading

FDA commissioner looks to curb tactics that restrict drug competition

By Cori Goldberg (US) on November 13, 2017 Posted in FDA & Food Safety

On November 8, 2017, the U.S. Food and Drug Administration (“FDA”) Commissioner Scott Gottlieb spoke as a keynote speaker at the Federal Trade Commission (“FTC”) workshop, Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics (“Workshop”) and called to “end the shenanigans” that can delay or restrict generic drug competition. Gottlieb discussed his … Continue reading

FDA commissioner discusses greater scrutiny of health claims on food packaging

By Cori Goldberg (US) and Krishna Kavi (US) on October 13, 2017 Posted in FDA & Food Safety

On October 10, 2017, the U.S. Food and Drug Administration (“FDA”) Commissioner Scott Gottlieb spoke at the Wall Street Journal Global Food Forum (“Forum”) and shed light on his views regarding food labeling. Specifically, Dr. Gottlieb said that he wants FDA to take a closer look at the health claims on food packaging. He further … Continue reading

Restaurant and convenience store trade groups sue NYC over menu labeling regulations

By Cori Goldberg (US) and Krishna Kavi (US) on July 24, 2017 Posted in FDA & Food Safety

On July 14, 2017, the National Association of Convenience Stores, New York Association of Convenience Stores, Food Marketing Institute, and Restaurant Law Center (“trade groups”) filed a lawsuit against the New York City Department of Health and Mental Hygiene and its Commissioner Dr. Mary Travis Bassett, the New York City Board of Health, and the … Continue reading

FDA extends compliance date for Nutrition Facts Label rule

By Cori Goldberg (US) and Krishna Kavi (US) on June 16, 2017 Posted in FDA & Food Safety

On June 13, 2017, the US Food and Drug Administration (“FDA”) announced that it was extending the compliance date for the Nutrition Facts Label rule. The FDA will provide the final details regarding the extension of the compliance date through a Federal Register Notice that it will publish at a later date. The FDA released … Continue reading

Mandatory kilojoule labeling – Victoria, Australia

By Kate Sherburn (AU) on May 18, 2017 Posted in FDA & Food Safety, International

The Victorian Government has introduced the requirement that all major Victorian food outlets and supermarket chains must display kilojoule contents on their menus. The Food (Kilojoule Labelling Scheme and Other Matters) Amendment Act 2016 will, from May 2018, require large chain food businesses and large chain supermarkets to display: the average kilojoule content of standardised, … Continue reading

FDA announces plans to create a centralized digital health unit

By Benjamin Wallfisch (US) and Blake Walsh (US) on May 9, 2017 Posted in FDA & Food Safety

The U.S. Food and Drug Administration (“FDA”) has announced plans to create a centralized digital health unit within the Center for Devices and Radiological Health (“CDRH”), further supporting CDRH’s 2016-2017 vision to establish a more robust national evaluation system for medical devices. FDA will form the new digital health unit within CDRH’s Office of the … Continue reading

Latest Executive Order shows support for agribusiness development and food safety

By Cori Goldberg (US) and Krishna Kavi (US) on May 1, 2017 Posted in FDA & Food Safety

On April 25, 2017, President Trump issued the Presidential Executive Order on Promoting Agriculture and Rural Prosperity in America. The Executive Order established the Interagency Task Force on Agriculture and Rural Prosperity that will identify legislative, regulatory, and policy changes to promote in rural American agriculture, such as economic development, job growth, and infrastructure improvement. … Continue reading

Retailers petition FDA to revise menu labeling rule

By Cori Goldberg (US) and Krishna Kavi (US) on April 13, 2017 Posted in FDA & Food Safety

On April 5, 2017, the National Grocers Association (“NGA”) and National Association of Convenience Stores (“NACS”) filed a citizen petition with the U.S. Food and Drug Administration (“FDA”). The citizen petition (“petition”) urged the FDA to halt and consider changes to its final menu labeling rule (“final rule”), which is set to take effect on … Continue reading

Court upholds Health Canada decision requiring additional information ‎on certain Apotex drugs manufactured in India

By Ian Trimble (CA), Kristin Wall (CA) and Sara Zborovski (CA) on April 6, 2017 Posted in FDA & Food Safety, International

The Federal Court dismissed Apotex’s application for judicial review of the Minister of Health’s decision to require additional information from Apotex as part of its submissions for certain drugs manufactured in India by Apotex affiliates. Read the full update here.… Continue reading

Global health trends impacting the regulation of food and beverage labels

By Georgina Hey (AU) and Isobel Taylor on February 3, 2017 Posted in FDA & Food Safety, International

As global rates of obesity and related diseases continue to rise, consumers around the world are becoming more health conscious, and are expecting their food products to reflect their desire for healthier options. A recent Nielsen Global Health and Wellness Survey found that, of the 30 000 people across 60 countries surveyed, 49% consider themselves … Continue reading

Health Canada releases draft guidance documents for consultation related to good manufacturing practices and drug establishment licensing

By Jillian Hyslop (CA) and Sara Zborovski (CA) on February 1, 2017 Posted in FDA & Food Safety, International

On January 18, 2017, Health Canada released five draft guidance documents for consultation relating to good manufacturing practices and drug establishment licensing. The consultation period is open until April 18, 2017. Read the full update in Norton Rose Fulbright’s Pharma in brief – Canada.… Continue reading

FDA receives citizen petition regarding labeling of added sugars in food

By Cori Goldberg (US), Kim Gold (US) and Krishna Kavi (US) on February 1, 2017 Posted in FDA & Food Safety

On January 25, 2017, the nonprofit science group, Union of Concerned Scientists, filed a citizen petition with the U.S. Food and Drug Administration (“FDA”), urging the FDA to prohibit foods with high amounts of added sugars from being labeled or advertised as nutritious or healthy. The petition is open for public comment until July 25, … Continue reading

New proposed food safety regulations open for comments

By Érika Bergeron-Drolet and Sara Zborovski (CA) on January 31, 2017 Posted in FDA & Food Safety

They’re finally here! The long-awaited Safe Food for Canadians Regulations have been pre-published in the Canada Gazette I for comment, and the CFIA has officially kicked off consultation on the proposed regulations. The proposed Regulations are made under the Safe Food for Canadians Act (the “Act”), which was adopted back in 2012 with a view … Continue reading

21st Century Cures Act: impact on FDA

By Benjamin Wallfisch (US) and Chaula Mehta (US) on January 30, 2017 Posted in FDA & Food Safety, News from DC

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the “Cures Act”). We detailed the Cures Act’s provisions affecting hospitals in a prior Health Law Pulse post and will focus on a more in-depth analysis of its impact on the U.S. Food and Drug Administration (the “FDA”) here. The Cures … Continue reading

Just before inauguration, FDA issues memo to address off-label promotion

By Cori Goldberg (US) and Leaf McGregor (US) on January 30, 2017 Posted in FDA & Food Safety, News from DC

On January 18, 2017, two days before President Trump took office, the US Food and Drug Administration (FDA) issued two pieces of draft guidance for off-label communications. The first addresses communications with payors and formulary committees, and the second outlines “Questions and Answers” about how FDA evaluates communications about information not contained in approved labels … Continue reading

How pharma cos. can shape the drug-pricing landscape

By Robin Adelstein (US), Cori Goldberg (US) and Krishna Kavi (US) on January 25, 2017 Posted in Enforcement, FDA & Food Safety, News from DC, Regulatory

Unless you have been living under a rock, you no doubt have noticed that drug price increases have resulted in a wave of public criticism, playing right into the media’s demonization of the pharmaceutical industry, and even becoming an election year issue. The United States is one of the only developed nations that largely does … Continue reading

FDA proposes revised oversight approach for lab developed tests

By Frederick Robinson (US), Cori Goldberg (US) and Chaula Mehta (US) on January 17, 2017 Posted in FDA & Food Safety

In November 2016, in a departure from its prior position, the US Food and Drug Administration (the “FDA”) announced that it would not develop final guidance to regulate laboratory developed tests (“LDTs”), as we covered previously on Health Law Pulse. In a discussion paper published on January 13, 2017, the FDA instead has proposed a … Continue reading