Cori Goldberg (US)

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FDA releases 2017 enforcement statistics and recall draft guidance

On January 17, 2018, the U.S. Food and Drug Administration (“FDA”) released its 2017 enforcement statistics. Overall, the statistics showed that there were no food importation debarment enforcement actions in the past year. Notably, there were 15,318 warning letters issued, 9,199 products recalled, and 2,945 recall events. There were 12 injunctions, 5 drug product debarments, … Continue reading

FDA relaxes FSMA enforcement

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

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

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 commissioner looks to curb tactics that restrict drug competition

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

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

FDA releases new guidances on increasing generic drug competition

The United States Food and Drug Administration (“FDA”) released four new draft guidances on October 2, 2017 that aim to reduce the barriers for certain generic drugs to enter the market and ultimately, reduce drug prices.  Reducing drug prices was a stated objective of President Trump during his campaign and has also been a topic … Continue reading

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

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 and NIH finalize clinical trial protocol template

On May 2, 2017, the U.S. Food and Drug Administration (“FDA”) and The National Institutes of Health (“NIH”), through the NIH-FDA Joint Leadership Council, released the final version of a clinical trial protocol template in an effort to assist investigators conducting clinical trials and to create cost and time efficiencies in the medical product development … Continue reading

Latest Executive Order shows support for agribusiness development and 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

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

News from DC – GOP’s Draft Bill Illuminates Efforts to Repeal the Affordable Care Act (ACA)

While Congress was in recess last week, members met with constituents at home. For those senators and representatives who he­­­­ld town hall meetings, the ACA repeal and replace effort was the hot topic. Many constituents expressed concerns about loss of health insurance coverage. Meanwhile, a new Kaiser Family Foundation survey found that 48 percent of … Continue reading

News from DC – Immigration

On January 27, 2017, President Trump signed an executive order titled “Protection Of The Nation From Foreign Terrorist Entry Into The United States,” (EO) barring foreign nationals from Iraq, Iran, Libya, Somalia, Sudan, Syria and Yemen from entering the United States for 90 days, and if refugees, for 120 days except for Syrian refugees whose … Continue reading

News from DC – President Trump’s Executive Order & Congressional Action to Repeal ACA

Repeal and Replacement of the Patient Protection and Affordable Care Act (ACA) On January 12 and 13, 2017, the 115th Congress set the stage for the Trump administration by passing a budget resolution to repeal major provisions of the ACA with a simple majority vote. On January 27, 2017, President Trump signed an executive order … Continue reading

News from DC – Reducing Regulations

January 20, 2017 Memorandum from Reince Priebus On January 20, 2017, the White House issued a memorandum for the Heads of Executive Departments and Agencies. In the memorandum, Reince Priebus, Assistant to the President and Chief of Staff, provided a directive including the following: Do not send any regulations to the Office of the Federal … Continue reading

FDA receives citizen petition regarding labeling of added sugars in food

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

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

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

New administration delays implementation of final Common Rule to protect human research subjects

The recent executive order issued by the Trump administration delays implementation of the final Common Rule to protect human research subjects. With respect to all regulations that have been published but have not yet taken effect, President Trump has temporarily postponed their effective date for 60 days for the purpose of reviewing questions of fact, … Continue reading

Government agencies finalize updates to Common Rule to protect human research subjects

On January 19, the U.S. Department of Health and Human Services (HHS) and 15 other government agencies published a final rule updating regulations governing the protection of human research subjects, which is commonly referred to as the “Common Rule.” As described in our September 4 post, these revisions are intended to enhance the current system … Continue reading

How pharma cos. can shape the drug-pricing landscape

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

Biologics: what’s in a name? Health Canada and EMA take a different approach from FDA

Last week the US Food and Drug Administration (“FDA”) provided guidance on the Nonproprietary Naming of Biological Products. Each biologic, whether originator, related product or subsequent entry (biosimilar) will now be given a non-proprietary name comprised of a core name and a meaningless four-letter suffix. This is an important divergence from the practice in Canada … Continue reading