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Cori Goldberg (US)

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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

FDA proposes revised oversight approach for lab developed tests

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

FDA enforcement spike targets drug promotions

The Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) focused its end-of-year enforcement efforts on drug manufacturers’ promotions on tv, social media ads, and electronic promotion efforts. The OPDP issued in December six of its eleven total enforcement letters for 2016.  The eleven disciplinary letters represents a small spike from previous years’ … Continue reading

FDA finalizes guidance on medical device safety

The Food and Drug Administration (“FDA”) released its final guidance on medical device safety on December 14, 2016, titled “Public Notification of Emerging Postmarket Medical Device Signals (Emerging Signals).” The final guidance comes almost a year after FDA issued a similar draft guidance on the topic. As with the draft guidance, industry remains concerned about … Continue reading

FDA delays lab developed test guidance

The US Food and Drug Administration (“FDA”) announced on November 18, 2016 that it will not release a final guidance to regulate laboratory developed tests (“LDTs”), in vitro diagnostic tests designed, manufactured, and used within a single laboratory. The announcement marks a significant reversal from the previous positions of the Obama administration, FDA, and specifically, Dr. … Continue reading

FDA issues draft guidance on Unique Device Identifiers

On July 26, 2016, the FDA issued draft guidance to help clarify the form and content requirements of the Unique Device Identifier (UDI). Industry groups have 60 days to comment on the draft guidance. Background The UDI final rule, which established the UDI system, was published on September 24, 2013. The rule aims to develop … Continue reading
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