Yvonne Puig (US)

Yvonne Puig (US)

US Head of Life Sciences and Healthcare Yvonne Puig has a substantial commercial litigation practice in both state and federal courts. She represents hospitals, HMOs, managed care organizations, medical schools and other institutional health care providers and educational services companies. A partner in Norton Rose Fulbright’s Austin office, Yvonne’s practice involves commercial and health care litigation, antitrust, regulatory and compliance advice, crisis management, staff privileges, exclusive contracting and administrative law.

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COVID-19 Update: HHS OGC Issues PREP Act Advisory Opinion

On January 8, 2021, the U.S. Department of Health and Human Services released Advisory Opinion 22-01  entitled On The Public Readiness and Emergency Preparedness Act Scope of Preemption Provision.   The Advisory Opinion addresses the Fourth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 and Republication of … Continue reading

COVID-19 Update: Secretary Azar Extends Pubic Health Emergency

On January 6, 2021 U.S. Department of Health and Human Services Secretary Alex Azar renewed the Public Health Emergency declaration, effective January 21, 2021.  In a tweet, Secretary Azar announced the renewal and stated that “[o]ur work to combat the virus will continue, as will our work to ensure a peaceful and orderly transition.”  The … Continue reading

COVID-19 Update: First Person Receives COVID-19 Vaccine in U.S.

Almost eleven months after the first confirmed coronavirus patient in the State of Washington (HL Pulse post here), the first dose of Pfizer and BioNTech’s COVID-19 vaccine was administered in the U.S. to a critical care nurse a little after 9:00 a.m. ET.  This happened just three days after the U.S. Food and Drug Administration … Continue reading

COVID-19 Update: First COVID-19 vaccine approved in UK

On December 2, 2020 the United Kingdom’s Medicines and Healthcare Products Regulatory Authority (“MHRA”) announced approval of Pfizer and BioNTech’s coronavirus vaccine.  According to a press release from the U.K. government: This was done using a regulatory process known as a ‘rolling review’. A ‘rolling review’ can be used to complete the assessment of a … Continue reading

COVID-19 Update: First EUA for COVID-19 Vaccine Filing Imminent; CDC Urges Americans Not to Travel for Thanksgiving

On Friday November 20, Pfizer and BioNTech announced they would submit a request to the U.S. Food and Drug Administration (“FDA”) seeking Emergency Use Authorization for their vaccine candidate.  Earlier this week, the companies announced that at the completion of their Phase 3 trial, the vaccine was 95 percent effective.  In addition to the effectiveness, … Continue reading

COVID-19 Update: Progress toward a vaccine candidate

On November 9, Pfizer and its German counterpart BioNTech announced initial clinical results found their coronavirus vaccine candidate to be more than 90 percent effective. Pfizer will wait to seek Emergency Use Authorization (“EUA”) from the US Food and Drug Administration (“FDA”) under Section 564 of the Food, Drug, and Cosmetic Act. Clinical study subjects must … Continue reading

COVID-19 Update: CDC Updates Guidance on Public Transportation and Close Contacts

The U.S. Centers for Disease Control (“CDC”) continues to update COVID-19 guidance as more information is known about how the coronavirus spreads.   On October 21, 2020, the CDC made a significant update to the definition of “close contact”.  Individuals that have spent 15 cumulative minutes within six feet of an infected individual during a 24-hour … Continue reading

COVID-19: OSHA Updates and Reporting Requirements

The Occupational Safety and Health Administration (“OSHA”), part of the U.S. Department of Labor, continues to update guidance for employers regarding protection of employees from exposure to COVID-19.  Despite their best intentions, many employers have struggled to adapt to the constantly changing safety and reporting requirements during the COVID-19 pandemic.   OSHA recently updated its COVID-19 … Continue reading

COVID-19 Update: U.S. Surpasses 200,000 Fatalities; CDC Releases Holiday Guidelines

This past week the United States surpassed the grim milestone of 200,000 COVID-19 deaths and seven million cases of COVID-19.  The spread of the virus has altered the way we work, live, and play around the world and will soon touch on one of the most treasured times of the year, the holiday season.  The … Continue reading

President Trump Signs Most Favored National Executive Order

President Trump signed a controversial Executive Order on September 13, 2020  entitled Executive Order on Lowering Drug Prices by Putting America First  with the intention of tying drug costs paid by the Medicare program to the costs borne by countries that have national health systems.   The Executive Order provides that “[i]t is the policy of … Continue reading

COVID-19 Update: Biopharmaceutical Executives Release Joint Statement on Vaccine

Chief executive officers of nine biopharmaceutical companies signed an unprecedented joint pledge, entitled BIOPHARMA LEADERS UNITE TO STAND WITH SCIENCE, acknowledging the U.S. Food and Drug Administration’s (“FDA”) role in the development of a COVID-19 vaccine, and pledging to: Always make the safety and well-being of vaccinated individuals our top priority. Continue to adhere to … Continue reading

COVID-19 Update: CMS Updates Conditions of Participation for Hospitals and CAHs to Require COVID-19 Reporting

On Tuesday, August 25, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released an interim final rule that updates the Medicare Conditions of Participation to require all hospitals to which 42 CFR Part 482 applies, as well as critical access hospitals (“CAHs”), to electronically report information including the number of confirmed or suspected COVID-19 … Continue reading

COVID-19 Update: CMS Announces Resumption of Survey Activities

On August 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced it was resuming inspections of Medicare and Medicaid certified providers and suppliers, which had been suspended in late March in response to the COVID-19 public health emergency.   More specifically, CMS will be resuming onsite revisit surveys for surveys with end dates on, … Continue reading

COVID-19 Update: Trump Issues ‘Buy American’ Executive Order Related to Drugs

On August 6, 2020 President Trump signed an Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States.  The Executive Order states that “the domestic supply chains must be capable of meeting national security requirements for responding to threats arising from CBRN (chemical, biological, radiological, and nuclear) threats … Continue reading

COVID-19 Update: Senators Release Liability Protection Draft Legislation

On July 27, 2020, Senators Mitch McConnell (R-KY) and John Cornyn (R-TX) released the SAFE TO WORK Act (“the Act”).   The Act was released as part of the Senate Republicans draft coronavirus legislation, the HEALS Act, which stands for Health; Economic Assistance; Liability protection; and Schools.  The Act seeks to limit liability for healthcare providers … Continue reading

COVID-19 Update: FDA Inspections Signal Resumption of Government Enforcement Efforts

On July 10, 2020, the U.S. Food and Drug Administration (FDA) announced it would resume domestic on-site inspections beginning the week of July 20.  Due to the COVID-19 pandemic, the FDA suspended inspections of facilities in March “to help slow the spread of the virus and help flatten the curve of the COVID-19 pandemic.”   To … Continue reading

COVID-19 Update: The Joint Commission Resumes Laboratory Survey Activities

In a special LabFocus The Joint Commission revealed they have resumed some laboratory survey activities.  TJC stated that “[a]ccount executives are contacting organizations due for a survey to assess the impact that the coronavirus pandemic had on their operations and their current state.”   To determine which organizations will be surveyed, TJC is looking at “a … Continue reading

COVID-19 Update: World Health Organization Warns of Dangerous Phase

During a press conference on June 19, 2020, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus stated that “[t]he pandemic is accelerating” and that we are now in a “dangerous phase” where the virus is “spreading fast.”   June 22, 2020 saw the largest single day spike in cases, with 183,020 new cases worldwide.   In the … Continue reading

COVID-19 Update: FDA revokes EUA for malaria drugs used as COVID-19 treatment

On June 15, 2020, the U.S. Food and Drug Administration (FDA) revoked emergency use authorization (EUA) for chloroquine (CQ) and hydroxychloroquine (HCQ).  The FDA found that the criteria for issuance of the EUA are no longer met and “in light of ongoing reports of serious cardiac adverse events and several newly reported cases of methemoglobinemia … Continue reading

COVID-19 Update: CDC Issues Guidelines for Events and Gatherings

On Friday June 12 the U.S. Centers for Disease Control and Prevention (CDC) published guidelines for events and gatherings ranging from lowest risk (virtual-only) to highest risk (large, in-person, where difficult to space at least six feet apart and attendees come from other areas).  The guidelines arrive at a time when cities and states have … Continue reading

COVID-19 Update: The Joint Commission to Resume Hospital Surveys

The Joint Commission (TJC) is resuming regular surveys and reviews after suspending them at the outset of the COVID-19 pandemic.  Safety will be “the first and foremost priority” as surveys and reviews are resumed and the survey’s will “assess the impact that the coronavirus pandemic had on their operations and their current state.”   The surveys … Continue reading

COVID-19 Update: CDC Releases Interim Guidelines on Antibody Testing

On May 24, 2020 the U.S. Centers for Disease Control (“CDC”) issued interim guidelines for COVID-19 antibody tests.  The CDC states that data on serologic testing is “rapidly evolving” and “will have an important public health and clinical uses to monitor and respond to the COVID-19 pandemic.”  The interim guidelines specifically address: Development of Antibodies … Continue reading

COVID-19 Update: CDC Publishes Additional Guidance on Reopening

The U.S. Centers for Disease Control and Prevention (“CDC”) has quietly released more expansive guidance regarding the reopening of different types of organizations.  The document, entitled  CDC Activities and Initiatives Supporting the COVID-19 Response and the President’s Plan for Opening America Up Again,  builds upon the decision tools issued by the CDC last week.  The … Continue reading
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