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Elizabeth K. Conti

Associate

[email protected]

+1.202.434.7317

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Elizabeth focuses her practice on regulatory compliance and enforcement defense matters for companies in the pharmaceutical, medical device, dietary supplement, cosmetics, and food industries as well as pharmacies and distributors. She advises clients on the Food and Drug Administration (FDA) regulations related to labeling, promotions and advertising, securing clearances and approvals for drugs and devices, importing and exporting, and manufacturing practices. Her counseling and compliance support work reaches into several aspects of FDA-regulated companies’ operations.

Beyond FDA matters, Elizabeth’s practice also encompasses administrative and regulatory matters related to the Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), Environmental Protection Agency (EPA), and the National Advertising Division of the Better Business Bureau (NAD).

Prior to joining Mintz, Elizabeth was a health law associate in the Washington office of a Wisconsin-based national law firm, where she assisted clients with a wide range of FDA, DEA, and health care fraud and abuse enforcement matters. Earlier, she was a winter associate at that firm.

While earning her law degree, Elizabeth also completed a clerkship at the White House Council on Environmental Quality and clerkships with the Environmental Protection Agency’s Office of the General Counsel and Office of Enforcement and Compliance Assurance. At law school, she served as a note & comment editor of the Catholic University Law Review.

Education

  • Catholic University of America (JD, cum laude)
  • George Washington University (BA, magna cum laude)

Experience

  • Worked with the Health and Wellness Compliance Office for a major pharmacy chain to draft new Standard Operating Procedures related to the several aspects of the pharmacy’s controlled substance operations, including prescriptions, distribution, disposal, storage, among others.
  • Managed responses to federal and state regulatory requests including subpoenas and Requests for Information (RFIs) for a major drug distributor regarding controlled and non-controlled substance prescriptions and over-the-counter drugs.

Involvement

  • Member, Food and Drug Law Institute
  • Member, American Society of Pharmacy Law
  • Member, American Bar Association
  • Member, Women's Bar Association of the District of Columbia
  • Member, Junior Board of Directors & Pro Bono Associate Committee for Network for Victim Recovery of DC (NVRDC)

Languages

- German

Viewpoints

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Bioethics in a Pandemic: Operation Warp Speed

September 23, 2020 | Blog | By Bridgette Keller, Elizabeth Conti

References to Operation Warp Speed (OWS) have been present throughout our coverage of the ethical questions related to the development and distribution of a COVID-19 vaccine. In fact, OWS is part of a broader public-private effort to accelerate COVID-19 countermeasures, such as the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. OWS has ambitious goals. It intends to deliver 300 million doses of a safe and effective vaccine for COVID-19 by January 19, 2021. Here, we provide a brief overview of OWS, its current progress, and relevant ethical considerations.
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Introduction to the Due Diligence Process, Second Edition

September 2, 2020 | Video | By Elizabeth Conti

In this video, Elizabeth Conti provides an overview of “Introduction to the Due Diligence Process,” a high-level guide through the transactional due diligence process from a regulatory affairs perspective, recently published by the Regulatory Affairs Professionals Society (RAPS). Elizabeth co-authored the book with Mintz's Joanne Hawana and Benjamin Zegarelli.
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FDA Greenlights Updates to the Purple Book Database

August 6, 2020 | Blog | By Elizabeth Conti

As promised, the Food and Drug Administration (FDA) updated the Purple Book: Database of FDA-licensed Biological Products, providing greater transparency and a more user-friendly search functionality for the biological product and biosimilar industries. Earlier this year, FDA transitioned the Purple Book to a searchable online database. The August 3, 2020 release offers additional information on all FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by the Center for Biologics Evaluation and Research (CBER) expanding the dataset used by the database. FDA also updated the available exclusivity information for further industry ease of reference. This update is the next phase of the agency’s plan to improve the accessibility of information related to biological products through expansion and digitization.
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A panel of federal appellate judges has sided with drugmakers by upholding a lower court ruling from 2019 that struck down a regulation proposed by the Department of Health and Human Services (HHS). In a closely watched case, the United States Court of Appeals for the District of Columbia Circuit issued a decision on June 16, 2020 affirming the district court’s judgement that vacated the HHS Drug Pricing Disclosure Rule. This ruling is yet another example of a court invalidating the Drug Pricing Disclosure Rule, which sought to require drugmakers’ television advertisements to disclose the list prices of their prescription drug products.
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OTC Monograph Reform: Key Takeaways and What Industry Can Expect

June 10, 2020 | Blog | By Benjamin Zegarelli, Elizabeth Conti, Joanne Hawana

On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which in part describes reforms to modernize the regulatory framework for over-the-counter (OTC) monograph drugs. We previously blogged about the surprise addition of the OTC monograph reforms within the CARES Act. On May 29, 2020, the Office of Nonprescription Drugs within the Food and Drug Administration (FDA) held a webinar titled “Monograph Reform is Here!” (a recording of the webinar is available here), which included key highlights from the OTC monograph reform.
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FDA Reverses Decision to Authorize Use of Chinese KN95 Respirators

May 8, 2020 | Blog | By Benjamin Zegarelli, Elizabeth Conti

Citing poor quality, the U.S. Food and Drug Administration (FDA) has barred the importation of certain KN95 filtering facepiece respirators manufactured in China. On May 7, 2020, FDA revised and reissued the Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China Emergency Use Authorization (EUA) that provided eligibility criteria authorizing the importation of respirators from China that are not approved by the National Institute for Occupational Safety and Health (NIOSH) (i.e., not certified as meeting the N95 standard).
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FDA Expands Focus for COVID-19 Response

May 4, 2020 | Blog | By Benjamin Zegarelli, Elizabeth Conti

The Food and Drug Administration (FDA) continues to churn out policy statements, guidance documents, and emergency use authorizations (EUAs) to address the COVID-19 public health emergency. At the outset of the pandemic in early 2020, the agency concentrated its efforts on measures relating to devices that may help directly diagnose, treat, or prevent COVID-19, such as facemasks, ventilators, and diagnostic test kits. Recently, however, FDA appears to have shifted its focus to devices that may assist in the defense against the spread of COVID-19. For example, FDA issued enforcement policies and EUAs that help to expand the availability and capability of various remote monitoring devices and systems that can be used to diagnose and monitor medical conditions while mitigating circumstances that could lead to patient and health care workers’ exposure to SARS-CoV-2 (the virus that causes COVID-19) for the duration of the public health emergency.
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CARES Act Creates and Updates Drug and Medical Device Shortage Requirements

April 9, 2020 | Blog | By Elizabeth Conti, Aaron Josephson

In response to the COVID-19 pandemic, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed into law on March 25, 2020. In addition to the $2 trillion made available for medical countermeasure development, business relief, and other measures, the CARES Act amends the drug shortage reporting requirements and creates new requirements related to medical device shortages. With increased demand for products used to diagnose and treat COVID-19 patients and the stress placed on the manufacturing and delivery of vital products, having more information about drug, drug ingredient, and device shortages is becoming more critical.
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As a follow up to our recent blog post, FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round, President Trump signed the bipartisan over-the-counter (OTC) monograph teform bill into law on March 27, 2020.  The passage of the OTC monograph reform bill is a surprise addition into the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the third COVID-19 stimulus bill enacted since the pandemic began. The reform legislation represents the first significant update to federal oversight of OTC drug products since 1972. It enables the Food and Drug Administration (FDA) to quickly respond to safety concerns and keep pace with innovation in hopes of protecting consumers from unsafe drugs and permitting manufacturers to market new products more expeditiously. 
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We have previously blogged about the regulation of cannabidiol (CBD) products by the Food and Drug Administration (FDA) and the government’s actions to create a comprehensive regulatory framework for CBD, which includes introducing the Cannabidiol and Marijuana Research Expansion Act and hosting an FDA Public Hearing in May 2019 to obtain scientific data and safety information regarding cannabis-derived compounds. Most recently, on March 5, 2020, Commissioner Stephen Hahn provided an update to FDA’s efforts to increase education, research, and enforcement in this area. While the update alerted consumers, health professionals, and industry of FDA’s ongoing efforts to regulate CBD products, the efforts themselves are not dramatically new.
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Events

Apr
14
2020

FDA in the Time of COVID-19

View the Webinar Recording

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