Skip to main content

Elizabeth K. Conti

Associate

[email protected]

+1.202.434.7317

Share:

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

Health Care Viewpoints Thumbnail
The Food and Drug Administration’s (FDA’s) enforcement against cannabidiol (CBD)-containing products continues through the issuance of two new warning letters. On March 22, 2021, FDA published a press release cautioning companies against illegally selling over-the-counter (OTC) CBD products for pain relief. In the warning letters, FDA cited products listing CBD as an inactive ingredient for unapproved drug and misbranding violations.
Read more
Health Care Viewpoints Thumbnail
The Food and Drug Administration (FDA) and the National Telecommunications Information Administration (NTIA) in partnership with three domain name registries disabled nearly 30 websites illegally offering opioids for sale. Working together as part of a pilot program jointly created by the Department of Health and Human Services (HHS) and the Department of Commerce (Commerce), FDA and NTIA aim to reduce the availability of unapproved and misbranded opioids illicitly offered for virtual sale. Based on several joint warning letters and the subsequent shuttering of numerous websites illegally selling opioids, it would appear the partnership is a success. Both agencies and the domain registries have committed to continuing this working relationship beyond the pilot program. Time will tell if the continued joint effort reduces the unlawful sale of opioids online and in turn, minimizes the risks associated with the opioid crisis.
Read more
Health Care Viewpoints Thumbnail

Recent Amendments to the FDA Laws Attempt to Clarify and Improve Existing Systems

January 28, 2021 | Blog | By Joanne Hawana, Elizabeth Conti

Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings (as reported by our colleagues in this post), several important changes to the laws enforced by the Food and Drug Administration (FDA) were recently enacted by Congress. As legislative actions, those changes are of course unaffected by President Biden’s regulatory freeze and so we thought worth a summary to ensure our readers are up to speed on the large amount of activity that occurred in the final weeks of the 116th Congress and the Trump Administration.
Read more
Health Care Viewpoints Thumbnail

Are Speaker Programs a Thing of the Past? OIG’s Fraud Alert Indicates It Thinks They Should Be

November 25, 2020 | Blog | By Laurence Freedman, Elizabeth Conti

In the midst of the pandemic emergency, the Department of Health and Human Services Office of Inspector General (OIG) issued a stern warning about in-person educational programs for health care professionals (HCPs), known as “speaker programs.” The OIG’s Special Fraud Alert (Alert) highlights what it deems the “inherent fraud and abuse risks” associated with the offer, payment, solicitation, or receipt of remuneration related to speaker programs by pharmaceutical and medical device companies. The OIG expressed that is skeptical of the educational value of such programs, and thus the Alert sends a clear signal that such programs will undergo intense scrutiny under the federal Anti-Kickback Statute (AKS). OIG is using the pandemic as an opportunity to caution the pharmaceutical and medical device industry to limit or eliminate in-person speaker programs once such programs are able to resume.
Read more
Health Care Viewpoints Thumbnail

DEA Releases Long-Awaited Suspicious Orders Proposed Rule

November 6, 2020 | Blog | By Elizabeth Conti, Joanne Hawana

It has been a long time coming. On November 2, 2020, the Drug Enforcement Administration (DEA) released its long-awaited proposed rule to revise the regulations related to suspicious orders of controlled substances. The proposed rule will implement the Preventing Drug Diversion Act of 2018 (PDDA) and clarify the procedures a registrant must follow for orders received under suspicious circumstances, referred to as “ORUSCs.” There are four key regulatory changes being proposed by DEA: (1) new definitions, (2) expansion of the types of registrants required to report, (3) procedures for identifying and reporting suspicious orders, and (4) reporting and recordkeeping requirements.
Key to the proposed rule is the establishment of a “two-option framework” for registrants to deal with ORUSCs: namely, they could (1) decline to ship the ORUSC and immediately file a suspicious order report to DEA’s centralized database, or (2) conduct due diligence into the ORUSC and make a determination about the order’s validity within seven calendar days, among other requirements. DEA is accepting electronic and written comments on the proposed rule through January 4, 2021.
Read more
Health Care Viewpoints Thumbnail

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.
Read more
Video Viewpoint Thumbnail

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.
Read more
Health Care Viewpoints Thumbnail

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.
Read more
Health Care Viewpoints Thumbnail
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.
Read more
Health Care Viewpoints Thumbnail

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.
Read more

Events

Apr
14
2020

FDA in the Time of COVID-19

View the Webinar Recording

Webinar Reference Image