Our Website Uses Cookies
We and the third parties that provide content, functionality, or business services on our website may use cookies to collect information about your browsing activities in order to provide you with more relevant content and promotional materials, on and off the website, and help us understand your interests and improve the website.
For more information, please contact us or consult our Privacy Notice.
Your binder contains too many pages, the maximum is 40.
We are unable to add this page to your binder, please try again later.
This page has been added to your binder.
Kristie Gurley advises pharmaceutical and biotechnology companies on marketing authorization and market access issues, including with respect to product development, product approval and launch, pricing and reimbursement activities, advertising and promotion, payer communications, value-based contracting, and related areas. Ms. Gurley routinely advises on regulatory compliance and enforcement risk, commercial transactions, and administrative and legislative policy opportunities.
Ms. Gurley is an author of the U.S. chapter of a global treatise on drug pricing and reimbursement.
- Advising clients on public policy developments and compliance implications for new legislation or regulations, particularly with respect to recent drug pricing initiatives.
- Preparing public comments and various submissions to FDA, CMS, and other agencies.
- Advising pharmaceutical companies on regulatory strategies for product development, approval, and market access.
- Analyzing state and federal regulatory compliance obligations related to contracting, pricing, manufacturing, distribution, prescribing, and dispensing medical products.
- Providing strategic regulatory advice in False Claims Act cases and other litigation.
- Conducting regulatory due diligence for mergers, acquisitions, and public offerings.
Pro Bono
- Represents non-profit organizations in various state and federal policy efforts related to research and development, patient access, and healthcare issues.
- Represents low income tenants in eviction proceedings before the DC Landlord and Tenant Branch.
- Provided regulatory advice to non-profit organization for its sponsorship of Summer Food Service Programs across the United States.
December 17, 2020, Covington Alert
On December 10, 2020, the Supreme Court of the United States issued a decision in Rutledge v. Pharmaceutical Care Management Association holding that Arkansas’s Act 900, which regulates pharmacy benefit managers’ (“PBMs”) pharmacy reimbursement practices, is not pre-empted by the Employee Retirement Income Security Act of 1974 (“ERISA”). PBMs have long asserted ...
November 23, 2020, Covington Alert
On November 20, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued an interim final rule (“IFR”) implementing President Trump’s Most Favored Nation (“MFN”) executive order, which would tie Medicare Part B payments for certain drugs to the lowest price paid in other economically advanced countries (the “MFN IFR”). In a press conference on November ...
September 15, 2020, Covington Alert
The Trump Administration has released the much-anticipated executive order entitled “Lowering Drug Prices by Putting America First” (commonly referred to as the “Most-Favored-Nation” or “MFN” executive order). President Trump initially had announced the MFN executive order during his July 24, 2020 press conference highlighting four separate executive orders ...
May 18, 2020, Covington Alert
On May 11, 2020, the U.S. Food and Drug Administration (“FDA”) issued new guidance on the development of drugs and biologics to treat or prevent COVID-19: COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products (“Pre-IND Guidance”) and COVID-19: Developing Drugs and Biological ...
May 15, 2020, Covington Alert
On May 7, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced that it had finalized the Notice of Benefit and Payment Parameters for 2021 (“2021 NBPP Final Rule”). The final rule, which will go into effect on July 13, 2020, expressly allows certain health plans to determine, to the extent permitted by state law, whether to count pharmaceutical ...
November 7, 2017, Covington Alert
On August 18, 2017, President Donald Trump signed into law the FDA Reauthorization Act of 2017 (FDARA). This law, containing nine titles, reauthorizes and amends the user fee programs for prescription drugs, medical devices, generic drugs, and biosimilars.
November 14, 2016, Covington Alert
On November 10, 2016, the Food and Drug Administration (FDA) released its final guidance for industry on the voluntary qualified importer program (VQIP). The final guidance builds upon draft guidance issued in June 2015, as part of FDA’s implementation of the FDA Food Safety Modernization Act of 2011 (FSMA) mandate to establish a voluntary, fee-based program to ...
June 2, 2016, Covington Alert
On June 1, 2016, the FDA announced draft guidance on voluntary sodium reduction targets that could have a substantial effect on food manufacturers and restaurants. The Draft Guidance proposes short-term and long-term targets for various categories of commercially processed, packaged, and prepared foods, as well as recommended upper bounds for sodium in each food ...
2015, Harvard Journal on Legislation