Noellyn K.M. Davies

Noellyn Davies is an associate in the Food & Drug and Health Care practice groups in the firm’s Washington, DC office.  She has experience providing regulatory advice and strategic guidance to drug, biologic, and medical device companies, as well as related trade organizations.  Ms. Davies has particular experience with legal and regulatory issues related to advertising and promotion, interactions with health care professionals, fraud and abuse, the Hatch-Waxman amendments, and clinical trials.

Representative Matters

• Participate in Promotional Review Committees, providing pharmaceutical companies with regulatory advice related to advertising, labeling, and other promotional materials.
• Advise pharmaceutical companies on interactions with health care providers, including medical education, speaker programs, medical information requests, and investigator-sponsored studies.
• Advise companies on clinical trial registration, clinical trial agreements, informed consent documents, and financial disclosures relating to clinical trials.
• Provided regulatory advice regarding labeling; helped draft a letter to FDA that persuaded the agency to allow relevant clinical information in the label.
• Assisted with representation of major pharmaceutical companies in Congressional and related investigations.
• Developed legal strategies and researched and drafted citizen petitions to FDA on behalf of drug manufacturers.
• Assisted companies and trade organizations in drafting comments on pharmaceutical and medical device approval pathways and bioequivalence issues.
• Conducted regulatory due diligence of medical device and pharmaceutical transactions.
• Internal investigation for a major pharmaceutical company related to compliance with a corporate integrity agreement and potential allegations of off-label promotion.
• Advise pharmaceutical companies regarding state manufacturer and wholesale distribution licensing requirements.
• Assisted a pharmaceutical company in conducting a GMP investigation related to manufacturing.

Previous Experience

• Team Leader at Fortune 100 communications company.

Pro Bono

• Providing legal advice on landlord/tenant issues to low-income DC residents through a local non-profit organization.
• Represented four-year-old girl as Guardian ad Litem in child custody dispute between biological parents in Washington, DC Superior Court.
• Assisted a local non-profit organization enroll individuals for the Medicare prescription drug benefit.

Publications and Speeches

• "Clinical Trial Developments in 2012," Covington E-Alert (2/1/2013), Co-Author
• "Health Care Reform: Therapeutic Discovery Project Tax Credits and Grants for Small Employers," Covington E-Alert (April 2010), Co-Author
• "HHS Issues Guidance and Request for Information on Technologies and Methodologies to Secure Protected Health Information for the Purposes of Breach Notification Provisions," Covington E-Alert (4/29/2009), Co-Author