Heather D. Bañuelos

Counsel

Contact

  • Washington, DC
    p202.955.1562
    f202.828.3707
  • Washington, DC
    p202.955.1562
    f202.828.3707

Heather's practice focuses on FDA regulation of drugs, biologics, medical devices, foods, and cosmetics.

Heather works with pharmaceutical, biotechnology, medical device, food, and cosmetic companies on a wide range of regulatory and enforcement issues, including representation of clients in matters before the Food and Drug Administration (FDA), Department of Agriculture (USDA), Federal Trade Commission (FTC), and other regulatory agencies and organizations.

Heather has significant experience advising on regulatory strategies and initiatives for drug and device development, approvals, labeling, and promotion and advertising. She also counsels clients on a range of other drug and device regulatory issues, including clinical trials, user fees, pharmacovigilance, postmarketing reporting, and compliance, among others.

Formerly, Heather served as Associate Chief Counsel in the FDA's Office of the Chief Counsel. In that capacity, she advised the FDA's Center for Food Safety and Applied Nutrition on various matters pertaining to the regulation of foods, dietary supplements, and cosmetics. Her experience in this area includes product composition and design, nutrition labeling, labeling and advertising claims, medical foods, functional foods, ingredient notifications and approvals, and marketing strategies.

Prior to joining the firm, Heather practiced food and drug law at another Washington, DC firm. She has served as senior in-house regulatory counsel for pharmaceutical companies, providing legal advice on domestic and global regulatory issues related to drugs, biologics, and medical devices.
Upon graduation from law school, Heather was honored with a Shattuck Award recognizing her commitment and contributions to public service. She was also a grateful recipient of the USC Carolyn Craig Franklin Scholarship. Heather continues to support public service through pro bono work at the firm.

Relevant Experience

  • Counseled pharmaceutical, biotechnology, and medical device companies on advertising and promotion issues related to FDA-regulated products, including regular and ongoing copy review processes, compliance issues, and communications with the FDA.
  • Advised pharmaceutical, biotechnology, and medical device companies regarding nonpromotional activities, including the use of reprints, responses to unsolicited requests for off-label information, and support of Continuing Medical Education (CME) activities, among other topics. 
  • Advised pharmaceutical, biotechnology, and medical device companies on regulatory strategies and initiatives for product development, approval, and commercialization.
  • Represented clients in trade complaints to competitors, the FDA, and other federal agencies regarding the marketing and promotion of drug and device products.
  • Represented pharmaceutical companies in drafting and negotiating various contracts and agreements, including manufacturing and distribution agreements, confidentiality agreements, consulting agreements, clinical trial agreements, and general services agreements.
  • Served as specialty pharmaceutical company’s sole in-house FDA counsel, responsible for all regulatory issues related to company products, including biologics, prescription and nonprescription drugs, medical devices, and cosmetics.
  • Served as temporary in-house counsel for Fortune 500 pharmaceutical company, covering all legal issues for product-based team, including contracts and consulting agreements, drug advertising and promotion, labeling, sales training, scientific publications, and medical education.
  • Counseled various clients on conflict of interest laws and regulations pertaining to clinical investigators, consultants, and FDA advisory committees.
  • Provided legal and regulatory advice to pharmaceutical companies on product tampering and counterfeiting issues.
  • Advised pharmaceutical and biotechnology companies on federal and state pedigree, licensing, and distribution requirements.
  • Counseled companies on regulatory status and classification of FDA-regulated products, including drugs, foods, biologics, and medical devices, and developed appropriate and successful marketing strategies.
  • Advised food companies on nutrition labeling, food labeling claims, including "natural" claims, and compliance with the USDA's National Organic Program.
  • Advised food companies regarding regulations governing the marketing of medical foods.
  • Represented clients in trade complaints to the FDA and other organizations, including the National Advertising Division of the Council of Better Business Bureaus, regarding the advertising of foods, cosmetics, and nonprescription drugs.
  • Prepared, researched, and analyzed various issues pertaining to nutrition labeling in consumer fraud class action case.
  • Prepared and submitted Citizen Petitions on a variety of issues, including requests about food labeling and alternative drug approval processes.
  • Prepared white papers, responses to Citizen Petitions, and comments on FDA rulemaking initiatives, including nutrition labeling issues, food labeling claims, and matters concerning drug approval decisions.
  • Advised pharmaceutical, biologics, food, and dietary supplement companies on due diligence matters related to the acquisition of other companies and/or FDA-regulated products.
  • Advised various pharmaceutical and food companies on legislative initiatives and enacted legislation affecting their businesses.
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