Food and Drug

Representative Experience

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  • Represented largest producer of Vidalia Onions in reviewing labeling and packaging artwork for client’s full line of food products.
  • Represented Israel-based provider of personal care medical products in revising social media, website and  product labeling in accordance with FDA and FTC requirements. Helped client revise clinical protocol for study to support performance claims for skincare product.
  • Assisted a European manufacturer of skin care products with manufacturing and quality systems agreements for OTC drug sunscreen products, proper labeling for the products, and  quality control testing.
  • Assisted manufacturer of medical devices that aid in early detection of disease to prepare 510(k) submission to FDA for the device and related software.
  • Assisted clients with preparation of regulatory opinion for IPO filings.
  • Assisted a Belgian biotech company to prepare submission to FDA for GRAS status of new enzyme food ingredient system.
  • Advised a European pharmaceutical company on potential regulatory approval pathways, including 505(b)(2) new drug applications, that competitor products might use for U.S. market entry. Provided ongoing research on legal strategies to maintain market share against competitor products.
  • Successfully represented a Georgia home health provider in a request for reconsideration of a CMS contractor’s decision to terminate the provider’s Medicare enrollment.
  • Worked with the FDA’s Office of the Ombudsman to help facilitate meetings or discussions between a pharmaceutical company sponsor and the FDA on a stalled clinical development program and when communications broke down.
  • Worked with the FDA’s Office of the Ombudsman to help facilitate meetings or discussions between a pharmaceutical company sponsor and the FDA on a stalled clinical development program and when communications broke down.
  • Counseled a European pharmaceutical client on market exclusivity strategies under U.S. law and FDA regulations.
  • Facilitated process for an Israeli client to obtain a deferred payment plan for U.S. FDA prescription drug user fees.
  • Worked with an Israeli combination product manufacturer to determine the appropriate regulatory approval pathway for the product and assisted with developing supporting rationale for the FDA to review the product under the client’s preferred approval pathway.
  • Served as counsel to a specialty pharmaceutical company in connection with the formation of a strategic alliance with a medical device development company to develop, market and sell obstetric products.
  • Served as counsel for First Horizon Pharmaceutical Corporation, a specialty pharmaceutical company, in its initial and follow on public offerings totaling approximately $245 million.
  • Successful in defense of putative 10b-5 class action litigation, prevailing by dismissal with prejudice on motion for failure to state a claim.
  • Served as counsel for acquirer in a stock-for-stock acquisition by merger of publicly traded healthcare company.
  • Served as counsel in initial public and follow on public offerings for Microtek Medical Holdings, Inc. totaling approximately $130 million.
  • Reviewed product labeling and product claims for a pharmaceutical company manufacturing and distributing dietary supplements and over-the-counter drug products.
  • Advised start-up company in the area of hair restoration research regarding most advantageous regulatory pathway for development and marketing of biological-device combination product.
  • Advised both sponsors and principal investigators of human clinical trials regarding compliance issues and related responses to the FDA.
  • Assisted a Georgia-based pharmaceutical company with preparation of FDA submissions and adverse events reports.
  • Advised a pharmaceutical company regarding labeling and advertising activities for drug products.
  • Served as lead counsel for a pharmaceutical company in connection with responses to FDA inspectional observations, warning letters, and FDA investigations, and the defense of seizure, injunctions and criminal actions in federal court.
  • Advised an eye care manufacturer regarding labeling and advertising activities for device products.
  • Served as lead counsel for an eye care manufacturer in connection with responses to FDA inspectional observations.
  • Advised multinational manufacturer of human biological and device products regarding approval strategies, advertising and promotional activities, and compliance issues.
  • Served as lead counsel for a biomedical company in connection with responses to FDA inspectional observations, warning letters, and FDA investigations, and the defense of seizure, injunctions and criminal actions in federal court.
  • Advised a biomedical company regarding labeling and advertising activities for multiple product lines.
  • Assisted a Georgia-based biologics and device company with preparation of FDA submissions, including 510(k) premarket notifications, new drug applications (NDAs), medical device premarket applications (PMAs), biological license applications (BLAs) and adverse events reports.
  • Advised a research pharmaceutical company regarding compliance issues and related responses to the FDA.
  • Assisted a Georgia-based long-term care facility with preparation of DEA submissions for pharmacy operation.
  • Advised a urological physician regarding compliance issues and related responses to the FDA.
  • Assisted a New Jersey-based pharmaceutical company with preparation of FDA submissions, including 510(k) premarket notifications, new drug applications (NDAs), medical device premarket applications (PMAs), biological license applications (BLAs) and adverse events reports.
  • Advised a major food service distributor regarding USDA food safety investigations at multiple facilities.
  • Serving as general counsel to the National Frozen & Refrigerated Foods Association.
  • Served as lead counsel for a nonprofit healthcare system in connection with responses to FDA inspectional observations concerning clinical trials.
  • Assisted a Georgia-based medical devices manufacturer with preparation of FDA submissions, including 510(k) premarket notifications and medical device premarket applications (PMAs).
  • Defended a California-based non-dairy food manufacturer in FTC investigation concerning substantiation support for advertising claim promoting cardiovascular health and wellness.
  • Advised numerous medical device manufacturers concerning product recalls and market withdrawals to minimize business disruption, cost and damage to brand.
  • Served as lead counsel for a medical device manufacturer in connection with responses to FDA inspectional observations and warning letters
  • Advised a leading supplier to the food service industry and manufacturer of non-dairy frozen foods concerning product recalls and market withdrawals to minimize business disruption, cost and damage to brand.
  • Advised a leading manufacturer of frozen baked foods regarding labeling and advertising activities, and in advertising substantiation by the FTC.
  • Served as lead counsel for a provider of frozen specialty seafood in connection with responses to FDA inspectional observations, warning letters, and FDA investigations, and the defense of seizure, injunctions and criminal action in federal court.
  • Served as lead counsel for an officer of a drug distribution firm in connection with DEA investigation and the defense of criminal action in federal court.
  • Coordinated regulatory due diligence for New-York based private equity firm evaluating acquisition of major medical devices company.
  • Advised hedge fund clients concerning FDA regulatory actions affecting their investment in pharmaceutical company.
  • Helped prepare a Citizen Petition, submitted by King Pharmaceuticals, a publicly traded company subsequently acquired by Pfizer, defending a challenge to the company’s sale of an approved drug product; the product remains on the market to date.
  • Represented a number of pharmaceutical clients before local FDA district offices and the FDA’s Office of Compliance to develop proactively a phase-out program of Drug Efficacy Study Implementation (DESI) products before the FDA took enforcement action against the companies.