Mark M. Yacura, Partner

Representative Experience

  • Advised beer clients on various ingredient safety and adulteration issues, use of genetically modified yeasts in the manufacturing process, BATF label warning requirements. and EPA issues regarding the use of CFC as a refrigerant.
  • Advised clients and negotiated with the FDA to obtain ANDA approval for complex generics, as well as for generics mimicking an innovator drug that had been voluntarily removed from the market for reasons other than safety.
  • Advised clients in the cell phone industry on FDA clearance and CMS reimbursement possibilities for the use of their PDMA technology to monitor patient with heart disease, diabetes, or other disease states.
  • Advised clients on approval/clearance strategies for medical device and diagnostic product. Prepared or aided in the preparation of 510(k) and IDE, and review labeling for submissions.
  • Advised clients on parameters for making health claims for various traditional or functional foods.
  • Advised clients on product life cycle issues, including approval of new dosage forms for existing products and new uses for existing products.
  • Advised clients regarding various drug reimbursement and rebate issues before the CMS, as well as fraud, abuse, and antitrust issues.
  • Advised companies sponsoring drug companies, clinical trial service companies (CRO), IRBs, and clinical investigators on compliance and enforcement actions regarding good clinical practices and investigator fraud issues.
  • Advised diagnostic clients on various permitted "research only" uses and other device status issues such as whether the diagnostic product will require a 510(k) or a PMA based on intended use and claims made.
  • Advised dietary supplement makers regarding avoidance of drug claims identified in FDA regulations.
  • Advised dietary supplement makers regarding new dietary ingredient filing requirements.
  • Advised various energy drink marketers on ingredient label content and internet issues for compliance with the FDCA and the FTCA.
  • Assisted clients in creating expert panels for evaluations as to the GRASE? status of the product.
  • Assisted clients in obtaining monographs in the United States Pharmacopeia (USP) for their drug ingredients and drug products.
  • Assisted clients in the preparation of food additive applications.
  • Assisted clients on FDA and DEA inspections of their manufacturing facilities, including responses to Form 483 observations and compliance requirements.
  • Assisted clients regarding Citizen Petitions on a variety of subjects including the status of "old" GRASE andDESI drugs, and requesting the FDA to refund improper user fee assessments.
  • Assisted clients regarding various DEA registration, drug shortage, rescheduling, and alleged compliance/enforcement violations.
  • Assisted clients with obtaining release of detained products at the U.S. borders.
  • Assisted clients with various FDA enforcement initiatives, including product recalls, responses to Warning Letters, border detentions, seizure actions, consent decrees, and injunctions.
  • Attended FDA pre-IND, end of Phase II, pre-NDA and other official meetings to negotiate and advocate for client's drug testing plan for approval.
  • Counseled clients on compliance/enforcement initiatives by the FDA, including manufacturing inspections, Form 483 responses, Warning Letter responses, and product recalls.
  • Counseled clients on various forms of exclusivities including new drug exclusivities and Waxman/Hatch patent exclusivities, 30-month stays, and Orange Book issues.
  • Counseled medical gas companies regarding drug and device claims for their combination product.
  • Met and negotiated with the FDA regarding product clearance, labeling and enforcement initiatives on behalf of the clients.
  • Represented and advised client regarding the cosmetic use and medical device approval of hyaluronic acid product for wrinkle filling.
  • Represented and advised companies on drug approval strategies for abbreviated new drug applications, 505(b)(1) and 505(b)(2) new drug applications, and suitability petitions, as well as Orphan Drug, patent term, and new drug exclusivities, and user fees matters.
  • Represented clients before the National Advertising Division of the Better Business Bureau regarding alleged unsubstantiated claims.
  • Represented clients in response to FTC cease and desist letters regarding alleged unsubstantiated claims.
  • Represented clients in response to official FDA Warning Letters, Untitled Letters, and Consent Decrees concerning unapproved new drug, misbranding, adulteration, and good manufacturing practice violation allegations. Represented clients whose products are subject to border stops and seizure actions.
  • Represented clients on Prescription Drug Marketing Act requirements regarding promotions of their prescription drugs.
  • Represented clients regarding border detentions and assisted the clients in relabeling the product to include permitted cosmetic claims so that products could enter U.S. commerce.
  • Represented clients regarding combination products issues involving both device and drug products.
  • Represented clients whose food products were contaminated with various microorganisms such as E. Coli or Salmonella and a client whose grain products were sprayed with unapproved pesticides.
  • Represented foreign sunscreen makers regarding petitioning the FDA for inclusion in the OTC monograph for sunscreens.
  • Represented makers of homeopathic drug products regarding label claims and FDA inspections.
  • Review labels, promotional labeling websites and advertising of prescription and OTC drug products to advise clients on compliance with the "intended use" aspects of the FDCA and related laws. Advised clients on "off-label" promotion issues based on scientific literature.
  • Reviewed advertising claims in print and electronic media (e.g., Internet and infomercials) regarding compliance with the FTCA. Represent clients before the FTC and state agencies on false or misleading claims allegations.
  • Reviewed infomercials regarding various cellulite claims for their truthfulness and substantiation by clinical studies.
  • Reviewed labels and promotional labeling for compliance with the FDCA and its implementing regulations.