For Law Firms

FDA & Medical Counsel allows firms to capture the transactional, regulatory, and litigation expertise of a highly sought-after former head of an AmLaw 100 K St FDA practice group turned free agent, and the medical and scientific expertise of a well-known physician, scientist, and lawyer with an even hand and unmatched experience. Together, or separately, we bring our wealth of knowledge into your house on an as-needed basis, for you to pass through to your clients – and they need not look elsewhere.
We are on-demand to perform due diligence on any financial transaction involving FDA-regulated, medical, or science companies; we frequently field questions about whether there is are potential regulatory FDA or specialized scientific and medical issues implicated in matter of all kinds; finally, we are often called upon to broadly support all phases of litigation involving claims with FDA-regulated, scientific, and medical foundations.
Finally, as former AmLaw 100 partners, Ms. Gilmore and Dr. Borrillo are both sensitive to the needs of law firm clients with regard to client optics, billing, and other internal matters.
DIRECT FDA COMPLIANCE
For Your FDA-Regulated Clients

The federal Food & Drug Administration (FDA) has regulatory oversight of 1 in every 4 consumer products sold in the U.S. From tongue depressors to echocardiograms, lipstick to pet food, and vitamin C to chemotherapy drugs, the FDA’s legal footprint is massive and complex. With regard to each product, the scope of FDA’s jurisdiction is also wide – the Agency controls their development, manufacture, advertising, sales, and follow-up quality reporting. Moreover, FDA requires each company involved in providing these products to consumers to register and conform to regulatory requirements.

As a result, the development, manufacture, and marketing of regulated products require an in-depth understanding of the Food, Drug & Cosmetic Act, FDA’s regulatory and enforcement processes, as well as the experience to work confidently with the Agency in day-to-day client issues. FDAmc provides comprehensive FDA legal services – counseling, consulting and advocacy services on all matters of pre- and post-approval compliance, including:

  • Interaction with FDA on all compliance issues
  • Inspection preparation and assistance
  • Form 483 and warning letter response and representation
  • Recall management and intervention
  • Adverse event reporting
  • GMP/QSR manufacturing requirements
  • Post-marketing quality control
  • Recordkeeping requirements
  • Medical Science Liaison
  • Medical Affairs
  • Labeling and product claims counseling
  • Marketing and promotion regulations
  • Off-label issues
  • Substantiation – scientific evidentiary requirements
  • Ingredients, DSHEA, GRAS, voluntary and mandatory submissions
  • Product formulation
  • Disclaimers
  • Product Review and Classification processes
  • 510(k), de novo, PMA
  • Device modifications
  • 503A/503B Compounding Quality Act
  • OTC compliance
  • Establishment registration and listing
  • Labeler and product NDC codes
  • Import assistance, import alerts, and border detention
  • Assessment and remediation of enforcement and liability risks.
  • Assistance with FDA-related compliance aspects of commercial contracts, including manufacturing, sales, and distribution agreements.
REGULATORY DUE DILIGENCE
For Corporate Transactions Involving FDA-Regulated Companies

Corporate practice groups face the daunting task of having to use both business and legal acumen in crafting transactions for companies in every industry under the sun. FDA Regulatory Counsel provides deal teams with a due diligence checklist to navigate through those environments by assessing compliance, regulatory framework, and business risk and implications.

Moreover, when the ability to win a deal depends on bringing FDA subject matter expertise to the team, FDA Regulatory Counsel allows clients to compete for business they could not otherwise capture. From broad pre-deal industry questions to granular company diligence, FDA Regulatory Counsel provides its law firm clients with the regulatory due diligence capabilities needed to support informed decisions when crafting deals in FDA-regulated spaces.

Transactional Subject Matter Expertise

  • FDA due diligence on regulated companies:
    • drug
    • medical device
    • dietary supplements (nutraceuticals)
    • food and beverage
    • cosmetics
    • veterinary products
    • pharmacies.
  • Vet prospective deals based on industry posture and target companies/products.
  • Review and advise on compliance posture, history and potential vulnerabilities
  • Assess regulatory risk in order to support informed business decisions.
  • Assist with negotiation of pragmatic deal terms.
  • Draft credit, purchase, and other agreement language, including tailored reps and warranties.
  • Advise on ancillary regulatory requirements (transfers, registrations, contracts).
  • Advise on prospective liability from regulatory enforcement or consumer action.
  • Provide high level industry insight where regulatory issues affect business outcomes.
SPECIAL COUNSEL
For Matters Involving FDA-Regulated Companies

Litigation involving FDA-regulated entities overlay regulatory law with consumer and government claims. Cases often require not only statutory proficiency, but also familiarity with real world practices. With regard to product liability, case theory, scientific medical causation, and existing medical file review, FDA Regulatory Counsel brings the benefit of native FDA, medical, and scientific practices to litigation teams. Whether as an internal supplement, in expert discovery, or for expert witness testimony, FDAmc can bring the subject matter expertise.

Litigation Support

  • Augment litigation team with specialty FDA, medical, and scientific counsel
  • Assess strength of client position
  • Consult on case theory
  • Scientific/medical causation expertise
  • Provide regulatory and medical insight
  • Perform expert discovery – interrogatories, requests for production, depositions
  • Identify regulatory and scientific issues potentially bearing on litigation