OFW Law’s Drug and Health Care Privacy Practices focus on advising our clients regarding every aspect of the regulatory process related to bringing a product to market, post-marketing compliance, and issues central to the privacy of personal health information. Specific areas of focus include the following:
Prescription Drugs/Drug Exclusivity Counseling
For over 20 years, we have advised clients on how to bring generic drugs to market under the Hatch-Waxman Amendments and Medicare Modernization Act amendments to the Federal Food, Drug, and Cosmetic Act. We aid clients in their approval and market entry strategies – including New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), and 505(b)(2) applications – by advising them on questions concerning clinical development, application processes, labeling, patent certifications, 180-day exclusivity provisions, and the scope of various non-patent exclusivity provisions.
We routinely advise firms on marketing products under over-the-counter (OTC) tentative and final drug monographs.
OFW Law assists clients with development, submission, and approval requirements related to the conduct of human clinical research for drugs and biologic products, including new chemical entities, well-characterized proteins, and antibodies, and the development, submission, and approval of NDAs and Biologic License Applications (BLA). We also advise institutions clients on clinical development, informed consent, and Institutional Review Board oversight.
Our attorneys have comprehensive experience serving clients involved with the manufacture and distribution of drugs that also are designated controlled substances or listed chemicals, the oversight of which falls under a parallel regulatory scheme administered by the U.S. Drug Enforcement Administration (DEA) and the states.
Our representation of clients does not stop once a product is on the market. After drugs leave their place of manufacture, they enter a complex distribution chain and our attorneys are especially knowledgeable about the pharmaceutical distribution chain. We provide a wide-variety of legal advice concerning the marketing and distribution of drug products, including: drug importation and re-importation; “pedigree” issues arising under the Prescription Drug Marketing Act of 1987 (PDMA) at the federal and state levels; additional state requirements; the secondary market; repackaging; and combating counterfeiting and diversion.
Marketing and Promotion
We routinely advise clients on issues involving the marketing and promotion of FDA-regulated products, including review of promotional materials, sales representative conduct and practices, institutional promotion, direct-to-consumer promotion, and pharmacy- and physician-based communications. In addition, we provide counsel regarding Federal Trade Commission (FTC) regulations. OFW Law also has been involved in the negotiation, development, and implementation of corporate compliance programs.
We routinely advise on clients’ business arrangements to assure that they do not violate the requirements of the anti-kickback and beneficiary inducement statutes.
Enforcement and Compliance
OFW Law represents clients on the entire range of issues related to marketed products, including labeling, advertising, recordkeeping, reporting obligations, inspections, current good manufacturing practices, warning letters, and recalls. Our extensive experience enables us to act as effective intermediaries between regulators and the regulated industry during and after facilities inspections with regard to 483s and Untitled and Warning Letters.
Human Cell and Tissue Products
OFW Law has extensive knowledge of FDA’s regulatory program for human cell and tissue products (HCT/P). We advise clients on the establishment registration, product listing, donor screening and testing, and current good tissue practices, labeling, and reporting requirements for HCT/Ps.
Privacy of Personal Health Information
We advise clients on a wide-range of issues centered on the requirements for maintaining the privacy of personal health information, including the applicability of federal and state privacy requirements on communications programs focused on individual patients based on their personal information. This advice encompasses the myriad legal and regulatory requirements that apply to providers of health care products and services, from individual health care practitioners to non-physician health care providers, major pharmaceutical manufacturers, and medical device companies in matters including the privacy of Protected Health Information (PHI) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
OFW Law attorneys often represent drug and health care clients before Congress, federal agencies, and state legislatures.