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Prescription Pharmaceuticals

Fuerst Ittleman David & Joseph serves a wide variety of public and closely held companies operating in the over-the-counter (OTC), homeopathic, and prescription pharmaceutical industries. The firm is also highly experienced in handling matters for clients involved in the rapidly evolving biologics industry. Our services include:

  • Assisting clients with understanding OTC monographs and homeopathic monographs
  • Registration and listing
  • Product labeling and advertising
  • Market discipline and competitor complaints
  • cGMPs
  • Advising clients regarding clinical research including working with clinical trials and complying with FDA’s rules for INDs, NDAs, and BLAs
  • FDA and FTC enforcement actions and litigation

 

Over-the-Counter (OTC) Drugs

Non-prescription drugs, also referred to as over-the-counter or “OTC” drugs, are an important health resource. These products represent a tightly regulated industry, subject to FDA scrutiny and oversight. If you are looking for counsel to assist you in matters involving OTC drugs, Fuerst Ittleman David & Joseph’s FDA regulatory attorneys bring a wealth of experience and knowledge on non-prescription drug regulation. We assist clients by performing label reviews to ensure full compliance with FDA regulations, particularly OTC monographs. We counsel on current Good Manufacturing Practices (cGMPS) and proper operating requirements. We evaluate drug advertisements and promotional materials for FDA and FTC compliance.

Our lawyers understand the complex regulatory framework involving OTC drugs and how it differs from dietary supplements, homeopathic drugs, medical foods, and prescription drug products. If you are launching a new product and looking for the correct regulatory scheme, let Fuerst Ittleman David & Joseph guide you. Whether it’s filing an NDA, navigating the monograph system of approval or seeking an Rx to OTC switch, we can provide a judicious and efficient path to protection. Fuerst Ittleman David & Joseph can also assist with Time and Extent Applications (TEA) for amendments to an OTC monograph. Furthermore, our attorneys understand the post-approval requirements for OTC drugs including adverse event reporting and the ancillary regulations involved such as wholesaling, drug recalls, tamper-evident requirements, and National Drug Code (NDC) directory matters.

Homeopathic Drugs

Homeopathy is based on the principle that “like cures like,” that the more diluted a drug is, the more potent it becomes, i.e. “The Law of Infinitesimals.” Homeopathic drugs have a long and storied tradition in the United States and include a myriad of products, dilutions, and potencies. Homeopathic drugs have a unique regulatory framework with specific requirements that pose important challenges in manufacturing and marketing, distinct from allopathic drugs, dietary supplements, and medical foods. In fact, homeopathic drugs include a number of critical requirements separate from other products that demand specific counsel.

Fuerst Ittleman David & Joseph assists clients in understanding the manner in which FDA regulates this growing market of products. Our food, drug, and life sciences practice group helps a wide array of clients in the homeopathic industry understand the parameters applicable to them in marketing and advertising, registration and listing, and product formulation. We can assist with matters involving the need for pre-market approval and post-marketing regulation (current Good Manufacturing Practices (cGMPS), marketing, and sales). Fuerst Ittleman David & Joseph also has extensive experience and skill directing product labels, advertising, reimbursement, prescribing, extemporaneous compounding, importation, state regulation of homeopathic drugs and responding to FDA Warning Letters.

Prescription Pharmaceuticals

For our clients doing business in the prescription drug industry, Fuerst Ittleman David & Joseph can provide invaluable assistance early on in the research and development process and throughout post-approval obligations including a myriad of ancillary responsibilities and regulatory requirements.

Research and development of prescription drugs can be a complicated and costly endeavor. Our attorneys are available throughout the process to help clients successfully navigate the process and properly position themselves for efficient approval. We can help determine the need for an Investigational New Drug Application (IND) and facilitate pre-IND meetings with FDA officials. We can advise on Phase I, Phase II, Phase III, and Phase IV research studies for compliance with state and federal rules and regulations, including the Common Rule (45 C.F.R. Part 46) and local institutional review boards (IRBs).

We routinely advise clients on labeling, current good manufacturing practices (cGMPs), FDA review dates and accelerated approval pathways. Fuerst Ittleman David & Joseph also understands the complex regulatory scheme under the Hatch-Waxman Act including authorized generics, therapeutic equivalents, patent listing in the Orange Book, Paragraph IV Certifications, and the application of pediatric exclusivity requirements. Our tax practice helps clients realize the tax benefits of orphan drug designation and the costs incurred with the Prescription Drug User Fee Act (PDUFA). Fuerst Ittleman David & Joseph can also counsel clients on veterinary drug applications including NADA, ANADA and CNADA.

Let Fuerst Ittleman David & Joseph assist you. Our attorneys understand the drug distribution process and can counsel clients on wholesale distribution, importation and re-importation, drug pedigrees and counterfeit drugs. We can help establish required standard operating procedures (SOP) for manufacturer facilities and help meet the requirements of the Application Integrity Policy (AIP). Additionally, Fuerst Ittleman David & Joseph’s associates help clients navigate drug recalls including developing a comprehensive strategy from risk assessment and proper communication through effectiveness evaluation.