The U.S. Food and Drug Administration’s (“FDA”) is responsible for the regulation and oversight of the U.S. OTC drug market. Congress has granted FDA regulatory authority over the formulation, manufacturing, labeling, marketing and promotion; and import / export of OTC drug products into the U.S. Under this current regulatory regime, there are 3 pathways that a company may follow to enter the OTC drug market including (a) following an appropriate Drug Monograph; (b) with an Agency approved New Drug Application (“NDA”); or (c) via the currently popular Rx-to-OTC Switch Process.
This course on FDA regulation of OTC drug products is intended to provide attendees with the knowledge and skills needed to develop and produce an OTC Drug Product for marketing and sale in the U.S. Attendees will gain an understanding of :
- Various available options for producing and selling an OTC drug product,
- U.S. Food and Drug Administration’s (“FDA”) regulation of OTC drug products,
- Strategic recommendations for mitigating the risk of enforcement action in the future.
Learning Objectives:
Participants who attend this course on FDA regulation of OTC drugs will:
- Gain a comprehensive understanding of how OTC Drug Products are regulated in the U.S.
- Learn to distinguish between a potential Rx pharmaceutical product and an OTC drug.
- Recognize the difference between the various pathways for commercializing an OTC Drug Product.
- Understand how to identify and successfully navigate an OTC Drug Monograph.
- Recognize when reliance on a Proposed Rule, Final Rule and/or Drug Monograph is appropriate.
- Understand how to determine whether an Ingredient is considered Safe or GRAS/E for use in an OTC Drug and understand the difference between Category I, II and II Ingredient designations.
- Identify the required elements of a compliant OTC Drug Label.
- Take away strategies for marketing and promoting OTC drug products, and for mitigating potential enforcement risks.
- Possess a working knowledge of the Rx-to-OTC Switch Process.
- Review and evaluate several of FDA's current OTC Monographs
- Registration Process - (8:30 am till 9:00 am)
- Session Start Time: 9:00 AM
- Lecture 1: Overview of Drug Regulation in the United States
- Role and function of FDA generally
- FDA’s purpose and mission
- FDA’s jurisdiction
- FDA’s six “product centers”
- Center for Food Safety and Applied Nutrition (CFSAN)
- Center for Drug Evaluation and Research (CDER)
- Center for Biologics Evaluation and Research (CBER)
- Center for Devices and Radiological Health (CDRH)
- Center for Tobacco Products
- Center for Veterinary Medicine (CVM)
- FDA’s operation
- Structure of FDA: Specifics of CDER
- CDER’s mission
- CDER’s jurisdiction
- CDER’s organization (discuss divisions and duties within each office)
- Introduction to the FDCA, Regulations, and Guidance Documents
- Overview of FDCA and regulations
- Introduction to FDA guidance
- Role and function of FDA generally
- Lecture 2: OTC drugs v. Rx Drugs
- Differences between the two
- How to distinguish
- Lecture 3: History of Regulation of OTC Drugs in the US
- Statutory and Regulatory Authority for OTC Drugs
- 1938: Federal Food Drug Cosmetic Act (FFDCA) drug safety requirement.
- 1951: Durham-Humphrey Amendments to Federal Food, Drug and Cosmetic Act (FFDCA) designated drugs that cannot be used safely without professional supervision as prescription drugs and all other drugs as OTC.
- In order for an OTC drug active ingredient to be included in an OTC monograph it must have been marked prior to May 11, 1972.
- Two legal pathways for OTC drug marketing post 1938.
- Marketing in compliance with drug monograph
- Marketing under the authority of an approved New drug application (NDA).
- Statutory and Regulatory Authority for OTC Drugs
- Lecture 4: OTC Drug Review Process
- New Drug Approval Process
- NDA
- Rare for a company to pursue an approved NDA for a non-prescription drug because of the expense and effort involved with obtaining FDA approval.
- Rx-to-OTC
- The Rx-to-OTC Switch regulatory pathway is becoming increasingly popular as companies look for ways to extend the life cycle of their branded prescription products but similar to the option above, an Rx-to-OTC Switch requires FDA’s approval of an NDA.
- NDA
- OTC Drug Monograph System
- Developed in the 1970’s in response to a whole class of marketed non-prescription drug products that existed in the market that had never been reviewed for safety and effectiveness.
- Attempt to “clean up” the market
- Development of the monograph process (or “OTC Drug Review”)
- OTC drugs as Generally Recognized as Safe & Effective (“GRAS&E”).
- New Drug Approval Process
- Lecture 5: OTC Drug Monographs
- Process
- Notice of Proposed Monograph
- Proposed Final Monograph
- Final Monograph
- Final OTC monograph establishes the acceptable:
- active ingredients
- concentration of the active ingredients
- therapeutic claims
- indications
- labeling/warning requirements
- directions for use
- Marketing the OTC drug product when the Monograph is not final
- Process
- Lecture 6: Status of specific OTC Monographs, their included Regulatory Requirements and Strategies for Commercialization
- Antimicrobial
- Cold & Cough
- External Analgesic
- Internal Analgesic
- Laxatives
- Nasal Decongestant
- Skinning Bleaching
- Skin Protectants
- Sunscreens
- Other Monographs as appropriate
- Lecture 7: OTC Drug Ingredients
- Substantiating the safety and efficacy of a proposed new ingredient
- Showing why an Ingredient should be included in the Monograph
- The concept of GRAS
- Lecture 8: Marketing a drug product that deviates from a final monograph
- Suitability Petitions
- Lecture 9: OTC Drug Labels, Labeling, Marketing and Advertising Issues
- An OTC product's indications are limited to (a) those approved by FDA in the case of an OTC application or an Rx to OTC Switch product, or (b) the uses and indications included in the relevant monograph.
- Beyond those indications, other labeled uses and indications are not permitted.
- Definitions of the terms “label” and “labeling”
- Labeling includes the Immediate Container, Outer Packaging, Package Insert, Client Information Sheet, Shipping Label
- Elements of an OTC Drug compliant label
- Active Ingredient
- Use
- Warnings
- Inactive Ingredients
- Purpose
- Directions
- Other Information
- Promotional Materials
- Brochures, Press Releases, Flyers, Audio and Advertising
- Written Media, Broadcast Media, Internet Media, Social Media
- Strategies for Regulatory Compliance
- An OTC product's indications are limited to (a) those approved by FDA in the case of an OTC application or an Rx to OTC Switch product, or (b) the uses and indications included in the relevant monograph.
- Lecture 10: FDA Enforcement Actions
- Noncompliance and Enforcement
- FDA Enforcement Authority over Development, Manufacture, Marketing, and Distribution
- FDA’s Office of Regulatory Affairs (ORA): Responsible for field activities, imports, inspections, and enforcement policy
- Local, State, and Tribal governments
- Types of Enforcement Actions
- Warning Letters and Untitled Letters
- Seizures
- Injunctions
- Monetary Penalties (21 USC §§ 303 and 307)
- Criminal Prosecution
- Debarment
- Park Doctrine – Corporate Official Liability under FDCA
- Overlapping Agency Jurisdiction – FDA, DOJ, FTC, USDA, and State Agencies
- FDA Enforcement Authority over Development, Manufacture, Marketing, and Distribution
- Noncompliance and Enforcement
Loren Gelber
Regulatory Compliance Consultant (Ex-FDA Official)
Dr. Loren Gelber has more than 40 years in the pharmaceutical industry. She spent her first ten years at FDA, followed by 20 years in Regulatory Affairs and Compliance at various pharmaceutical companies, and the last ten years as a Regulatory Compliance Consultant. During this time she was a member of various groups and committees that worked on many compliance issues. She has published a number of papers and delivered various seminars and talks. Dr. Gelber holds a BA in Biology from Brandeis University, an MS in Chemistry from Brooklyn Polytechnic Institute (now part of NYU) and a PhD in Medicinal Chemistry from Northeastern University School of Pharmacy and Allied Health Professions. She current resides in Charlotte, NC.
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Newark Museum:
The Newark Museum, in Newark, Essex County, is the state's largest museum. It holds fine collections of American art, decorative arts, contemporary art, and art from Asia, Africa, the Americas, and the ancient world. Its extensive collections of American art include works by Hiram Powers, Thomas Cole, John Singer Sargent, Albert Bierstadt, Frederick Church, Childe Hassam, Mary Cassatt, Edward Hopper, Georgia O'Keeffe, Joseph Stella, Tony Smith and Frank Stella. The Newark Museum's Tibetan galleries are considered among the best in the world. The collection was purchased from Christian missionaries in the early twentieth century.
Prudential Center:
Prudential Center is a multi-purpose indoor arena in the central business district of Newark. Opened in 2007, it is the home of the National Hockey League's (NHL) New Jersey Devils and the NCAA's Seton Hall Pirates men's basketball team. The arena seats 16,592 patrons for hockey and 18,711 for basketball. Fans and sports writers have affectionately nicknamed the arena "The Rock" in reference to the Rock of Gibraltar, the corporate logo of Prudential Financial, a financial institution that owns the naming rights to the arena and is headquartered within walking distance. In December 2013, the arena ranked third nationally and ninth internationally for self-reported annual revenue. It is located two blocks from Newark Penn Station in downtown Newark, just west of Newark's Ironbound district, making it easily accessible via New Jersey Transit, PATH, Newark Light Rail, and Amtrak.
Branch Brook Park:
Branch Brook Park is a county park of Essex County, located in the North Ward of Newark, between the neighborhoods of Forest Hill and Roseville. A portion of the park is also located within the Township of Belleville. At 360 acres, Branch Brook Park is the largest public park in the city of Newark. The park is noted for the largest collection of cherry blossom trees in the United States, with over 4,300 in more than fourteen different varieties collectively called Cherryblossomland, as well as its spectacular Cherry Blossom Festival each April. The festival attracts approximately 10,000 visitors each April. During World War II, the park's grounds served a tent city for recruits, as well as a landing strip for airplanes of the United States Postal Service. To the park’s east is the Cathedral of the Sacred Heart Basilica, one of the largest cathedrals in the United States.
Cathedral Basilica of the Sacred Heart, Newark, New Jersey:
The Cathedral Basilica of the Sacred Heart, the fifth-largest cathedral in North America, is the seat of the Roman Catholic Archdiocese of Newark. It is located at 89 Ridge Street in the Lower Broadway neighborhood of Newark, New Jersey. Envisioned as a fitting monument to the faith, construction began in 1899 and was finished in 1954. The original design called for an English/Irish-gothic church, but plans were later modified in favor of a French-gothic style. The Cathedral Basilica holds concerts open to the public throughout the year and it has the largest pipe organ ever built by the Schantz Organ Co. which includes 154 ranks playable from two consoles.
Newark Symphony Hall:
Newark Symphony Hall at 1020 Broad Street in Newark, Essex County, New Jersey, was built in 1925 and added to the National Register of Historic Places in 1977. Originally built by the Shriners at a cost of more than $2 million as Salaam Temple and colloquially known as The Mosque, the four-story building has been Newark Symphony Hall since 1964. The interior features Greek and Egyptian motifs, marble columns, a crystal chandelier, gold-leaf fret work and two-columned side promenades. The neo-classical building was design by Frank Grad, a prominent Newark architect, whose work includes the Lefcourt Newark Building and many others downtown. The 3,500-seat main concert hall is named for Sarah Vaughan, a native Newarker, and is renowned for its acoustics.
Military Park:
Military Park is a 6-acre city park in downtown Newark. It is a nearly triangular park located between Park Place, Rector Street and Broad Street. From 1667, when the city was planned, until 1869 it was a training ground for soldiers. In 1869, it became the town commons. The New Jersey Historical Society, Military Park Building and the New Jersey Performing Arts Center are located across Park Place from the park. A $3.25 million renovation was announced in February 2012 and the park reopened in June 2014.
John Ballantine House:
The John Ballantine House was the home of Jeannette Boyd (1838–1919) and John Holme Ballantine (1834–1895). John was the son of Peter Ballantine, founder of the Ballantine beer brewery, and became president of the family business in 1883 after his father died. The house was built in 1885 at 49 Washington Street in the Washington Park section of Newark, Essex County, New Jersey. It is now part of the Newark Museum and is open to the public for tours.
