Joan Bergstrom Henkel Consumer Goods, Inc.

Slides:



Advertisements
Similar presentations
Over The Counter Drugs (OTC) Dina R. Utter MSN Student Viterbo University.
Advertisements

Patent-Extender Drugs: Loop-holes in the Law Sandy H. Yoo 4/14/06.
Pharma Workshop IV Patent Linkage in the USA Lawrence T. Welch Eli Lilly and Company.
Structured Product Labeling Overview
FDA Counsel.com 1 ANDAs, OTCs, Orphans and Cosmetics -- Key Issues Wednesday, August 18, 2004 SDRAN RAC STUDY COURSE Michael A. Swit, Esq. FDACounsel.com.
Consumer Safety and Drug Regulations
1 Hatch-Waxman Boot Camp July 19-20, 2010 Mary C. Till Legal Advisor Office of Patent Legal Administration.
The Hatch-Waxman Act and How it Works: Balancing Incentives to Innovate with the Need for Affordable Drugs Minnesota Intellectual Property Association.
Clinical Trials — A Closer Look. The Food and Drug Administration (FDA) is the main consumer watchdog for numerous products: Drugs and biologics (prescription.
History of FDA and Related Regulatory Agencies
Introduction to Regulation
RAC Study Group Chapter 16
FEDERAL REGULATIONS OF MEDICATIONS Food, Drug and Cosmetic Act Protect consumers from adulterated and misbranded foods, drugs, cosmetics, or devices.
Development and Review Process of NDA, ANDA/AADA and OTC Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D Associate Professor Department of Pharmaceutics KLE.
Special Topics in IND Regulation
Pharmaceutical Development and Review Process Rev. 10/21/2014 APGO Interaction with Industry: A Medical Student Guide.
Oncology Pediatric Initiatives Richard Pazdur, MD Director, Division of Oncology Drug Products.
The FDA Landscape AdvaMed September 2008 Judith K. Meritz
Investigational New Drug Application 21 CFR Part 312 A Review for OCRA US RAC Study Group September 2005 Ginger Clasby, MS Promedica International
Regulation of Generic Drugs Office of Generic Drugs Craig Kiester Regulatory Support Branch.
© 2009 Pharmaceutical Law Group PC Market Exclusivity Paradigm Gregory J. Glover, MD, JD Pharmaceutical Law Group
Joint NDAC/PAC meeting October 18, 2007 OTC Cold and Cough Products: Use in Children Advisory Committee Meeting October 18, 2007 Joel Schiffenbauer, MD.
1 Patent Term Extension under 35 U.S.C. § 156 Mary C. Till Legal Advisor Office of Patent Legal Administration.
The Life Sciences Lawyer’s Guide to PTA and PTE
OTC Dermatologic Topical Corticosteroids Michael L. Koenig, Ph.D. Interdisciplinary Scientist Division of Over-the-Counter Drug Products Center for Drug.
Stages of drug development
What You Want to Know About Generic Drugs Generic Drugs: Safe. Effective. FDA-Approved.
DRAFT Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing Denise Sánchez, J.D.,
Subsequent Entry Biologics (SEBs) – Canada Presentation to AIPLA Biotechnology Committee January 25, 2012 Daphne C. Lainson
Data protection and extension of patent rights TRIPS requirements & TRIPS-plus provisions Carlos Correa.
Stakeholders In Clinical Research Government and Regulatory Bodies Professor Phil Warner.
Industry Perspective on Challenges for Product Developers - Drugs Christine Allison, M.S., RAC Associate Regulatory Consultant, Global Regulatory Affairs.
Investigational New Drug Application (IND)
When do I need an IND ? FDA Guidance for Industry – Investigation New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted.
Drug Submissions: Review Process Agnes V. Klein, MD Biologics and Genetic Therapies Directorate February, 2003 www/hc-sc.gc.ca/hpb-dgps/therapeut.
From the Lab to Market Unit 3.04 Understanding Biotechnology research & Development.
Investigational Drugs Drug Laws, Drug Approval Process.
Investigational Drugs in the hospital. + What is Investigational Drug? Investigational or experimental drugs are new drugs that have not yet been approved.
FDA Focus On Consumer Protection
NDAC December 14, Nonprescription Drugs Advisory Committee Meeting Silver Spring, Maryland December 14, 2007 Mary S. Robinson, MS Division of Nonprescription.
Overview of FDA's Regulatory Framework for PET Drugs
1/33.  What is INDA ?  Types of INDAs  Objectives of INDAs  Format & Contents of an INDA  IND Safety reports  IND Annual Reports  IND Review Process.
Center for Drug Evaluation and Research (CDER) Tanya Eberle Kamal Diar David Clements.
The FDA: Basic Facts It takes 12 to 15 years to develop a single drug Only 1 in 10,000 potential medications makes it completely through the process Only.
History of Pediatric Labeling
History and Overview of OTC Topical Antifungal Drug Products Houda Mahayni, R. Ph., Ph.D. Division of Over-the-Counter Drug Products.
CFC Essential Use Status of Albuterol: Medical Considerations Pulmonary-Allergy Drugs Advisory Committee Meeting June 10, 2004 Eugene J. Sullivan, MD,
Biotechnology Chemical Pharmaceutical Customer Partnership
Over-the-Counter Drug Products Over-the-Counter (OTC) drug products are those drugs that are available to consumers without a prescription. There.
Investigational Devices and Humanitarian Use Devices June 2007.
Monograph Regulation of Weight Control Products for Over-The-Counter (OTC) Use Joint Nonprescription Drugs Advisory Committee and Endocrine and Metabolic.
Food and Drug Administration Amendments Act of 2007 Reauthorization of Pediatric Initiatives Lisa L. Mathis, M.D. Pediatric and Maternal Health Staff Office.
PHARMACY LAWS.
Initiatives Drive Pediatric Drug Development January 30, 2002.
Hatch-Waxman As Amended (MMA) Thomas O. Henteleff Kleinfeld, Kaplan and Becker, LLP November 9, 2005.
Jamie Bango Lindsey Croker Kristen Lantz Achidi Ndiforchu.
Regulation of Generic Animal Drugs in the United States
Clinical Trials.
FDA DRUG APPROVAL FDA’s Lengthy Drug Approval Process in Twelve Steps Overview of the FDA Drug Approval Process Drug Developed June 13, 2016 | Emilia Varrone.
New Drug Application(NDA) Vs Abbreviated new drug application (ANDA)
Premarket Notification 510(k) process
How to Put Together an IDE Application
Clinical Trials — A Closer Look
Biotechnology Chemical Pharmaceutical Customer Partnership
Pharma Workshop IV Patent Linkage in the USA
Suzanne M. Sensabaugh, MS, MBA
Opening an IND: Investigator Perspective
Pediatric Therapeutics Still working to get it right for kids
Compounded Drugs and Lack of Premarket FDA-Approval
Generic vs Name Brand Drugs
Presentation transcript:

Joan Bergstrom Henkel Consumer Goods, Inc. Fundamentals of Regulatory Affairs, 8th edition Ch. 14 Patents and Exclusivity Joan Bergstrom Henkel Consumer Goods, Inc.

Introduction Hatch-Waxman Act of 1984 gave brand-name drug companies incentives to do new drug research including: Patent term extension for time lost during Regulatory review Listing patent in Orange Book Eligibility for a period of non-patent exclusivity Additional incentives created by other laws including: Orphan Drug Act – drug development for rare diseases Best Pharmaceuticals for Children Act – developing medicine for kids

Patents and Exclusivity Affords right to prevent competitor from making same Granted by the Patent and Trademark office Awarded anytime during development of a drug Usual duration is 17-20 years Affords manufacturer exclusive marketing rights Granted by the FDA Awarded upon approval of a drug (NDA) A statutory provision, if requirements are met Duration varies

Patents and Exclusivity Patents can be expired before drug approval, issued after drug approval, and anywhere in between Exclusivity is granted upon approval of a drug product if the statutory requirements are met Some drugs have both patent and exclusivity protection while others have just one or none Patents and exclusivity may or may not run concurrently and may or may not encompass the same claims Exclusivity is not added to the patent life

Patent-Related Market Exclusivity Patent generally keeps other companies from making same product for a period of time, protecting the $ investments by patent holder Time is lost during regulatory review of a product is an issue Regulatory Review Time = Testing Phase Time + Review Phase Time Period from submission to approval of NDA Hatch-Waxman Act of 1984 says patent term may be extended Extension = ½ Testing Phase time + Review Phase time Assuming due diligence is maintained! Not to exceed 14 years after date of approval of marketing application

Patent Term Extension Law Definition: “Drug Product” is active ingredient (AI) of a new drug, and salts or esters, as a single entity or in combination with other AI Law provides that patent for drug may be extended from original issue date IF: Term of patent has not expired Patent not previously been extended Extension application submitted by owner w/in 60 days of NAD approval Product in Reg. Review before it is commercially available NDA is first permitted commercial use of drug product

Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) Lists drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act First published in 1980, now electronic database Orange Book Data updated Monthly Generic Drug Product Information updated Daily Patent Information updated Daily

Orange Book Patent Listing Patent information is required to be submitted with all new drug applications at the time of NDA submission Patent information is published in the Orange Book after approval of NDA, upon receipt of FDA form 3542 For patents issued after approval of the NDA, the applicant holder has 30 days in which to file the patent to have it considered as a timely filed patent. Patents may still be submitted beyond the 30 day timeframe, but the patent is not considered a timely filed patent. Expired patents and exclusivity are not included in the published list

Non-Patent Statutory Market Exclusivity Five Year Exclusivity 5-year exclusivity granted to sponsor of a drug not previously approved under NDA, referring to a New Chemical Entity Sometimes called “NCE Exclusivity”, prevents approval of a generic equivalent for 5 years Three Year Exclusivity 3-year exclusivity granted to sponsor of a drug previously approved under NDA, but reports New Clinical Investigations (studies) Must be studies essential to approval Must be studies conducted by same sponsor Called the “NCI Exclusivity” or “New Use Exclusivity”

Non-Patent Statutory Market Exclusivity (cont.) Pediatric Exclusivity Provides an additional 6 months exclusivity to sponsor that conducts acceptable and beneficial Pediatric Studies Submit Pediatric Written Request (PWR) to FDA Applies to ALL indications of the drug or formulation, not just pediatric Orphan Drug Exclusivity Grants 7 year exclusivity to sponsor of a drug for a “rare disease or condition” Affects fewer than 200,000 people or sponsor shows inability to recover development or marketing costs Other or subsequent drugs must be “different” or “clinically superior” to be approved within the 7 years

Duration of Drug Exclusivity How long is exclusivity granted for? It depends on what type of exclusivity is granted: New Chemical (NCE) - 5 years Orphan Drug (ODE) - 7 years New Clinical Investigation (NCI) - 3 years, if criteria are met Pediatric (PED) - 6 months added to existing Patents/Exclusivity Patent Challenge (PC) – 180 days (this exclusivity is for ANDAs only) See 21 C.F.R. 314.108 New Drug Product Exclusivity

Patent Filing Leahy-Smith America Invents Act (AIA) of 2011 significantly modified the patent filing process AIA went into effect March 2013 Grants the patent to the entity “first to file” the application regardless of any previous publications Caused defensive publication planning by many companies Requires greater diligence of competitive landscape

Joan Bergstrom Henkel Consumer Goods, Inc. Fundamentals of Regulatory Affairs, 8th edition Ch. 15 Over-the-Counter Drug Products Joan Bergstrom Henkel Consumer Goods, Inc.

Introduction Over-the-counter (OTC) drugs play increasingly important role Durham-Humphrey Amendment to the FD&C Act in 1951 established three criteria for Prescription status drugs Habit forming drugs Not safe for use unless supervised by healthcare professional Limited to prescription use under NDA All drugs that did not meet these criteria = OTC drugs

Regulation of OTC Drugs Regulations applicable to Rx drugs also apply to OTC drugs All aspects of drug manufacture and testing (GMP’s) Facility listing and inspections Drug registrations Clinical trials and safety oversight Both review and approval of OTC drugs done by FDA Center for Drug Evaluation and Research’s (CDER) office Two main avenues to receive approval for an OTC drug OTC Monograph route – Safety and efficacy data known, using approved active ingredients and labeling NDA / ANDA route – submit safety and efficacy data

OTC Monograph Route In 1972, FDA initiated OTC Drug Review Process Encompassed review of safety and efficacy of products on the market Started by grouping products into therapeutic categories and evaluating the active ingredients rather than each product FDA now reviews active ingredients and labeling for more than 80 therapeutic classes of drugs (monographs, not all finalized) OTC Monograph is developed and published in the Federal Register

OTC Monograph Review Process Review of safety and efficacy data done by therapeutic category specific Advisory Panels, subject matter experts Advisory Panel recommended active ingredients be classified as Category I – generally regarded as safe and effective, not misbranded Category II – not generally regarded as safe and effective, or is misbranded Category III – insufficient data to permit classification After comment periods, FDA published conclusions as Tentative Final Monographs (Proposed Rule) Final Monograph (Final Rule) No defined timelines to move from TFM to FM, can be lengthy process Can market products under TFMs FDA can amend FMs as new information is available

NDA Route Products not covered by OTC monographs are subject to NDA process prior to marketing Four NDA Routes Direct-to-OTC NDA – same requirements as Rx NDA, PLUS demonstration product can be safely used without healthcare professional supervision Rx-to-OTC Switch – used when Rx shows it can be safely used without healthcare professional supervision NDA Monograph Deviation – used when a drug product deviates in any aspect from the OTC Monograph, like dosage form. NDA submitted with S&E data. Generic (ANDA) - same requirements as Rx NDA, with bioequivalence data

OTC NDA Products and Specific Studies Manufacturers must conduct Safety, Efficacy, and Preclinical studies Additional studies for OTC products: Label comprehension – evaluate extent to which a consumer can understand and apply information on OTC label when making drug product use decisions Open label and uncontrolled No drug product is used Self-selection – evaluate whether consumer makes correct decision on use/no use based on label information and knowledge of personal medical history No drug product used Suitable label based on comprehension should be created before test Actual use test (AUT) or Simulation Trial – evaluate consumer behavior Conducted under an IND “all comers” study with actual product

Labeling of OTC Drugs Primary responsibility over OTC drug labeling belongs to FDA In 1999, “Drug Facts” labeling rule became effective Standardized format, content, headings, graphics, and min. type size Ensure product information is easy to find and understand when used by ordinary people

Drug Facts Label Regulation 21 CFR 201.66 Specific information on OTC label: Active ingredient Uses Warnings Inactive ingredients Purpose Directions

OTC Drug Packaging Requirements Tamper evident packaging has become standard Regulation 21 CFR 211.132 Statement on both inner and outer pack show tamper-evident features Must comply with child-resistant package requirements Requirements as defined in the Poison Prevention Packaging Act (PPPA) of 1970 Consumer Product Safety Commission (CPSC) enforces child-resistant package requirements

FDA Oversight All OTC drug manufacturing activities must comply with 21 CFR 210 and 211 Drug manufacturing sites are required to register with the FDA Subject to prior approval inspections for NDA products and other routine inspections All OTC drug products must be drug listed, though NDC number not required on OTC drug product label Mandated safety reporting per the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006

Assigning a Product Class Classified based on intended use as defined by FD&C Act Intended use determined by: Product claims ex. Cleans Consumer perception Drug ingredients ex. Fluoride Products can be both cosmetics and drugs – if two intended uses Examples: Antidandruf shampoo, antibacterial hand soap Must comply with requirements for either/both drugs and cosmetics

Advertising Since 1971, Regulated by the Federal Trade Commission (FTC) No requirement to submit advertising to FTC before use FTC has policy guides on advertising that must be consulted National Advertising Division (NAD) of the Better Business Bureau is the investigative arm of the voluntary self-regulation program NAD casework includes competitive challenges from other advertisers self-monitoring traditional and new media Ensure all claim support data is available before advertising