Hatch waxman act and post marketing survillance

Include information about Hatch- waxmann act and amendments, this also include information about post marketing survillance

1. Presented by: Mrunal More 1 st year M.pharm (Pharmaceutics) AISSMS College of Pharmacy,Pune . HATCH-WAXMAN ACT & AMENDMENTS POST MARKETING SURVILLANCE

2. CONTENTS INTRODUCTION OBJECTIVES OF THE ACT DRUG APPROVAL NEW BRANDED DRUG APPROVAL GENERIC DRUG APPROVAL CONCLUSION BONUS

3. INTRODUCTION  Also known as “THE DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT” .  Enacted in 1984  Amended the patent laws  Before 1962- new drug approval based on safety alone  In 1962-proof of efficacy made compulsory for marketing approval of a new drug  There was no provision for patent term extension prior to enactment of the hatch- waxman act to make up for the time lost out of the total patent term during the marketing approval process

4.  Generic companies were required to submit their own comprehensive NDA which were costly & time consuming .  To overcome the above problems, an act was needed to promote generic companies.

5. OBJECTIVES  Reducing the cost associated with the approval of a generic drug.  Allowing early-experimental use .  Compensating the branded drugs manufacturers for the time lost from the patent term because of the regulatory approval formality.  Motivating the generic drug manufacturers.

6. DRUG APPROVAL  The FDA requires every new drug, including generic drugs, to be safe and effective .  Before the adoption of the Hatch- Waxman Act , the FDA required branded and generic drug companies alike to demonstrate the safety and efficacy of their products in the same manner through a New Drug Application (NDA) .

7.  The Hatch-Waxman Act changed certain aspects of the new drug application process and the new drug’s patent term .  In addition, the Hatch-Waxman Act created an abbreviated process to allow generic drug companies to obtain FDA approval of generic drugs. Because of this, today it is far easier for generic drug companies to demonstrate the safety and efficacy of their generic drugs .

8. NEW BRANDED DRUG APPROVAL  A branded drug company seeking FDA approval to market a new drug must submit an NDA to the FDA . The information provided in the NDA allows the FDA to determine whether: 1)The new drug is both safe and effective . 2)Certain other regulatory requirements are met , such as those concerning labeling and good manufacturing processes.  Obtaining and submitting this information frequently is a time-consuming process requiring the branded drug company to conduct many extensive and expensive clinical trials .

9. GENERIC DRUG APPROVAL  The FDA reviews generic drug applications for compliance with the appropriate scientific and regulatory criteria. If an application meets those criteria, the FDA may grant either: a) Tentative approval b) Final approval  Under the Hatch-Waxman Act , generic drug companies can typically file one of two different kinds of abbreviated applications for approval of a generic drug: a)An Abbreviated New Drug Application (ANDA) b)A Section 505(b)(2) application, which is often called a paper NDA.

10. a) ABBREVIATED NEW DRUG APPLICATIONS  Under an ANDA, a generic drug company must establish that the generic drug is effectively a duplicate of the branded, NDA drug , which is referred to as the Reference Listed Drug (RLD). Specifically, the generic drug company must show that the proposed generic drug : a)Has the same active ingredient, route of administration, dosage form, strength and intended use as the RLD . b) Is bioequivalent with the RLD, so that it performs in the same manner as the RLD in the body.

11. b)Section 505(b)(2) Applications  A proposed generic drug may differ in significant ways from the RLD.  Under these circumstances, the proposed generic drug must be approved through the Section 505(b)(2) paper NDA application process, which is a hybrid of a full NDA and an ANDA . This application includes less data than an NDA but more data than an ANDA.

12. NEW DRUG EXCLUSIVITY (The practice of excluding) A)Non-patent Exclusivities  ( 1.) Orphan drug exclusivity , which is granted to drugs: a)that treat a disease or condition that affects less than 200,000 people in the US; or b)for which it is unlikely that US sales of the drug will recoup its development costs. This exclusivity period is seven years , but only applies to use in treating the specific rare disease or condition.

13. ( 2) New chemical entity (NCE) exclusivity .  This is granted if the FDA has not previously approved the “active drug moiety .”  NCE exclusivity bars a generic drug company from filing an application for approval of a generic drug five years from the first approval of the relevant NDA.  However, a generic drug company may file an ANDA with a Paragraph IV certification four years after the first NDA approval

14. ( 3)New clinical study exclusivity.  This applies when new clinical studies lead to new or changed formulations, dosing regimens or patient population .  The applicant is entitled to this exclusivity if an application or supplement contains reports of new clinical investigations conducted or sponsored by the applicant that were essential for approval .  This exclusivity, sometimes called data exclusivity, prohibits the FDA from approving a generic drug application for the new dosage form or use for three years after the first NDA approval .  However, it does not otherwise bar approval of generic drug applications.

15. ( 4)Pediatric exclusivity  This applies if the FDA requested that the NDA holder conduct studies with the drug in pediatric populations.  Pediatric exclusivity adds six months of exclusivity to any marketing or patent exclusivity.

16. NON PATENT EXCLUSIVITY TYPES TERM NEW CHEMICAL ENTITY EXCLUSIVITY 5 YEARS NEW CLINICAL STUDY EXCLUSIVITY 3 YEARS ORPHAN DRUG EXCLUSIVITY 7 YEARS PEDIATRIC EXCLUSIVITY 6 MONTHS 180 DAYS GENERIC MARKET EXCLUSIVITY 180 DAYS

17. B) Patent exclusivity & the orange book  An NDA holder must provide the FDA with the patent number and expiration date of any patent that claims either : a)The drug, including the active ingredient and the formulation for the active ingredient . b)A method of using the drug, but not other inventions such as : ;-metabolites; ;- synthetic intermediates; or ;- methods of making the drug. When the FDA approves the NDA , the FDA publishes the patent information in the FDA’s Approved Drug Products with Therapeutic Equivalence Determinations publication (also called the Orange book )

18. PATENT TERM EXTENSION  The Hatch-Waxman Act provides a patent term extension for patents covering certain products and methods, including human drug products, that are subject to FDA approval . Only one extension can be granted in connection with a particular product, and it must be for a patent that claims either a: a) Drug product , which means the active ingredient and any approved drug using that active ingredient . b)Method of using a drug product. c)Method of manufacturing a drug product

19. PATENT LITIGATION UNDER THE HATCHWAXMAN ACT  Various time periods concerning aspects of the litigation that may affect the FDA’s approval process  Certain defenses and counterclaims that drug companies may raise  Specific remedies the parties tend to seek  Unique challenges in entering into settlement agreements

20. CONCLUSION  The hatch- waxman act provides an expedited USFDA program for speedy generic entry and market exclusivity  The hatch- waxman act allows for a patent term extension of a maximum of 5 years for the branded drug manufacturer to compensate for the time lost during the NDA approval by the USFDA.

21. REFERENCE https:// www.fda.gov/drugs/abbreviated-new-drug-application-anda/hatch-waxman-letters https:// www.fda.gov/drugs/drug-and-biologic-approval-and-ind-activity-reports/first-generic-drug-approvals https :// www.fda.gov/drugs/types-applications/new-drug-application-nda

22. Post Marketing Surveillance

23. Content: Introduction Advantages Source of the information Need of it Method of PMS Reference

24. INTRODUCTION  To market a drug, the manufacturer must provide evidence of its efficacy and safety to the U.S food and drug administration and specified regulatory authorities.  In premarketing testing, the numbers and types of patients used to demonstrate a drug's efficacy and safety are limited compared with the numbers and types of patients who will eventually be prescribed the drug after it is marketed.  Post-marketing surveillance of drug therefore play an important role to discover an undesirable effect that might present at RISK . It provides additional information on the benefits and risk of the drugs.

25. ADVANTAGES  No fixed Duration / patient population.  Starts immediately after marketing .  Report all ADRs  Helps to detect : Rare ADR’s Drug Interaction’s .  Also new uses for drugs {Sometimes called Phase V}

26. SOURCE OF THE INFORMATION The following maybe considered as sources of information, Some sources are pro active and some are reactive Expert users groups ("focus groups '). Customer surveys. Customer complaints and warranty claims. Post CE(clinical evaluation)- market clinical trials . Literature reviews. Device tracking/implant registries. User reactions during training programmers. The media.

27. NEED OF IT  The primary objective of post-marketing studies is to develop information about drug effects under customary conditions of the drug use .  Access to more patients and better data .  Given diversity of data sources, innovative approaches to retrieval of key data may have great potential vs. single unified system .  Better background rates, comparable "control" populations.  Increase in "non-medical' data sources e.g., pharmacy, supermarket, employer vaccination.  All patients vaccinations and health outcomes are immediately and continuously accessible in automated database allowing optimal detection and analysis are applicable to safety initiatives for other medical products.

28. METHODS OF PMS Thus, four types of studies are generally used to identify drug effects : (3c’s)  Controlled clinical trials ,  Spontaneous or voluntary reporting  Cohort studies, and  Case-control studies

29. Controlled clinical trials :  PMS studies conducted after the launch of a product is part of Phase IV development of the drug. Some of these studies may be retrospective case-control evaluations. These are done to evaluate rare suspected side effects . Cohort studies:  These studies are a type of medical research used to investigate the cause of disease, establishing links between risk factors and health out comes. Cohort studies are usually forward looking that is , they are “prospective” studies planned in advance and carried out over a future period of time.

30. Spontaneous or voluntary reporting :  Spontaneous reports are, by definition, submitted voluntarily although under certain circumstances these reports may be encouraged, or "stimulated", by media reports or articles published in medical or scientific publications, or by product lawsuits.  In many parts of the world adverse event reports are submitted electronically using a defined message standard by physicians and other health providers & hospitals which may act to alert FDA and pharmaceutical firms to possible adverse effects of drugs.

31. Case-control studies : Case-control studies identify patients with the adverse effects to be studied (the cases), and compare them with a sample (the controls), drawn from the same cohort that gave rise to the cases.

32. THANK YOU FOR YOUR ATTENTION ANY QUESTIONS ?