DOCSLIB.ORG

Pharmaceutical Sector

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Pharmaceutical Sector MARKET REVIEW ON PRIORITY SECTOR UNDER COMPETITION ACT 2010 PHARMACEUTICAL SECTOR Malaysia Competition Commission (MyCC) 27 December 2017 TABLE OF CONTENTS Executive Summary 2 List of Abbreviations 7 Glossary 9 Introduction 16 Methodology and Limitations 18 Policy Context for the Review 24 PART ONE: OVERVIEW OF MALAYSIA’s PhARMACEUTICAL SECtor Chapter 1: Overall Growth of the Healthcare and Pharmaceutical Sectors 28 Chapter 2: Market Structure and Supply Chain 41 Chapter 3: Market Share and Market Concentration 69 Chapter 4: Market Dominance and Impact on Availability, Affordability and Accessibility of Medicines 93 PART TWO: COMPETITION CONCERNS IN THE PHARMACEUTICAL SECtor Chapter 5: Key Existing Laws and Regulations and An Assessment of Impacts 118 Chapter 6: Competition Concerns Among Industry Players 148 Chapter 7: Selected Case Studies on Anti-Competitive Conduct 177 PART THREE: CONCLUSION AND RECOMMENDatIONS Chapter 8: Conclusion and Recommendations 208 APPENDICES Appendix 1: Guiding Questions for Interviews with Industry Players 224 Appendix 2: Malaysian Organization of Pharmaceutical Industries (MOPI) Members 229 Appendix 3: Brief Profiles of Top 6 Malaysian Local/Joint Venture Pharmaceutical Companies 230 Appendix 4: Pharmaceutical Association of Malaysia (PhAMA) Members 232 Appendix 5: Malaysian Association of Pharmaceutical Suppliers (MAPS) Members 233 Appendix 6: Drug Registration Process 234 References 236 EXECUTIVE SUMMARY The aims of Malaysia’s National Medicines Policy are to promote equitable access to, and rational use of, safe, effective and affordable medicines by its population. In order to maximize social welfare, this policy is strengthened by Malaysia’s Competition Act of 2010 and the establishment of the Malaysia Competition Commission (MyCC) to bring about allocation, production and innovation efficiencies. The Malaysian healthcare system has changed from a predominantly public healthcare system to a dual or two-tiered system where public and private healthcare expenditure are almost equal today. The big rise in the incidence of non-communicable diseases and out-of-pocket expenses in the healthcare system has wielded significant financial impact on both the private and public sectors. The pharmaceutical sector has grown by an average annual rate of 8% over the last decade, reaching RM8.6 billion or 16.5% of total healthcare expenditure (RM52 billion) in 2016. Imported medicines at RM5.4 billion still account for the largest part (63%) of the RM8.6 billion pharmaceutical market, while exports are only RM0.7 billion. Generic medicines now account for 55% of the controlled (prescription) medicines market by value. The market structure of Malaysia’s pharmaceutical sector is characterized by a three-level supply chain, starting with manufacturers of generic medicines and importers of originator and generic medicines at the first level, wholesalers and distributors at the second level, and providers at the third level who provide medicines to patients and end users. The scope of this pharmaceutical sector Market Review is limited to controlled medicines. These are pharmaceutical products containing scheduled poisons as listed in the First Schedule under the Poisons Act 1952. They are commonly known as prescription medicines. The Review focuses primarily on manufacturers/importers at level 1 of the pharmaceutical supply chain, and the wholesalers/distributors at level 2. Due to time constraints, it was not possible to do a more in-depth study of the providers in level 3. A dedicated study should be carried out on the level 3 players as they represent an important link in the supply chain. That study will also need to examine the interactions between level 3 and levels 1 and 2. Out of 28 companies manufacturing controlled medicines in Malaysia, 23 are locally owned and 5 are foreign-owned, with none from high-income countries. The total sales revenue of this market was RM1.7 billion in 2014/15. Though there are few players, the market is competitive, with a Concentration Ratio (CR) 5 of 54% and Herfindahl-Hirschman Index (HHI) of 824, with little evidence of price fixing. The companies produce generic drugs, facing price competition from imports from India and increasingly from other Southeast Asian and Eastern European countries. 2 Market Review on Priority Sector under Competition Act 2010 – Pharmaceutical Sector Out of 54 importers in this study, 35 are foreign-owned, accounting for RM3.9 billion or 87% of market share, with 19 locally owned companies taking 13% of market share. This market’s CR5 of 47% and HHI of 643 indicate a low degree of market concentration. However, market concentration measured in this traditional way does not capture market power. Importers are dominated by subsidiaries of multinational corporations (MNCs) from high-income countries that import patented (originator) medicines from their parent companies. The importers have market exclusivity over those products while pricing decisions lie with their parent companies. At the second level of the supply chain, out of 709 companies holding wholesale licences issued by the National Pharmaceutical Regulatory Agency (NPRA) to distribute controlled medicines, 72 companies were studied. Four categories of wholesalers and distributors were identified: large independent distributors, Bumiputera agents, wholesalers and distributors that are subsidiaries of manufacturers, and retail pharmacies that also do wholesaling. Despite the large number of players, this market is highly concentrated, with a CR5 of 83% and HHI of 2,370. Whilst high market concentration should imply a high degree of market power over pricing, this is not the case here as the wholesalers and distributors do not own the products they distribute and hence have no power over pricing. The third level of the supply chain is made up of the providers, which consist of general practitioners’ and specialists’ clinics (individual and group clinics), private hospitals (individual and group hospitals), retail pharmacies (single outlet and chain pharmacies) and public hospitals and clinics. In 2014, there were 6,978 private GP and specialist clinics, 184 private hospitals, 1,413 pharmacy companies with 2,098 outlets, 150 public hospitals and 2,871 public clinics. Owing to time limitations, no market concentration study was done at this level. In the pharmaceutical sector, standard measures of market concentration using CR and HHI are inadequate to measure and understand market power at the companies’ level. There is no strong correlation between market concentration (traditionally defined as sales revenue share), market power and anti-competitive behaviour. Other important factors such as entry barriers, supply conditions, and particularly patents may be more important factors in determining market power. Unlike with other consumer goods, patients have little consumer choice in the frequency and type of medicines to take. This problem is compounded by information and knowledge asymmetry between patients and doctors, where those who prescribe have more power to decide than the consumers. As medicines are not easily substitutable, the definition of relevant market becomes critical. Functional similarities are insufficient to establish substitutability as the efficacy and side effects of taking a product can differ from one patient to another. Prescription medicines cannot be purchased at will and the prescribing doctor may not know the price-sensitivity of a particular patient, or may place a lesser priority on the patient’s medical costs in a treatment. Market Review on Priority Sector under Competition Act 2010 – Pharmaceutical Sector 3 For these reasons, in this sector, defining the market for anti-competition purposes is sometimes examined at a very detailed level, frequently down to the chemical substance level of Anatomical Therapeutic Chemical (ATC 5) where the originator company, through patent and other exclusive rights, has legal exclusive market rights, enjoys dominant market position and often unbridled power to determine prices. With the lack of substitutability, competition is only enabled when generic medicines enter the market – prices often drop dramatically, by up to 90%, as seen in the case of HIV medicines. (Generic competition also often results in significant lowering of originator prices.) While patents are accepted as one form of incentive and reward for innovation, competition law is increasingly used to remedy misuse of the patent regime when such conduct adversely impacts on the fostering of competition in, and growth of, the domestic industry as well as consumer welfare and public health. In Malaysia, many medicines treating non-communicable diseases, such as cardiovascular illnesses and cancer, remain high even where patent rights in relation to these medicines have expired in other parts of the world. Experience shows that prolonged patent terms can be one reason for the continued high price of these medicines. Patent and product life-cycle management strategies are employed by originator companies to extend the monopoly over blockbuster medicines in the form of patent clusters or thickets where multiple patents are filed on, for example, methods, formulations and salts. These lead to many secondary patents and follow-on products which do not necessarily have added therapeutic benefits. For this reason, the European Commission, upon completing its inquiry into competition in the pharmaceutical sector in 2009, now monitors patent settlement agreements
Load more

Recommended publications
  • Identifying the Defendant in Products Liability Litigation: Alternate Theories for Compensating Injured Plaintiffs
    International Journal of Business and Social Science Vol. 9 • No. 8 • August 2018 doi:10.30845/ijbss.v9n8p2 Identifying the Defendant in Products Liability Litigation: Alternate Theories for Compensating Injured Plaintiffs Richard J. Hunter, Jr. Professor of Legal Studies Seton Hall University United States John H. Shannon Professor of Legal Studies Seton Hall University United States Henry J. Amoroso Associate Professor of Legal Studies Seton Hall University United States Abstract A spirited public policy debate has raged in the United States for more than four decades revolving around the responsibility of drug manufacturers for their products that cause injury to unsuspecting plaintiffs. An important part of the debate centers around a drug—DES—that was marketed as a benefit to women in preventing miscarriages. Some interesting or "alternate" theories for assessing liability have received attention in the generic area of products liability. This article will discuss three of the most prominent and still controversial theories—alternative liability, enterprise liability, and market share liability. In addition, the article will include several case studies exemplifying the legal principles discussed — some coming to very difficult conclusions — regarding the efficacy and application of these theories to particular facts developed during litigation. Keywords: Alternative Liability; Enterprise Liability; Market Share Liability 1. Introduction DES (Diethylstilbestrol, a synthetic form of the female hormone estrogen) litigation in the United States has been both extensive and controversial. Forty years ago, at the height of the DES crisis, in a seminal law review article in the Fordham Law Review, Sheiner (1978) estimated that the number of women who took DES during pregnancy ranged from 1 1/2 million to 3 million.
    [Show full text]
  • V. : Civil Action No. DKC 14-3607
    Case 8:14-cv-03607-DKC Document 47 Filed 07/29/15 Page 1 of 73 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MARYLAND : MALLINCKRODT INC. : v. : Civil Action No. DKC 14-3607 : UNITED STATES FOOD AND DRUG ADMINISTRATION, et al. : MEMORANDUM OPINION Plaintiff Mallinckrodt Inc. (“Mallinckrodt”), a pharmaceutical manufacturer, brings this action seeking judicial review of actions taken by the United States Food and Drug Administration (“FDA”), regarding its methylphenidate hydrochloride extended-release tablets, a generic version of the brand-name drug Concerta. Presently pending and ready for review in this action are several motions: (1) a motion to dismiss filed by Defendants FDA and United States of America (“Defendants”) (ECF No. 30); (2) a motion to compel production of the administrative record filed by Mallinckrodt (ECF No. 31); (3) a motion for summary judgment filed by Mallinckrodt (ECF No. 34); and (2) two motions to seal filed by Mallinckrodt (ECF Nos. 4 and 20). The relevant issues have been briefed, and the court now rules, no hearing being deemed necessary. Local Rule 105.6. For the following reasons, Defendants’ motion to dismiss will be granted in part, and summary judgment will be granted in part Case 8:14-cv-03607-DKC Document 47 Filed 07/29/15 Page 2 of 73 against Plaintiff. Mallinckrodt’s motion to compel production of the administrative record will be denied as moot, and Mallinckrodt’s motions to seal will be denied. I. Background A. Statutory and Regulatory Background The FDA regulates the approval, manufacture, sale, and labeling of prescription drugs.
    [Show full text]
  • Brief of Consumers Union of United States, Inc., As Amicus Curiae in Support of Petitioners, Riegel & Riegel V
    Georgetown University Law Center Scholarship @ GEORGETOWN LAW 2007 Brief of Consumers Union of United States, Inc., as Amicus Curiae in Support of Petitioners, Riegel & Riegel v. Medtronic, Inc., No. 06-179 (U.S. Aug. 27, 2007) Lisa Heinzerling Georgetown University Law Center Docket No. 06-179 This paper can be downloaded free of charge from: http://scholarship.law.georgetown.edu/scb/40 This open-access article is brought to you by the Georgetown Law Library. Posted with permission of the author. Follow this and additional works at: http://scholarship.law.georgetown.edu/scb Part of the Consumer Protection Law Commons, and the Torts Commons No. 06-179 ~ ~!~! GLE~a~K IN THE £ upreme ¢£ourt of nite tate CHARLES R. RIEGEL AND DONNA S. RIEGEL, Petitioners V. MEDTRONIC, INC., Respondent ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT BRIEF OF CONSUMERS UNION OF UNITED STATES, INC., AS AMICUS CURIAE IN SUPPORT OF PETITIONERS LISA HEINZERLING Counsel of Record 600 New Jersey Ave., N.W. Washington, D.C. 20001 (202) 662-9115 MARK SAVAGE Consumers Union of United States, Inc. 1535 Mission Street San Francisco, CA 94103-2512 Counsel for Amicus Consumers Union of United States, Inc. WILSON-EPES PRINTINGCO., INC. - (202) 789-0096 - WASHINGTON, D. C. 20002 QUESTION PRESENTED Whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. § 360k(a), preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the Food and Drug Administration.
    [Show full text]
  • The Life Cycle of Sterling Drug, Inc.*
    22 Bull. Hist. Chem., VOLUME 25, Number 1 (2000) THE LIFE CYCLE OF STERLING DRUG, INC.* Joseph C. Collins and John R. Gwilt The foundations of Sterling Drug were laid by William partners were bought out. Weiss and Diebold realized E. Weiss and Albert H. Diebold, boyhood friends in that expansion required more product lines and that these Canton, Ohio. Weiss graduated from the Philadelphia would best be obtained by acquisition. This policy con- College of Pharmacy in 1896 and went to work in a tinued throughout the life of the organization, at least drug store in Sistersville, West Virginia. Diebold raised 130 companies being acquired, directly or indirectly, funding from his father’s company, Diebold Safe and Lock, and in 1901 the friends set up business together in Wheeling, WV. In fact, Sterling operated a plant in that town until 1962. The history of the Corporation can conveniently be divided into five periods: 1901-1917 The Neuralgyline Period 1917-1928 Sterling Products I 1928-1933 Drug Inc. 1933-1942 Sterling Products II 1942-1988 Sterling Drug, Inc. The Neuralgyline Period On May 4, 1901, Weiss and Diebold, with three local business men as partners, established the Neuralgyline Company with the sole purpose of manufacturing and Figure 1. Where it all began: in 1901 the selling a pain-relieving preparation which they called Neuralgyline Company occupied two upstairs rooms “Neuralgine.” There is now no company record of its in this house in Wheeling, WV. composition, but it seems to have been a mixture of ac- from 1902 through 1986. Ironically, the eventual fate etanilide, caffeine, and sodium salicylate.
    [Show full text]
  • Overview: Malaysian Healthcare Biotechnology
    Overview: Malaysian Healthcare Biotechnology The Malaysian Healthcare Biotechnology Sector A Frost & Sullivan Whitepaper 2009 1 Contents Please note; all data included in this paper is from published sources or Frost & 04 •Introduction Sullivan’s proprietary information, or from industry participants. Where currencies are mentioned, the conversion of Malaysian Ringgit to US Dollar 05 •Goals and Strategies for the Sector uses the following exchange rate: RM 3.6 = US$1.0 Malaysian Biotechnology Policy Disclaimer 9th Malaysia Plan Information, opinions or recommendations provided by Frost & Sullivan are presented solely for informational purposes. The information used and statements of fact made 08 •Malaysian Healthcare: Over the years and today have been obtained from sources considered reliable but we neither guarantee nor represent the completeness or accuracy of such statements. The information presented 10 •Healthcare Biotechnology Focus Areas and the opinions expressed are subject to change without notice. Frost & Sullivan Focus Sector Overview: CMO takes no responsibility for any incorrect information supplied to us by published Focus Sector Overview: CRO sources or industry participants; however all care is taken to verify data. Quantitative Focus Sector Overview: Biopharmaceuticals/Biogenerics market information is subject to fluctuation. In no event will Frost & Sullivan or Focus Sector Overview: Medical Devices & Diagnostics employees thereof be liable for any decision made or action taken in reliance on the Focus Sector Overview: Therapeutics information in this report or for any consequential, special or similar damages, even if Focus Sector Overview: Drug discovery and Drug Delivery advised of the possibility of such damages. About Frost & Sullivan 17 •Key Success Factors Frost & Sullivan, a global growth consulting company, has been partnering with Biodiversity: Healthcare/Therapeutics clients to support the development of innovative strategies for more than 45 years.
    [Show full text]
  • Case No COMP/M.2192 - 3* SMITHKLINE BEECHAM / BLOCK DRUG
    EN Case No COMP/M.2192 - 3* SMITHKLINE BEECHAM / BLOCK DRUG Only the English text is available and authentic. REGULATION (EEC) No 4064/89 MERGER PROCEDURE Article 6(1)(b) NON-OPPOSITION Date: 11/01/2001 Also available in the CELEX database Document No 301M2192 Office for Official Publications of the European Communities L-2985 Luxembourg COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 11.01.2001 SG(2000)D/285020 In the published version of this decision, some PUBLIC VERSION information has been omitted pursuant to Article 17(2) of Council Regulation (EEC) No 4064/89 concerning non-disclosure of business secrets and other confidential information. The omissions are MERGER PROCEDURE shown thus […]. Where possible the information ARTICLE 6(1)(b) DECISION omitted has been replaced by ranges of figures or a general description. To the notifying party Dear Sir/Madam, Subject: Case No COMP/M.2192 – SmithKline Beecham/Block Drug Notification of 17.11.2000 pursuant to Article 4 of Council Regulation No 4064/89 1. On 17 November, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EEC) No 4064/89 (“the Merger Regulation”), by which the UK company, SmithKline Beecham plc (“SB”) notified its intention to acquire sole control over the US company, Block Drug Company Inc. (“Block Drug”), through purchase of shares. 2. Following examination of the notification, the Commission has concluded that the notified operation falls within the scope of the said Council Regulation and does not raise serious doubts as to its compatibility with the common market and the EEA agreement.
    [Show full text]
  • Preliminary Guide to the Parke, Davis Research Laboratory Records
    Preliminary Guide to the Parke, Davis Research Laboratory Records NMAH.AC.0001 Robert Harding 1983 Archives Center, National Museum of American History P.O. Box 37012 Suite 1100, MRC 601 Washington, D.C. 20013-7012 [email protected] http://americanhistory.si.edu/archives Table of Contents Collection Overview ........................................................................................................ 1 Administrative Information .............................................................................................. 1 Biographical / Historical.................................................................................................... 3 Arrangement..................................................................................................................... 3 Scope and Contents........................................................................................................ 3 Names and Subjects ...................................................................................................... 4 Container Listing ............................................................................................................. 5 Series 1: Corporate Materials, 1887-1951............................................................... 5 Series 2: Financial Materials, 1880-1970............................................................... 11 Series 3: Employee/Personnel Materials, 1900-1989............................................ 12 Series 4: Advertising/Sales Materials, 1868-1980.................................................
    [Show full text]
  • Robert J. Desalvo Papers Business Combinations in the Cosmetic and Pharmaceutical Industries 1944
    Robert J. DeSalvo Papers Business Combinations in the Cosmetic and Pharmaceutical Industries 1944 - 1990 Collection #107 Abstract Robert J. DeSalvo’s research focused on business combinations (acquisitions, mergers, and joint ventures in the cosmetic and pharmaceutical industries. This topic was the basis for his master’s thesis in pharmacy administration at the University of Pittsburgh and continued as a life-long interest. This collection consists of two series of notebooks that Dr. DeSalvo developed to record relevant business combinations. The first series records acquisitions, proposed acquisitions, mergers, and joint ventures for the period of 1944 –1990 in an alphabetical arrangement. The information on these entries is cumulative so that the history of an organization is collected in one place. The second series of notebooks is arranged in chronological blocks. The information is arranged alphabetically by the name of the acquirer. The name of the acquired (merged), type of combination (acquisition, proposed acquisition, joint venture) and the date is also provided. The information is cross-referenced between the two series so that the researcher can approach the information by the name of the parent company or chronologically. Dr. DeSalvo used this resource for many of his publications as well as his master’s thesis. A copy of these publications and his thesis make up the remainder of the collection. Donor Gift of Barbara DeSalvo, 2000 Biography Robert James DeSalvo was born on July 20, 1933 in Toledo, OH. He died on January 23, 1993 in Cincinnati, OH. DeSalvo graduated from high school in Toledo and attended pharmacy school at the University of Toledo where he received his B.S.
    [Show full text]
  • Journal Officiel De L'union Européenne 23.9.2003
    450 FR Journal officiel de l'Union européenne 23.9.2003 Appendice A visé au Chapitre 1, point 2, de l'annexe XI (*) Liste, fournie en une seule langue par Malte, des médicaments pour lesquels l'autorisation de mise sur le marché délivrée en vertu du droit maltais avant la date d'adhésion demeurera valable jusqu'à ce qu'elle soit renouvelée conformément à l'acquis ou jusqu'au 31 décembre 2006, si cette dernière date est plus proche. L'inscription d'un médicament sur cette liste ne signifie pas forcément que l'autorisation de mise sur le marché obtenue est conforme à l'acquis. LISTE DES MÉDICAMENTS À INCLURE DANS L'ARRANGEMENT NÉGOCIÉ DANS LE CADRE DU CHAPITRE I Trade Name Dosage Form Dose MA Holder Country 0.45% SODIUM CHLORIDE IN 5% INFUSION SOLUTION N/A B.BRAUN MELSUNGEN GERMANY GLUCOSE AG 0.45% SODIUM CHLORIDE SOLUTION FOR 0.45% ABBOTT LABORATORIES UNITED STATES OF INJECTION USP INJECTION AMERICA 0.45% SODIUM CHLORIDE SOLUTION FOR IV 4.5MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION, USP INJECTION AMERICA 0.9% SOD. CHLORIDE AND 5% SOLUTION FOR N/A BAXTER HEALTHCARE UNITED KINGDOM GLUCOSE INJECTION LIMITED 0.9% SODIUM CHLORIDE AND 5% INFUSION SOLUTION N/A B.BRAUN MELSUNGEN GERMANY GLUCOSE IV INF AG 0.9% SODIUM CHLORIDE SOLUTION FOR INJ 9MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA 0.9% SODIUM CHLORIDE SOLUTION FOR 0.9% ABBOTT LABORATORIES UNITED STATES OF INJECTION USP INJECTION AMERICA 0.9% SODIUM CHLORIDE SOLUTION FOR 0.9% ABBOTT LABORATORIES UNITED STATES OF INJECTION USP INJECTION AMERICA 0.9% SODIUM CHLORIDE SOLUTION FOR 9MG/ML ABBOTT LABORATORIES UNITED STATES OF IRRIGATION IRRIGATION AMERICA 0.9% SODIUM CHLORIDE SOLUTION FOR 0.9% ABBOTT LABORATORIES UNITED STATES OF IRRIGATION USP IRRIGATION AMERICA 0.9% W/V SODIUM CHLORIDE SOLUTION FOR 0.9% W/V B.BRAUN MELSUNGEN GERMANY INJECTION BP INJECTION AG 0.9% W/V SODIUM CHLORIDE IRRIGATION SOLUTION 0.9% W/V B.BRAUN MELSUNGEN GERMANY IRRIGATION SOL.
    [Show full text]
  • The Societal Value of Prescription Drug Advertisements in the New Millenium: Targeted Consumers Become the Learned, 9 J
    Journal of Law and Policy Volume 9 Issue 2 SYMPOSIUM: Article 9 Constitutional Lawyering in the 21st Century 2001 The oS cietal Value of Prescription Drug Advertisements in the New Millenium: Targeted Consumers Become the Learned Caroline L. Nadal Follow this and additional works at: https://brooklynworks.brooklaw.edu/jlp Recommended Citation Caroline L. Nadal, The Societal Value of Prescription Drug Advertisements in the New Millenium: Targeted Consumers Become the Learned, 9 J. L. & Pol'y (2001). Available at: https://brooklynworks.brooklaw.edu/jlp/vol9/iss2/9 This Note is brought to you for free and open access by the Law Journals at BrooklynWorks. It has been accepted for inclusion in Journal of Law and Policy by an authorized editor of BrooklynWorks. THE SOCIETAL VALUE OF PRESCRIPTION DRUG ADVERTISEMENTS IN THE NEW MILLENNIUM: TARGETED CONSUMERS BECOME THE LEARNED Caroline L. Nadal* INTRODUCTION In a majority of jurisdictions throughout the United States, a prescription drug manufacturer will not be liable to the ultimate drug consumer when it has heavily advertised its product to that consumer yet failed to provide adequate warnings of the dangers associated with its use.' Under the learned intermediary doctrine,2 the manufacturer absolves itself from liability by providing *Brooklyn Law School, Class of 2002; B.A. Davidson College 1994. The author would like to thank Professor Aaron Twerski for his guidance. The author would also like to thank her husband for his continuing support. See, e.g., In re Norplant Contraceptive Prod. Litig., 165 F.3d 374 (5th Cir. 1999) (affirming summary judgment for defendant manufacturer despite its aggressive marketing of contraceptive devices to consumers); Skill v.
    [Show full text]
  • The Pharmaceutical Industry
    Chapter 5 The Pharmaceutical Industry ‘‘It has now been more than fifteen years since Robert Swanson, a young man who understood both finance and science, invited Herbert Boyer, a shy molecular biologist at the University of California, San Francisco, out for a beer. Swanson described his vision to Boyer: that the techniques and ideas that Boyer had devised for manipulating DNA could be translated into products at a private company yet to be established. As a result of that meeting, Genentech, the first well-known biotechnology corporation, was founded; Swanson and Boyer made their fortunes; and profound changes ensued in academic biomedical research, ’ Robert Bazell The New Republic, April 1991. CONTENTS Page INTRODUCTION . 73 RESEARCH AND Development . 73 Drug Discovery . ...+........~”+ 73 Drug Development . 75 BIOTECHNOLOGY-DEWED DRUGS .. .. .. .. .+ . 75 COMPETITIVE FACTORS . 81 Industry Overview . ........9. 81 Dedicated Biotechnology Companies and the Pharmaceutical Industry . 87 Competitive Influence of Government policies . 89 SUMMARY . ....+. 93 CHAPTER PREFERENCES . 94 Boxes Box Page 5-A. FDA Clinical Trials . 76 5-B. Types of Biotechnology Products in Development . 79 5-C. Pharmaceuticals-A Global Industry . 82 5-D. Price and Cost Containment . 84 5-E. Japan’s Pharmaceutical Industry . 86 5-F. Effects of Regulatory Decisions on Wall Street . 90 5-G. The Drug Export Amendments Act of 1986 . 91 5-H. The Orphan Drug Act . 92 5-I. Patent Term Extension for Pharmaceuticals . 93 Tables Table Page 5-1. Approved Biotechnology Drugs/Vaccines . 77 5-2. Conditions for Which Biotechnology-Derived Drugs Are Under Development . 78 5-3. Testing for Additional Indications for Approved Drugs . 78 5-4.
    [Show full text]
  • UNITED STATES SECURITIES and EXCHANGE COMMISSION Washington, D.C
    UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 13, 2020 Kadmon Holdings, Inc. (Exact name of registrant as specified in its charter) Delaware 001-37841 27-3576929 (State or other jurisdiction (Commission (I.R.S. Employer of incorporation) File Number) Identification No.) 450 East 29th Street New York, NY 10016 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code (212) 308-6000 N/A (Former name or former address, if changed since last report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common stock, par value $0.001 per share KDMN The New York Stock Exchange Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
    [Show full text]