Prin of Intellectual Property
Prin of Intellectual Property GMS 6095
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This 53 page Class Notes was uploaded by Cierra Schamberger on Wednesday September 23, 2015. The Class Notes belongs to GMS 6095 at University of South Florida taught by William Marshall in Fall. Since its upload, it has received 30 views. For similar materials see /class/212603/gms-6095-university-of-south-florida in Graduate Medical Sciences at University of South Florida.
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Date Created: 09/23/15
iH i f SET 615 5mm mem EIN 6430 OVERVIEW OF REGULATED INDUSTRIES Week 1 About Me Educa on BS Oklahoma State 1973 MS Oklahoma State 1979 MPA University of Oklahoma 1981 PhD University of Oklahoma 1989 Expenence 2001 Present CEO of FTSI a contract sterilizer of medical devices and consumer goods in Polk County Small NASDAQlisted company that is FDA registered and ISO 134852003 certified Prior to FTSl I spent 25 years in government agencies mostly public health and regulatory 2 Contacting Me By Phone Work 8634250039 tell Secretary you are a student Cell 8138171005 leave a voice mail message ifl do not answer Please do not call me after 10 PM By EMail EN6430verizonnet In Person Let me know by phone or email if you need to meet with me and I will make myself available either before or after class What is this course about Provides a broad overview of why and how technologybased industries are regulated by government entities Describes the processes used to establish and enforce regulations Uses the medical device industry to provide specific examples of regulations and compliance Note I am aware that not all students in the class are pursuing degreescertificates associated specifically with medical device manufacturing My goal is to provide information applicable to all regulated industries while concentrating on medical device manufacturing 4 Course Objective Provide knowledge of How regulations are promulgated at both the Federal and State levels The administrative law process Organization and operating structure of Government agencies Selected regulatory requirements Regulatory compliance strategies Influencing agency decisionmaking The medical device industry as an example of regulatory requirements and compliance a L 4 UNIVERSITY OF SOUTH FLORIDA Grading and other information Tests Two each represents 15 of grade 30 total Tests are online open materials Multiplechoice and short answer questions Time limited Questions from lectures and readings for period covered Homework Four assignments each representing 5 of grade 20 of grade Individual project dealing with some problem or aspect of starting or operating a regulated industry Represents 25 of grade Final short answer multiple choice TF covering entire class Represent 25 of grade Extracredit questions worth 2 of total grade Time limited Traditional grading ie C 7079 B 8089 A90 No curve Class Resources l have not found a text that is specific to the regulation of technology industries and will use webbased resources for this class The Blackboard site contains links to general references and these will be supplemented with links to readings specific to each lecture All readings and references will be posted to the Blackboard using a tinyurl address A note about tinyurls They make long web addresses short Click the hyperlink when provided If you must type in the address do not include w in the address Use exactly as shown 7 General Class Resources Federal Food Drug and Cosmetic Act httptinvurlcomdqff3 Part 820 httptinvurlcom2vzs5z Medical Device Quality Systems Manual A Small Entity Compliance Guide httptinvurlcom44d6u7 Other FDA Online Resources Device Advice httptinvurlcomhr5c8 Administrative Procedures Act httptinvurlcom5qo7k2 Code of Federal Regulations httptinvurlcombddmw Why is EIN 6430 important Companies must be aware of the regulations they must follow and achieve compliance Failure to comply can lead to legal actions bad publicity and loss of business Companies must understand the process by which rules are established This provides better communication to agencies and the ability to influence regulations being promulgated Companies must understand the process by which rules are enforced in the event they are subject to enforcement action Federalism Federalism is the US system of government in which power is divided between a central government and the government of each state The US constitution provides the federal government with enumerated powers such as the right to levy taxes declare war and regulate interstate commerce The federal government also has implied powers to pass any law quotnecessary and properquot for the execution of its enumerated powers US Government Organization Organized into 3 Branches Legislative Branch The Congress consisting of the House of Representatives and the Senate Pass Legislation and approve budgets Executive Branch The President Proposes budgets and signs legislation into law Manages executive branch agencies such as Health and Human Services houses FDA Judicial Branch The Supreme Court Rules on constitutionality of laws Legislative Powers Article I Section 8 The Congress shall have Power To regulate Commerce with foreign Nations and among the several States and with the Indian Tribes commerce clause To make all Laws which shall be necessary and proper for carrying into Execution the foregoing Powers and all other Powers vested by this Constitution in the Government of the United States or in any Department or Officer thereof necessary and proper clause Interstate Commerce Business activity among inhabitants of different states including transportation of persons and property and navigation of public waters for that purpose as well as purchase sale and exchange of commodities Most regulations are based on power delegated to the Federal Government by the Commerce Clause As manufacturing and transportation systems have expanded throughout the US the impact of this power has grown Executive Powers Article II Section 1 The executive Power shall be vested in a President of the United States of America Judicial Powers Article III Section 1 The judicial Power of the United States shall be vested in one supreme Court and in such inferior Courts as the Congress may from time to time ordain and establish State Powers Article XII Amendment X The powers not delegated to the United States by the Constitution nor prohibited by it to the States are reserved to the States respectively or to the people The US Constitution generally describes the rights and responsibilities of state governments and state officials in relation to the federal government These have been refined by Supreme Court decisions Increasing Federal Powers After the Civil War the federal government increased its influence on everyday life relative to state governments Many people believe the federal government has surpassed its enumerated powers but the Supreme Court rarely invalidates any federal statute as exceeding Congress39 power Most actions by the federal government can find some basis in the enumerated powers particularly the Commerce Clause which is often used to justify the need to regulate businesses Why are industries regulated Control Monopolies AKA Economic Regulation by OMB Regulated because there are no or few competitors This may be desirable where infrastructure costs are high and need to be spread over a large customer base Regulations relate to entry into business service areas assurance of supply and rate structures The later prevents overpricing while assuring a fair rate of return Examples Utilites Why are industries regulated cont d Prevent Fraudulent Activities AKA Economic Regulation Ensure companies with large amounts of other people s money act responsibly Regulations deal with entry into business financial reserves business practices Example Banking and insurance Note Some regulations to prevent fraudulent activities apply to a wide range of Companies irrespective of their business Example SarbanesOxley sets financial oversight and reporting requirements for all publicly traded Companies Why are industries regulated cont d Protect Public Health and Safety AKA Social Regulation by OMB Verify that products are safe for use and manufactured under conditions that assure reproducible quality Examples Foods cosmetics biologics pharmaceuticals medical devices diagnostics veterinary products OMB defines a third class of regulations that set administrative requirements as Process Regulations social security income tax This class will deal with industries regulated to protect public health and safety 20 Civil and Criminal Law in the US Criminal Law Litigation always filed by the government the prosecution Burden of proof beyond reasonable doubt Guilty defendant can be imprisoned executed or fined paid to government Regulatory actions can escalate to criminal cases Civil or Common Law Litigation filed by non governmental party the plaintiff Burden of proof preponderance of evidence Losing defendant can only be made to pay damages to plaintiff Read Standler 1998 found here httptinyurlcom5d4zzg 21 Civil and Criminal Law in the US A verdict guilt or innocence in a criminal regulatory case may be followed by civil lawsuits from those claiming damages It is common to see pressure from public advocacy groups or the media drive regulatory investigations With or without findings of violations these investigations provide free discovery for plaintiffs in later civil lawsuits Civil actions may be successful because lower burden of proof standard Example OJ Simpson 22 Laws and Statutes Laws Any system of regulations to govern the conduct of the people of a community society or nation in response to the need for regularity consistency and justice based upon collective human experience Statute a law enacted by the legislative branch of a government Laws and statutes are passed by a legislative body and signed into law by the executive They may provide a general framework and assign an agency to carryout the legislative intent 2393 Regulations Rules and administrative codes issued by governmental agencies at all levels municipal county state and federal Although they are not laws regulations have the force of law since they are adopted under authority granted by statutes and often include penalties for violations Regulations are the specific requirements of the agency 24 Regulations cont d In many cases the enabling legislation delegating the responsibility for a program is very broad and Congress leaves it to the agency to design and implement the program through rulemaking Some argue that the entire process violates the Constitution and has resulted in an abuse of power by the Federal Government In 1998 the CFR contained 134723 pages in 201 volumes requiring 19 feet of shelf space Read Ginsburg 1993 found here httptinyurlcomc394b 25 Differences Between Statutes and Regs At the State and Federal level Statutes are passed by a legislative body and signed into law by the Governor or President Typically they provide a general framework and assign an agency to carryout the legislative intent within that framework Regulations or rules are procedures passed by an agency acting within its statutory authority Usually reviewed through a legislatively set process Both are laws in the sense they are enforceable through a legal system eitherjudicial or administrative 26 Administrative Law Defines the activities of government agencies and includes rulemaking adjudication and enforcement of a specific regulatory program Typically requires a defined process be followed in rulemaking that mandates public notice and allows for public comment Provides for appeal to the judicial system when the administrative law process is violated or exhausted At the Federal level the requirements are detailed in the Administrative Procedures Act 27 Administrative Procedures Act Found in USC Title 5 Chapter 5 sections 511 599 See it at httptinyurlcom5go7k2 Law under which 55 federal regulatory agencies create rules and regulations needed to implement and enforce major legislative acts Examples of agencies EPA FDA OSHA Examples of acts Food Drug and Cosmetic Act Clean Air Act Occupational Health and Safety Act 28 APA Definitions Rule the Whole or a part of an agency statement of general or particular applicability and future effect designed to implement interpret or prescribe laW or policy or describing the organization procedure or practice requirements of an agency Rulemaking Agency action Which regulates the future conduct of either groups of persons or a single person it is essentially legislative in nature not only because it operates in the future but because it is primarily concerned With policy considerations 29 Promulgating Rules Under the APA Agencies must publish all proposed rules new regulations or changes to existing regulations in the Federal Register at least 30 days before they take effect Must provide a way for interested parties to comment offer amendments or to object Enabling legislation may require only publication and comments or may require formal heanngs Once effective it becomes final rule and is published in the Code of Federal Regulations Other laws require OMB approval before major rules take effect or allow Congress to rejectO Promulgating Rules UNIVERSITY OF UTll FLU Congressional Bill signed Example The Safe Into Law by President Medical Devices Act of gives authority to agency 1990 Pub L 101629 Example Current Good Agency proposes rules and notifies public via Minggancjgggrzrgf giiggl Federa39 Reister devices 43 FR 31508 Final rule takes effect after 30 days and is Published in Code of Federal Regulations Example Quality System Requirements for Medical Devices 21 CFR Part 820 31 The Federal Register Is a method of communication for US Federal agencies It contains Proposed new rules and regulations Final rules Changes to existing rules and Notices of meetings and adjudicatory proceedings Created in 1935 and expanded by the APA in 1946 Published MF Organized into 4 categories Presidential Documents Rules and Regulations Proposed Rules Notices of hearings and public meetings 32 The Code of Federal Regulations CFR The enumeration of the general and permanent rules published in the Federal Register by the executive and independent agencies The CFR is divided into 50 titles which represent broad areas subject to federal regulation Each title is divided into chapters and parts The chapters usually bear the name of the issuing agency The entire code is revised on an annual basis Access the CFR at httptinyurlcombddmw 33 State Equivalents of the APA All States have administrative laws that allow State agencies to promulgate and enforce rules authorized by legislation The State notification process is similar to the APA requiring publication and acceptance of comments In Florida final rules are published in the Florida Administrative Code Most States also require approval by an oversight agency before a rule can take effect 34 Enforcing administrative requirements UNIVERSITY OF SOUTH FLORIDA Police power The inherent authority of a government to impose restrictions on private rights for the sake of public welfare order and security Regulations establish both requirements for compliance and penalties for non compliance Most regulations use a form of progressive discipline whereby firsttime violators or minor violations receive minor sanctions As those regulated continue to violate or for severe firsttime violations the sanctions become more punitive 3 539 Administrative Law Decisions Agencies have adjudicatory power for questions about their regulations This allows them to settle disputes with regulated parties A dispute may arise when agency staff make a case specific ruling about regulatory compliance or apply a sanction The party may appeal the decision to an administrative lawjudge ALJ After a factfinding process known as a hearing the ALJ issues a ruling The ruling may be appealed to the agency head then through the federal courts Most federal agencies write formal opinions and many post on their website 3639 Administrative Law Enforcement Process SOUTH FLORIDA CompanyIndividual Enters Process Voluntarily requesting license etc or Involuntarily fails inspection etc l Agency staff denies license Or issues Company Accepts Initial action citation Agmy ACHO Issue resowed Warning etc CompanyIndividual appeals agency action 37 Administrative Law Enforcement Process UNIVERSITY OF SOUTH FLORIDA Agency staff conduct Informal hearing or C mpany Accepts 4 Issue resolved I Agency Action Conference to resolve Case argued before Hearing officerAdministrative Law Judge Recommended order issued Agency head modifies or Company Accepts accepts recommended order Agency Action ti Issue resolved I and signs Company or Individual appeals order to Courts 38 Role of the Executive Branch in APA President AppointsNominates Agency Heads Secretary or Commissioners President issues executivebranch specific guidance and policy Agency head issues agency guidance Agency promulgates and enforces regulations IAW APA 39 Role of the Legislative Branch in APA Confirms Agency Heads Secretary or Commissioners Passes laws authorizing regulatory programs Passes agency budgets 40 Role of the Judicial Branch in APA Hears cases involving regulations and underlying legislation Court of original jurisdiction for States suing States and States suing Federal Government 41 Federal Administrative Justice System Model SOUTH FLORIDA Constitution Congress President A l I I Statutes Budget Executive Policy Information Authority Ori39ers DefISIons From Cooper 1983 Supreme Court Administrative Procedure Act Agency I Secretary or Commission I decisions 39 decisions I Appellate lCouil 39 Hearing Officer StaffInformal Process Filter 4 l T Opinion on claims Service demands 39 License requests gt Licenses services Investigatory demands Routeand rate requests Rules benefits Bene ts requests Technical Information Routes and rates AdVIsory groupstask forces Outputs Single Shot Players Repeat Players 41 Delegations and Agreements Some Federal Laws or Regulations allow regulatory enforcement to be delegated to State Government In such cases the State voluntarily requests delegation of the program and passes State laws that mirror the Federal regulations The State is then delegated the authority to operate the regulatory program and typically collects fees from the regulated party to fund the program Example regulation of radioactive materials is delegated to 35 agreement states by the US Nuclear Regulatory Commission 43 CostsBenefits of Regulation Costs Time Personnel Facilities and Equipment LicenseRegistration Fees Benefits Product Quality Customer Perception Reduced Legal Exposure 44 Costs of Regulations American s spent 843 billion in 2000 to comply with Federal Regulations This does not include taxes used to support Government efforts Those costs were 189 billion in 2000 This is 8 of the GDP Small businesses are disproportionately impacted Firms employing fewer than 20 employees had regulatory burden of 6975 per employee in 2000 That is 3960 percent higher than regulatory burden for firms over 500 employees 45 Benefits of Regulations No overall quantification available although methodology has been developed There clearly are nonquantifiable benefits eg Chinese quality issues over past several years There are also many individual examples of regulatory failures leading to personal injury and legal problems for manufacturers See Dalkon Shield reading assignment for next class 46 Discussion What recourse does Congress have if it does not like the manner in which executive branch agencies are executing the regulatory laws that Congress has passed Example Congress has been very critical of the manner in which the Consumer Products Safety Commission is regulating Chinesemade toys potentially containing leadbased paints 47 Discussion From an industry perspective what are the advantages and disadvantages of the administrative law process as applied by US regulatory agencies 48 Discussion What is the impact of a State regulating an industry more stringently than the Federal government and why would a State take such actions Example Auto emission standards established by the California Air Resources Board 49 Individual Project I want you to identify a topic related to one or more regulated industries and write a paper discussing that topic in detail The topic you select may address any regulated industry and need not be specific to medical devices Your paper should be a comprehensive discussion of the subject and include references as appropriate Anticipate 10 to 12 page 2X spaced minimum length Project papers will be due on or before class on November 24 2008 Week 14 and will count for 25 of your total grade 50 Individual Project Topic Approval Please get my approval of your topic before you begin writing Prior to Class 3 on September 8 email your proposed project to me at ElN6430verizonnet Be sure to include your name in the email I will respond by email with approval or further questions within 48 hours 51 No Class on September 1 Note there is no class on September 1 due to the Labor Day Holiday 52 Week 3 PreWork Do the following new prework before week 3 Email your proposed project topic to me at ElN6430verizonnet Read article on Dalkon Shield at httptinvurlcom5cnkbi Read FDA Regulatory Programs Cooperation and Common Sense Typify a Record of Success at httptinvurlcom5n9vxk Read FDA in 2000 at httptinvurlcom66s9lk Read Necessary but Not Sufficient Amending the Medical Device Law at httptinvurlcom60hm4t Read article about the Debarment Act at httptinvurlcom6lvbs5 53
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