pharmacy law Flashcards
definition of law
Requirements for human conduct applying to all persons within their jurisdiction
Factors courts commonly apply in reaching decisions:
– Fundamental notions of fairness
– Custom or history involved
– Command of a political entity
– Best balance between conflicting societal interests
reasons to regulate drugs
market failures:
– public goods
– externalities
– natural monopolies
– info. asymmetry
public goods
Necessary and beneficial commodities that private entities will not supply because there is no incentive/financial return
example: orphan drugs & vaccines
what is a market failure
when there is an inefficient distribution of goods and services that leads to a lack of equilibrium in a free market.
orphan drug
is a pharmaceutical agent that is developed to treat certain rare medical conditions
externality
When the production or consumption of a good affects someone who does not fully consent to the effect
When the costs of the good are not fully incorporated in the price of the good
– Example: indiscriminate use of antibiotics
monopoly
When the fixed costs of providing a good are high, relative to the variable costs of producing the good
– Example: patents and market exclusivity for new drugs
info. asymmetry
When the consumer is uninformed about the true value of a good
– Examples: prescription only drugs; written consumer information for certain drugs
limits of the law
Certain human relationships
* De minimis violations
*Protecting individual freedoms while preventing harm to others
sources of the law
U.S Constitution
legislatures
administrative agencies
courts
legislatures: statutory law
U.S.Congress(federal laws)
State constitutions
State legislatures (state laws)
Political subdivisions (ordinances)
law made by admin. agencies
admin, agencies are created by legislatures to admin. a body of substantive law
Law Made by Administrative Agencies:
Legislative Function
Promulgateregulations
– Regulations interpret, define, and add detail to statutes.
* Regulationsenactedvianoticeandcomment rulemaking
* Validitytestsofaregulation:
– Within scope of board’s authority – Based on statutory authority
– Reasonable relationship to public health, safety, and welfare
Law Made by Administrative Agencies: Judicial Function
Render decisions pursuant to “hearings” resembling court proceedings
- Decisions subject to judicial review
– The court will review record to determine if
decision was based on substantial evidence.
– De novo: If substantial evidence is lacking, court will conduct an entirely new trial.
Federal Agencies
Regulations published in Federal Register(Fed.
Reg.) and Code of Federal Regulations (CFR)
– Federal Register: daily publication of proposed
and final regulations and notices
– CFR: compilation of final regulations divided and indexed by subject matter
Law Made by Courts: Common Law
Common law refers to judicial opinions; adopted from the English judicial system
* Judicialopinions:decisionsofthecourt
– Enforceable as law
– Binding on lower courts in the same jurisdiction
* Staredecisis
– Opinions are binding on lower courts in the same
jurisdiction and serve as precedent.
– Reasons for deviating from precedent include factual distinctions and changing times or circumstances.
Relationship of Common Law to Statutory Law
Courts often must interpret the meaning and application of statutes.
* Principles of interpretation include:
– Determining legislative intent, if possible – Ordinary meaning of words
– Due process rights of the individual
Distinguishing Criminal, Civil, and Administrative Actions
Criminal: government v. private party
– Charged with a crime as prohibited by a statute and
subject to penalties specified by statute
– Objectives: deter, punish, rehabilitate
* Civil:privatepartyv.privateparty
– May be based upon statute or common law legal rights – Objective: compensation to injured party
* Administrative:agencyv.privateparty
– Disciplinary determination which may include warning, fines, licensure revocation or suspension, probation
Legislative Process:
Federal Level
Congress – Senate
Legislative Process:
Federal Level (1 of 2)
– House of Representatives
* The sponsor of a bill must be a legislator.
* The bill is sent to appropriate congressional committee.
– Holds hearings, conducts investigations
– Determines whether bill will go to Senate or House floor
After the bill leaves the committee, majority leadership places the bill on a calendar.
* The bill must be debated and passed in one chamber before being sent to other chamber for debate and passage.
* The conference committee must rectify differences.
* Role of the president
– Approve or veto bill
* Congress can override veto with two-thirds
Legislative Process: State Level
State legislatures generally modeled after
Congress
* Legislative history generally harder to determine because fewer written records of committee hearings and reports
The Judicial Process: Federal Court System
U.S Supreme Court
– Highest U.S. court. Nine justices; lifetime appointment
– Original jurisdiction only in cases involving ambassadors, other public ministers, consuls, and when a state is a party
– Other cases heard by writ of certiorari * Courtofappeals
– 12 judicial circuits and courts; primarily hear appeals * Districtcourts
– Jurisdiction primarily based on whether there is a federal law or constitutional issue; diversity citizenship; or if a state or the U.S. is a party
* Specialty courts
State Court System
State supreme court
– Each state has one
* Intermediate appellate courts
– In more populated states * Trialcourts
– Often called county courts, superior courts, district courts, or circuit courts
– Nearly unlimited jurisdiction
* Limited jurisdiction courts: i.e., probate, family, juvenile * Very limited jurisdiction courts:i.e., traffic, small claims
Civil Court Procedures: Selection of Court
State court likely unless:
– Federal issue is involved
– Parties are from different states
Civil Court Procedures: Parties
Plaintiff: person bringing the action
* Defendant: person action is brought against
* Plaintiff’s name appears first in title of case
* Plaintiff must prove“ standing”
– The challenged conduct has caused the plaintiff injury.
– There is a legally protectable interest.
Civil Court Procedures: Statute of Limitations
- Limits the period of time in which a case can be filed
Civil Court Procedures: what are Summons, Complaint, and Answer
Summons: issued by court notifying defendant of suit and commanding defendant to file an answer
- Complaint: contains all material facts of case and remedy requested
Answer:admittingtoordenyingallegations – Default judgment if answer not filed
Civil Court Procedures: Discovery
Pretrial process in which each side must give the other all facts, evidence, and names of witnesses upon which it will rely
* Deposition:out-of-courttestimonybyawitnessunder oath
Civil Court Procedures: Jury Selection
Voir dire examination: the questioning by each side of potential jurors
The jury’s role is to determine questions of fact.
*The judge must determine questions of law.
Civil Court Procedures: Witnesses
Witnesses
– May be subject to subpoena, an order to appear in
court
– Failure to appear may result in contempt of court.
* Expert witnesses
– Called when the factual subject matter is beyond the scope of jurors
Civil Court Procedures: The Trial
Motion for summary judgment: one party attempts to convince the judge that the claims of the other side have no merit, even if correct.
Motion for directed verdict: after the introduction of evidence, one party alleges that the other lacks sufficient evidence.
- Objections: attempt to restrict the introduction of evidence or testimony; might constitute issues of law for appeal
- After all evidence is presented, the judge instructs the jury as to the applicable law.
Civil Court Procedures: Verdict and Appeal
Judgment notwithstandingtheverdict (NOV):the judge may rule contrary to the jury if the jury clearly reached the wrong verdict.
* A mistrial maybe granted if a major error or violation of law or procedure occurred during the trial.
* Either party may appeal the final verdict based on an error of law.
* For an appeal, attorneys submit a “brief” to the court, citing the legal principles and precedent involved and why the lower court erred.
Criminal Court Procedures
A defendant can be either indicted or arrested.
* Indictments are issued by a grand jury when it determines that enough evidence exists for an arrest and trial.
* If arrested, the judge must determine at a preliminary hearing if there is enough probable cause for an arrest; if so, the defendant must enter a plea at an arraignment.
* The parties may agree to a“plea bargain,”in which the defendant agrees to a lesser charge rather than face a trial.
* Burden of proof is“beyond a reasonable doubt,”rather than a “preponderance of the evidence” as in a civil trial.
Case Citations
State and federal appellate court decisions are often reported and have citations.
* From the citation, one can tell the names of the parties, which court decided the case, and the volume and page number where the case can be found.
Federal Versus State Law
When federal and state law conflict, federal law will preempt state law under the Supremacy Clause of the U.S. Constitution.
* Conflicts generally exist when state law is less strict than federal law.
* Federal authority to regulate drugs generally arises from the Interstate Commerce Clause of the U.S. Constitution.
* State authority to regulate generally derives from the Tenth Amendment to the U.S. Constitution and under its inherent police powers.
* State laws must bear a reasonable relationship to the public health, safety, and welfare.
Historical Overview of the Act part 1
Pure Food and Drug Act(1906)
- Food, Drug ,and Cosmetic Act(1938)
- Durham-Humphrey Amendment(1951)
Food Additives Amendment(1958)
Color Additive Amendments(1960)
Kefauver-Harris Amendment(1962)
Historical Overview of the Act
Medical Device Amendments(1976)
Orphan Drug Act (1983)
Drug Price Competition Act(1984)
Prescription Drug Marketing Act(1987)
Safe Medical Devices Act(1990)
Generic Drug Enforcement Act(1992)
Prescription Drug User Fee Act (1992)
Nutrition Labeling and Education Act(1990)
Historical Overview of the Act part 3
Dietary Supplement Health and Education Act(1994)
Food and Drug Administration Modernization Act(1997)
Medical Device User Fee and Modernization Act(2002)
Food and Drug Administration Amendments Act(2007)
Patient Protection and Affordable Care Act(2010)
FDA Safety and Innovation Act(2012)
Drug Quality and security Act(2013)
The 21st Century Cures Act(2016)
FDA Reauthorization Act (2017)
Federal Food and Drug Administration (FDA)
Housed under the Department of Health and Human Services (DHHS)
* Authority for administering the FDCA
* FDA secretary appointed by president with confirmation of Senate
Structure of FDA
what are the 4 offices under commissioner
National headquarters and extensive field force * Five offices under commissioner:
– Office of Foods and Veterinary Medicine
– Office of Global Regulatory Operations and Policy
– Office of Medical Products and Tobacco
– Office of Operations
– Office of Policy, Planning, Legislation and Analysis
Office of Medical Products and Tobacco
Center for Drug Evaluation and Research(CDER) * Center for Biologics Evaluation and Research
* Center for Devices and Radiological Health
* Center for Tobacco Products
* Oncology Center of Excellence
* Office of Special Medical Programs * Patient Affairs Staff
Functions of FDA
Rulemaking
* Issue guidance documents
* Incorporate advice from standing advisory committees of outside experts
What Is a Drug?
Articles recognized in the USP or homeopathic pharmacopeia
* Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease (Part B)
* Articles other than food intended to affect the structure or function of the body (Part C)
* Definition is intentionally broad to include almost anything with an intended therapeutic purpose or purpose of altering the structure or function of the body
Evidence a Product Is a Drug
Labeling
* Advertising
* Natureofproduct
Food or Drug?
Generally depends upon intended use
* Food definition not very helpful in itself
* Congress likely intended the meaning of food in the exclusion from part C of drug definition to apply to food used for its ordinary purpose and in an ordinary manner.
Special Food Categories
Legal categories
– Special dietary foods – Medical foods
* Publicly conceived categories
– Nutraceuticals and functional foods
Health or Disease Claims for Foods
A health claim for a food made by a manufacturer could result in the product being considered a drug.
* The Nutrition Labeling and Education Act of 1990 and subsequently FDAMA allow foods to contain health claims if approved by the FDA by regulation or by the “significant scientific agreement” test.
* Manufacturermustsubmitconsiderableevidenceto support the claim to obtain FDA approval.
Dietary Supplement and/or Drug?
DSHEA
– Created a new special category of food called “dietary supplements” (DSs)
– DSs do not require premarket approval
– DS defined as a vitamin, mineral, herb, or other botanical, amino acid, or substance used to supplement the diet by increasing total dietary intake
Nutritional or Structure/Function Claims
DSHEA permits four types of nutritional support claims:
– Benefiting a classical nutrient deficiency disease
– Describing role of the DS in affecting the structure/function of the body
– Characterizing the mechanism by which a DS acts to maintain the structure or function
– Statements of general well-being
* Claims must be substantiated as truthful and not
misleading.
* The label must contain a disclaimer.
Health or Disease Claims
DSHEA only permits DS manufacturers to make health claims if either the FDA approves the claim by regulation or by the significant scientific agreement test.
* Pearson v. Shalala, however, held that DS manufacturers could make health claims not approved by the FDA, provided they are not false or misleading and accompanied by a disclaimer.
* The FDA now allows qualified and unqualified health claims.
Dietary Supplements Containing Drugs
DSHEA excludes an article as a DS if it was approved as a drug prior to being marketed as a DS.
* The Pharmanex case establishes that DSs cannot be specially manufactured to concentrate the natural drug ingredient.
Safety Issues
Safety Issues
* The FDA can only remove a DS on the basis of the product being adulterated, defined as presenting “significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling.”
* Example:ephedrine alkaloidDS
* The Dietary Supplement and Nonprescription Drug Consumer Protection Act requires manufacturers to report serious adverse events.
Implications of DSHEA for Pharmacists
Product selection
* Education of patients as opposed to promotion of
products
* Restrictions regarding the display of DS publications
Drug and/or Device?
The historical approach of the FDA prior to the Medical Device Amendments was to declare devices as drugs when necessary.
* The definition of device excludes articles that achieve their purpose through chemical action and metabolism.
* Whether a device containing drugs is a drug or device is dependent on various factors.
Drug and/or Cosmetic?
The definition of cosmetic generally includes topical articles intended for cleansing, beautifying, or altering appearance.
* A cosmetic can become a drug if the seller makes a health or structure/function claim.
* “Ignorant, unthinking consumer”standard likely applied
* Someproductscanbebothcosmeticsanddrugs.
Labels and Labeling
The term labeling includes labels.
* Labeling is defined as written or printed or graphic matter “accompanying” the article.
* Courts have defined accompanying.
* If the written, printed, or graphic matter is not labeling, it is advertising.
Official Compendia
USP
– Published by the USPC
– Sets uniform standards
– USPC works closely with the FDA, but is private.
* HPUS
– Publishes standards for homeopathy products by
the HPCUS, a private organization
– Role and legal authority of HPUS
* Pursuant to FDCA, if a drug is recognized in USP or HPUS, the drug product must meet all standards of the compendia.
Prohibited Acts
Most prohibited acts involve misbranding or adulteration.
* Violation of FDCA is subject to strict liability – Good faith excuse applicable
* Applicable to pharmacies
– The receipt and subsequent delivery of an
adulterated or misbranded drug (Section 301(c))
– The doing of any act which causes a drug to be counterfeit (Section 301(i)(3))
– The alteration, mutilation, etc. of the labeling (Section 301(k))
FDA Enforcement Authority
Injunction
* Criminal action
* Seizure of products * Warning letters
Corporate Officer Liability: “Park Doctrine”
Affirmative duty of corporate officers to be aware of and correct violations
Product Recalls
- The FDAAA established FDA authority to order drug recalls for certain products, but not drugs.
- Three classes of recalls
- Manufacturers responsible for notifying seller; seller
responsible for notifying consumers, if necessary - Pharmacistsresponsibleforknowingofproduct recalls
Adulteration (1 of 2)
Adulteration provisions focus on both the facility and the product. A pure drug may be considered adulterated on the basis of the facility.
* A drug is adulterated if its strength, quality, or purity differs from compendia standards, unless plainly stated on label.
* A drug is adulterated if its strength, quality, or purity differs from label.
Adulteration (2 of 2)
A product is adulterated unless manufacturer complies to CGMP.
* CGMP is an exhaustive set of standards directed at manufacturers.
* The failure to manufacture a product in a tamper- resistant container when required by law is adulteration and also misbranding.
Misbranding
Labeling must not be false or misleading, including healthcare economic information.
* Labeling must include a listing of active ingredients and quantity and listing of inactive ingredients in alpha order.
* Labeling must contain“adequate directions for use” and “adequate warnings against use” by children and others for whom use might b it is misbranding if a drug imitates another drug.
Nonprescription Drug Labeling
User-friendly format including pharmacological category or principal intended use, cautions and warnings, adequate directions for use, and “Drug Facts” panel
* Pharmacies that relabel or repackage must conform to the same labeling requirements as manufacturers.
* Professional OTC labeling maybe published by manufacturers for indications not appropriate for lay diagnosis or treatment.
* Drugs that are both OTC and prescription exist when some indications can be labeled with adequate directions for use and some cannot.
Prescription Drug Labels and Labeling
Regulations specify information requirements of commercial label.
* Unit dose labeling is subject to different information requirements.
* Newer package insert requirements include a “Highlights” section at the beginning, a table of contents, “Full Prescribing Information” organized to give prominence to most important information, and a “Patient Counseling Information” section.
Black Box Warnings
Required in labeling when use of a drug may lead to death or serious injury
* Required for many prescription drugs
Pregnancy Warnings
The labeling system prior to June30,2015 required that drugs potentially risky during pregnancy be placed into one of five categories: A, B, C, D, X.
* A 2014 regulation replaces the above system.For drugs approved after June 30, 2015, labeling will require the inclusion of three subsections to describe risks: “Pregnancy,” “Lactation,” and “Females and Males of Reproductive Potential.”
* Drugs approved prior to June 30,2015 will be gradually phased into the new labeling standards.
National Drug Code Number
10-digit three segment code(4-4-2,5-3-2,or5-4-1)
* The first segment identifies manufacturer or distributor; the second identifies strength, dosage for, and formulation; and the third identifies package size and type of drug.
* Billings and claims submissions require an11-digit NDC number.
New Drug Approval
No person may introduce a“new drug”into interstate commerce unless approved by the FDA.
* “New drug”is defined as a drug that is not generally recognized by qualified experts as safe and effective (GRASE) for use under the conditions recommended in the drug’s labeling and has been used for a material extent and time for conditions recommended in labeling.
* The FDA will not accept a GRASE application and requires a new drug application.
Approved Drugs as New Drugs
An approved drug can become a new drug under certain conditions:
– Addition of new substance
– New combination of approved drugs
– Change in proportion of ingredients
– New intended use
– Dosage, method, or duration of administration or application is changed
New Drug Application (NDA) Process
IND Investigational New Drug Application
– The sponsor must receive approved Notice of Claimed Investigational Exemption for a New Drug in order to ship drug in interstate commerce to conduct phase 1, 2, and 3 clinical studies.
– The FDA may terminate testing at any time under risk–benefit criteria; the decision is not subject to appeal or judicial review.
– The FDAAA requires NDA sponsors to publish summary information regarding phase 1 trials on a public registry.
Informed Consent
Informed consent required in all three phases
* Research subjects required to know risks, possible benefits, and alternative courses of treatment
* Institutional Review Board(IRB) approval required in some settings
New Drug Application (NDA)
The FDA has 180 days to act on a completed NDA, but delays are common.
* Approval is based on proof of safety and efficacy, the manufacturing process, and risk–benefit ratio.
* Applicant may judicially appeal a rejected NDA, but success is very unlikely.
21st Century Cures Act and New Drug
* Passed in 2016
Approval
Objectives include streamlining and adding flexibility to the drug development and approval process and creating a more patient-focused approach to the process.
* It encourages the consideration of novel clinical trial designs and the incorporation of “real-world evidence” into the decision-making process.
* The law also creates or amends four pathways or programs for drugs that treat serious or life-threatening diseases that affect smaller populations or diseases with significant public health risk.
Drug Rating and Classification System
A priority Classification system rates new drugsby chemical type and therapeutic potential; this determines how quickly the drug will move through the IND/NDA process.
* A number designates chemical type, and a letter(S,P, or O) designates therapeutic potential.
Supplemental New Drug Application (SNDA)
SNDA generally required when a manufacturer makes any change in an approved drug or in its production
* Three categories of SNDA
* A “change being effected(CBE)” SNDA allows the sponsor to make the change before FDA approval and is important for labeling changes.
Postmarketing Surveillance
Required of manufacturer after NDA approval
* Must submit to FDA reports of serious adverse drug reactions and any new information of safety and efficacy
Phase 4 Studies
The FDAAA empowered the FDA to require manufacturers to conduct phase 4 studies when adverse event reporting or active surveillance is inadequate.
Risk Evaluation and Mitigation Strategy (REMS)
The FDAAA granted the FDA authority to require REMS as a condition for approval of an NDA or post market when the FDA believes it necessary to ensure benefits outweigh risks.
* Under REMS authority, the FDA can require a variety of procedures ranging from Medication Guides to limiting the drug to specified settings for dispensing.
Postmarket Labeling
The FDAAA Gave the FDA the authority to require manufacturers to add safety information or warnings post market.
Postmarket Drug Safety Information for Patients and Providers
The FDAAA required the FDA to develop and maintain a website for patients and providers including labeling, safety information, REMS, guidance documents, etc.
* The FDAAA also established “SentinelInitiative” designed to detect early signs of a drug’s risk.
Drug Efficacy Study Implementation (DESI
Initiated to evaluate the efficacy of drugs approved between 1938 and 1962
* The FDA created the ANDA for generic drugs approved between 1938 and 1962.
* The ANDA only requires of bioequivalence and manufacturing methods rather than proof of safety and efficacy.
* TheU.S.SupremeCourtruledthatgenericdrugsare new drugs and subject to FDA approval.
Paper NDA
The FDA lacked authority to allow ANDAs for post- 1962 generics, so it created the “paper NDA.”
* The paper NDA was not very effective.
Drug Price Competition and Patent Term Restoration Act (PTRA) of 1984
Statutorily created the ANDA, expediting generic approval
* Concessions to innovator drug companies included: – Patent extensions
– Market exclusivity
Patent Considerations of ANDA
The generic manufacturer must make one of four types of patent certifications.
* A paragraph IV certification contends that the parent drug’s patent is invalid or will not be infringed by the generic company. The ANDA applicant must notify patent holder. If holder sues, FDA is enjoined for 30 months, unless a court rules otherwise. The generic company receives 180 days of market exclusivity if it prevails under a paragraph IV certification.
Controversies for Healthcare Practitioners
Bioequivalence of generics to the parent and each other
* Whether a drug without market exclusivity fora particular indication could be prescribed and dispensed for that indication
Drug Manufacturer Controversial Practices
Producing “authorized generics”
* 30-months tay from ANDA approval awarded
when a patent holder sues for patent infringement
* Filing of secondary patents, often for product changes and attempts to shift market share to new product
* Exclusion payments (pay-for-delayagreements)
Generic Drug Labeling Controversies
Whether FDA can approve an ANDA for ag eneric when the labeling will not include one or more of the indications contained on the innovator drug product’s labeling
* Whether generic drug manufacturers should be required to change labeling to reflect a known adverse effect
Section 505(b)(2) NDAs
Similar to extinct“paperNDA” * Used to filefor:
– New indications for approved drugs
– Generic approvals that do not qualify under ANDA
Drug Competition Action Plan
The goal is to institute new policies aimed at bringing more competition to the drug market, most notably improving the efficiency of the generic drug approval process.
* Policies designed to bring complex generic drugs to market more quickly
* GuidancealsoreleasedtostreamlinetheANDA process for all generic drugs
OTC Drug Review
TheOTCdrugreviewprocessapprovesdrugsonthe basis of therapeutic category and conformance to a monograph rather than on a drug-by-drug basis like prescription drugs.
Marketed Unapproved Drugs
TheFDAestimatesthattherearethousandsof unapproved drugs on the market today.
* Reasonsinclude:
– Pre-1938 drugs
– The FDA has yet to remove some drugs lacking efficacy after DESI.
– Lax FDA policies applied to generic approvals prior to 1984
– Unscrupulous manufacturers
* IfamanufacturerobtainsNDAapprovalforan unapproved marketed drug, all marketed drugs in the class must obtain NDA approval within one year.
Patient Treatment with Investigational Drugs on a Widespread Basis
Aninvestigationaldrugmaybeusedfortreatment outside of phase 1, 2, or 3 clinical tests.
* Onlyforpatientswithseriousorlife-threatening diseases for which no comparable or satisfactory alternative therapy is available
* Certainconditionsmustbemet.
Individual Patient Access to Investigational Drugs
Individualpatientsactingthroughaphysicianmayrequest an investigational drug for treatment purposes if the physician determines the patient has no comparable or satisfactory alternative and that the risk from the drug is no greater than the risk from the disease or condition. The FDA had restricted requests to drugs in phase 3 leading to the Abigail Alliance lawsuit.
* TheAbigailAlliancedecisionrejectedtheplaintiffs’claim that they have a constitutional right to investigational drugs.
FDA’s Expanded Access Program
TheFDAenactedregulationspermittinggreater access by patients to investigational drugs.
* Permitspatientstoseekaccesstoexperimentaldrugs even in phase 1
* Expandsandclarifiesthetreatmentuseof experimental drugs
* Clarifiesandestablishesthecriteriafordrug manufacturers to charge patients for investigational drugs
* Severalstateshavepassed“right-to-try”laws
Expedited Approval Process: “Fast Track”
Expeditedreviewispossiblefordrugsintendedto treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs for the condition and have an effect on a clinical endpoint predictive of clinical efficacy.
* Conditionalonmanufactureragreeingtophase4 testing
* “Acceleratedapproval”alsoavailableforcertain drugs
Biologics
Productsderivedfromlivingorganisms
* LicensurebyPHSA,butsubjecttoFDCAandFDA requirements
* TheBiologicsPriceCompetitionandInnovationAct created a regulatory framework in 2010 for biosimilars or “follow-on” biologics.
* TheFDAPurpleBooklistsbiologicalproducts, including any biosimiliar and interchangeable biological product
MedWatch
Voluntaryreportingsystemtoallowhealthcare professionals to report any serious adverse events, product use errors, and product quality issues
* TheFDAemphasizestheimportanceofreportingby healthcare professionals.
* TheFDAAArequirespharmaciestoprovidepatients with the MedWatch number and a statement about reporting side effects.
Medical Device Amendments of 1976
Establishescriteriaforclassifyingdevicesintooneof three classes
* TheFDAhasauthoritytoreclassifydevicesbasedon new safety and efficacy information.
* Medicaldevicemanufacturersanddevice-user facilities must report any deaths or serious injuries related to their products.
* TheFDAcanrequirefirmstonotifyhealthcare professionals, repair or replace devices, or refund purchase price of devices.
* TheFDAcanrecalldevices
Cosmetics
Nopremarketapproval,norconformancewithCGMP
* Manufacturersmustsubstantiateproductsafety.
* TheFDAmayremoveifmisbranded,adulterated,ora health hazard.
* Mustbelabeledwithlistofingredientsindescending order of predominance and appropriated warnings
Drug Advertising and Promotion
TheFDAregulatesRxdrugadvertising,andFTC regulates OTC drug advertising.
* TheFirstAmendmentrestrictsgovernmentregulation of commercial advertising.
* Anyregulationwillbeevaluatedpursuanttothefour factors established by the U.S. Supreme Court.
Adequate Provision Requirement
Applicabletobroadcastmedia
* Themanufactureronlyneedstoinclude“majorrisks” as opposed to brief summary.
* Themanufacturermustmakeadequateprovisionsfor the dissemination of the labeling.
Prescription Drug Advertising: Manufacturer to Professionals
Section502(n)requiresalladvertisementstocontain“true statement” and “brief summary.”
* Reminderadvertisingisexempt.
* Truestatementisnotmetifadvertisingisfalseor misleading, does not present a fair balance, and fails to reveal material facts.
* Advertisingincludesadsinjournalsandotherperiodicals, broadcast media, and telephone communications.
* Brochures,booklets,mailings,bulletins,calendars,and other information distributed to healthcare professionals by a manufacturer is labeling.
Prescription Drug Advertising: Manufacturer to Professionals part 1
Journaladvertising
– Actively scrutinized by FDA after early studies showed
considerable violation
* Industry-supportededucationalprograms
– Concerns that programs are independent and objective
– Factors distinguishing independent from promotional
programs published in guidance document
– The court decision requires that the guidance document be used as a “safe harbor.”
– PhRMA has published self-policing guidelines.
Prescription Drug Advertising:
Manufacturer to Professionals part 2
*PhysicianPaymentSunshineAct
*FDABadAdProgram
Prescription Drug Advertising:
Manufacturer to Consumer (DTC) part 1
Significantcongressionalandpubliccontroversy
* Nospecificlawsandregulations,thusSection502(n)
applies
* BecausecompliancewithSection502(n)isimpractical,
FDA allows manufacturers to apply the “adequate
provision” requirement.
* Theconsumermustbeofferedfulllabelinginformation
from one or all of four sources.
Prescription Drug Advertising:
Manufacturer to Consumer (DTC)
ForDTCprintadvertising,FDAencourages manufacturers to present key risk information in user- friendly ways.
* Reminderandhelp-seekingadsareexemptfrom requirements.
* TheGAOreportnotedFDAweaknessesinregulating DTC ads.
* TheFDAAAhasprovidedFDAwithauthorityto require prereview of ads.
Promoting Prescription Drugs and Devices Through Social Media
FDAguidancedocumentsrelatingstandardsfor:
– Communications through interactive promotional
media
– Communications through social media platforms with space limitations
– Correcting third-party misinformation through the internet or social media
Promoting Prescription Drugs for Off-Label Uses
Manufacturers providing off-label use information is very controversial; FDAMA allowed with restrictions
* The 2009 compliance guide reinstituted most of FDAMA off- label use provisions, clarified by 2014 compliance guide.
* The U.S. v. Caronia decision may limit FDA’s authority to regulate off-label use communications.
* Amarin Pharma, Inc. v. FDA ruled against the FDA to allow the company to engage in truthful and non-misleading “promotion” of off-label use information to healthcare professionals.
* Due to confusion, the FDA responded with two draft guidance documents in January 2017.
Nonprescription Drug Advertising by Manufacturers
TheFTCundertheFTCActregulatesdeceptive ads.
* Adsaredeceptivewhentheyarelikelytomislead reasonable consumers; ad claims must have a reasonable basis.
* TheFTCneedonlyproveconsumersare“likely”to be misled, not that they actually are misled.
* TheFTChasauthoritytorequirecorrective advertising.
Lanham Trademark Act
Prohibitsuseofanyfalsedescriptionor representation
* Allowsforprivatecauseofactionandrecoveryof monetary damages
