Law and Ethics- Test 1
The Poison Prevention Packaging Act (1970).
The intent of the Act is to protect children from accidental poisoning from household substances.
What Prompted Congress to act?
They used everything about the hog, except for the squeal" Public concern over unsanitary conditions in the food and drug industries, due in part to the publicity surrounding publication of Upton Sinclair's book, "The Jungle", that detailed the unsanitary conditions in the meat packing industry in the United States at the turn of the 20th Century.
New Drug Applications
This new vehicle required both the drug AND its indication to be approved by the FDA. Therefore an active drug can be marketed under different indications.
under the terms of DSHEA, the FDA may not regulate
dietary supplements as food additives ◦ Food additive = an additive to food to enhance its shelf life, flavor or appearance (e.g. preservatives, food coloring).
The FDA will regulate ________ AND their ______ based on their: safety AND efficacy.
drugs indication
The Medical Device Act of 1976 differentiates
drugs from devices by stating: ◦ A device does not achieve any of its intended purposes through chemical action ◦ Is not dependent on being metabolized for the achievement of any of its principal purposes
} Consumer Medication Information (CMI) leaflets are provided for
each prescription. These contain information for the patient about their medication.
Judicial Decisions
establish enforceable legal principles either by expanding or by interpreting statutes and regulations
The FDA position has always been that investigational drugs must be used only for
experimentation, not treatment. This view changed with the increase of AIDS in the USA as researches began developing new experimental treatments.
Part "C" of definition of "drug" specifically excludes
foods
special categories include
foods formulated with folic acid, vitamin B-6, and B-12 combination products for treatment of hyperhomocysteinemia. } Examples: ◦ Formulas ◦ Formulas for metabolic disorders } To help manage dietary concerns
under the terms of DSHEA, the manufacturer is responsible
for determining if its product is safe and its claims are substantiated by adequate evidence ◦ Unlike drugs, which have to have premarket approval
In 2000, the FDA reorganized the critical information in the insert so that
health care professionals can find it more quickly by adding: ◦ A highlights section that summarizes the important information about the drug ◦ A Patient Counseling Section ◦ Prominent Black Box warnings for about 450 drugs
Under which section of 502 would this action be illegal: I manufacture an ephedra/caffeine tablet to look just like generic Adderall.
i(2) - the imitation clause.
Natural Justice/Natural Right
idea proposed by the Greek philosophers Plato and Aristotle that basic rights and morality are inherent in the reasoning of man
The DSHEA permits statements that describe the role of the supplement
in affecting the structure or function of the body (e.g. "increases urine acidity to promote healthy urinary tract")
the term device includes
in vitro diagnostic products used to aid in the diagnosis of disease or verification of pregnancy
adulteration (501)
(a)(1) A drug is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance; (2) if it has been prepared, packaged or held under unsanitary conditions
A drug may be adulterated, even if it is pure, if it is:
(a)(2)(A) Prepared, packed or held under conditions where it may have been contaminated (a)(3) Exposed to a container that may have been contaminated (a)(2)(B) Manufactured under conditions that do not conform to current Good Manufacturing Practices (cGMP) promulgated by the FDA
A drug may also be Adulterated
(a)(4) if it contains an unsafe color additive (b) if it is subject to compendia standards and if its strength, quality or purity differs from those standards unless the variations are clearly stated on the label. (c) if it is not subject to compendia standards and its strength, quality or purity differs those stated on the label
the 1906 Act (wiley Heyburn) was a major advancement in prohibiting adulteration and misbranding
(only with respect to 1) strength, 2) quality and 3) purity) It did not prevent fraudulent claims of efficacy. It did not require proof of safety. It did not stop purposeful omissions from the label.
class 1 recall
-A reasonable possibility exists that use of or exposure to the drug or device will cause adverse effects or death Example: Late 2011, the generic Microgestin class 1 recall of incorrect placebo pill placement.
FEDERAL AGENCIES AFFECTING PHARMACY: DRUG ENFORCEMENT AGENCY (DEA)
-HOUSED IN THE US JUSTICE DEPARTMENT (ATTORNEY GENERAL) -Responsible for overseeing and enforcing laws regarding controlled substances and the abuse thereof
FEDERAL AGENCIES AFFECTING PHARMACY: FOOD AND DRUG ADMINISTRATION (FDA)
-Housed by the Department of Health and Human Services (HHS) -Responsible for the general manufacturing and distribution of all drugs, foods and cosmetics
FEDERAL AGENCIES AFFECTING PHARMACY: UNITED STATES PATENT AND TRADEMARK OFFICE (USPTO)
-Housed in the Department of Commerce -Responsible for approving all patents on novel drugs
FEDERAL AGENCIES AFFECTING PHARMACY: CENTER FOR MEDICARE AND MEDICAID SERVICES (CMS)
-Housed in the Department of Health and Human Services (HHS) -Responsible for reimbursement policies to pharmacies and other health care providers participating in medicare and medicaid services
FEDERAL AGENCIES AFFECTING PHARMACY: FEDERAL TRADE COMMISSION
-Independent agency (outside the purview of executive departments) -Responsible for antitrust laws in the general stream of commerce (including pharmacy market)
clinical testing phase 1
-Involves a small number of patients in controlled studies to determine toxicity, metabolism, absorption and elimination to ascertain preferred route of administration and safe dosage
clinical testing phase 4
-Involves post-marketing surveillance of approved uses to detect adverse effects or other problems not encountered in the previous three phases of testing due to the limited number of patients in clinical testing
STATE AGENCIES AFFECTING PHARMACY:
-Kentucky Board of Pharmacy - acts as the State FDA (but even more plenary and expansive -Cabinet for Health and Family Services - Founded by the Kentucky Controlled Substance Act, acts as the State DEA
In order for an Administrative Rule to be valid:
-must be based on an organic statute that gives the agency authority to promote the rule -must be within the scope of the agency's authority -must bear a reasonable relationship to the public health, safety and welfare -subject to review by the legislative body granting authority to the agency -ARE SUBJECT TO APPEAL TO A HIGHER COURT
English Common Law
-natural law was very important in the development of English Common Law -derived from the period following the Norman Conquest of England
IF A STATE AND FEDERAL LAW REGULATE THE MATTER, THE
...MORE STRINGENT LAW PREVAILS
REASONS FOR THE GOVERNMENT TO REGULATE MEDICINAL DRUGS
1) PUBLIC GOODS (orphan drugs) 2) EXTERNALITIES (antibiotic resistance) 3) NATURAL MONOPOLIES (promote incentive and competition) 4) INFORMATION ASYMMETRY (allowing pharmacists to be experts in this field, public doesn't understand the benefits of drugs
TWO REASONS A COURT MAY VARY FROM PRECEDENT
1) there must be factual distinctions between a case before it and previous decisions upon which the court relies 2) a court may vary from a precedent because of changing times or circumstances
TWO PURPOSED OF STARE DECISIS
1) to establish continuity of decisions 2) to expedite judicial decision-making
} In 1972, the FDA began reviewing OTC drugs marketed between
1938 and 1962 and continues for those OTC's marketed post-1962 and is conducted on the basis of therapeutic category
In determining if a pharmacist is engaged in compounding or manufacturing, the FDA will consider
9 points (see slides)
Reliance on Precedents
A legal system that gives great weight to the principle that it is unfair to treat similar facts differently on different occasions (Common Law)
Med watch voluntary reporting
A voluntary reporting system that allows health professionals to report any serious adverse events, potential and actual use errors and product quality problems directly to the FDA and requires pharmacies to provide patients with a toll free number to report adverse effects
Can you explain the difference between "adequate directions for use" vs. "adequate information for use"?
Adequate directions for use is a requirement to avoid misbranding under §502 for OTC items. (DOC instruction)Adequate information for use is a requirement for prescriptions (at the order of a prescriber) in lieu of adequate directions for use. Components in adequate information are: Indications, side effects, dosages, routes, contraindications, other warnings and precautions.
The FDA has two post-marketing tools to protect consumers (both strict-liability offenses):
Adulteration Misbranding
Two major points of the FDCA is to define and prohibit:
Adulteration; AND Misbranding
TREATIES
Agreements between nations thus creating international laws
the NDC Number
All drugs are uniquely identified by an 11 digit number called the National Drug Code (NDC) number (e.g. 55555-1111-22). } The first segment (five digits) of the code is assigned by the FDA and identifies the manufacturer or distributor. } The second segment identifies specific strength, dosage form and formulation for a particular firm. } The third segment identifies package size and type of drug.
The 1938 Act (21 USC § 321(g)(1)) defines a drug as:
Articles recognized in the USP, the Homeopathic Pharmacopeia or the National Formulary Articles intended for use in the diagnosis, treatment, cure, mitigation or prevention of disease in man or animals Articles other than food intended to affect the structure or function of the body of man or other animals Articles intended for use as a component of any articles specified above
impact of OBRA 90 on Pharmacy
As a result of the OBRA 90 mandates, nearly all States have statutes or regulations that require pharmacists to perform these functions } States can make this more stringent by deciding to cover all patients, and not just Medicaid patients.
The Prescription Drug Marketing Act (1987)
Bans re-importation of drugs manufactured for human use into the US except for emergencies with the permission of the Dept. of HHS Requires practitioners to request drug samples in writing Bans pharmacies from holding or distributing drug samples Bans the sale, trade or purchase of samples
Code/Civil Law Jurisdictions
Based on Roman Law under Emperor Justinian (the Code of Justinian) in 6th Century, judicial precedent is given less weight and scholarly literature is given more weight in decision-making. The judge in a given case has more freedom to interpret the text of a statue independently Ex. the Napoleonic Code upon which Louisiana law is based
ADMINISTRATIVE LAW
Both Congress and State Legislatures delegate authority to administrative agencies (via organic statutes) to promote regulations that interpret and define statutes and procedures for enforcement of statutes
Interstate Commerce
Congress has authority to regulate drugs and other articles of commerce pursuant to its power to regulate
Kefauver-Harris Amendment of 1962
Efficacy was finally made as a requirement in addition to safety. This was retroactive to all drugs marketed between 1938 and 1962. When analyzed, of the ~3400 drugs that were tested for efficacy, ~2200 showed to be effective, ~1050 showed to be ineffective and ~150 remained as pending.
The Medical Device Amendments
Enacted in 1976 The 1938 Act did not give FDA authority to review medical devices for safety and efficacy before marketing. Public concerns with certain devices (such as the Dalkon Shield), prompted Congress, to act and pass the medical device amendments, which require: Classification of devices according to function Premarket approval Performance standards Conformance with GMP regulations Record and reporting requirements
medical foods
FDCA created formulated for oral use under medical supervision and intended for specific dietary management of a disease or condition for which distinctive nutritional needs are established and include foods formulated without the amino acid, phenylalanine for the treatment of phenylketonuria
special dietary foods
FDCA created supply a special dietary need and include infant formulas, artificial sweeteners and caloric supplements ◦ To accommodate dietary limitations
United States v. Sullivan
Facts: Pharmaceutical manufacturer in Chicago shipped properly labeled bottles of sulfathiazole tabs (legend drug per FDA) to an Atlanta, GA wholesaler. Pharmacist Sullivan (Columbus, GA) bought from wholesaler and sold without an Rx. Issue: Sullivan contended that the FDCA did not apply to transactions between his pharmacy and his customers because these were entirely intrastate transactions. Rule: FDA has purview over all prescription transactions per the interstate commerce clause, even if the transaction was wholly conducted within a single state. Analysis: Court held that the Act extends to even these intrastate transactions because its intent is to protect the public and that intent would be subverted by a narrow definition of interstate commerce. Conclusion: So look at the market as a whole, and not as a narrow instance like this case. The market is an interstate market, even if this small example is intrastate.
Rite Aid of NJ v. Board of Pharmacy (1973)
Facts: Several pharmacies, including Rite Aid, filed suit against the Board of Pharmacy after promulgating a regulation indicating that "prescription records" for each patient be kept on file as part of their "patient profile". The legislation regarding "patient profiles" did not mandate "prescription records" among the list of requirements. Issue: Can the Board of Pharmacy interpret a legislation dictating specific requirements in the statute to add an additional requirement to satisfy a "patient profile"? Rule: Yes. The Board of Pharmacy was allowed to create an additional regulation furthering the statute. Analysis: This was allowed because the Board of Pharmacy was furthering the objective of the state law requiring pharmacists to keep records to protect the public. Conclusion: Courts may interpret statutes that appear narrow, in a broad sense to let government agencies modify them. WHEN A REGULATION NARROWS A STATUE, THAT IS FINE. CANNOT MAKE A STATUTE MORE BROAD. THE MORE STRINGENT LAW ALWAYS WINS!!
section 201 of FDCA
Food means: 1. Articles used for food or drink for man or other animals (Note: This is extremely open to interpretation. So FDA and courts will subjectively determine this). 2. Chewing gum 3. Articles used for components of any such article.
Law is more than a collection of mandates and prohibitions:
Framework whereby people in a society resolve their disputes in a way that does not involve force and consistently yields results that are satisfactory to most of society
Criminal Court
Government vs. Person, end result is imprisonment
The Drug Price Competition and Patent Restoration Act of 1984 also known as the
Hatch-Waxman Act
When hit with one of these two post-marketing "big sticks" of the FDA, the violator will be subject to:
Hate mail (warning letters) Seizure of drug Injunctions Fines Criminal Prosecution
Compounding can essentially create a new drug every time it is performed. How come it is not subject to the NDA process per 21 USC 353a? What is the philosophy behind this?
Having compounding subject to misbranding and adulteration regulations would in effect end the process of compounding because the NDA process is time consuming and costly
Common Law
Henry II established (in 1154) a uniform system of law 'common' to the country by incorporating and elevating local customs to the national custom, this ended local control and peculiarities, eliminated arbitrary remedies and reinstated the jury system
the Omnibus Budget Reconciliation Act of 1990
Important to note that Medicaid is a state program, but the US government helps fund it, so to make it more efficient, it created standards:
Sulfanilamide Elixir Story
In 1937, the S.E. Massengill Co. marketed sulfanilamide (40 gr. Per ounce) in a solution with diethylene glycol to treat hemolytic streptococcal infections. No toxicity tests were conducted and very little was known about the inherent toxicity of diethylene glycol (automotive antifreeze). As a result more than 100 persons died before it was removed by the FDA. At the time, the FDA could not remove a drug from the market because it was unsafe. However, the reason for removal was it was misbranded not that it was toxic! It was misbranded on a technicality: Because elixirs have alcohol in it, and this did not.
The Safe Medical Devices Act
In 1990, Congress further strengthened the Medical Devices Amendment by Granting FDA additional authority related to post marketing requirements Expediting the premarket approval process
Action on Smoking Health v Harris (655 F2d 224 (DC Cir 1980)
In this action, the Supreme Court ruled in favor of the FDA that ruled that the drug definition only applies to brands of cigarettes for which a supplier makes therapeutic claims.
category 3 OTC
Includes ingredients for which data are insufficient to permit classification. } The FDA has permitted continued marketing of products in Category III until sufficient evidence is available to place them in either I or II.
Category 2 OTC
Includes ingredients that are not generally recognized as safe and effective or that are misbranded
clinical testing phase 3
Involves trials to evaluate whether the data obtained in Phase 1 and Phase 2 studies can reasonably assure the safety and efficacy of the drug or if the drug has a potential value outweighing its possible hazards
clinical testing phase 2
Involves use of the drug on a small number of patients for specific disease treatment or prevention along with additional pharmacology studies to further determine safety
This was the result of the scandal surrounding the thalidomide tragedy. In 1960, the William S. Merrill Co. marketed experimental thalidomide under the trade name Kevadon but the FDA did not give final approval, largely due to the insistence of Dr. Frances Kelsey, an FDA physician who demanded more proof of safety. It was discovered that the drug caused birth defects and was removed from clinical testing.
Kefauver-Harris Amendment of 1962
STATUTORY LAWS
Laws (Statutes) enacted by a legislative body (federal or state); ordinances enacted by a municipal or county council
Several of these aforementioned laws affected the marketing requirements of commercial containers. These are all established in the misbranding section of the FDCA. These requirements include:
Name and address of manufacturer ◦ Established name of product ◦ Ingredient information, including the quantity and proportion of each active ingredient ◦ Name of inactive ingredients if not for oral use ◦ A statement of identity (generic and proprietary names) etc etc
For foods and what would be permitted prompted Congress to enact the
Nutritional Labeling and Education Act of 1990.
The Durham-Humphrey Amendment authorizes the FDA to switch drugs from Rx only to
OTC status by regulation. A switch may occur: ◦ When a manufacturer requests the switch by submitting a supplemental application to its approved NDA ◦ If the FDA amends an OTC monograph ◦ If a manufacturer petitions the FDA
Notification to patients must be distributed to patients with each new and refill Rx and may occur:
On a sticker attached to the container or package ◦ On a pre-printed vial cap ◦ On a separate sheet of paper ◦ In patient medication information distributed by the pharmacy ◦ In a MedGuide
EXECUTIVE ORDERS
Orders issued by the president with the full force of the law behind it (essentially piggy back the federal organic statutes that created the federal agency)
Civil Court
Person vs. Person, end result could be damages ($$) or specific performance (must perform as task)
§503:
Pharmacy Exception from §502 Misbranding 353(b)(2) exempts pharmacies, when repackaging a drug, from labeling requirements set forth in §502 except mislabeled, packaging poison, immitation, drug has diteriorated.
court decision in johnson
Prompted the Congress to amend the 1906 Act to prohibit false and fraudulent efficacy claims. It was still difficult to enforce as it required the government to prove fraudulent intent on the part of one making false statements on the label of a product.
misbranding (502)
REVIEW THE SLIDE!!!!!!!!!!! A drug or device is misbranded (codified in 21 USC §352): (a) if its labeling is false or misleading in any particular (b) if its packaging does not contain the name and place of business of the manufacturer, etc !!!!!!!!!!!!!!(h) if it has been found to be a drug liable to deterioration!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! (i)(3) if it is offered for sale under the name of another drug
Hatch-Waxman Act
Required the FDA to approve generic drugs shown to be bioequivalent to a previously approved drug Provides innovator firms 5 years of patent restoration or at least 5 years of exclusive marketing once their drug is approved. First generic to file for market entrance receives six months of generic exclusivity.
The FDA has two pre-marketing tools to protect consumers:
Safety Efficacy
when is a dug not a drug
Some products containing substances considered drugs are not always classified as drugs
HART-FULLER DEBATE
Stated no vehicles in the park -Skateboard in the park -Moral vs. Civil (Code) Law -Morality: look at what the law that was passed was intended to prevent, purposed instead of meaning -Civil (Code): strict definition (even though there will still be a need for interpretation of the law), vehicles should strictly be defined (cars, trucks, etc.). Strict meaning, legislative intent is irrelevant.
NATURAL LAW Statement/Reasoning
Statement: Murder is wrong Reasoning: Nature and logic dictate it
MORAL LAW Statement/Reasoning
Statement: Prostitution is wrong Reasoning: Morality and ethics (more of a religious subset) dictates it
standards of the Omnibus Budget Reconciliation Act of 1990
The Act requires drug manufacturers to provide pharmaceuticals to Medicaid programs at their "best price", the lowest price they sell to any customer. } Requires Drug Utilization Review (DUR) for Medicaid patients to improve outcomes } Requires pharmacists to offer counseling to Medicaid patients or their care-givers to improve outcomes and minimize potential problems } Requires pharmacists to maintain records of the counseling, i.e. patient medication records.
under the terms of DSHEA, the fda cannot require
The FDA cannot require pre-market approval of dietary supplements
the package insert
The FDCA regulates information that accompanies the drug product. The package insert contains necessary scientific and medical information for safe and effective use of the drug by health care professionals. It cannot be promotional in nature, false or misleading.
What was the intent of Part "C"? 'Was it to exclude all substances normally defined as "foods" regardless of their intended use?'
The Federal Courts provided a partial answer in Nutrilab Inc et.al. v Schweiker 713 F2nd 335 (7th Cir 1983)
Sometimes known as the Drug Diversion Act
The Prescription Drug Marketing Act (1987)
United States v Guardian Chemical Corp , 410F2d 157 (2nd Cir.1969).
The question of distinguishing "labeling" and advertising was determined in the case Guardian sold a product for the purpose of cleaning dairy equipment and discovered it was also effective in treating kidney and bladder stones (((slides)))
The FDC Act of 1938
The resulting scandal prompted Congress to enact new legislation, which further clarifies adulteration and misbranding and requires proof of safety. PROVEN Efficacy still wasn't required until the Kefauver-Harris Amendments of 1962. The 1938 Act requires pre-approval before marketing a new drug with an approved New Drug Application (NDA) but exempts drugs on the market prior to the effective date of the Act.
CONSTITUTIONAL LAWS
The supreme law of the USA is the Constitution. Every federal or state law must not conflict with the Constitution
The FDA has authority under the DurhamHumphrey Amendment to categorize as prescription drugs those drugs that are:
Unsafe for use except under the supervision of a practitioner because of the toxicity, method of use, or the collateral measures necessary to use the drug ◦ Subject to the NDA approval process
class 3 recall
Use or exposure is not likely to cause serious adverse health consequences
class 2 recall
Use or exposure may cause temporary or medically reversible adverse effects on health or where the probability of serious adverse effects is remote
Where are Common Law systems used?
Widespread use in nations that trace their legal heritage to England as former colonies (ex. USA, Canada)
The Common Law
a consistent system of law developed by the means of precedents and common throughout the country
ORGANIC STATUES
a statute enacted by Congress that creates an administrative agency and defines its authorities and responsibilities
Durham-Humphrey Amendment of 1951
created OTC and the ability for oral (called in) prescriptions and for refills The 1938 FDCA required all drugs to be labeled with "adequate directions for use" to help consumers.(1951)
Common (Case) Law
decisions of the courts as a result of litigation involving disputes because of statutes or actions of the parties involved in a litigation. The court's duty in these situations is to apply proper law to the facts before it and resolve the mater through a judicial decision
Manufacturer ships bottles of Humulin to wholesaler under improper refrigeration standards
adulteration
Manufacturing is regulated under the
adulteration and misbranding portion of the FDCA ◦ NDA (505) ◦ cGMP (Under 501)
The NLEA
allows food labeling to contain a health or disease prevention claim if the FDA has promulgated a rule approving the claim and the conditions by which it can be used.
Forerunner to the FDCA: Pure Food and Drug Act of 1906
also called the Wiley-Heyburn Act Created the Food and Drug Administration to enforce its provisions
The DSHEA permits statements that describe the general well
being from consumption of a nutrient or supplement (e.g. "energizer" or "muscle enhancement")
HOW STATE LAWS ARISE
can arise for any reason, plenary power Ex. Tenth amendment - gives states all power not delegated to feds
HOW FEDERAL LAWS ARISE
can only arise under a Constitutional basis Ex. Interstate Commerce Clause - liberal usage
sullivan case helped to
clarify the effect and juisdiction of the act to intrastate commerce
If the IND is approved
clinical testing on humans may egin
Dietary Supplement Health and Education Act of 1990 (DSHEA).
congress created This Act created the category of dietary supplements and mandates that FDA treat them as a special type of food rather than drugs
products rated with the first letter B are not
considered therapeutically equivalent
functional foods
include foods that have been fortified with a dietary supplement such as calcium or ginseng. } Currently, the FDCA does not "recognize" these products or "Nutraceuticals" that are touted to provide some health or medical benefit.
Category 1 OTC
includes ingredients generally recognized as safe, effective and not misbranded
Currently, anything in Phase 1 of NDA can be marketed as an
investigational drug if limited safety and efficacy standards are met. But they will be tagged as
1890, Congress enacted legislation granting authority to the President to
issue a proclamation to prohibit importation of dangerously adulterated articles for food and drink.
If the FDA wishes to switch an OTC drug to Rx only status
it must prove two issues: ◦ That the toxicity and method of use require practitioner supervision ◦ That the collateral measures necessary to use the drug require supervision. } U.S. v Article of Drug-Decholin 264 F. Supp 473 (E.D. Mich 1967)
Today, NDA's require three
main pre-approval phases (more on this later): Phase 1: Safety Phase 2: Dosages Phase 3: Efficacy (as stated, this requirement comes later)
Whose duty is it to notify sellers of a drug recall?
manufacturer
The DSHEA permits statements that characterize the documented
mechanism by which a nutrient or supplement acts to maintain the structure or function. (e.g. "helps maintain healthy intestinal flora")
Pharmacist dispenses generic cephalexin under the brand name Keflex
misbranding
Manufacturer ships bottles of ibuprofen labeled 800mg that are filled with ibuprofen 600mg
misbranding adulteration
wiley hepburn act was defective because
misbranding provisions of the Act did not prevent false or misleading claims of efficacy. The manufacturer of a product claimed its product was effective against cancer, knowing the representation was false. The Court further held the law only prevented false statements as to the drug's identity, strength, quality and purity.
The 1962 Kefauver-Harris Amendment to the FDCA mandated
not only prescription drugs but also OTC drugs had to demonstrate efficacy.
the DSHEA permits manufacturers to make four types of
nutritional support statements without fear of FDA considering their products as "drugs". ◦ Statements that the product will benefit a classical nutrient deficiency disease as long as it discloses the prevalence of the disease in the USA (e.g. "benefits common osteoporosis by increasing calcium")
"This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease." is required when
one of the DSHEA claims are made
In 1970, the FDA required a PPI for
oral contraceptives; in 1977 it required a PPI for estrogen containing products. } This was followed by establishing Medication Guides or Med Guides for certain drugs that pose a serious and significant concern to public health (180 drugs required to have Med Guides).
Since the effective date of the Drug Diversion Act, (1988) it is illegal for a pharmacy
other than a pharmacy in a hospital or healthcare facility to possess drug samples for consumer use.
Therapeutic equivalence =
pharmaceutical equivalence + bioequivalence Pharmaceutical equivalence = same active ingredients
} Emergency contraception (EC) is a method of
preventing pregnancy after contraception fails or after unprotected sex. It is NOT to be confused with abortion drugs
By definition, dietary supplements are
products intended for ingestion and intended to supplement the diet and contain one or more of the following: ◦ A vitamin; a mineral; an herb or other botanical; an amino acid; ◦ A dietary substance to supplement the diet by increasing total dietary intake ◦ A concentrate, metabolite , extract of the previous.
Natural Law
propelled the idea of creating a legal system, the idea of human made law is credited by an analyzation of the inherent, natural law humans are given
Charitable pharmacies can
provide samples
If a drug or device that has been approved and marketed is later found to be responsible for adverse effects, it is subject to
recall
Laws
requirements for human behavior, applying to all persons within a jurisdiction, commanding what is right, prohibiting what is wrong and imposing sanctions for violations
The Stoics
responsible for the development of the tradition of natural justice into one of natural law, believed in the existence of a purposeful order in the universe and the means by which a person lived in accordance with this order was the natural law
The FDA will regulate drugs AND their indication based on their:
safety AND efficacy.
pharmaceutical equivalence
same active ingredients same strengths and dosage forms
bioequivalence
same bioavailability at the site of action under similar conditions
Whose duty is it to notify consumers of a drug recall?
seller
POSITIVE LAW
simply man-made law derived from a societal body
Drug diversion act mandates
storage, handling and record-keeping requirements for samples Bans trafficking in or counterfeiting of drug coupons Prohibits resale of Rx drugs by hospitals or healthcare facilities except under certain conditions
The FDA Modernization Act (1997) enacted to
streamline regulatory procedures to ensure expedited availability of safe and effective drugs; Expands FDA authority over OTC drugs-establishing labeling ingredient requirements for inactive ingredients; Replaced "Caution: Federal Law prohibits.." with a simple phrase "Rx only" If Legend or Rx is not on the bottle, it is considered misbranded.
Sterile compounding is subject to
strict FDA regulation. 503(B) defines an "outsourcing facility" as a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B.
Before a new drug can be marketed: } An IND (Investigational New Drug) application is
submitted to FDA for approval. The IND includes proof of pre-clinical testing of the new drug on animals to substantiate the safety of proposed clinical testing on humans.
Federal vs. State Law
the Constitution gives certain powers to the federal government, while reserving the rest for the states. In general, a state has authority to regulate in any area it deems necessary within the boundaries of its jurisdiction as long as there is no conflict with a federal law or regulation. If there is a conflict, the federal law prevails under the Supremacy Clause of the Constitution.
All of the data collected in the clinical testing is incorporated into
the New Drug Application and submitted to FDA for approval prior to general marketing of the product
The Import Drug Act of 1848:
the first federal statute to protect US citizens from harmful drugs. This Act prohibited importation of adulterated drugs. (Antimalarial drugs for US troops in Mexico were found to be adulterated)
in all clinical testing phases the investigators must obtain
the informed consent of the research subjects.
1902, Congress banned the
the introduction into interstate commerce falsely labeled dairy products.
STARE DECISIS
the rule by which a judge is bound to follow precedent of the decisions made and recorded by judges who preceded them
◦ If the FDA doesn't regulate compounding, who does?
the state
products rated with the first letter A are
therapeutically equivalent
In 2009, Congress enacted Public Law 111-31: The Family Smoking Prevention and Tobacco Act
which gives FDA authority to: ◦ Regulate contents of tobacco products ◦ Require disclosure of product contents ◦ Prohibit certain additives ◦ Require more effective warnings ◦ Strictly control or prohibit marketing directed at children
Nutrilab Inc et.al. v Schweiker 713 F2nd 335 (7th Cir 1983)
} The manufacturer of a weight-reduction product known as a "Starch Blocker" derived from kidney beans maintained it was a food. } The FDA sued and the Court held the product did not meet the statutory definition of food or the commonsense definition
FDA v Brown and Williamson Tobacco Corp (529 US 120 (200)
} The tobacco industry sued and the Supreme Court ruled that Congress intended to exclude tobacco from the FDA's jurisdiction.
Household substances are defined as:
◦ A hazardous substance included in the Federal Hazardous Substances Act ◦ An economic poison included in the Federal Insecticide, Fungicide and Rodenticide Act ◦ A food, drug or cosmetic included in the FDCA ◦ A household fuel when used in a portable container
where do you here about recalls
◦ News media (FDA media release); FDA list serve ◦ Manufacturer/Wholesaler ◦ National publications ◦ Pharmacy hot lines ◦ Corporate recall systems
(OTC) In addition to statements of conditions and uses, labeling of a drug product must include:
◦ The quantity or dosage for each intended use and for persons of different ages and physical conditions ◦ The frequency of administration or application ◦ The duration of administration or application ETC READ SLIDES