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OTC Drugs. Class of OTC drugs created by Durham-Humphrey Amendment to FDCA. OTC drugs are reviewed by therapeutic class , not individually 100,000-500,000 individual products Only about 200 active ingredients. NonPrescription Drug Labeling. 1. Product Name

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Otc drugs
OTC Drugs

  • Class of OTC drugs created by Durham-Humphrey Amendment to FDCA.

  • OTC drugs are reviewed by therapeutic class, not individually

  • 100,000-500,000 individual products

  • Only about 200 active ingredients


Nonprescription drug labeling
NonPrescription Drug Labeling

1. Product Name

2. Name, address of manuf, packer or distributor

3. Net contents

4. Established name of all active ingredients and quantity of certain other ingredients, active or not i.e..., alcohol, dyes…

5. Name of any habit forming drug


Non prescription drug labeling
Non-Prescription Drug Labeling

6. Consumer cautions/warnings – “may cause drowsiness”

7. Adequate directions for use – “shake well”, time(s) to administer


Rx to otc switch
Rx to OTC Switch

  • Authorized by Durham-Humphrey

  • Manufacturer or FDA can initiate

  • Insurance company can initiate (e.g. Prilosec)

  • OTC Drug Review Process primary mechanism by which drugs are switched

  • There is a committee at FDA which advises on Rx to OTC switches

  • Rx examples switched to OTC: Benadryl, Actifed, Hydrocortisone, Drixoral, Dimetapp, Monistat, Ibuprofen, Zantac, Tagamet, Pepcid, Aleve, Claratin, Prilosec...


Prescriptive authority
Prescriptive Authority

  • Durham Humphrey states that legend drugs may be prescribed by a practitioner “licensed by law to administer such drug”

  • Determined by state practice acts (MD, DO, NP, PA, DVM, NP, OD)


Unapproved use of prescription drugs
“Unapproved” Use of Prescription Drugs

  • Called “off-label”, “unlabeled”, or “unapproved” use

  • “Legal” for prescriber to use a drug for any indication (“ethical” in every case?)

  • Promotion of unlabeled uses by manufacturer is restricted

  • See NYT article 1/11/06:

    Drug Makers Scrutinized Over Grants


Prescription drug labeling
Prescription Drug Labeling

Labeled for the health professional, not general public-and contains:

1. Name, address of manufacturer, packager or distributor

2. Established name of drug product

3. Ingredient information-quantity and proportion of active ingredients

4. Quantity in terms of weight or measure (mg)


Rx drug labeling
Rx Drug Labeling

5. Net quantity in the container (no. of tabs/caps, mL)

6. Rx legend (“Rx Only”)

  • Route of Adm, if not oral

  • Lot number

    9. Container requirements to dispense (tight, light resistant - USP Stdandsrds)

    10. Expiration date


Package insert
Package Insert

  • FDCA regulates what must be placed in package insert

  • And in what order

  • Can not be promotional

  • Often negotiation between FDA and Manufacturer

  • Provides legal cover for manufacturer


National drug code
National Drug Code

  • 11 digits (XXXXX-XXXX-XX)

  • 12345 manufacturer

  • 6789 drug/strength

  • 10 package size.

  • Unique to specific product and dose


Investigational new drug ind application
Investigational New Drug (IND) Application

  • Prescription drugs must be approved by FDA prior to marketing

  • Must be proven safe and effective (?)

  • Usually only effective vs. placebo and not vs. similar drugs

  • IND is first step in process and leads to the New Drug Application (NDA)


Investigational new drug ind application1
Investigational New Drug (IND) Application

  • There are three IND types:

    • Investigator IND

    • Emergency Use IND

    • Treatment IND

  • IND application must contain

    • Animal Pharmacology and Toxicology Studies

    • Manufacturing Information

    • Clinical Protocols and Investigator Information


The new drug application nda
The New Drug Application (NDA)

  • A complete application could contain 100-200,000 pages.

  • Submitted electronically

  • Complete evaluation of efficacy and safety


Goals of the nda
Goals of the NDA

Provide enough information to permit FDA to make the following key decisions:

  • Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.

  • Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.

  • Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.


Abbreviated or supplemental nda
Abbreviated or Supplemental NDA

  • Abbreviated NDA

    • Generic drug

    • New combination of approved drugs

    • Proportion of ingredients in combination is changed

  • Supplemental NDA

    • New intended use of the drug (labeling change)

    • Dose, method or duration of administration is changed

    • Change in manufacturing process or location


Clinical trials in humans
Clinical Trials in Humans

  • 3 phases

    • Phase I - small number of patients (healthy males)

    • Phase II - tested on patients with the disease

    • Phase III - safety and efficacy on hundreds or thousands of patients

  • Must have informed consent from patient before testing proceeds


Fda new drug rating classification system
FDA New Drug Rating & Classification System

Rates new drugs by chemical type and therapeutic potential

Rating determines how rapidly drug will get through NDA process

“Standard review” vs. “Priority review”


Post marketing surveillance
Post Marketing Surveillance

  • FDA MedWatch Drug Quality Reporting System

    • Anything that deals with product quality - label, bad pills…

  • USP Drug Quality Reporting System (DQRS)

    • Product quality, an adverse reaction-any type of problem

    • These are sent by USP to FDA

  • “Phase IV” clinical trials

    • voluntary vs. mandatory


Drug price competition and patent term restoration act
Drug Price Competition and Patent Term Restoration Act

  • Streamlined the approval process for generic drugs

  • Generic manufacturer now needs to establish that their product is bioequivalent to the reference drug

  • See FDA Orange Book


Drugs intended to treat serious diseases aids avian flu
Drugs Intended to Treat Serious Diseases (AIDS, Avian Flu...)

NDA process criticized over the years as being too slow to approve breakthrough drugs

FDA modified its process

FDA Modernization Act of 1997

codified fast-track approval of break through drugs


Voluntary reporting programs previously discussed
Voluntary Reporting Programs-Previously Discussed Flu...)

  • Drug Quality Reporting System (USP)

  • MedWatch (FDA)

  • MedMaRx (USP/ISMP)

  • Vaccine Adverse Event Reporting System (VAERS) (FDA)


Drug advertising
Drug Advertising Flu...)

FDA regulates Rx Advertising

FTC regulates OTC Ads

Lanham Trademark Act allows private parties a cause of action against false ads

Also regulated by State Pharmacy Practice Acts


Rx ads to professionals
Rx Ads to Professionals Flu...)

Drug misbranded unless manuf includes in all ads

drug name

formula

brief summary

look at examples in pharmacy & medical journals

must have “fair balance”


Direct to consumer advertising
Direct to Consumer Advertising Flu...)

No Federal regulations specifically on this subject

two categories of these ads

non product specific - no drug names – usually discusses a medical condition and states “see your doctor!”

product specific - i.e.., Cialis, Levitra, Detrol, Neulasta …

Recent FDA hearing on DTC advertising


Otc ads by manufacturer
OTC Ads by Manufacturer Flu...)

Regulated by FTC

FTC can’t regulate ads before they are run

FTC reviews Ads being run for accuracy and claims

OTC ads must be “reasonable”


Otc review
OTC Review Flu...)

  • Kefauver-Harris Amendments applied to OTC and Rx Drugs

  • OTC products reviewed on a class basis

  • Were OTC products effective as marketed?

  • Antihistamines as “daytime sedative” Sominex...


Otc review resulted in three categories
OTC Review Resulted in Three Categories Flu...)

1. Ingredients safe, effective, not misbranded

2. Ingredients not ...and are misbranded

3. Insufficient data to permit classification


Third class of drugs
“Third Class” of Drugs Flu...)

Historic Issue

Drugs sold only by a pharmacist

ie.,those that just came off Rx status

Common in many other countries

Only in Florida so far

Proposal for EC


Prescriptive authority1
Prescriptive Authority Flu...)

Granted by the State

RPhs can prescribe Formulary items in some states (but not in Oregon)

Practitioners - MD, DO, DDS*, DVM*, PA*, NP*, ND*, OD*

* Restrictions on prescribing


Patient package inserts
Patient Package Inserts Flu...)

FDA required PPIs for estrogen-containing products in early 1970s

Now common with many drugs

See example on FDA web site


Approved drugs for unlabeled indications
Approved Drugs for Unlabeled Indications Flu...)

MD, DO (Doctor of Osteopathy) Practitioners may prescribe any drug for any indication

Others must stay within their scope of practice


Pharmacy compounding
Pharmacy Compounding Flu...)

Controversial Area

RPh may compound pursuant to a Rx

Or in anticipation of an Rx

Is regulated by State law and is not considered manufacturing


Pharmacy compounding1
Pharmacy Compounding Flu...)

Is manufacturing if product is sold to another pharmacy

It is manufacturing if pharmacy repackages OTC products for sale to other health providers

Pharmacy can’t compound an existing Rx product

Can not “compound” non-approved drug


Fda orange book
FDA “ Flu...)Orange Book”

Publishes FDA Classification of drugs therapeutic equivalence

AA-no bioequivalence problems

AT-topical -no problems

AB-drugs meeting necessary bioequivalence requirements

BC-Extended release with problems


Fda ratings con t
FDA Ratings-CON'T Flu...)

  • BT-Topical with problems

  • BX-insufficient data

  • B*-No determination will be made until other questions answered

  • See FDA web-site


Federal alcohol tax
Federal Alcohol Tax Flu...)

  • Federal government does not tax alcohol when used by

    • Gvt for scientific/mechanical purposes

    • Schools/colleges for scientific/ mechanical purposes

    • Labs for research

    • hospitals etc for patient care

    • pathology labs for patient care


Poison prevention packaging act
Poison Prevention Packaging Act Flu...)

  • Intended to prevent child poisonings

  • Established child resistant safety cap

  • Established that household substances must be “child proof”

  • Hazardous substances, economic poisons (insecticides…), food, drug or cosmetic or household fuel in a portable container


Poison prevention packaging act1
Poison Prevention Packaging Act Flu...)

  • Enforcement by Consumer Product Safety Commission

  • Exempts some drugs from safety cap

  • If either MD or patient requests ez open caps

  • Some OTCs used by elderly or handicapped

  • Hospital drugs i.e..., unit dose and some other Rx items i.e..., OCs, nitroglycerin...


Obra 90
OBRA 90 Flu...)

  • Background: Requires RPh to review patient’s medication therapy--counseling

  • Rebates from drug manuf to state Medicaid

  • DUR-Retrospective and Prospective

  • Mandated Patient Counseling, RPh document counseling activities, enforcement of RPh activities by state board of pharmacy

  • Applies only to Medicare/Medicaid patients

  • Most states broadened to apply to all patients

  • Will discuss under State laws


Reimportation of rx drugs
Reimportation of Rx Drugs Flu...)

  • “Personal use” exemption for limited quantities

  • Internet purchases from outside US “technically” illegal

  • Common practice

  • Drugs sold from outside of US are not “FDA approved” (even if made in same factory as FDA-approved version)


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