Regulatory Class - Nov 7 Flashcards
What groups oversee advertising of prescription drugs, biologics and devices?
CDER - Office of Prescription Drug Promotion [OPDP] (formerly DDMAC)
CBER - Advertising and Promotional Labeling Branch
CDRH - Office of Compliance
Act specifically gives right for enforcement of drugs but it also applies to biologics and devices
Label vs Labeling
Label - written, printed, or graphic material on the drug’s immediate container (physical packing item)
Labeling - any written, printed or graphic material on the drug product; containers or wrappers; any materials issued in association with the drug (including drug promotion)
Requirements for Non-promotional drug labeling
Contain summary of essential scientific info
Be submitted to FDA with marketing application
Be updated when new safety info becomes available (require supplement)
Cannot contain false or misleading statement
Cannot be promotional
Package Insert: Highlights Section
Package inserts are made for pharmacists
Statement that not info is included in the highlights
Drug names, dosage form, route of administration
Date of initial FDA approval
Boxed warning
List of recent (w/in 1 yr) changes to labeling
Indications for use
Contraindications, warnings and precautions, adverse reactions, and drug interactions
Use in specific populations
Patient counseling info
Date of most recent revision
Package Insert: Full Prescribing Info
Contents Boxed Warning Indications and usage Dosage and administration Dosage forms and strengths Contraindications (known hazards) Warnings and precautions (AEs with frequency) Adverse reactions (only those associated with drug) Drug interactions Use in specific populations (pregnancy, pediatrics, geriatrics) Drug abuse and dependence Overdose Drug description Clinical pharmacology (Mechanism of action, PK) Nonclinical toxicology Clinical Studies How supplied, and storage and handling Patient counseling info
Patient Labeling
Derived from professional labeling
Written in consumer friendly language
Focus on directions for use and risks associated with drug
The medication guide
Medication Guide
For certain drugs with serious and significant risks
Distributed to patients each time the drug is dispensed
Device Labeling Contents
Manufacturer name and principal place of business (so, they can be contacted) Device name and Established name Description Indications and usage Contraindications Warnings Precautions Use in specific patient populations Adverse reactions Prescription device statement Date of issue/revision of labeling Need to include operations, servicing, and calibration info and any info necessary for the user (usually given as a user's manual)
Fair Balance
All claims of effectiveness must be accompanied by info about product’s risks
Marked by the amount of info and its format (where it’s located in the Ad)
Applies to each piece of promo material
Must be an adequate representation of all risks
Must refer readers to risk info in multipage Ad
Most frequently violated
General package label requirements
Manufacturer, packager or distributor’s name and
address
Statement of ingredients Expiration date
Bar codes
Statement of identity
Quantity of contents
Statement of dosage
Professional labeling
For product use by healthcare professionals
Package insert - full prescribing info
Specific populations addressed in full prescribing info
These populations must be address in the prescribing info, even if only to say, not applicable. Pregnancy Labor and delivery Nursing mothers Pediatric use Geriatric use
For devices without clinical trials (510k), what are the side effects?
Side effects and warnings are listed as those typical of that type of device and/or procedures related to device use
Distributing materials for off-label use
A lot of constraints, so not used too much
Must be a plan in place for a trial for this use
Cannot use a competitor’s materials
Must submit to FDA 60 days prior to dissemination
Must maintain records of persons receiving the info
Constraints:
Drug is approved for another use
Information is directed to healthcare practitioner
Reprint/copy of article in peer-reviewed scientific or medical journal discussing scientifically sound clinical trial
Does not pose significant risk to public health
Not false or misleading
Not derived from clinical trial conducted by another manufacturer
Disclose that use is not approved/cleared
Comparative or Superiority Claims
Cannot make claims that a product is better, safer, more effective, unless demonstrated by substantial evidence
Substantial evidence must include:
Usually requires 2 adequate and well-controlled trials
Head-to-head clinical trials
Comparison must be clinically and statistically significant
Pharmacoeconomic (PE) claims
Cost-effectiveness claims, do not include clinical efficacy
Must be based on competent and reliable evidence, directly related to an approved indication
Data not based on studies but scientific cost-modeling
May only be provided to formularies, insurance companies, manage-care providers
FDA monitoring promo activity
Don’t care who in the company says it, only cares what is said
Monitors all promo exhibits at medical conferences and meetings
Preapproval promo (drugs)
Cannot represent that an investigational drug (or use) is safe and effective
Exceptions:
Institutional Ads - company states it’s doing research in an area but can’t mention drug name: goal is to get physicians to call about the study and then any convo about the drug is not promotional
Coming Soon promo - can only reveal the name, no suggestions of use for indications or claims of safety or efficacy, cannot be used for drugs with black box warnings
Must choose only 1 of the 2 exceptions, not both
