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The drug can be manufactured, marketed, and sold once it has been approved. Adverse events (AE) are reported to the FDA by patients, healthcare providers, and facilities through the MedWatch program. The FDA checks for regulatory compliance by performing periodic inspections of production facilities (announced or unannounced) and by testing material samples either provided by the pharmaceutical company or acquired through retail channels.
Post-Marketing 15-Day Alert Report
Any adverse experience (serious and unexpected) must be reported within 15 days of being informed of the issue. For three years after marketing, the company must also submit a Periodic Adverse Experience Report (PAER), which demonstrates investigation and actions of adverse effects.
Patents and Exclusivity
Brand-name drug manufacturers have patent exclusivity for 20 years in the US. However, some drugs may qualify for patent & non-patent exclusivities, which can delay the market application of a generic drug. Drug patents are a complex issue in the US due to this specifically. Patent term extension can be given for exclusivity with antibiotic drugs, orphan drugs, pediatric drugs, and prescription-to-OTC designation change, to name a few.
The Orange Book
Once drugs are approved for the market, they are included in the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book because the original had an orange cover). This list provides information for prescription and OTC drugs and biologics and includes therapeutic equivalence evaluations and patent and exclusivity rights. https://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm
Go to The Orange Book and search for any drug you currently use: www.accessdata.fda.gov/scripts/cder/ob/default.cfm
Prescription Drug Labeling and Advertising
The FDA also has authority over labeling and marketing of drugs. Labeling here is not only what is written on the container, but any material associated with the product, including package inserts, Medication Guides, marketing material (direct to consumer and promotional) even social media!
21 CFR 201.56 and 21 CFR 201.57
Guidance for Industry
Labeling for Human Prescription Drug and Biological Products. There are specific requirements of labeling outlined in 21 CFR 201, some of which include appropriate placement and prominence of words on the label. All labeling, advertising, and promotional material must be submitted to the FDA for review before product approval. Here is a summary of a few of the guidance documents regarding labeling.
|21 CFR 201.57(c)(1)||Boxed Warnings & Precautions|
|21 CFR 201.57(c)(2)||Indications & Usage|
|21 CFR 201.57(c)(3)||Dosage & Administration|
|21 CFR 201.57(c)(4)||Dosage forms & Strength|
|21 CFR 201.57(c)(6)||Warnings|
|21 CFR 201.57(c)(7)||Adverse Reactions|
|21 CFR 201.57(c)(8)||Drug Interactions|
|21 CFR 201.57(c)(10)||Drug Abuse & Dependence|
|21 CFR 201.57(c)(11)||Over dosage|
|21 CFR 201.57(c)(17)||Storage and handling|
Test Your Knowledge!
- Decide on a drug that influences your life (positive or negative). Why did you choose this drug?
- Look up your drug on the FDA database and write a one-paragraph summary including its name, who makes it, and what it is used for. https://www.accessdata.fda.gov/scripts/cder/daf/
- On the top left corner is the drug’s NDA APPLICATION NUMBER: ________________
- Look up the dates of when your drug was approved, and its patent expire date. Search by Application number! www.accessdata.fda.gov/scripts/cder/ob/default.cfm
More Study Resources on CDER
CDERLearn is an FDA website for training regulatory affairs professionals about drug approval. There are over ten chapters targeting specific areas of drug development. Quite a few significant ones can be found at CDERworld.