Legal Issues (OTC)

The first major federal legislation enacted to regulate drugs

Pure Food and Drug Act (1906)

T/F: Unsafe and non-efficacious drug products were not prohibited

True

Regulated of labeling / drug claims

Sherley Amendment (1912)

Mandated drug safety + Required approval before marketing

Food, Drug, and Cosmetic Act of 1938 (FD&C Act)

Established two classes of drugs: Prescription (legend) + Nonprescription (OTC)

Durham-Humphrey Amendment (1951)

What does the federal legend on a prescription drug state?

Caution: federal law prohibits dispensing without a prescription (now commonly says RX ONLY)

What act amended to RX ONLY symbol in 1977

Food and Drug Administration Modernization Act (FDAMA - 1977)

Safely used without medical supervision + labeling that includes adequate directions for use is considered what?

OTC

All new drugs must be shown to be effective, as well as safe, for their intended use (strengthened FDA’s power)

Kefauver-Harris Amendment (1962)

What was the purpose of DESI?

To evaluate the effectiveness of prescription drugs that have been approved since 1938.

FDA initiated a scientific review of the active ingredients in nonprescription drug formulations to ensure that they were safe and effective and that they bore fully informative labeling

OTC Drug Review (1972)

Category 1 Outcome of the OTC Drug Review Act (1972)

Generally recognized as safe and effective (GRASE)

Category 2 Outcome of the OTC Drug Review Act (1972)

Not generally recognized as safe and effective or had unacceptable indications (NRASE) - products were removed from market or re-formulated

Category 3 Outcome of the OTC Drug Review Act (1972)

Drug had insufficient data to permit classification (either dropped from formulations or additional data developed)

Which drugs require an NDA?

All new drugs introduced for marketing after 1938

What is a grandfathered drug and are they exempt from being evaluated?

A drug that was marketed before 1938 and does not need an NDA. They are being or have been evaluated

Does an NDA apply to both OTC and prescription drugs?

Yes

OTC Drug Review Panels developed therapeutic monographs that include:

1. Labeling (including therapeutic indications)

2. Dosage instructions

3. Warning about side effects

4. Potential for misuse and abuse

Is FDA approval required for marketing a product containing an ingredient covered under an OTC monograph

No

What is MedWatch?

FDA system available for reporting adverse events for Rx drugs as well as OTCs

Is there a legal or regulatory requirement to report adverse events associated with OTC drugs?

No

When was the OTC Monograph Process Modernized?

In 2020 as part of the CARES Act

The ______ box contains the information that is required by the FDA

Drug Facts

List the OTC Labeling FDA Requirements on a Drug Facts Label

1. Product Name/Ingredients

2. Product Indications/Claims

3. Package Contents

4. Directions for Use

5. Contraindications/Warnings/Precautions/ Adverse

6. Effects

7. Indications for Seeking Medical Attention

8. Manufacturer’s Information

9. Expiration Date and Batch Code

10. Label Flags

Which OTC products are exempt from having an expiration date?

OTC products that do not have a dosage limit and are stable for at least 3 years ( certain topical drugs, skin protectants, lotions, and astringents)

What are the packaging requirements for OTC products?

• Special storage conditions must be stated when applicable.

• Tamper-evident packaging is required.

• Must have one or more barriers to entry to help show whether the package has been opened or tampered with.

Name the 10 Tips for Smart OTC Medicine Use

1. Read the label

2. Choose a med that treats only the symptoms

3. Know what to avoid

4. Ask before you use

5. Take the med as stated

6. Use caution when taking more than 1 OTC

7. Don’t combine prescriptions and OTC without talking to a healthcare professional

8. Keep a list of all OTC, prescription drugs, and dietary/herbal supplements you take

9. Give infants + children meds according to their age and weight

10. Don’t use expired medicines

What are some potential problems associated with OTC medication use?

• Not reading or understanding the label

• Not understanding when the OTC should be discontinued

• Casual or inappropriate use

• Overuse, which can lead to serious adverse consequences

What are examples of OTC medication overuse?

• Taking more than the recommended amount at one time

• Taking the next dose sooner than directed

• Taking more than the recommended number of doses

What is a complete Rx-to-OTC switch?

The Rx product is converted to OTC with all dosage strengths available OTC, and no Rx version remains available. (Example: Nicorette® gum)

What is a partial Rx-to-OTC switch?

One or more lower strengths are switched to OTC, while higher strengths remain Rx-only. Example: Ibuprofen.

Name the 3 traditional ways a drug could be switched from Rx to OTC

1. FDA initiated review process

2. Manufacturer submits a supplemental application to an approved NDA

3. Manufacturer or another party petitions the FDA (Example: Blue Cross of California requested nonsedating antihistamines become OTC to create cost savings for third-party payers and state/federal healthcare programs.)

Under the Affordable Care Act (ACA), could drugs purchased without a prescription be paid for or reimbursed through FSAs, HRAs, HSAa, or Archer MSAs?

No.

Were there exceptions to the ACA restriction on OTC products?

Yes. Insulin and non drug medical products (devices, supplies, and similar medical related items)

How did the CARES Act (2020) change the rules of OTC products and flexible spending accounts?

It reversed the ACA restriction allowing OTC meds and menstrual products to be purchased or reimbursed using FSAs, HRAs, HSAs, and Archer MSAs

Serve as a forum for exchange of views regarding Rx vs. OTC status for various drugs and for safety/efficacy issues + Provide recommendation to FDA regarding switch

Non Prescription Drug Advisory Committee (1991)

List the major driving forces behind Rx to OTC drug reclassification

1. Self-Care Movement: empowers consumers to manage their own health

2. Patient expectations: better access to meds + cost savings

3. Market Expansion: increases manufacturer sales and profits

4. Generic Competition

5. Cost Containment

6. FDA’s Greater Attention to OTC Drugs

What factors does the FDA consider when determining whether a drug is appropriate for Rx to OTC reclassification?

1. Disease State (is it self-diagnosable/treatable)

2. Safety Profile

3. Misuse/Abuse

4. Habit Forming

5. Risk vs. Benefit

6. Margin of Safety

7. Drug Interactions

8. Length of USe

9. Efficacy

What is the proposed Pharmacy Care OTC Category?

Nonprescription meds available only in outlets with a pharmacy, allowing consumers to obtain certain medications OTC while still having access to a pharmacist

What are the goals of the Pharmacy Care OTC Category?

Facilitate interactions between consumers and pharmacists + Make meds available for chronic, asymptomatic conditions that may benefit from pharmacist involvement

What organization/task force proposed the Pharmacy Care OTC concept?

The APhA Task Force on Pharmacy Care OTCs

Why do companies use product line extensions (same brand, just different versions)?

To capitalize on brand name recognition, consumer trust, and brand loyalty

What are potential problems with product line extensions?

• They can duplicate other products already on the market

• Cause consumers to misinterpret or confuse one product with another in the same line

• Result in inappropriate drug selection

Who regulates OTC advertising?

The Federal Trade Commission

What does the FTC Act prohibit advertisers from doing with OTC products?

Using therapeutic benefit claims that have not been approved by the FDA for labeling

List the potential issues with the quality and contents of complementary and alternative medicine products

1. Products may not contain the listed ingredients

2. May not contain the quantity of ingredients stated on the label

3. May be no consistency between products

4. Contaminants are frequent

5. Quality assurance and whether manufacturers follow good manufacturing practices

Does the FDA control the quality assurance of dietary supplements?

No. This creates concerns about the purity, consistency, and accuracy.

Established the regulatory framework for dietary supplements

Dietary Supplement and Health Education Act ( DSHEA 1994)

Who is primarily responsible for the quality assurance of dietary supplements under DSHEA?

The manufacturer

What manufacturer info must be included on a dietary supplement label?

All ingredients, name, and address of the manufacturer, distributor, or packer

What is a Nutrient Content Claim?

A claim about a substance/nutrient that has an established daily value

What is a Health Claim?

A claim that describes a relationship between a health condition and a food, diet, or dietary product

What is a Structure/Function Claim?

A claim about how a product maintains or supports normal body structure or function. It may make a health-maintenance claim, but not a disease-specific claim.

What disclaimer is required for Structure/Function Claims?

“This statement has not been evaluated by the Food and Drug

Administration. This product is not intended to diagnose, treat,

cure, or prevent any disease.”

Are there any FDA approved products labeled as homeopathic?

No.

Has the FDA evaluated homeopathic products for safety or effectiveness?

No. The FDA has not evaluated them for their ability to diagnose, treat, cure, prevent, or mitigate diseases or conditions

What is significant about the premarketing requirements for homeopathic drugs?

They have never been required to demonstrate safety or efficacy before marketing

Are homeopathic drugs included in DESI or nonprescription drug review?

No.

Who governs the homeopathic drugs?

The Homeopathic Pharmacopoeia of the United States (HPUS) and its supplements.