Drug Approval

Question 1

What does Health Canada evaluate when accessing a drug?

Answer 1

• safety
• efficacy
• quality of data

Question 2

What happens if a drug is approved by the FDA or Health Canada?

Answer 2

• benefits can outweigh the risks
• risks can be dealt with
• drug issued a notice of compliance
• Drug is issued a drug identification number (DIN)

Question 3

What happens if a drug is denied approval by the FDA or Health Canada?

Answer 3

• sponsor can supply additional information
• Sponsor can re-submit later with additional data
• Sponsor can appeal decision

Question 4

When was the first year of the deadly HIV epidemic?

Answer 4

1980s

Question 5

What was ACT UP?

Answer 5

a group of people frustrated with the slow pace of HIV research into treatments

Question 6

What did ACT UP do?

Answer 6

Their political actions shut down the FDA

Question 7

Who is Vito Russo?

Answer 7

an activist who presented a speech in New York about HIV

Question 8

What were some of the demands from the activists of ACT UP?

Answer 8

• shorten the drug approval process
• Immediate free access to drugs proven safe and effective after Phase 1 trials
• No double-blind placebo trials
• New drug must be measured against other approved drugs (or other therapies)
• Include people of all populations and all stages of HIV
• drug trials recruit participants from all groups affected

Question 9

What happened after the ACT UP demonstrations shut down the FDA?

Answer 9

• 8 days later, the FDA announced new regulations to accelerate the approval
• Feb 1989 FDA approval of AIDs-related pneumonia
• Aug 1989 AZT: slowed the progression of AIDS in ppl with no symptoms
• Oct 1989: second drug made available
• April 1993: 15 pharmaceutical came together to spend the process

Question 10

What is the priority review process?

Answer 10

Faster review for drugs for life-threatening or severe conditions

Question 11

What are Phase 4 trials?

Answer 11

any study performed after drug approval and related to the approved indication (not off-label use)

It looks at safety over time, and other aspects of the treatment (quality of life or cost-effectiveness)

Question 12

What do phase 4 trials permit?

Answer 12

• assessment in “real world” settings
• identifications of less common side effects

Question 13

What are some reasons the FDA might recall a drug?

Answer 13

• manufacturing/ purity
• mild side effect
• major side effects

Question 14

What is an emergency use authorization?

Answer 14

During an emergency:
- increases the availability of an unapproved medication or vaccine
- increases the availability of an approved drug for unapproved uses

Question 15

What is the off-label use of medication?

Answer 15

• prescribing a drug product in a wat that is inconsistent with the approved label

Question 16

What are some common populations of off-label prescriptions?

Answer 16

• oncology
• pediatrics
• elderly