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Pharma Industry (Federal Trade Commission (Enforcement actions (Anti-trust…
Pharma Industry
Federal Trade Commission
Stats
Enforcement actions
Anti-trust cases
REMS investigations
Purpose
Protect consumers
Maintain competition
Congress
Power to
Declare Gaming illegal
Continued malpractice
Call for action
fast track life saving/sustaining option
CREATES ACT
IF becomes LAW
Courts award
Damage costs to generics
for Gaming actions
Test samples
USA
Customers
Prices
up to 100% increase
Product unvalued
Petition to Congress
to lower prices
Allow Medicare to negotioate
Currently not lawful
Competiton
Lacking
Equals
Lower prices
FDA
Approval
No jurisdiction on prices
Process
Exclusivity
Marketing rights
Timescales
3-12 years
No new approvals for generic versions
Apply
Hatch-Waxman Act
Congress
Access to low cost generics
Preserve patents/exclusivity
Effecgive
Safe
Anti-trust Violations
Pay to Delay
Pay generics
Not to compete
Specific period
Patent extension :
Patent and Trademark Office (US)
Timescales
20 years
Cant make
Sell
Use
For Public Disclosure of Drug
Loopholes
Re-purpose
Re-Brand
REMS
Restrict
Access to samples
Access to REMS controls
Shared safety systems
Delay negotioations
REMS not always mandatory
FDA actions
Drug competition Action Plan - JUNE17
Understand barriers
Look for abuses
Publish
Off-Patents
Off-exclusivity
Priorities applciations
where limited competition
Passed by SENATE - AUG 2017