Importation of Prescription Drugs

1
Importation of Prescription Drugs

• A Short Legislative History
• By
• Donna U. Vogt
• Congressional Research Service

2
Types of Prescription Drug Imports

• Commercial use
• Personal use

3
Commercial Imports Prescription Drug Marketing
Act

• Drug Diversion
• Quality Concerns
• Closed System of Distribution

4
Personal Use Import Policy

• Mid 1980s increase in AIDS incidence
• Lengthy review of New Drug Applications
• Solution PDUFA in 1992
• More drugs become available

5
Price Disparities Continue

• Costs of R D increase
• U.S. Favorable Research Climate
• Costs of Rx starts to climb

6
2000House Action

• Crowley Amendment
• No funds were to be expended to enforce
  Section 801(d)(1) the PDMA section prohibiting
  everyone but manufacturers from importing
  prescription drugs

• Coburn Amendment
• No funds could be used to interfere with
  FDA-approved drugs being imported from an
  approved facility in Canada, Mexico or
  manufactured in the United States

7
2000 House Action

• The Drug Import Fairness Act of 2000
• (H.R. 3240, introduced by Rep. Gutknecht)
• Included in the FY2001 Ag Approps bill
• Prohibited FDA from sending warning letters to
  individuals unless the agency specifies how the
  imported drug violates the law

8
2000Senate Action

• Medicine Equity and Drug Safety Act of 2000
• (Included in the FY2001 Ag Approps bill
  added Section 804 of the FFDCA)
• A 5-year program for pharmacists and drug
  wholesalers
• Drugs imported only from specific countries
• No controlled or other substances

9
Conditions for Implementation of the MEDS Act of
2000

• Demonstrate to Congress that
• 1. Pose no additional risk to the publics health
  and safety
• 2. Result in a significant reduction in the cost
  of covered products to U.S. consumers
• Neither the Clinton nor Bush Administrations have
  certified so

10
States and Municipalities

• So far in 2004, 22 states have introduced 42
  bills and resolutions
• Websites
• Pilot projects
• Waivers

11
Current Situation

• It remains illegal to import prescription drugs
  for personal or commercial use
• Only the manufacturer can import drugs