Summary: H.R.4614 — 107th Congress (2001-2002)All Information (Except Text)

There is one summary for H.R.4614. Bill summaries are authored by CRS.

Shown Here:
Introduced in House (04/25/2002)

Amends provisions of the Federal Food, Drug, and Cosmetic Act set forth in the Medicine Equity and Drug Safety Act of 2000 to: (1) direct the Secretary of Health and Human Services to promulgate regulations permitting pharmacists and wholesalers to import Food and Drug Administration (FDA)-approved prescription drugs from Canada (currently, from Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, the countries in the European Union and the European Free Trade Association, or other countries designated by the Secretary); and (2) exclude an infused or intravenously injected drug or a drug that is inhaled during surgery.

Prohibits discrimination in the sale of prescription drugs by manufacturers to pharmacists or wholesalers, requiring: (1) terms as favorable as those provided to foreign purchasers; and (2) full access to drugs permitted to be imported.

Continues the requirement that exported donated prescription drugs may only be reimported by the manufacturer.

Permits the Secretary to waive the prohibition against importing a prescription drug or device on a case-by-case basis, particularly those from Canada that are FDA-approved and for limited personal use.

Requires a study and report by the: (1) Institute of Medicine of the National Academy of Sciences on the regulatory compliance of importers of drugs; and (2) Comptroller General on how drug prices were affected.