Wednesday, May 4, 2016

Current Legislation for Personal Importation of Medicines


Status of Personal Importation of Prescription Medicine Bills in Congress


S.122 - Safe and Affordable Drugs from Canada Act of 2015114th Congress (2015-2016)
BILL
Sponsor:
Sen. McCain, John [R-AZ] (Introduced 01/08/2015)
Committees:
Senate - Health, Education, Labor, and Pensions
Latest Action:
01/08/2015 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.  (All Actions)
Tracker:
This bill has the status Introduced
Here are the steps for Status of Legislation:
1.    Introduced
2.    Passed Senate
3.    Passed House
4.    To President
5.    Became Law
More on This Bill
Subject — Policy Area:
Summary: S.122 — 114th Congress (2015-2016)All Bill Information (Except Text)
There is one summary for S.122. Bill summaries are authored by CRS.
Shown Here:
Introduced in Senate (01/08/2015)
Safe and Affordable Drugs from Canada Act of 2015
Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the Department of Health and Human Services (HHS) to promulgate regulations within 180 days permitting individuals to import a prescription drug purchased from an approved Canadian pharmacy that:
  • is dispensed by a pharmacist licensed in Canada;
  • is purchased for personal use in quantities not greater than a 90-day supply;
  • is filled using a valid prescription issued by a physician licensed to practice in the United States; and
  • has the same active ingredient or ingredients, route of administration, dosage form, and strength as a prescription drug approved under the FFDCA.
Sets forth exceptions, including for controlled substances and biological products.
Establishes a certification process for approving Canadian pharmacies. Requires HHS to publish a list of approved Canadian pharmacies.

S.2023 - Prescription Drug Affordability Act of 2015 114th Congress (2015-2016) Get alerts
BILL
Sponsor:
Sen. Sanders, Bernard [I-VT] (Introduced 09/10/2015)
Committees:
Senate - Finance
Latest Action:
09/10/2015 Read twice and referred to the Committee on Finance.  (All Actions)

Introduced in Senate (09/10/2015)
  • requires the Centers for Medicare & Medicaid to negotiate lower prices on behalf of beneficiaries for drugs covered under Medicare Part D;
  • accelerates closure of the Medicare Part D coverage gap known as the "donut hole," under which beneficiaries who have reached a certain level of yearly drug costs become fully responsible for any additional drug costs up to a certain limit;
  • requires drug manufacturers to issue rebates for prescription drugs dispensed to eligible low-income individuals under Medicare or Medicaid; and
  • expands the application of certain prescription drug rebate requirements under Medicaid to include rebates for generic drugs.

The bill also requires drug manufacturers to produce and share annual reports containing specified information related to domestic and foreign sales.

Tracker:
This bill has the status Introduced
Here are the steps for Status of Legislation:
1.    Introduced
2.    Passed Senate
3.    Passed House
4.    To President
5.    Became Law
More on This Bill
Subject — Policy Area:
Summary: S.2023 — 114th Congress (2015-2016)All Bill Information (Except Text)
There is one summary for S.2023. Bill summaries are authored by CRS.
Shown Here:
Prescription Drug Affordability Act of 2015
This bill amends titles XVIII (Medicare) and XIX (Medicaid) of the Social Security Act to modify provisions related to the affordability of prescription drugs under the Medicare and Medicaid programs. Specifically, the bill:
The bill also amends the Federal Food, Drug, and Cosmetic Act to: (1) allow the importation by individuals of prescription drugs from Canada and, potentially, other countries; and (2) establish certain conditions on the award of market exclusivity with respect to drugs. Specifically, a drug manufacturer's market exclusivity shall be terminated if the manufacturer commits, or fails to report, a drug-related violation such as misbranding, illegal marketing, or fraud.
In addition, the bill amends the Federal Trade Commission Act to: (1) establish restrictions on certain anticompetitive patent settlements known as "pay-for-delay" agreements, which effectively block generic drug competition; and (2) allow the Federal Trade Commission to initiate proceedings to enforce these restrictions against any parties to such a settlement.

H.R.2623 - Personal Drug Importation Fairness Act of 2015114th Congress (2015-2016) | Get alerts
BILL

Sponsor:
Rep. Ellison, Keith [D-MN-5] (Introduced 06/03/2015)
Committees:
House - Energy and Commerce
Latest Action:
06/05/2015 Referred to the Subcommittee on Health.  (All Actions)
Tracker:
This bill has the status Introduced
Here are the steps for Status of Legislation:
1.    Introduced
2.    Passed House
3.    Passed Senate
4.    To President
5.    Became Law
More on This Bill
Subject — Policy Area:
Summary: H.R.2623 — 114th Congress (2015-2016)All Bill Information (Except Text)
There is one summary for H.R.2623. Bill summaries are authored by CRS.
Shown Here:
Introduced in House (06/03/2015)
Personal Drug Importation Fairness Act of 2015
This bill allows a drug to be imported by a person other than the drug's manufacturer if the drug: (1) has the same active ingredients, route of administration, and strength as an approved drug; (2) may be lawfully marketed in, and is imported or reimported from, a country included on a list in this Act that the Food and Drug Administration determines has standards for ensuring drug safety and effectiveness that are at least as protective as U.S. standards; (3) is dispensed by a licensed pharmacist; (4) is shipped directly to, or is imported by, the ultimate consumer; (5) is shipped or imported in quantities that do not exceed a 90-day supply; (6) is accompanied by a copy of a valid prescription; and (7) is not a controlled substance.

No comments:

Post a Comment