Prescription Drug Affordability Act of 2015

Bill: 114-hr-3513
Sponsor: Rep. Cummings, Elijah E. [D-MD-7]
Introduced: 2015-09-16 in the House
Policy area: Health
Subjects: Business records
Canada
Civil actions and liability
Competition and antitrust
Congressional oversight
Fraud offenses and financial crimes
Government information and archives
Health care costs and insurance
Health care coverage and access
Indian social and development programs
Inflation and prices
Intellectual property
Manufacturing
Medicaid
Medicare
Military medicine
Minority health
Prescription drugs
Public contracts and procurement
Research and development
Retail and wholesale trades
Trade agreements and negotiations
Trade restrictions
Veterans' medical care

Summary:
action_date: 2015-09-16
text: 

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: 
 
 
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 &quot;donut hole,&quot; 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 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 &quot;pay-for-delay&quot; 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.

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


Legislative actions:
action_date: 2015-09-18
text: Referred to the Subcommittee on Health.
action_date: 2015-09-18
text: Referred to the Subcommittee on Health.
action_date: 2015-09-16
text: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2015-09-16
text: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2015-09-16
text: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2015-09-16
text: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2015-09-16
text: Introduced in House
action_date: 2015-09-16
text: Introduced in House