Competition Prescription Act of 2019

Bill: 116-hr-3947
Sponsor: Rep. Meadows, Mark [R-NC-11]
Introduced: 2019-07-24 in the House
Policy area: Health
Subjects: Administrative law and regulatory procedures
Administrative remedies
Civil actions and liability
Competition and antitrust
Consumer affairs
Contracts and agency
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Employee benefits and pensions
Federal district courts
Federal preemption
Government employee pay, benefits, personnel management
Government information and archives
Health care costs and insurance
Health information and medical records
Health technology, devices, supplies
Inflation and prices
Insurance industry and regulation
Licensing and registrations
Medicaid
Medical ethics
Medical research
Medicare
Military medicine
Prescription drugs
Product development and innovation
Research and development
Retail and wholesale trades
Right of privacy

Summary:
action_date: 2019-07-24
text: 

Competition Prescription Act of 2019

 
 This bill revises various requirements related to the development, production, and sale of prescription drugs and biological products.
 
First, the bill permits the developer of a drug or biological product to bring a civil action against the license holder of an approved product if the license holder has declined to make available sufficient quantities of the approved product for the developer's testing.
 
The bill also requires the Food and Drug Administration (FDA) to establish a process for developers of generic complex drugs to request and receive expedited development and priority review. Further, upon request by a drug sponsor, a drug that treats a life-threatening disease or condition must be designated for expedited review if there are fewer than three drugs currently available for such treatment.
 
States are prohibited from placing restrictions on dispensing substitute biological products that have been determined to be interchangeable with another product by the FDA.
 
Additionally, the bill prohibits sponsors of Medicare Part D prescription drug plans from reducing a payment to a pharmacy after a claim without defect has been submitted by such pharmacy. The bill establishes requirements for pricing standards for pharmacy benefits managers under Medicare and other federal prescription drug benefits programs. Starting in 2025, the bill removes the cap on rebates paid by manufacturers of outpatient prescription drugs under Medicaid.
 
Further, the bill requires the publication of specified information regarding licensed biological products, exempts from antitrust prohibitions specified drug-price negotiation strategies, and establishes a Chief Pharmaceutical Negotiator in the Office of the U.S. Trade Representative.
 

 


Legislative actions:
action_date: 2019-08-28
text: Referred to the Subcommittee on the Constitution, Civil Rights, and Civil Liberties.
action_date: 2019-08-28
text: Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
action_date: 2019-08-28
text: Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
action_date: 2019-07-25
text: Referred to the Subcommittee on Health.
action_date: 2019-07-25
text: Referred to the Subcommittee on Military Personnel.
action_date: 2019-07-24
text: Referred to the Subcommittee on Health.
action_date: 2019-07-24
text: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, the Judiciary, Armed Services, and Oversight and Reform, 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: 2019-07-24
text: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, the Judiciary, Armed Services, and Oversight and Reform, 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: 2019-07-24
text: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, the Judiciary, Armed Services, and Oversight and Reform, 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: 2019-07-24
text: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, the Judiciary, Armed Services, and Oversight and Reform, 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: 2019-07-24
text: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, the Judiciary, Armed Services, and Oversight and Reform, 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: 2019-07-24
text: Introduced in House
action_date: 2019-07-24
text: Introduced in House