Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act
- Last Action
- 6/26/2019
Actions
- 2019-06-26Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
- 2019-06-26Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
- 2019-05-15Referred to the Subcommittee on Health.
- 2019-05-14Referred to the Committee on Energy and Commerce, and in addition to the Committee on 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.
- 2019-05-14Referred to the Committee on Energy and Commerce, and in addition to the Committee on 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.
- 2019-05-14Introduced in House
- 2019-05-14Introduced in House
CRS Summary
As of 2019-05-14 (00)
Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act
This bill addresses prescription drugs and extends several health care, research, and workforce programs.
Currently, a generic drug manufacturer is awarded 180 days of exclusivity on the market if it is the first applicant to file an application with the Food and Drug Administration (FDA), and the exclusivity period begins upon the first applicant's commercial marketing. The bill authorizes the FDA to approve a subsequent generic drug application prior to the first applicant's first date of commercial marketing if certain conditions are met.
The bill prohibits a brand-name, generic, or biosimilar drug manufacturer from entering into certain agreements to resolve or settle a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement, with specified exclusions, is a violation of the bill if the filer of the subsequent generic application receives something of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biological product.
The developer of a drug or biological product, such as a generic or biosimilar version of a drug, may bring a civil action against the license holder of an approved drug if the holder has declined to make available sufficient quantities of the approved drug for the developer's testing.
The bill also extends several health care, research, and workforce programs, including the National Health Service Corps, through FY2020.
Cosponsors (20)
- GREG WALDEN (R-OR)
- FRED UPTON (R-MI)
- David McKinley (R-WV)
- Earl Carter (R-GA)
- Larry Bucshon (R-IN)
- Gus Bilirakis (R-FL)
- Markwayne Mullin (R-OK)
- Cathy Rodgers (R-WA)
- Billy Long (R-MO)
- Bill Flores (R-TX)
- Richard Hudson (R-NC)
- JOHN SHIMKUS (R-IL)
- Tim Walberg (R-MI)
- Adam Kinzinger (R-IL)
- Pete Olson (R-TX)
- Bill Johnson (R-OH)
- Brett Guthrie (R-KY)
- H. Griffith (R-VA)
- Jeff Duncan (R-SC)
- Susan Brooks (R-IN)
Subjects
- Administrative law and regulatory procedures
- Appropriations
- Child health
- Civil actions and liability
- Competition and antitrust
- Consumer affairs
- Digestive and metabolic diseases
- Drug safety, medical device, and laboratory regulation
- Education programs funding
- Family planning and birth control
- Federal Trade Commission (FTC)
- Health care costs and insurance
- Health care coverage and access
- Health facilities and institutions
- Health personnel
- Health programs administration and funding
- Health promotion and preventive care
- Indian social and development programs
- Inflation and prices
Sourced from Congress.gov (public domain).
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.