Protecting Consumer Access to Generic Drugs Act of 2023
Impact
If enacted, this bill would enforce stricter regulations regarding how patent disputes are settled in the pharmaceutical industry. It would amend the current laws allowing brand name and generic companies to enter agreements that might limit the entry of cheaper alternatives to the market. The Federal Trade Commission (FTC) is empowered to investigate violations and take action against companies engaging in such agreements. This change could significantly impact drug pricing and accessibility for consumers, particularly for biologics and biosimilars, which are often more expensive than traditional medications.
Summary
House Bill 6275, titled the 'Protecting Consumer Access to Generic Drugs Act of 2023', aims to prohibit brand name drug manufacturers from paying generic manufacturers to delay the market entry of their products. This practice, often referred to as 'pay-for-delay', has raised concerns over the accessibility and affordability of medications. The bill seeks to enhance competition in the pharmaceutical industry by making it unlawful for manufacturers to settle patent disputes in a manner that limits competition from generic alternatives.
Contention
Despite the bill's intentions to promote consumer access to affordable drugs, there might be notable points of contention. Pharmaceutical companies may argue that this legislation undermines their patent rights and financial investments in research and development. Critics of the bill might also highlight concerns that it could discourage innovation in drug development by reducing the financial incentives offered by patent protections. Consequently, while consumer advocacy groups may support the bill for its pro-competition stance, it may face pushback from industry stakeholders who fear potential adverse effects on drug innovation.
Relates to preserving access to affordable drugs; provides that an agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a pharmaceutical product, shall be presumed to have anticompetitive effects if a nonreference drug filer receives anything of value from another company asserting patent infringement and if the nonreference drug filer agrees to limit or forego research, development, manufacturing, marketing, or sales of the nonreference drug filer's product for any period of time.
Provides that an agreement resolving a patent infringement claim, in connection with the sale of a pharmaceutical product, is to be presumed to have anticompetitive effects if a nonreference drug filer receives anything of value.