Increasing Prescription Drug Competition Act

Increasing Prescription Drug Competition Act

This bill provides that certifications in generic drug applications of certain patents involved in Risk Evaluation and Mitigation Strategy (REMS) programs have no effect upon the drug's approval. (The Food and Drug Administration sometimes requires a REMS program for certain drugs with safety risks, which may include restrictions on a drug's distribution through elements to ensure safe use (ETASU), such as special requirements for pharmacies that dispense the drug.)

Specifically, certifications in generic drug applications with respect to patents that involve an ETASU for REMS requirements have no effect on the effective date of the drug's approval, notwithstanding any other provisions that allow for a stay of approval pending litigation outcomes (i.e., 30-month stay).

The bill also specifies that in a civil action alleging patent infringement with respect to REMS requirements, the sponsor of the approved brand-name drug may only seek damages from (rather than an injunction against) the generic drug applicant.

Bill 118 hr 4692, also known as the Increasing Prescription Drug Competition Act, aims to promote competition in the pharmaceutical industry in order to lower prescription drug prices for consumers. The bill was introduced in the House of Representatives on March 10, 2021.

The main provisions of the bill include:

1. Allowing the Federal Trade Commission (FTC) to take action against pharmaceutical companies that engage in anti-competitive practices, such as pay-for-delay agreements that delay the entry of generic drugs into the market. 2. Requiring drug manufacturers to provide samples of their brand-name drugs to generic manufacturers in a timely manner, in order to facilitate the development and approval of generic alternatives. 3. Prohibiting pharmaceutical companies from using tactics to prevent generic drug manufacturers from obtaining the necessary ingredients to produce their drugs. 4. Providing incentives for generic drug manufacturers to enter the market and compete with brand-name drugs, such as expedited review processes and marketing exclusivity. Overall, the Increasing Prescription Drug Competition Act aims to increase competition in the pharmaceutical industry, which in turn is expected to lead to lower prescription drug prices for consumers. The bill has received bipartisan support in Congress and is currently being considered for passage.