S. 2345: Short on Competition Act

The bill titled the Short on Competition Act aims to address issues related to drug shortages and market competition for prescription drugs in the United States. It includes provisions to expedite the approval of generic drugs and allow for the temporary importation of certain prescription drugs.

Key Provisions

Temporary Importation of Prescription Drugs

The bill modifies existing regulations to grant the Secretary of Health and Human Services the authority to temporarily import prescription drugs if there is a shortage of those drugs in the U.S. This importation can last for a period of up to three years. Key criteria for this importation include:

• The drug must have the same active ingredients as the drug in shortage.
• The drug must be approved for marketing in certain countries.
• The drug's manufacturer must indicate their intention to seek approval for the drug in the U.S.
• The importer must provide information confirming compliance with these requirements.

The Secretary may deny importation if the drug is deemed unsafe or ineffective.

Marginally Competitive Drug Markets

The bill establishes a framework for identifying "marginally competitive markets," which exist when fewer than five commercially available versions of a drug are present for at least two consecutive months. In these cases:

• The Secretary can treat the situation as a drug shortage, which allows for expedited review and importation processes.

A drug is considered "marginally competitive" if it was approved over ten years ago and all its related patents have expired.

Annual Reporting on Drug Shortages

The bill also mandates the collection of data regarding drug shortages, which requires annual reports that include:

• The number of drugs that were granted temporary importation status.

In summary, the Short on Competition Act seeks to enhance competition in drug markets and ensure better access to prescription medications through temporary importation and streamlined approval processes for generic drugs, particularly in cases where drug shortages exist.

Relevant Companies

None found