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1 bill on this topic
“Brand-name drug companies should face limits on how many related patents they can use to sue generic and biosimilar competitors.”
1 bill on this topic
“When a proposed generic drug does not match the brand-name drug's inactive ingredients, the FDA should tell the applicant which inactive ingredients differ and how much any ingredient amount differs, even when federal confidentiality limits would otherwise restrict that disclosure?”
1 bill on this topic
“The FDA should be able to tell eligible generic drug applicants whether their proposed drug matches the brand-name drug in required inactive ingredients, including during review even if the applicant did not ask first.”
1 bill on this topic
“The FTC should be able to sue people or companies in federal court for filing, or causing someone else to file, sham FDA citizen petitions tied to generic drug or biosimilar approvals.”
1 bill on this topic
“The FTC should study how prescription drug middlemen, suppliers, insurers, and other payers are connected, why health care payers use those middlemen, and whether patients and payers should get clearer information about what the middlemen do.”
1 bill on this topic
“The FTC should recommend policy or legal changes to make the prescription drug supply chain easier to understand, more competitive, and less vulnerable to unfair or anticompetitive business practices.”
1 bill on this topic
“HHS should publish guidance explaining how the FDA decides whether a generic drug matches a brand-name drug's inactive ingredients and amounts, including acidity-adjusting chemicals, let the public comment for at least 60 days, and finish final guidance within one year after comments close.”
1 bill on this topic
“FDA should be able to approve a later generic drug when it is ready, the first generic filer has not launched after a long wait, and same-day first filers still get a limited priority period.”
1 bill on this topic
“After a generic drug maker submits its application, the FDA should usually have to stand by an earlier decision that the proposed generic matches the brand-name drug in inactive ingredients, unless the brand-name formula changed for safety or effectiveness reasons or the FDA writes down that it made an error.”
1 bill on this topic
“One FDA citizen petition should count as a sham only if it has no real objective basis and uses the FDA review process itself to interfere with a generic drug or biosimilar competitor.”
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