Fairness in Orphan Drug Exclusivity Act

Bill: 116-hr-4712
Sponsor: Rep. Dean, Madeleine [D-PA-4]
Introduced: 2019-10-17 in the House
Policy area: Health
Subjects: Competition and antitrust
Drug safety, medical device, and laboratory regulation
Licensing and registrations
Marketing and advertising
Prescription drugs

Summary:
action_date: 2019-10-17
text: 

Fairness in Orphan Drug Exclusivity Act

 
This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats; the sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.)
 
Specifically, when determining whether to grant an exclusivity period to a drug that has orphan status due to low expected sales, the FDA shall consider the sales of all drugs from the sponsor that have the same core molecule or ion that is responsible for the drug's physiological or pharmacological action.

action_date: 2020-11-16
text: 

Fairness in Orphan Drug Exclusivity Act

 
This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats; the sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.)
 
Under this bill, if a drug is designated as an orphan drug on the basis that there is no reasonable expectation that the sponsor will recover the costs of developing and distributing the drug from U.S. sales, the drug shall be granted the seven-year exclusivity period only if the sponsor demonstrates that there is no reasonable expectation that it will recover such costs specifically within its first 12 years of U.S. sales of the drug. This requirement shall also apply retroactively to an orphan drug that was granted such an exclusivity period before this bill's enactment. 
 
When deciding whether an orphan drug meets this requirement, the FDA shall consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation.

action_date: 2020-11-17
text: 

Fairness in Orphan Drug Exclusivity Act

 
This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats; the sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.)
 
Under this bill, if a drug is designated as an orphan drug on the basis that there is no reasonable expectation that the sponsor will recover the costs of developing and distributing the drug from U.S. sales, the drug shall be granted the seven-year exclusivity period only if the sponsor demonstrates that there is no reasonable expectation that it will recover such costs specifically within its first 12 years of U.S. sales of the drug. This requirement shall also apply retroactively to an orphan drug that was granted such an exclusivity period before this bill's enactment. 
 
When deciding whether an orphan drug meets this requirement, the FDA shall consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation.


Legislative actions:
action_date: 2020-11-18
text: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2020-11-17
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2020-11-17
text: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H5807)
action_date: 2020-11-17
text: Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H5807)
action_date: 2020-11-17
text: DEBATE - The House proceeded with forty minutes of debate on H.R. 4712.
action_date: 2020-11-17
text: Considered under suspension of the rules. (consideration: CR H5807-5809)
action_date: 2020-11-17
text: Mr. Pallone moved to suspend the rules and pass the bill, as amended.
action_date: 2020-11-16
text: Placed on the Union Calendar, Calendar No. 470.
action_date: 2020-11-16
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-572.
action_date: 2020-11-16
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-572.
action_date: 2020-07-15
text: Ordered to be Reported (Amended) by Voice Vote.
action_date: 2020-07-15
text: Committee Consideration and Mark-up Session Held.
action_date: 2020-03-11
text: Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
action_date: 2020-03-11
text: Subcommittee Consideration and Mark-up Session Held.
action_date: 2019-10-18
text: Referred to the Subcommittee on Health.
action_date: 2019-10-17
text: Referred to the House Committee on Energy and Commerce.
action_date: 2019-10-17
text: Introduced in House
action_date: 2019-10-17
text: Introduced in House