Fairness in Orphan Drug Exclusivity Act

Bill: 117-hr-1629
Sponsor: Rep. Dean, Madeleine [D-PA-4]
Introduced: 2021-03-08 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: 2021-03-08
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: 2021-05-19
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: 2021-05-20
text: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2021-05-19
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2021-05-19
text: On passage Passed by the Yeas and Nays: 402 - 23 (Roll no. 150). (text: CR H2561)
action_date: 2021-05-19
text: Passed/agreed to in House: On passage Passed by the Yeas and Nays: 402 - 23 (Roll no. 150).(text: CR H2561)
action_date: 2021-05-19
text: Considered as unfinished business. (consideration: CR H2572-2573)
action_date: 2021-05-19
text: POSTPONED PROCEEDINGS - At the conclusion of debate on H.R. 1629, the Chair put the question on passage and by voice vote, announced that the ayes had prevailed. Mrs. Greene (GA) demanded the yeas and nays and the Chair postponed further proceedings on the question of passage until a time to be announced.
action_date: 2021-05-19
text: The previous question was ordered pursuant to the rule.
action_date: 2021-05-19
text: DEBATE - The House proceeded with one hour of debate on H.R. 1629.
action_date: 2021-05-19
text: Rule provides for consideration of H.R. 1629 and H. Res. 275. The resolution provides for consideration of H.R. 1629 under a closed rule and H. Res. 275 under a closed rule. The resolution provides for one hour of debate on both the bill and resolution. The rule provides that H. Res. 398 is hereby adopted. The rule provides at any time through the legislative day of Thursday, May 20, 2021, the Speaker may entertain motions offered by the Majority Leader or designee with respect to multiple measures that were object of motions to suspend the rules on the legislative days of May 17 or 18, 2021.
action_date: 2021-05-19
text: Considered under the provisions of rule H. Res. 403. (consideration: CR H2560-2563)
action_date: 2021-05-17
text: Rules Committee Resolution H. Res. 403 Reported to House. Rule provides for consideration of H.R. 1629 and H. Res. 275. The resolution provides for consideration of H.R. 1629 under a closed rule and H. Res. 275 under a closed rule. The resolution provides for one hour of debate on both the bill and resolution. The rule provides that H. Res. 398 is hereby adopted. The rule provides at any time through the legislative day of Thursday, May 20, 2021, the Speaker may entertain motions offered by the Majority Leader or designee with respect to multiple measures that were object of motions to suspend the rules on the legislative days of May 17 or 18, 2021.
action_date: 2021-05-11
text: On motion to suspend the rules and pass the bill Failed by the Yeas and Nays: (2/3 required): 250 - 168 (Roll no. 134).
action_date: 2021-05-11
text: Failed of passage/not agreed to in House: On motion to suspend the rules and pass the bill Failed by the Yeas and Nays: (2/3 required): 250 - 168 (Roll no. 134).
action_date: 2021-05-11
text: Considered as unfinished business. (consideration: CR H2184-2185)
action_date: 2021-05-11
text: At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.
action_date: 2021-05-11
text: DEBATE - The House proceeded with forty minutes of debate on H.R. 1629.
action_date: 2021-05-11
text: Considered under suspension of the rules. (consideration: CR H2181-2183; text: CR H2181-2182)
action_date: 2021-05-11
text: Mr. Pallone moved to suspend the rules and pass the bill.
action_date: 2021-03-09
text: Referred to the Subcommittee on Health.
action_date: 2021-03-08
text: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Budget, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2021-03-08
text: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Budget, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2021-03-08
text: Introduced in House
action_date: 2021-03-08
text: Introduced in House