To amend the Federal Food, Drug, and Cosmetic Act with respect to facilitating dissemination of health care economic information.

Bill: 114-hr-2452
Sponsor: full_name: Rep. Long, Billy [R-MO-7]
Introduced: 2015-05-19
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation

Health information and medical records
Latest action: action_date: 2015-05-22
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2015-05-19
action_desc: Introduced in House
text: <p>This bill amends the Federal Food, Drug, and Cosmetic Act to revise the requirements for health care economic information that is provided to entities selecting drugs for coverage or reimbursement, such as formularies. The information must include a conspicuous and prominent statement describing the differences between the information and the labeling approved for the drug.</p> &quot;Health care economic information&quot; is an analysis that describes the economic consequences of the use of a drug. Such an analysis is no longer required to compare the use of the drug to another intervention or no intervention. An analysis that relates only to an indication for which the drug is not approved is not health care economic information.

tv_txt: I 114th CONGRESS 1st Session H. R. 2452 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. Long (for himself, Mr. Schrader , and Mr. Burgess ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to facilitating dissemination of health care economic information.

1. Facilitating dissemination of health care economic information Section 502(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 352(a) ) is amended— (1) by striking (a) If its and inserting (a)(1) If its ; (2) by striking a formulary committee, or other similar entity, in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations and inserting a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis, carrying out its responsibilities for the selection of drugs for coverage or reimbursement ; (3) by striking directly relates and inserting relates ; (4) by striking and is based on competent and reliable scientific evidence. The requirements set forth in section 505(a) or in section 351(a) of the Public Health Service Act shall not apply to health care economic information provided to such a committee or entity in accordance with this paragraph and inserting , is based on competent and reliable scientific evidence, and includes, where applicable, a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug under section 505 or under section 351 of the Public Health Service Act. The requirements set forth in section 505(a) or in subsections (a) and (k) of section 351 of the Public Health Service Act shall not apply to health care economic information provided to such a payor, committee, or entity in accordance with this paragraph ; and (5) by striking In this paragraph, the term and all that follows and inserting the following: (2) (A) For purposes of this paragraph, the term health care economic information means any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, measures, or describes the economic consequences, which may be based on the separate or aggregated clinical consequences of the represented health outcomes, of the use of a drug. Such analyses may be comparative to the use of another drug, to another health care intervention, or to no intervention. (B) Such term does not include any analysis that relates only to an indication that is not approved under section 505 or under section 351 of the Public Health Service Act for such drug. .