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US Laws | Affordable Health Care Act (HR3950F)
TITLE VI--TRANSPARENCY AND PROGRAM INTEGRITY
Subtitle H--Elder Justice Act

(3) CONGRESSIONAL ACTION- After receiving the report submitted by the Secretary under paragraph (2)(D), the Committee on Finance of the Senate and the Committee on Ways and Means and the Committee on Energy and Commerce of the House of Representatives shall, as they deem appropriate, take action based on the recommendations contained in the report. (10692)

(4) AUTHORIZATION OF APPROPRIATIONS- There are authorized to be appropriated such sums as are necessary for the purpose of carrying out this subsection. (10693)

(d) Conforming Amendments- (10694)

(1) TITLE XX- Title XX of the Social Security Act (42 U.S.C. 1397 et seq.), as amended by section 6703(a), is amended-- (10695)

(A) in the heading of section 2001, by striking "TITLE" and inserting "SUBTITLE"; and (10696)

(B) in subtitle 1, by striking "this title" each place it appears and inserting "this subtitle". (10697)

(2) TITLE IV- Title IV of the Social Security Act (42 U.S.C. 601 et seq.) is amended-- (10698)

(A) in section 404(d)-- (10699)

(i) in paragraphs (1)(A), (2)(A), and (3)(B), by inserting "subtitle 1 of" before "title XX" each place it appears; (10700)

(ii) in the heading of paragraph (2), by inserting "SUBTITLE 1 OF" before "TITLE XX"; and (10701)

(iii) in the heading of paragraph (3)(B), by inserting "SUBTITLE 1 OF" before "TITLE XX"; and (10702)

(B) in sections 422(b), 471(a)(4), 472(h)(1), and 473(b)(2), by inserting "subtitle 1 of" before "title XX" each place it appears. (10703)

(3) TITLE XI- Title XI of the Social Security Act (42 U.S.C. 1301 et seq.) is amended-- (10704)

(A) in section 1128(h)(3)-- (10705)

(i) by inserting "subtitle 1 of" before "title XX"; and (10706)

(ii) by striking "such title" and inserting "such subtitle"; and (10707)

(B) in section 1128A(i)(1), by inserting "subtitle 1 of" before "title XX". (10708)

Subtitle I--Sense of the Senate Regarding Medical Malpractice (10709)(Text)

SEC. 6801. SENSE OF THE SENATE REGARDING MEDICAL MALPRACTICE. (10710)(Text)

It is the sense of the Senate that-- (10711)

(1) health care reform presents an opportunity to address issues related to medical malpractice and medical liability insurance; (10712)

(2) States should be encouraged to develop and test alternatives to the existing civil litigation system as a way of improving patient safety, reducing medical errors, encouraging the efficient resolution of disputes, increasing the availability of prompt and fair resolution of disputes, and improving access to liability insurance, while preserving an individual"s right to seek redress in court; and (10713)

(3) Congress should consider establishing a State demonstration program to evaluate alternatives to the existing civil litigation system with respect to the resolution of medical malpractice claims. (10714)

TITLE VII--IMPROVING ACCESS TO INNOVATIVE MEDICAL THERAPIES (10715)(Text)

Subtitle A--Biologics Price Competition and Innovation (10716)(Text)

SEC. 7001. SHORT TITLE. (10717)(Text)

(a) In General- This subtitle may be cited as the "Biologics Price Competition and Innovation Act of 2009". (10718)

(b) Sense of the Senate- It is the sense of the Senate that a biosimilars pathway balancing innovation and consumer interests should be established. (10719)

SEC. 7002. APPROVAL PATHWAY FOR BIOSIMILAR BIOLOGICAL PRODUCTS. (10720)(Text)

(a) Licensure of Biological Products as Biosimilar or Interchangeable- Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended-- (10721)

(1) in subsection (a)(1)(A), by inserting "under this subsection or subsection (k)" after "biologics license"; and (10722)

(2) by adding at the end the following: (10723)

"(k) Licensure of Biological Products as Biosimilar or Interchangeable- (10724)

"(1) IN GENERAL- Any person may submit an application for licensure of a biological product under this subsection. (10725)

"(2) CONTENT- (10726)

"(A) IN GENERAL- (10727)

"(i) REQUIRED INFORMATION- An application submitted under this subsection shall include information demonstrating that-- (10728)

"(I) the biological product is biosimilar to a reference product based upon data derived from-- (10729)

"(aa) analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; (10730)

"(bb) animal studies (including the assessment of toxicity); and (10731)

"(cc) a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in 1 or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product; (10732)

"(II) the biological product and reference product utilize the same mechanism or mechanisms of action for the condition or conditions of use prescribed, recommended, or suggested in the proposed labeling, but only to the extent the mechanism or mechanisms of action are known for the reference product; (10733)

"(III) the condition or conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been previously approved for the reference product; (10734)

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