II 110th CONGRESS 2d Session S. 3020 IN THE SENATE OF THE UNITED STATES May 15, 2008 Mrs. Boxer introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to the postmarket surveillance of devices.

1.

Short title

This Act may be cited as the Food and Drug Administration Accountability and Transparency Act.

2.

Postmarket surveillance of devices

(a)

Availability of postmarket surveillance plans

Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) is amended by adding at the end the following: (c)

Availability of plans

(1)

In general

Subject to paragraph (2), the Secretary shall publish in the Federal Register, and make available to interested persons upon request, a plan (and any amendments to such plan) submitted to the Secretary under subsection (b). (2)

Limitation

The Secretary shall not disclose information under paragraph (1) that is exempted from disclosure under section 552 of title 5, United States Code (popularly known as the Freedom of Information Act). . (b)

Increased civil penalties for failure To comply with postmarket surveillance plan

(1)

In general

Section 303(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)) is amended— (A)by redesignating paragraphs (5), (6), and (7) as paragraphs (6), (7), and (8), respectively; and (B)by inserting after paragraph (4) the following: (5)(A)Any manufacturer that fails to comply with a requirement of section 522, including a requirement of a required surveillance plan under such section, shall be subject to a civil monetary penalty of— (i)not more than $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding; or (ii)in the case of a violation that continues after the Secretary provides written notice to the manufacturer, the manufacturer shall be subject to a civil monetary penalty of $250,000 for the first 30-day period (or any portion thereof) that the manufacturer continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $1,000,000 for any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding. (B)In determining the amount of a civil penalty under subparagraph (A)(ii), the Secretary shall take into consideration whether the manufacturer is making efforts toward correcting the violation of the requirement for which the manufacturer is subject to such civil penalty. . (2)

Conforming amendments

Section 303(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)) is amended— (A)in paragraph (6), as so redesignated, by striking , or (4) each place it appears and inserting (4), or (5); (B)in paragraph (7), as so redesignated, by striking (5)(A) and inserting (6)(A); and (C)in paragraph (8), as so redesignated, by striking paragraph (6) each place it appears and inserting paragraph (7).

3.

Notifications

Section 518(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(a)(1)) is amended by inserting or that a violation of section 522 by the manufacturer of a device presents an unreasonable risk of substantial harm to the public health after public health.

4.

Effective date; applicability

The amendments made by this Act— (1)shall take effect 180 days after the date of enactment of this Act; and (2)shall apply to a class II or class III device approved or cleared by the Secretary of Health and Human Services under chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) before, on, or after the date of enactment of this Act.