Page:United States Statutes at Large Volume 121.djvu/978

 PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 957

‘‘(5) DEFINITIONS.— ‘‘(A) APPLICATION.—For purposes of this subsection, the term ‘application’ means an application submitted under subsection (b)(2) or (j). ‘‘(B) PETITION.—For purposes of this subsection, other than paragraph (1)(A)(i), the term ‘petition’ means a request described in paragraph (1)(A)(i).’’. (b) REPORT.—Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit a report to the Congress on ways to encourage the early submission of petitions under section 505(q), as added by subsection (a). SEC. 915. POSTMARKET DRUG SAFETY INFORMATION FOR PATIENTS AND PROVIDERS.

dkrause on GSDDPC44 with PUBLAW

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by section 914(a), is amended by adding at the end the following: ‘‘(r) POSTMARKET DRUG SAFETY INFORMATION FOR PATIENTS AND PROVIDERS.— ‘‘(1) ESTABLISHMENT.—Not later than 1 year after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, the Secretary shall improve the transparency of information about drugs and allow patients and health care providers better access to information about drugs by developing and maintaining an Internet Web site that— ‘‘(A) provides links to drug safety information listed in paragraph (2) for prescription drugs that are approved under this section or licensed under section 351 of the Public Health Service Act; and ‘‘(B) improves communication of drug safety information to patients and providers. ‘‘(2) INTERNET WEB SITE.—The Secretary shall carry out paragraph (1) by— ‘‘(A) developing and maintaining an accessible, consolidated Internet Web site with easily searchable drug safety information, including the information found on United States Government Internet Web sites, such as the United States National Library of Medicine’s Daily Med and Medline Plus Web sites, in addition to other such Web sites maintained by the Secretary; ‘‘(B) ensuring that the information provided on the Internet Web site is comprehensive and includes, when available and appropriate— ‘‘(i) patient labeling and patient packaging inserts; ‘‘(ii) a link to a list of each drug, whether approved under this section or licensed under such section 351, for which a Medication Guide, as provided for under part 208 of title 21, Code of Federal Regulations (or any successor regulations), is required; ‘‘(iii) a link to the registry and results data bank provided for under subsections (i) and (j) of section 402 of the Public Health Service Act; ‘‘(iv) the most recent safety information and alerts issued by the Food and Drug Administration for drugs approved by the Secretary under this section, such as product recalls, warning letters, and import alerts;

VerDate Aug 31 2005

08:41 Jul 13, 2009

Jkt 059194

PO 00001

Frm 00135

Fmt 6580

Sfmt 6581

O:\FROMSTAT\PUBL085.121

Deadline. Web site.

APPS10

PsN: PUBL085

�