POSTMARKET DRUG SAFETY INFORMATION FOR PATIENTS AND PROVIDERS.

SEC. 915. POSTMARKET DRUG SAFETY INFORMATION FOR PATIENTS AND PROVIDERS. 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;121 STAT. 958“(v) publicly available information about implemented RiskMAPs and risk evaluation and mitigation strategies under subsection (o);“(vi) guidance documents and regulations related to drug safety; and“(vii) other material determined appropriate by the Secretary;“(C) providing access to summaries of the assessed and aggregated data collected from the active surveillance infrastructure under subsection (k)(3) to provide information of known and serious side-effects for drugs approved under this section or licensed under such section 351;“(D) preparing, by 18 months after approval of a drug or after use of the drug by 10,000 individuals, whichever is later, a summary analysis of the adverse drug reaction reports received for the drug, including identification of any new risks not previously identified, potential new risks, or known risks reported in unusual number;“(E) enabling patients, providers, and drug sponsors to submit adverse event reports through the Internet Web site;“(F) providing educational materials for patients and providers about the appropriate means of disposing of expired, damaged, or unusable medications; and“(G) supporting initiatives that the Secretary determines to be useful to fulfill the purposes of the Internet Web site.“(3) Posting of drug labeling.—The Secretary shall post on the Internet Web site established under paragraph (1) the approved professional labeling and any required patient labeling of a drug approved under this section or licensed under such section 351 not later than 21 days after the date the drug is approved or licensed, including in a supplemental application with respect to a labeling change.“(4) Private sector resources.—To ensure development of the Internet Web site by the date described in paragraph (1), the Secretary may, on a temporary or permanent basis, implement systems or products developed by private entities.“(5) Authority for contracts.—The Secretary may enter into contracts with public and private entities to fulfill the requirements of this subsection.“(6) Review.—The Advisory Committee on Risk Communication under section 567 shall, on a regular basis, perform a comprehensive review and evaluation of the types of risk communication information provided on the Internet Web site established under paragraph (1) and, through other means, shall identify, clarify, and define the purposes and types of information available to facilitate the efficient flow of information to patients and providers, and shall recommend ways for the Food and Drug Administration to work with outside entities to help facilitate the dispensing of risk communication information to patients and providers.”.