An amendment to insert a new section providing authority for the Secretary to require that the manufacturer of an approved drug conduct one or more studies to confirm or refute an empirical or theoretical hypothesis of a significant safety issue with the drug.

At the end of the bill, insert after the last section the following:

Sec. 7__. (a) Postmarket Studies.--Chapter V of the the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 505B the following section:

“SEC. 505C. POSTMARKET STUDIES REGARDING SAFETY OF DRUGS; PHASE 4 STUDIES.

“The Secretary may require that the manufacturer of an approved drug conduct one or more studies to confirm or refute an empirical or theoretical hypothesis of a significant safety issue with the drug (whether raised with respect to the product directly or with respect to the class of the product) that has been identified pursuant to--

“(1) the MedWatch postmarket surveillance system;

“(2) a clinical or epidemiological study;

“(3) the scientific literature;

“(4) a foreign government that regulates drugs or devices;

“(5) an international organization concerned with the safety or effectiveness of drugs or devices; or

“(6) such other sources as the Secretary determines to be appropriate.”.

(b) Order Regarding Postmarket Labeling.--Section 502 of the the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following:

“(x) If it is a drug and the Secretary determines that its labeling fails to provide information, including specific wording, required by the Secretary by order on the basis that the information is necessary to ensure its safe and effective use.”.