FDA Act to Provide Online Scrutiny of Drug Tests

HR 3580, The Food and Drug Administration Amendments Act of 2007 recently signed by President Bush, will put tests of new drugs online, and provide the ability for people taking drugs to report harmful side effects. Previously, while prescription drug advertising went directly to consumers, reporting of serious side effects had to go through channels. Following the outcry around the harmful effects of Vioxx and other medications resulting in "black box" warnings on some prescription drugs, consumer advocates charged that the FDA and drug companies were in league to approve new drugs without adequate safeguards. An October Harris poll found that Americans' distrust of pharmaceuticals and drug companies was higher than with any other business sector except for oil companies, with 53 percent of the public surveyed saying drug companies should be more heavily regulated.

Within a year after enactment, says the bill, "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."

The Web site, says the bill, shall be "an accessible, consolidated Internet Web site with easily searchable drug-safety information." The bill goes on to say that the Web site shall be comprehensive and shall include such items as patient labeling and packaging inserts, product recalls, warning letters import alerts, and much more.