by Sally Greenberg, NCL Executive Director

Some good news for consumers: we’ll soon be getting far better disclosures about potential safety hazards for food and drugs. In a blog about a month ago, I cheered the passage of major reforms in the Consumer Product Safety Act, which will help protect consumers, especially the most vulnerable ones — children — from dangerous or defective products. Consumer Product Safety Commission (CPSC) regulates more than 15,000 consumer products, ranging from all-terrain vehicles to electrical outlets to high chairs and bassinets.

Last week I sat in on an all-day briefing, sponsored by the CPSC, detailing highlights of the new law. One of the most important and exciting changes is that CPSC will be setting up a public database to give consumers access to information about products that other consumers, or CPSC, or manufacturers themselves have found dangerous, defective, or otherwise problematic.

Also last week the CPSC announced that it was recalling — without the manufacturer’s cooperation — a bassinet that has been implicated in the deaths of two babies, and that it was making the announcement as a result of new powers Congress had granted under the reform legislation. As a parent shopping for a bassinet, you’d certainly like to know about any hazards associated with this product. In the past, CPSC hasn’t been able to share complaint information, unless the product had been recalled, without checking with the manufacturer first. Under the new law, more general disclosures will be available at the public database of the agency’s Web site. At the meeting last week, CPSC officials noted that the opening of the database is some months away from being ready, but they say they may get it up and running ahead of schedule, which is great news for consumers.

It’s no coincidence that the Food and Drug Administration also announced this week that it will begin to list drugs whose safety is under investigation on its Web site every three months. Once again, Congress directed FDA to do it. However, while the federal safety agency will name the drug and the nature of the “adverse events,” it will not describe their seriousness or the number of complaints received, according to the Washington Post. That’s too bad, because with that information consumers can better assess the level of risk when their doctor prescribes a drug with potentially harmful side effects.

Of course, publishing such information can have a downside. FDA says that its adverse event hotline has received many reports that turned out to be false alarms. The upside, however, is that many times the full impact of side effects isn’t understood until the drug hits the market and many more people are taking it. The hope is that the public will have access to much more information on the safety and side effects of the drugs they are taking through this more open process—always a good thing for consumers.

According to a fresh story in the Associated Press, the United States Food and Drug Administration has announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the warnings about the risk of developing opportunistic fungal infections. FDA’s statement said the agency “has reviewed 240 reports of histoplasmosis, an infection caused by the fungusHistoplasma capsulatum, in patients being treated with Enbrel, Humira, or Remicade. In at least 21 of the reports, histoplasmosis was initially not recognized by health care professionals, and antifungal treatment was delayed. Twelve of those patients died.”

Another significance of this announcement is that it involves the federal agency’s use of its new authority under the Food and Drug Administration Amendments Act of 2007 to make safety-related changes to prescribing information or labeling. Learn more here.