Product News and Recalls

FDA panel illustrates need for open records

From March 11 through 17, journalists, civic groups, nonprofits and other open government advocates are observing “Sunshine Week,” which is a national initiative to promote the importance of public access to government records and keeping government officials accountable.

The event’s name comes from the term “sunshine laws,” commonly used to describe the open records requirements that symbolically shine a light on government functions. Appropriately enough, Sunshine Week got its start in Florida in 2002. Editorial pages throughout the country have been running pieces spotlighting the need for open records laws in their individual communities and at a national level.

A recent episode concerning a U.S. Food and Drug Administration panel illustrates the need for federal government accountability.

In December, the FDA convened a panel of experts about to make a decision about the synthetic hormone drospirenone, in light of widespread reports that birth control pills containing the compound have caused potentially fatal health problems including stroke, blood clots and pulmonary embolism. The German corporation Bayer uses drospirenone as a component in the birth control pills Yasmin, Yaz, Beyaz, and Ocella.

Panel members voted 21-5 that the information about the risks of the pills provided to doctors and patients was inadequate, then voted 15-11 that the benefits outweigh the risks overall and the pills should stay on the market.

A subsequent investigation in The Washington Monthly found that at least four of the panel’s members had either done work for the drugs’ manufacturers or licensees or received research funding from them. The FDA failed to make those ties public.

If you’ve suffered injury as a result of taking Yaz, Yasmin, Ocella or Beyaz, contact Lopez McHugh for a free consultation.

See the Washington Monthly piece about the FDA panel here: http://www.washingtonmonthly.com/ten-miles-square/2012/01/the_yaz_men_members_of_fda_pan034651.php

For more information about Sunshine Week, see: http://www.sunshineweek.org/Home.aspx