AAHF backs Congressman Stupak's FDA Drug Safety Amendments
In our ongoing efforts for greater accountability within the Food and Drug administration, the AAHF strongly backs the efforts of Congressman Bart Stupak to make the agency more accountable to the American people. In May 2007 when Senator Kennedy's FDA Revitalization Act was approved in the Senate and sent on to the House of Representatives, Rep. Stupak was ready with six carefully crafted amendments to mandate greater accountability, efficiency and openness by the FDA.
Over the past seven years Stupak and his colleagues have painstakingly reviewed FDA activities repeatedly finding the FDA to be an agency characterized by a conflicts of interest between its roles in first approving and later monitoring products, a lack of transparency in many activities, delayed safety measures, failures to make known controversial findings, and frequent closed door meetings with pharmaceutical manufacturers.
What originally compelled Congressman Stupak in his campaign for reform, however, is a case in which the FDA possessed vital information, which if made known in a timely fashion would have saved the life of his teenage son. This initially inexplicable tragedy struck the family in May 2000 when Bart Stupak and his wife Laurie discovered their seventeen-year-old son, Bart Stupak Jr., known as "B.J.," dead from a self-inflicted wound. At the time of his death in May 2000 young B.J. Stupak was using a powerful anti-acne medication called Accutane. Available since the early 1980s, Accutane was long known to cause birth defects among teenage mothers. In the mid-1990s however evidence was accumulating that it was causing severe depression and in dozens of cases suicide. Two years earlier, in February 1998, the FDA had issued a MedWatch alert on the medication, based on adverse event reports detailing 31 cases of suicide, suicide attempt or suicide ideation associated with the use of Accutane. The FDA, however failed to require the manufacturer warn users of this danger on the product label. The Stupak family was not warned of this danger by their doctors or on the products labels.
