> >Press Release > >August 8, 2000 > >CONTACT: Jake Lewis or Laura Jones - (202) 265-4000 > > > > NADER CHARGES FDA POLICIES THREATEN PUBLIC HEALTH > > > >WASHINGTON, D. C. August 8-Ralph Nader charged today that changes in the > >drug approval policies at the Federal Drug Administration (FDA) threaten > >public health. > > > >"Today drugs are approved which would have been rejected in the past because > >of doubts about their safety and soundness" Nader said. > > > >Nader cited, as an example, the FDA-approved drug Rezulin which was taken > >off the market this spring after causing hundreds of cases of severe liver > >toxicity and at least 63 deaths. Rezulin was the fourth drug pulled off the > >market from among those approved in 1997, Nader noted. He said a drug > >approved in 1996 was later banned because it causes often-fatal primary > >pulmonary hypertension and heart valve damage. > > > >"In most of these cases, there was opposition by FDA's professional staff to > >the approval of these drugs, or urgings of stronger product warnings > >approval, or inadequately-heeded opposition from FDA advisory committee > >members," Nader said. "None of these banned drugs represented a significant > >breakthrough-there was no need for rapid approval." > > > >In 1998, FDA medical officers--physicians responsible for the primary review > >of New Drug Applications--were surveyed about recent changes in the drug > >approval process. Nader said many of the medical officers claimed that drugs > >they reviewed in the past three years were mistakenly approved. They said > >current standards of FDA review for safety and efficacy are lower than those > >in existence prior to 1995. Many of them stated that the pressure on them to > >approve a high proportion of new drugs was greater than during the period > >prior to 1995. > > > >"By contrast, recent surveys show that the drug and medical device > >industries have a more positive attitude about FDA than at any previous > >time," Nader said. "Given the record number of drugs approved by the FDA, > >mostly me-too drugs without a significant advantage over existing drugs, it > >not surprising that the drug companies are happy." > > > >Nader said there had been an absence of "constructive Congressional > >oversight of FDA. Instead of challenging the agency to do a better job > >protecting the public, Congress criticizes it for not being more > >industry-oriented, Nader said. > > > >Nader said the so-called FDA Modernization Act of 1997 and other legislative > >acts have seriously weakened FDA's regulatory capacity. > > > >"The manufacturers of medical devices now have a legal alternative to > >seeking approval of their products from the FDA," Nader said. "They can, > >instead, choose a private for profit company to review their application. > >The requirement of two well-controlled studies as a basis for drug approval > >has been changed: Only one such study now suffices. And for the first time, > >drug companies which have FDA approval for one use of a drug can promote the > >drug for treatment of another condition even without adequate evidence of he > >drug's safety and effectiveness with respect to the other condition." > > > >"New leadership is needed at the top levels of the FDA," Nader said. > > > > ### > >************************************************* > >Laura Jones > >Deputy Press Secretary > >Nader 2000 > >p: 202-265-4000 * fax: 202-265-0183 * www.votenader.org > > >---- >For instructions on joining, leaving, or otherwise using the Ban-GEF list, >send email to [EMAIL PROTECTED] with HELP in the SUBJECT line. > >Search the archives (since '97) at http://www.txinfinet.com/ban-gef/, or >go to a recent day's digest at >http://www.txinfinet.com/ban-gef/00/. Updated weekly. >----
