Food and Drug Administration (FDA) officials announced Tuesday they will impose tighter safety regulations on the testing, release and follow-up of new drugs, but abortion-related drugs did not receive specific mention.
Dr. Andrew von Eschenbach, commissioner of the FDA, said the agency carefully considered criticism of its fast track approval of drugs such as the abortion pill, RU-486.
"The extensive input we have received from stakeholders," von Eschenbach said, "has proven invaluable as we transform the drug and medical product safety system and continue to fulfill our mission to protect and promote the public health."
According to von Eschenbach, the FDA will improve its monitoring of pre-market testing and will continue that assessment once a drug has been on the market for 12 to 18 months.
Tony Perkins, president of Family Research Council, said the FDA puts lives at risk when it approves unsafe products like RU-486.
"If the FDA wants to restore its credibility with the American public," he said, "it has to not only keep big drug companies from influencing the approval process on questionable drugs, it must also keep its own ideologies and political agendas -- that are endangering women -- in check."
RU-486, sold under the name Mifeprex, can be taken up to 49 days after pregnancy begins and causes a spontaneous abortion. At least six women have died in the U.S. after taking it. More than 800 reports indicate other complications directly associated with the drug.
Wendy Wright, president of Concerned Women for America, said there are two key elements in the plan.
"We believe that the testing that was done on RU-486 was completely sub-standard," she said, "and didn't even meet the basic requirements that any other drug would have to go through."
Once RU-486 was on the market, Wright added, the FDA didn't seem to take action when reports about associated health risks started coming in.
"We know that there have been hundreds and hundreds of complications and numerous deaths related to RU-486," she said, "and yet the FDA didn't seem to be doing anything about it."
Wright said only about 10 percent of problems related to drugs or medical devices get reported -- and even after problems are reported, the FDA claims a lack of funding prevents post-market surveillance and action.
"So this (report) seems to be saying 'We're going to strengthen that,' " she said. "They may actually have some actions they'll be taking when it appears that a drug can cause serious complications after it's been on the market."
