by Steven Ertelt
August 14, 2006
Washington, DC (LifeNews.com) — The Bush administration has filed legal papers to respond to a lawsuit by a pro-abortion law firm seeking internal government documents and records to prove its contention that the Bush administration pressured the Food and Drug Administration to hold up over the counter sales of the morning after pill.
The Center for Reproductive Rights, a New York-based pro-abortion law firm, filed the suit, which government attorney Roslynn Mauskopf called a "burdensome fishing expedition."
Mauskopf, the U.S. attorney for the eastern district of New York, wrote, "Discovery from senior presidential advisers disrupts the functioning of the executive branch and raises serious separation-of-powers concerns."
She cited several precedents in previous cases involving White House records that were allowed to remain private.
The CRR lawyers previously argued that the FDA ignored its own procedures and needs the White House records and documents to prove it.
Simon Heller, the leading pro-abortion attorney, responded to Mauskopf’s legal brief and told the New York Sun newspaper its an attempt to intimidate the court.
"We’re not intruding on any presidential power because there’s no presidential power to determine the prescription status of drugs," he told the newspaper.
CRR released several of the depositions it obtained in the case in May.
The papers showed that the last two commissioners both intervened to halt or delay that status of the morning after pill.
Barr Laboratories, which makes the Plan B pill that can sometimes cause an abortion, originally asked the FDA to approve its request to sell the morning after pill to all women without a doctor’s visit.
Although an FDA committee voted strongly in favor of granting the request, the papers showed former FDA commissioner Mark McClellan stepped in and determined that the OTC status was inappropriate because the company didn’t provide enough information about its effects on teenagers.
McClellan noted that Barr did not include many teenagers in its studies and worried that promoting the Plan B drugs to teens would encourage them in engaging in risky sexual behavior since the drug does not prevent STDs.
Dr. Janet Woodcock, the FDA’s deputy commissioner for operations, testified in her deposition that this seemed like a reasonable concern.
"We did not have much data in the younger adolescent age group," she testified, according to a Los Angeles Times report.
"I discussed [with FDA staff] our inability as basically middle-aged health professionals … to really get into the minds of young teenagers and their behaviors," she told the pro-abortion law firm. "[We] have very proudly approved many drugs in the past that have become cult drugs in certain populations."
After the FDA rejected the request, it told Barr to resubmit its application and ask that women above the age of 16 be allowed to purchase the drug over the counter. Barr sent in a new application and the FDA delayed in rendering a decision on it.
Eventually, former FDA commissioner Lester Crawford indefinitely postponed a decision on the revised request.
Last week, FDA commissioner nominee Andrew von Eschenbach announced a deal with Barr to sell the Plan B drug to women over 18 but to keep it as a prescription-only drug for teenagers.