Daily Women's Health Policy 

Daily Women's Health Policy

5/12). FDA in May 2004 issued a "not approvable" letter in response to an application submitted by Barr Laboratories -- which bought Women's Capital -- to authorize nonprescription sales of Plan B. citing inadequate data on its use among girls age 16 and younger. After FDA rejected Barr's first application. the company submitted a revised application to make nonprescription Plan B available only to girls and women age 17 and older. In January 2005. FDA announced a delay in its decision on the revised application. CRR -- on behalf of the Association of Reproductive Health Professionals. the National Latina Institute for Reproductive Health and others -- subsequently filed a lawsuit against FDA in a U.S. District Court in New York. claiming the agency did not follow procedure when it first denied the application. The lawsuit also said that by not approving nonprescription sales. the agency violated women's rights to equal protection and privacy as guaranteed by the U.S. Constitution (
Thursday's Motion Jones on Thursday was seeking permission to depose five FDA officials and obtain deleted agency e-mails. A copy of McClellan's appointment calendar for April 21. a few days after Women's Capital's application submission. "Conference call w/Jay Lefkowitz re: Plan B submis." was presented during the motion. according to
. Lefkowitz is the former deputy assistant to President Bush on domestic policy and currently serves as special envoy on human rights in North Korea. "It has come to our attention that Mark McClellan at some point had a meeting with someone from the White House about Plan B." Jones told New York City-based federal Magistrate Viktor Pohorelsky. who is hearing arguments in a lawsuit regarding the Plan B application. Pohorelsky agreed to the depositions despite a request from Assistant U.S. Attorney Franklin Amanat to block them. The judge did not rule on the deleted e-mail request. A Barr spokesperson had no comment. and Lefkowitz did not return calls for comment. according to
CMS Administrator Mark McClellan. while head of FDA. had a discussion with a White House official about the emergency contraceptive Plan B while the drug's application for nonprescription sales was pending. Center for Reproductive Rights attorney Bonnie Jones told a federal judge on Thursday. Long Island
reports. The pharmaceutical company Women's Capital in April 2003 submitted an application for nonprescription sales of Plan B. which can prevent pregnancy if taken up to 72 hours after sexual intercourse (Kerr. 5/12). FDA in May 2004 issued a "not approvable" letter in response to an application submitted by Barr Laboratories -- which bought Women's Capital -- to authorize nonprescription sales of Plan B. citing inadequate data on its use among girls age 16 and younger. After FDA rejected Barr's first application. the company submitted a revised application to make nonprescription Plan B available only to girls and women age 17 and older. In January 2005. FDA announced a delay in its decision on the revised application. CRR -- on behalf of the Association of Reproductive Health Professionals. the National Latina Institute for Reproductive Health and others -- subsequently filed a lawsuit against FDA in a U.S. District Court in New York. claiming the agency did not follow procedure when it first denied the application. The lawsuit also said that by not approving nonprescription sales. the agency violated women's rights to equal protection and privacy as guaranteed by the U.S. Constitution (
Thursday's Motion Jones on Thursday was seeking permission to depose five FDA officials and obtain deleted agency e-mails. A copy of McClellan's appointment calendar for April 21. a few days after Women's Capital's application submission. "Conference call w/Jay Lefkowitz re: Plan B submis." was presented during the motion. according to
. Lefkowitz is the former deputy assistant to President Bush on domestic policy and currently serves as special envoy on human rights in North Korea. "It has come to our attention that Mark McClellan at some point had a meeting with someone from the White House about Plan B." Jones told New York City-based federal Magistrate Viktor Pohorelsky. who is hearing arguments in a lawsuit regarding the Plan B application. Pohorelsky agreed to the depositions despite a request from Assistant U.S. Attorney Franklin Amanat to block them. The judge did not rule on the deleted e-mail request. A Barr spokesperson had no comment. and Lefkowitz did not return calls for comment.




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