Healthcare Prof:
FDA and Barr Laboratories have agreed to meet to discuss the company’s application for nonprescription sales of its emergency contraceptive Program B, FDA announced in a statement Monday, adding that it hoped remaining concerns concerning the application “can be wrapped up in a matter of weeks,” the Philadelphia Inquirer reports (McCullough, Philadelphia Inquirer, 8/1). FDA in May possibly 2004 issued a “not approvable” letter in response to an application originally submitted by pharmaceutical firm Women’s Capital for nonprescription sales of Plan B, which can prevent pregnancy if taken up to 72 hours following sexual intercourse. Women’s Capital later was purchased by Barr (Kaiser Daily Women’s Well being Policy Report, 5/15). The agency cited inadequate data on its use amongst girls younger than age 16. Following FDA rejected Barr’s first application, the firm submitted a revised application to create the drug obtainable only to girls and ladies ages 16 and older (Kaiser Day-to-day Women’s Health Policy Report, 7/23/04). Following FDA rejected Barr’s first application, the firm submitted a revised application to create the drug offered only to girls and females ages 16 and older. Former FDA Commissioner Lester Crawford in August 2005 opened a 60-day public comment period on the application, saying science supported approval of nonprescription Program B access for women and girls ages 17 and older, but the application presented FDA “with a lot of tough and novel policy and regulatory problems,” which includes enforcement of an age restriction. The comment period expired in November 2005, as well as the agency did not indicate when it might make a decision on the application (Kaiser Day-to-day Women’s Wellness Policy Report, 5/25).
Letter
A July 31 letter from acting FDA Commissioner Andrew von Eschenbach to Barr’s subsidiary Duramed Pharmaceuticals says that 18 will be the “appropriate age” to enable women to buy Plan B without having a prescription (Alonso-Zaldivar, Los Angeles Times, 8/1). Within the letter, von Eschenbach asked Barr to raise the age restriction in its application from age 16 to 18 (Rockoff, Baltimore Sun, 8/1). FDA also requested that Barr make unspecified adjustments to the packaging for Program B and asked for a thorough description of Barr’s strategy to enforce the age restriction (Weiss, Washington Post, 8/1). Barr intends to make nonprescription Strategy B obtainable only at pharmacies — not in gasoline stations or convenience stores — and to require that the pills be placed behind the counter and that individuals purchasing the medication present photo identification, the New York Times reports (Saul, New York Times, 8/1). Von Eschenbach within the letter wrote that FDA desires to learn more about Barr’s strategy to monitor pharmacies’ compliance with all the age restriction and what the company plans to do “if a pharmacy fails to comply with them.” Von Eschenbach added, “If after our discussions we conclude (your) program isn’t sufficiently rigorous … Strategy B will stay [prescription]-only for ladies of all ages” (Graham, Chicago Tribune, 8/1). The letter “stopped far short” of saying FDA will approve Barr’s application, but the consideration of the application is a reversal of a previous implication that the agency might not have the legal authority to approve the application with an age restriction, the Washington Post reports (Washington Post, 8/1). The letter addresses the agency’s authority to approve the application and says that after reviewing a summarized and categorized contractor’s report, submitted Might 19, on the roughly 47,000 public comments, FDA agrees with all the majority of comments that stated it is not necessary to “engage in rule making” to address the age-related regulatory concerns (FDA letter, 7/31). The letter requests a meeting with Barr within seven days (Rackl, Chicago Sun-Times, 8/1).
Reaction
Barr CEO Bruce Downey said he is pleased with FDA’s communication but added that the proof will be within the outcome with the application. He said the company’s age-restriction strategy “provides adequate safeguards,” adding that he still believes the drug must be accessible without having a prescription to females and girls of all ages (Wilde Mathews, Wall Street Journal, 8/1). Barr spokesperson Carol Cox said that the business requirements to meet with FDA to receive “some clarity” about what FDA officials need from the organization (Rubin, USA Today, 8/1). She also stated that the company had some concerns about what Barr would be required to show to be in accordance with the letter’s specifications but added that Barr could be “pleased to set up a meeting as soon as possible with FDA.” She said, “Overall, I think [the letter is] a positive development” (Washington Post, 8/1). HHS Secretary Mike Leavitt said the letter shows a “good-faith effort on the portion of Dr. von Eschenbach to support resolve the concerns surrounding Program B” (Los Angeles Times, 8/1). In addition, the announcement has “raised hopes” among nonprescription Strategy B advocates that the “unusually glacial assessment of Plan B might soon accelerate,” according to the Post (Washington Post, 8/1).
Von Eschenbach Confirmation Hearing Begins
The Senate Committee on Wellness, Education, Labor and Pensions on Tuesday is scheduled to hold a confirmation hearing on the nomination of von Eschenbach to permanently head the agency (Kaiser Every day Women’s Health Policy Report, 7/26). FDA spokesperson Susan Bro stated the agency made the letter public “in anticipation of needing to bring before the committee … the agency’s response to the evaluation process” of Strategy B and to “resolve what has been one of the most divisive issues this agency has faced” (Carey/Crowley, CQ Today, 7/31). Bro said that von Eschenbach wanted to talk to the committee about the agency’s plan for a choice on the Strategy B application, adding, “This is a model for how he currently makes decisions and will continue to as the leader of this critically important public well being issue” (New York Times, 8/1). She also said von Eschenbach did not want Strategy B to be the focus of the hearing, adding he “believes that resolving this concern is a critical step in moving the agency’s agenda forward” (USA Today, 8/1).
Murray, Rodham Clinton Continue Hold on Nomination
Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) on Monday reiterated their program to place a hold on von Eschenbach’s nomination until FDA makes a final choice on Barr’s application (USA Today, 8/1). The agency’s announcement on Monday was “nothing more than yet another delay tactic,” Murray and Rodham Clinton said in a statement, adding, “Rather than moving this method forward and doing appropriate by the American people, the [Bush] administration is continuing to play a game of smoke and mirrors the day before Dr. von Eschenbach’s Senate confirmation hearing” (Pugh, McClatchy/Charlotte Observer, 8/1). Murray and Rodham Clinton said the hold must be sufficient to block von Eschenbach’s confirmation (USA Today, 8/1). Even so, if Bush gives von Eschenbach the job through a recess appointment, their efforts would be unsuccessful, they stated (Washington Post, 8/1). The White House declined to comment on the hold (USA Today, 8/1).
Related Editorial
“If the FDA is truly ready to give Program B its approval, then von Eschenbach surely will not mind a brief delay in his confirmation although the agency along with the drug maker work out the details” of the agreement, a Los Angeles Times editorial says. Even though FDA’s announcement comes at an “awfully convenient” time, if the agency “follows through” using the approval of Program B for nonprescription sales, then U.S. women will be the “real winners,” the editorial says, concluding, “[M]aybe Monday’s announcement is a sign that the FDA is less interested in acting as the judge of women’s morals than as the protector of their health” (Los Angeles Times, 8/1).
Related Lawsuit
The Center for Reproductive Rights in a July 21 letter to a federal judge requested that the White House present any letters, e-mails or records of conversations its staff exchanged with FDA in regard to Barr’s application, the AP/Forbes reports (AP/Forbes, 7/28). CRR — on behalf with the Association of Reproductive Well being Professionals, the National Latina Institute for Reproductive Wellness and others — filed a lawsuit against FDA in a U.S. District Court in New York, claiming the agency did not follow procedure when it denied the original nonprescription Plan B application (Kaiser Day-to-day Women’s Health Policy Report, 5/15). A hearing on the July 21 request — which was sent to federal Magistrate Viktor Pohorelsky, who is hearing arguments within the lawsuit — is scheduled for Thursday in New York City. CRR also is seeking to depose White House official Jay Lefkowitz, the AP/Forbes reports (AP/Forbes, 7/28). CRR attorney Bonnie Jones in May possibly told Pohorelsky that CMS Administrator Mark McClellan, although head of FDA, had a discussion having a White House official about Strategy B. A copy of McClellan’s appointment calendar for April 21, 2003, a few days after Women’s Capital’s application submission, reads, “Conference call w/Jay Lefkowitz re: Plan B submis.” Lefkowitz will be the former deputy assistant to President Bush on domestic policy and currently serves as special envoy on human rights in North Korea (Kaiser Everyday Women’s Well being Policy Report, 5/15). Todd Glass, a spokesperson for CRR, stated the government has requested a continuance in the lawsuit (Washington Post, 8/1).
Broadcast Coverage
Several broadcast programs recently reported on FDA’s letter regarding Strategy B:
ABCNews’ “World News Tonight”: The segment includes comments from Downey; Murray; and Wendy Wright, president of Concerned Females for America (Stark, “World News Tonight,” ABCNews, 7/31). Total video of the segment is available online.
APM’s “Marketplace Morning Report”: The segment includes comments from Bridget Behling, managing editor of the Tan Sheet, a publication covering nonprescription pharmaceutical and nutritional goods; and Brian Laegeler, an analyst for Morningstar (Milne-Tyte, “Marketplace Morning Report,” APM, 8/1). The total segment will be obtainable on the web in RealPlayer a few hours right after the broadcast.
NBC’s “Nightly News”: The segment consists of comments from Rodham Clinton; Vanessa Cullins, vice president for medical affairs at Planned Parenthood Federation of America; and Wright (Costello, “Nightly News,” NBC, 7/31). The total segment is obtainable on the internet in Windows Media. Additionally, video of a related MSNBC segment is obtainable on the web in Windows Media.
NPR’s “All Things Considered”: The segment includes comments from Bro and Kirsten Moore, president of the Reproductive Wellness Technologies Project (Rovner, “All Things Considered,” NPR, 7/31). The complete segment is accessible on-line in RealPlayer.
NPR’s “Morning Edition”: The segment includes comments from Bro and Murray (Rovner, “Morning Edition,” NPR, 8/1). The total segment is available on the internet in RealPlayer.
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