FDA Calls for Meeting on Emergency Contraception
FDA and Barr Laboratories have agreed to meet to discuss the company's application for nonprescription sales of its emergency contraceptive Plan B, FDA announced in a statement Monday, adding that it hoped remaining concerns regarding the application "can be wrapped up in a matter of weeks," the Philadelphia Inquirer reports (McCullough, Philadelphia Inquirer, 8/1).
FDA in May 2004 issued a "not approvable" letter in response to an application originally submitted by pharmaceutical company Women's Capital for nonprescription sales of Plan B, which can prevent pregnancy if taken up to 72 hours after sexual intercourse. Women's Capital later was purchased by Barr.
The agency cited inadequate data on its use among girls younger than age 16.
After FDA rejected Barr's first application, the company submitted a revised application to make the drug available only to girls and women ages 16 and older. After FDA rejected Barr's first application, the company submitted a revised application to make the drug available only to girls and women 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 Plan B access for women and girls ages 17 and older, but the application presented FDA "with many difficult and novel policy and regulatory issues," including enforcement of an age restriction. The comment period expired in November 2005, and the agency did not indicate when it might make a decision on the application (California Healthline, 5/25).
A July 31 letter from acting FDA Commissioner Andrew von Eschenbach to Barr's subsidiary Duramed Pharmaceuticals says that 18 is the "appropriate age" to allow women to buy Plan B without a prescription (Alonso-Zaldivar, Los Angeles Times, 8/1). In 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 changes to the packaging for Plan B and asked for a thorough description of Barr's plan to enforce the age restriction (Weiss, Washington Post, 8/1).
Barr intends to make nonprescription Plan B available 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 in the letter wrote that FDA wants to learn more about Barr's plan to monitor pharmacies' compliance with 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 ... Plan B will remain [prescription]-only for women 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 May 19, on the roughly 47,000 public comments, FDA agrees with the majority of comments that said it is not necessary to "engage in rule making" to address the age-related regulatory issues (FDA letter, 7/31).
The letter requests a meeting with Barr within seven days (Rackl, Chicago Sun-Times, 8/1).
Barr CEO Bruce Downey said he is pleased with FDA's communication but added that the proof will be in the outcome of the application. He said the company's age-restriction plan "provides adequate safeguards," adding that he still believes the drug should be available without a prescription to women and girls of all ages (Wilde Mathews, Wall Street Journal, 8/1).
Barr spokesperson Carol Cox said that the company needs to meet with FDA to receive "some clarity" about what FDA officials need from the company (Rubin, USA Today, 8/1). She also said that the company had some concerns about what Barr would be required to show to be in accordance with the letter's requirements but added that Barr would be "pleased to set up a meeting as soon as possible with FDA." Cox 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 part of Dr. von Eschenbach to help resolve the issues surrounding Plan B" (Los Angeles Times, 8/1).
In addition, the announcement has "raised hopes" among nonprescription Plan B advocates that the "unusually glacial review of Plan B might soon accelerate," according to the Post (Washington Post, 8/1).
The Senate Committee on Health, Education, Labor and Pensions on Tuesday is scheduled to hold a confirmation hearing on the nomination of von Eschenbach to permanently head the agency (American Health Line, 7/26).
FDA spokesperson Susan Bro said the agency made the letter public "in anticipation of needing to bring before the committee ... the agency's response to the review process" of Plan B and to "resolve what has been one of the most divisive issues the 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 decision on the Plan 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 health issue" (New York Times, 8/1).
Bro also said von Eschenbach did not want Plan B to be the focus of the hearing, adding he "believes that resolving this issue is a critical step in moving the agency's agenda forward" (USA Today, 8/1).
Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) on Monday reiterated their plan to place a hold on von Eschenbach's nomination until FDA makes a final decision on Barr's application (Rubin, USA Today, 8/1).
The agency's announcement on Monday was "nothing more than another delay tactic," Murray and Rodham Clinton said in a statement, adding, "Rather than moving this process forward and doing right 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 should be sufficient to block von Eschenbach's confirmation (USA Today, 8/1). However, if Bush gives von Eschenbach the job through a recess appointment, their efforts would be unsuccessful, they said (Washington Post, 8/1).
The White House declined to comment on the hold (USA Today, 8/1).
"If the FDA is truly ready to give Plan B its approval, then von Eschenbach surely will not mind a short delay in his confirmation while the agency and the drug maker work out the details" of the agreement, a Los Angeles Times editorial says. While FDA's announcement comes at an "awfully convenient" time, if the agency "follows through" with the approval of Plan 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).
The Center for Reproductive Rights in a July 21 letter to a federal judge requested that the White House provide 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 of the Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health 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 (American Health Line, 5/25).
A hearing on the July 21 request -- which was sent to federal Magistrate Viktor Pohorelsky, who is hearing arguments in the lawsuit -- is scheduled for Thursday in New York City. CRR also is seeking to depose White House official Jay Lefkowitz, AP/Forbes reports (AP/Forbes, 7/28).
CRR attorney Bonnie Jones in May told Pohorelsky that CMS Administrator Mark McClellan, while head of FDA, had a discussion with a White House official about Plan 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 is the former deputy assistant to President Bush on domestic policy and currently serves as special envoy on human rights in North Korea (American Health Line, 5/25).
Todd Glass, a spokesperson for CRR, said the government has requested a continuance in the lawsuit (Washington Post, 8/1).
Several broadcast programs reported recently on FDA's consideration of OTC approval of Plan B:
- ABCNews' "World News Tonight": The segment includes comments from Bruce Downey, chair of Barr; Murray; and Wendy Wright, president of Concerned Women for America (Stark, "World News Tonight," ABCNews, 7/31). Complete 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 products; and Brian Laegeler, an analyst for Morningstar (Milne-Tyte, "Marketplace Morning Report," APM, 8/1). The complete segment will be available online in RealPlayer a few hours after the broadcast.
- KPCC's "AirTalk": Guests on the program included Susan Bro, a spokesperson for FDA; Judy Brown, president of the American Life League; and Mary-Jane Wagle, CEO of Planned Parenthood Los Angeles (Mantle, "AirTalk," KPCC, 7/31). The complete segment is available online in RealPlayer.
- NBC's "Nightly News": The segment includes comments from Clinton; Vanessa Cullins, vice president for medical affairs at Planned Parenthood Federation of America; and Wright (Costello, "Nightly News," NBC, 7/31). The complete segment is available online in Windows Media. In addition, video of a related MSNBC segment is available online in Windows Media.
- NPR's "All Things Considered": The segment includes comments from Bro and Kirsten Moore, president of the Reproductive Health Technologies Project (Rovner, "All Things Considered," NPR, 7/31). The complete segment is available online in RealPlayer.
- NPR's "Morning Edition": The segment includes comments from Bro and Murray (Rovner, "Morning Edition," NPR, 8/1). The complete segment is available online in RealPlayer.