Age Restriction for Contraceptive Should Not Affect State Laws
FDA Center for Drug Evaluation and Research Director Steven Galson on Thursday said the agency's approval of an application to allow nonprescription sales of Barr Laboratories' emergency contraceptive Plan B to women ages 18 and older should not affect regulations in nine states that allow pharmacists to dispense the drug without a prescription to people of all ages, USA Today reports (Rubin, USA Today, 8/25).
FDA on Thursday announced it approved Barr's Plan B application, which requires Barr to "[m]onitor the effectiveness of the age restriction and the safe distribution of [nonprescription] Plan B to consumers [ages] 18 and above and prescription Plan B to women under [age] 18" (California Healthline, 8/24).
Barr has agreed to send "anonymous shoppers" into pharmacies to test compliance with the age restriction, to distribute with the drug a booklet about its proper use and to exclude gas stations and convenience stores from selling the drug (Wilde Mathews/Martinez, Wall Street Journal, 8/25).
Barr spokesperson Carol Cox said Plan B should be available for nonprescription sales this fall (Rubin, USA Today, 8/25).
Pharmacy chains CVS and Walgreen said they plan to begin selling Plan B without a prescription, the Columbia State reports. "We anticipate an October-November time frame that Plan B will be available without a prescription," CVS spokesperson Mike DeAngelis said (DuPlessis/Reid, Columbia State, 6/25).
Walgreen spokesperson Carol Hively said Barr will "provide new packaging before the end of the year ... then Walgreen can begin selling Plan B" without a prescription (McVicar, South Florida Sun-Sentinel, 8/25).
Duramed last year in anticipation of FDA approval developed a single container that has "visual appeal for consumer sales" along with space for a prescription label, USA Today reports (Howard, USA Today, 8/25).
Amy Niemann, Barr's vice president of proprietary marketing, said, "We have been and will continue to be committed to responsible marketing with this product," adding, "FDA must approve the packaging of Plan B and pending approval the pill could be on the market as early as Nov. 1" (Wilde Mathews/Martinez, Wall Street Journal, 8/25).
Planned Parenthood Federation of America will continue to dispense Plan B and have physicians on hand to assist minors in accessing Plan B, the Atlanta Journal-Constitution reports (Olivero/Campos, Atlanta Journal-Constitution, 8/25).
Wal-Mart spokesperson Kevin Gardner said the company has not yet decided whether it will sell Plan B without a prescription, adding that Wal-Mart will consider it after receiving more details about FDA's approval (Hamilton, Salt Lake Tribune, 8/25).
According to the Globe, some opponents of Plan B's approval said they plan to urge for people to stop buying from pharmacy chains that sell nonprescription Plan B (Boston Globe, 8/25).
The majority of private health insurers and Medicaid cover Plan B and require members and beneficiaries to contribute a small copayment for the prescription version of the pill -- a system that likely will change because of the application's approval -- the Journal reports (Wilde Mathews/Martinez, Wall Street Journal, 8/25). In addition, Cox said the cost of the prescription form of Plan B to girls ages 17 and younger, which is about $25 to $40, likely will increase because of higher distribution and packaging costs (Berenson, New York Times, 8/25).
Some advocacy groups are working on programs that would assist women enrolled in Medicaid to pay for Plan B if Medicaid discontinues coverage.
In related news, Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) on Thursday after the application's approval said they no longer will continue a hold on von Eschenbach's nomination to permanently head FDA, Reuters reports (Heavey, Reuters, 8/24). After Bush nominated von Eschenbach, Murray and Rodham Clinton announced in a statement that they planned to place a hold on his confirmation vote in the Senate until FDA made a decision on the application (California Healthline, 8/18).
Murray and Rodham Clinton in a statement on Thursday said the application's approval is an "important step in restoring the American people's faith in the FDA by demonstrating that the agency will return to its mission of putting science ahead of ideology" (Agence France-Presse, 8/24). They added, "As promised, we will lift our hold on the nomination of Acting FDA Administrator von Eschenbach and hope that he will provide the strong scientific leadership the FDA needs and deserves" (Murray/Rodham Clinton statement, 8/24).
Meanwhile, a "growing number of conservative groups, angered by von Eschenbach's Plan B decision," have said that they want someone else to be nominated to head FDA (Reuters, 8/24).
Senate Health, Education, Labor and Pensions Committee Chair Michael Enzi (R-Wyo.) said he could schedule a committee vote on von Eschenbach's nomination for early next month. He added that there are enough votes within the committee to send von Eschenbach's nomination to the full Senate for consideration (Boston Globe, 8/25).
Murray and Rodham Clinton said they have not yet decided how to vote on von Eschenbach's confirmation, adding that they are waiting on answers to questions they submitted to him (Crowley, CQ Today, 8/24).
Von Eschenbach's confirmation next month is expected to be approved by the full Senate, Long Island Newsday reports (Thrush, Long Island Newsday, 8/25).
Several broadcast programs reported on FDA's approval of Plan B for nonprescription sales to women ages 18 and older:
- ABCNews' "World News Tonight": The segment reports on the political ramifications of the approval and how it could affect U.S. women. The segment includes comments from Galson; Rodham Clinton; Cecile Richards, president of Planned Parenthood Federation of America; and Wright (Yellin/Weiner, "World News Tonight," ABCNews, 8/24). Video of the segment is available online.
- APM's "Marketplace": The segment includes comments from Susan Dudley, director of policy research for the National Research Center for Women and Families (Ryssdal, "Marketplace," APM, 8/24). The complete transcript and audio of the segment in RealPlayer are available online.
- CBS' "Evening News": The program reports on the approval of Plan B, how the medication works and whether U.S. teenagers will find methods of circumventing the age restriction for Plan B. The segments include comments from Galson; John LaPook, CBS' new medical correspondent; Perkins; Rodham Clinton; and U.S. pharmacists and women (Andrews/Alfonsi, "Evening News," CBS, 8/24). Video of the segment reporting on the approval is available online in RealPlayer. Video of the discussion on how Plan B works is available online in RealPlayer. Video of the segment on U.S. teenagers' access is available online in RealPlayer.
- CNN's "American Morning": The segment reports on misconceptions about Plan B, such as the differences between Plan B and mifepristone -- which when taken with misoprostol can induce a medical abortion -- and includes comments from a U.S. woman who sought access to Plan B (Gupta, "American Morning," CNN, 8/24). The complete transcript of the segment is available online. Video of the segment is available online.
- KCRW's "To the Point": The program on Friday is scheduled to include a discussion of the application's approval and the "roles of abortion politics and the religious right" in the U.S. debate over scientific and social issues (Olney, "To the Point," KCRW, 8/25). The complete segment will be available online in RealPlayer after the broadcast.
- KPBS' "KPBS News": The segment includes comments from Vince Hall, communications director for Planned Parenthood of San Diego and Riverside Counties (Goldberg, "KBPS News," KPBS, 8/24). The complete transcript is available online. The complete segment is available online in RealPlayer.
- NBC's "Nightly News": The segment includes comments from Galson; Richards; and Charmaine Yoest, vice president of external relations for Family Research Council (Bazell, "Nightly News," NBC, 8/24). The complete segment is available online in Windows Media.
- NPR's "All Things Considered": The segment includes comments from Julie Rovner, NPR health policy correspondent (Siegel, "All Things Considered," NPR, 8/24). The complete segment is available online in RealPlayer.
- NPR's "Morning Edition": The segment includes comments from Rovner (Montagne, "Morning Edition," NPR, 8/24). The complete segment is available online in RealPlayer.
- PBS' "NewsHour with Jim Lehrer": The segment includes comments from Galson (Brown, "NewsHour with Jim Lehrer," PBS, 8/24). The complete transcript is available online. The complete segment is available online in RealPlayer.