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." The approval came after the agency in May 2004 issued a "not approvable" letter in response to an application originally submitted by the pharmaceutical company Women's Capital for nonprescription sales of Plan B, which can prevent pregnancy if taken up to 72 hours after sexual intercourse. Barr purchased Women's Capital during consideration of the application. FDA in the "not approvable" letter cited inadequate data on Plan B's use among girls younger than age 16, and Barr subsequently submitted a revised application to make the drug available without a prescription only to girls and women ages 16 and older. In a July 31 letter to Barr subsidiary Duramed Research, acting FDA Commissioner Andrew von Eschenbach wrote that 18 is the "appropriate age" to allow women to buy Plan B without a prescription and asked Barr to raise the age restriction in its application from 16 to 18. Barr last week resubmitted its application (Kaiser Daily Women's Health Policy Report, 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).

Age Restriction Comments
Galson said the agency decided on 18 for the age restriction because there are "all kind[s] of age restrictions that click in at that age" -- including sales of tobacco and nicotine replacement treatments -- the Boston Globe reports (Henderson, Boston Globe, 8/25). The American College of Obstetricians and Gynecologists in a statement said that minors will continue to potentially face difficulty in obtaining Plan B and that "FDA has missed an unparalleled opportunity to prevent teenage pregnancies" (Graham, Chicago Tribune, 8/24). Tina Raine, an associate professor at the University of California - San Francisco who has studied EC use, said, "Teenagers are likely to start having sex before they're ready and able. They are more likely to have accidents. And they're going to be the ones less likely to have a doctor get a prescription. ... So to make it most difficult for them to get [Plan B] doesn't really make sense." She also said that EC availability has not been shown "to promote risky behavior" and that it can prevent unplanned pregnancies (Allday, San Francisco Chronicle, 8/25). Wendy Wright -- president of Concerned Women for America, which opposed approval of Barr's application -- said, "If the FDA thinks that enacting an age restriction will work or that the drug company will enforce it ... then they are living in a dream world" (Bridges, AP/Forbes, 8/25). Tony Perkins, president of the Family Research Council, said there is a "very legitimate concern that an older male could commit a criminal sex act with a young girl" and then buy Plan B and convince her to take it. Galson said although men have been approved to purchase Plan B without a prescription, FDA "will monitor the use of this drug and the prescription patterns. If changes are needed, we'll make them." Cox said that the company did not seek approval for sales of the drug to men, the Washington Times reports (Howard Price, Washington Times, 8/25).

Who Will Sell Nonprescription Plan B?
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).

Barr To Face Challenges in Advertising Plan B
Although FDA has approved Barr's application for nonprescription sales of Plan B to women ages 18 and older, the pharmaceutical company faces some challenges in marketing the product only to women ages 18 and over, USA Today reports (Howard, USA Today, 8/25). Barr has said its usual promotion method, a widescale ad campaign that includes commercials, likely will not be the method used because the company's target market is people in a one-time situation, not people using the drug regularly (Steinberg, Wall Street Journal, 8/25). In addition, the company must adhere to FDA prescription drug rules for ads, which require print ads to have "fair balanced" statements and warnings, as well as a list of precautions and possible drug interactions (Howard, USA Today, 8/25). Barr has not disclosed how much it will spend to market the pill and said that the final marketing decisions have not been made, according to the Journal. Niemann said Barr will be looking at a variety of advertising methods -- including the options of ads on women-oriented cable channels such as Lifetime and Oxygen, and in women's magazines, such as Cosmopolitan, Lucky and Glamour. Niemann added that the company plans to continue marketing the product to people who prescribe health care products.

Comments on Advertising
Terry Gallo -- president of Havas' Euro RSCG Life Adrenaline, a consumer health care marketing firm -- said that Barr might have "good reason to tread lightly" in its advertising campaigns because although discussions about "contraceptive failure" or "unprotected sex" might appeal to readers of a women's magazine, they could pose a problem on a broad-based TV network, the Journal reports. Anne Devereux, chief executive of TBWA Worldwide, an Omnicom Group network of health care marketing agencies, said "You're not going to spend a huge amount of money on a broad advertising campaign because this is a product that will need to be used very selectively, in 'emergency situations.'" Devereux also said the Internet and other, more discreet promotional venues could be very effective in promoting Plan B. In addition, in-store marketing campaigns, such as placing promotional signs and brochures on shelves and store counters, could be used, according to the Journal (Steinberg, Wall Street Journal, 8/25).

Cost Likely To Increase
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.

Political Ramifications, Reaction
According to the Journal, FDA's approval of Barr's application "could become an election-campaign issue" (Wilde Mathews/Martinez, Wall Street Journal, 8/25). In addition, some abortion-rights opponents "threatened political retribution" for President Bush's support of FDA's decision on the application, the New York Times reports. "Today's decision lies at the feet of President Bush and has created a lasting rift with the Catholic faithful who comprise a large part of his support base," the Rev. Thomas Euteneuer, president of Human Life International, said (Harris, New York Times, 8/25). White House spokesperson Dana Perino in a statement said Bush "appreciates that the FDA did an exhaustive review, that they recognized the critical distinction between minors and adults, and the risks a drug like this can pose" (Jordan, Newark Star-Ledger, 8/25). Sen. Tom Coburn (R-Okla.) said, "Exposing women to the high-dose hormones in Plan B without the guidance of a physician will put them at risk" (Harris, New York Times, 8/25). He added that FDA's decision "has nothing to do with science or FDA rules but has everything to do with politics" (Stein, Washington Post, 8/25). Susan Wood, former FDA assistant commissioner for women's health who resigned in protest of delays on a decision for Plan B, in a statement said, "For nearly three years politics took precedence over good science and good health policy decisions, and women's health suffered" (Rubin, USA Today, 8/25).

CRR To Continue Lawsuit
Center for Reproductive Rights lead attorney Simon Heller said the group will continue with its lawsuit against FDA over its rejection of Barr's first application for nonprescription Plan B sales, the Tribune reports (Chicago Tribune, 8/25). CRR -- on behalf of the Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health and others -- filed the suit 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 Daily Women's Health Policy Report, 8/4). In a deposition in the case, John Jenkins, director of FDA's Office of New Drugs, said that Galson told him "that he felt he didn't have a choice" but to reject Barr's original application. Jenkins added that Galson "characterized that in a sense that he wasn't sure that he would be allowed to remain as center director if he didn't agree with the action" (Harris, New York Times, 8/25). Heller said that CRR will seek to have the age restriction for nonprescription Plan B sales overturned through the lawsuit (Chicago Tribune, 8/25).

Sens. Murray, Rodham Clinton Lift Hold on Von Eschenbach's Confirmation as FDA Commissioner
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 (Kaiser Daily Women's Health Policy Report, 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 be(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).

Related Editorials
The New York Times and Washington Post on Friday published editorials responding to FDA's decision to approve nonprescription sales of Plan B to women ages 18 and older. Summaries appear below.

• New York Times: "There was never any good explanation" for delaying approval of nonprescription sales of Plan B and because "virtually all the scientific evidence shows that the pills are safe, no self-respecting FDA commissioner could reject" nonprescription sales "without looking foolish and craven," a Times editorial says. According to the editorial, FDA's "change of heart seems to be due to a combination of factors, including a threat by congressional Democrats to hold up nomination" of von Eschenbach as FDA commissioner "until a decision was made and a lawsuit forcing the agency to reveal the machinations behind the delay." The Bush administration also might "have decided that it had milked enough political advantage from the issue and could let the FDA judge the issue on its merits," the editorial says (New York Times, 8/25).
  


• Washington Post: "It should not have taken three years of dithering" for FDA approval of nonprescription sales of Plan B because the "arrangements announced this week to prevent" such sales to teenagers "could surely have been worked out long ago," a Post editorial says. The editorial adds, "Only with Mr. von Eschenbach's nomination held up in the Senate as leverage did the issue get resolved," and "this is no way to make important decisions on science and public health" (Washington Post, 8/25).

Broadcast Coverage
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.