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Mary Agnes Carey, associate editor of CQ HealthBeat, discusses the House’s passage of health data technology legislation, Medicare physician payments and an abortion-related bill passed last week by the Senate that would enable federal charges to be filed against individuals violating parental consent and notification laws in this week’s “Health on the Hill from kaisernetwork.org and CQ.” Carey notes that the House last week voted 270-148 to approve a bill (S 1418) that would promote use of well being IT. The bill differs from 1 (HR 4157) the Senate approved in November 2005 on privacy, funding and other problems. In other news, lawmakers within the House and Senate have said that they desire to take action this year to reverse a scheduled 5% reduction in Medicare physician payments. Carey notes that such a plan might be challenging because with the complexity with the concern, the limited amount of time left inside the congressional session and funding needed to reverse the cut. CMS Administrator Mark McClellan told lawmakers that CMS would perform with them to address the payment concern but stated that legislators would need to implement new quality measures and other steps prior to putting more funds into the payments. Finally, Carey talks about a bill (S 403) approved by the Senate that would establish as a federal crime the act of taking pregnant minors across state lines to avoid parental notification and contsent laws to obtain abortions. The House has passed a similar bill (HR 748), though some Democrats objected to immediately beginning a House-Senate conference to reconcile the legislation (Carey, “Health on the Hill from kaisernetwork.org and CQ,” 7/31).

The total audio version of “Health on the Hill,” transcript and resources for further analysis are accessible on-line.

“Reprinted with permission from http://www.kaisernetwork.org. It is possible to view the entire Kaiser Everyday Wellness Policy Report, search the archives, or sign up for e-mail delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Every day Health Policy Report is published for kaisernetwork.org, a free of charge service of the Henry J. Kaiser Household Foundation . 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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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:

5 (2 votes)

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Former Oglala Sioux Tribal President Cecelia Fire Thunder on Friday said she plans to challenge her impeachment by the Tribal Council for allegedly soliciting donations on behalf with the tribe for a proposed abortion clinic with no the council’s approval subsequent week within the tribe’s Supreme Court, the Rapid City Journal reports (Steen, Rapid City Journal, 7/28). Fire Thunder in March in response towards the approval of the South Dakota law (HB 1215) that bans abortion except to save a woman’s life said, “I will personally establish a Planned Parenthood clinic on my own land, which is within the boundaries with the Pine Ridge Reservation where the state of South Dakota has absolutely no jurisdiction.” Nevertheless, Fire Thunder in June said she had not intended to open a clinic that would perform the procedure but rather 1 that would offer household planning data, emergency contraception and other contraceptives. The tribal council last month voted 9-5 to replace Fire Thunder for allegedly soliciting donations with out the council’s approval for the proposed clinic. Tribal Judge Lisa Adams reinstated Fire Thunder last month, arguing that her removal violated tribal procedure. Nonetheless, she retracted her decision soon after receiving a motion that said she did not have the authority to issue an injunction against the tribe or a tribal official and later recused herself from the case (Kaiser Daily Women’s Well being Policy Report, 7/20). Fire Thunder stated she has not received due process in the lower court and is appealing the decision on procedural grounds. When Adams recused herself from Fire Thunder’s case, proceedings were put on hold to enable the tribal council to appoint a new judge. Tribal council attorney Tom Blanco on Friday filed a motion to dismiss Fire Thunder’s case (Rapid City Journal, 7/28).

Tribe’s View of Abortion
Tribe members officially have not been surveyed, but a lot of stated they support exceptions to an abortion ban inside the case of rape, incest or to protect the wellness with the pregnant woman, the Chicago Tribune reports. In accordance with Department of Justice statistics, American Indian girls are 3 times more likely to be sexually assaulted than white ladies, and rape and incest are more common on reservations than in the rest with the U.S. Regardless of people’s views on abortion, “people on both sides seem to agree” that “abortion is women’s business, not suitable for men to be discussing within the chambers with the tribal council or anywhere else,” according to the Tribune. The Oglala Tribal Council has passed an ordinance that prohibits abortion procedures on the reservation, the Tribune reports (Peres, Chicago Tribune, 7/30).

“Reprinted with permission from http://www.kaisernetwork.org. It is possible to view the entire Kaiser Every day Wellness Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Everyday Well being Policy Report is published for kaisernetwork.org, a totally free service of the Henry J. Kaiser Household Foundation . ? 2005 Advisory Board Business and Kaiser Family members Foundation. All rights reserved.

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The following highlights recent election-related news on women’s wellness issues.

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Democrats on the Senate Well being, Education, Labor and Pensions Committee on Tuesday during a confirmation hearing on acting FDA Commissioner Andrew von Eschenbach’s nomination to permanently head the agency questioned him relating to the FDA’s assessment of an application requesting approval for nonprescription sales of Barr Laboratories’ emergency contraceptive Plan B, the Washington Post reports (Weiss, Washington Post, 8/2). FDA in Could 2004 issued a “not approvable” letter in response to an application originally submitted by pharmaceutical organization Women’s Capital for nonprescription sales of Strategy B, which can avoid pregnancy if taken as much as 72 hours following sexual intercourse. Barr purchased Women’s Capital for the duration of consideration with the application. FDA inside the “not approvable” letter cited inadequate information on its use amongst girls younger than age 16, and Barr subsequently submitted a revised application to create the drug accessible only to girls and girls 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 Strategy B access for girls and girls ages 17 and older, but the application presented FDA “with numerous difficult and novel policy and regulatory issues,” including the best way to enforce an age restriction. In a July 31 letter to Barr subsidiary Duramed Study, von Eschenbach wrote that 18 could be the “appropriate age” to permit females to purchase Program B without a prescription and asked Barr to raise the age restriction in its application from 16 to 18. The letter also requested that Barr meet with FDA within seven days, make unspecified adjustments towards the packaging for Program B and offer a thorough description of the company’s program to enforce the age restriction. The letter says, “If following our discussions we conclude (your) program isn’t sufficiently rigorous … Plan B will stay [prescription]-only for women of all ages” (Kaiser Everyday Women’s Health Policy Report, 8/1). Barr spokesperson Carol Cox on Tuesday stated no decision had been made between FDA as well as the company on when the two would meet to talk about the application. FDA spokesperson Susan Bro on Tuesday said the agency plans to meet with Barr Monday (Bridges, AP/Forbes, 8/1).

Program B Comments at Hearing
Von Eschenbach in the hearing stated he could be open to approving nonprescription Strategy B sales for women ages 18 and older, adding that approval could occur within weeks, the New York Times reports (Zernike, New York Times, 8/2). Nevertheless, Democrats on the panel “hammered” the nominee on the “timing and substance” with the letter he sent to Duramed, the AP/Forbes reports (AP/Forbes, 8/1). “We all know what’s going on here,” Sen. Tom Harkin (D-Iowa) said, adding, “It’s the disregard of science for ideological concerns” (New York Times, 8/2). Von Eschenbach stated that he decided to consider the application based “not on a political ideology but on a medical ideology.” If the letter “leads to a swift and clear decision, I applaud it,” Sen. Edward Kennedy (D-Mass.), the ranking Democrat on the committee said, adding, “[B]ut we need to make particular that the [Bush] administration does not use it as however one more delaying tactic” (AP/Forbes, 8/1). Von Eschenbach stated, “No one told me what I ought to or could do. No one told me what decision I should or ought to not make. [The letter] was my decision” (Rockoff/Beasley, Baltimore Sun, 8/2). He added that he is committed to “sound science” and candidness.

Age Limit, Enforcement Needs Questioned
Sen. Jack Reed (D-R.I.) questioned why von Eschenbach requested a new age restriction for Barr’s application. “Is there new data?” Reed asked, adding, “New analysis? Or have you just decided you do not like the conclusion of one’s predecessor?” (Washington Post, 8/2). Von Eschenbach said, “It’s a cut[-off] point, and you have to have some cut[-off] point” (Alonso-Zaldivar, Los Angeles Times, 8/2). He added that the age 18 limit gives a “greater safeguard in protecting and promoting the health” of young girls (Pugh, McClatchy/Miami Herald, 8/1). Von Eschenbach also said that he decided on the age limit in portion since tobacco merchandise have the very same age restriction. Reed stated the limit “seems … arbitrary” (Los Angeles Times, 8/2). Sen. Hillary Rodham Clinton (D-N.Y.), who with Sen. Patty Murray (D-Wash.) has placed a hold on von Eschenbach’s nomination until FDA renders a choice on Plan B, questioned the requirement that Barr assure pharmacies are following the age restriction. She compared the condition to requiring that alcoholic beverage distillers make certain bars do not serve underage consumers.

Outlook for Nomination
Based on the Post, Republicans on the committee “generally sidestepped the Program B fight,” and all members on the panel “praised von Eschenbach’s resume.” Von Eschenbach served as director of the National Cancer Institute for 4 years and had a lengthy career at the University of Texas MD Anderson Cancer Center. Some senators criticized what they say could be the politicization of FDA, citing a survey released last month from the Union of Concerned Scientists (Washington Post, 8/2). The anonymous survey — in which 997 of five,918 FDA scientists responded — finds that about one in six FDA scientists who participated within the survey said they have felt pressure to adjust the results of their perform for nonscientific reasons (Kaiser Everyday Health Policy Report, 7/21). Sen. Barbara Mikulski (D-Md.) stated the next FDA commission requirements to enhance on oversight of drug safety and low spirits at the agency (Baltimore Sun, 8/2). Von Eschenbach stated he opposed proposed legislation to develop an independent center for drug safety within FDA but said he would emphasize drug safety. He added that he would set up means to usefully deal with scientific disagreements (Cohen, Newark Star-Ledger, 8/2). Assist Committee Chair Mike Enzi (R-Wyo.) said he intended to vote on von Eschenbach’s nomination following the Senate’s August recess. “The question isn’t no matter whether to confirm him. The question is regardless of whether to confirm him ahead of Program B is approved,” Enzi stated, adding, “So it’s not a question of qualifications” (Baltimore Sun, 8/2). Murray stated, “There are a whole lot of rumors about a recess appointment” for von Eschenbach to head the agency (Anderson, Dow Jones Newswires, 8/1). Rodham Clinton asked if von Eschenbach would accept a recess appointment from President Bush, to which he replied, “I wish to appear forward to the Senate’s confirmation of me as your selection to be commissioner of the FDA” (Crowley, CQ Today, 8/1). Enzi said nobody in the Bush administration had discussed a recess appointment with him (Dow Jones Newswires, 8/1).

Related Editorials

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A Sedgwick County, Kan., grand jury investigating the death of a woman who died three days right after undergoing an abortion at the Women’s Wellness Care Services clinic in Wichita, Kan., has been dismissed without having issuing an indictment, county District Attorney Nola Foulston said in a statement issued Monday, the Wichita Eagle reports (Sylvester, Wichita Eagle, 7/31). Christin Gilbert, a 19-year-old Texas resident with Down syndrome who was 28 weeks pregnant, died on Jan. 13, 2005, after undergoing an abortion at the clinic, which is owned by physician George Tiller. The Kansas State Board of Healing Arts, which regulates physicians, in December 2005 cleared Tiller and his staff of misconduct in Gilbert’s death. However, Kansas law makes it possible for a grand jury to be formed within 60 days of a petition filed with a state district court if the petition has at least 100 more signatures than 2% with the number of men and women within the county who voted within the most recent gubernatorial election. Sedgwick County Election Office officials in April delivered a certified petition to Richard Ballinger, chief judge of Kansas’s 18th judicial district, to convene a grand jury in Gilbert’s case. The petition alleges the clinic committed violations, including involuntary manslaughter, mistreatment of a dependent adult, failure to report abuse of children and violation of abortion-related statutes (Kaiser Every day Women’s Wellness Policy Report, 5/5). The grand jury in May began hearing testimony inside the case. The antiabortion group Operation Rescue, which gathered signatures for the petition, in a statement expressed discontent using the grand jury’s investigation (Wichita Eagle, 7/31).

“Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Everyday Well being Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Day-to-day Well being Policy Report is published for kaisernetwork.org, a free service with the Henry J. Kaiser Family members Foundation . ? 2005 Advisory Board Company and Kaiser Household Foundation. All rights reserved.

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The majority of South Dakotans disapprove of a state law (HB 1215) that bans abortion except to save a woman’s life, based on a KELO-TV/Sioux Falls Argus Leader poll released Monday, the AP/Washington Post reports (AP/Washington Post, 7/31). The ban, which has not yet taken impact, will be on the statewide ballot in November. If approved, the law would take effect and then likely would be challenged in court (Kaiser Every day Women’s Health Policy Report, 7/25). The poll, which was conducted by Mason-Dixon Polling and Study, surveyed 800 registered voters from July 24 through July 26, finding that 47% said they disapprove with the law, compared with 39% who approve of the measure and 14% who are undecided. The poll also finds that all of the men and women surveyed stated they likely will vote in the election in November. In addition, the poll finds that if the measure had been to allow for exceptions in cases of rape and incest, 59% of men and women would have supported it, compared with 29% who would have opposed it and 12% who would have been undecided. The margin of error within the poll was plus or minus three.5 percentage points. Brad Coker, managing director of Mason-Dixon, told the Sioux Falls Argus Leader, “It looks like that there’s no exception made for rape and incest seems to be the factor that could sink this.” He added, “That’s the hook the opponents [of the measure] can really build their arguments on” (AP/Yankton Press & Dakotan, 8/1).

“Reprinted with permission from http://www.kaisernetwork.org. You can view the whole Kaiser Daily Well being Policy Report, search the archives, or sign up for e-mail delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Everyday Well being Policy Report is published for kaisernetwork.org, a free of charge service of the Henry J. Kaiser Household Foundation . ? 2005 Advisory Board Company and Kaiser Loved ones Foundation. All rights reserved.

Healthcare Prof:

Some editorials and an opinion piece respond to a bill (S 403) that would allow federal charges to be filed against any individual who transports minors across state lines for the purpose of evading state abortion parental notification or consent laws. The Senate last week voted 65-34 to approve the bill, which was sponsored by Sen. John Ensign (R-Nev.). Under the bill, people who violate the measure would be subject to a fine or up to one year in prison. The measure includes an exception if an abortion is needed to save the life of a pregnant minor. In addition, the bill would bar a father who rapes his daughter from suing anybody who assists in her abortion, as properly as bars anyone committing incest on a minor from transporting her to another state to obtain an abortion. The House in April 2005 voted to approve similar legislation (HR 748) that would authorize fines of up to $100,000 or up to one year in prison, or both, for people who circumvent state parental notification or consent laws. The House version also requires out-of-state physicians to provide 24 hours’ notice to a minor’s parents or they will be subject to criminal prosecution and allows parents of minors who undergo abortion to file a lawsuit against the individual who performs the procedure. Sen. Richard Durbin (D-Ill.) on Tuesday prevented Senate Majority Leader Bill Frist’s (R-Tenn.) try to appoint members to a House-Senate conference committee to resolve differences on the measures, saying that the Senate bill had not yet been heard in a committee and that it would be too early to have discussions between the chambers (Kaiser Every day Women’s Health Policy Report, 7/28). Summaries appear below.

Editorials

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FDA and Barr Laboratories are scheduled to meet on Tuesday in Washington, D.C., to discuss the company’s application for nonprescription sales of its emergency contraceptive Plan B, FDA spokesperson Susan Bro stated Wednesday, Reuters reports (Reuters, 8/2). FDA in Might 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 avoid pregnancy if taken up to 72 hours after sexual intercourse. Barr purchased Women’s Capital for the duration of consideration of the application. FDA in the “not approvable” letter cited inadequate data on its use among girls younger than age 16, and Barr subsequently submitted a revised application to make the drug available only to girls and ladies 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 problems,” such as how to enforce an age restriction. In a July 31 letter to Barr subsidiary Duramed Study, acting FDA Commissioner Andrew von Eschenbach wrote that 18 is the “appropriate age” to allow women to buy Plan B with no a prescription and asked Barr to raise the age restriction in its application from 16 to 18. The letter also requested that Barr meet with FDA within seven days, make unspecified changes to the packaging for Plan B and supply a thorough description with the company’s plan to enforce the age restriction. The letter says, “If after our discussions we conclude (your) program isn’t sufficiently rigorous … Plan B will remain [prescription]-only for females of all ages” (Kaiser Everyday Women’s Well being Policy Report, 8/2).

“Reprinted with permission from http://www.kaisernetwork.org. You are able to view the whole Kaiser Every day Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Every day Well being Policy Report is published for kaisernetwork.org, a totally free service with the Henry J. Kaiser Household Foundation . ? 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.