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In developments with implications for teen pregnancy prevention, the federal Food and Drug Administration FDA ; announced August 26 that it still has not decided how to prevent teenagers from buying Plan B, the so-called `morning after' contraceptive, over the counter in drug stores. In the announcement, FDA Commissioner Lester Crawford explained that an earlier decision by the agency not to allow overthe-counter sales of Plan B had been based on fear that girls 16 years old and younger would not be able to read and understand label instructions for the drug, or would misuse it to engage in promiscuous sex. When the manufacturer, Barr Laboratories, then submitted a new application asking OTC approval for women over 16, with a doctor's prescription required for sales to younger women, that raised "unique regulatory issues" for the FDA, which has never before had to deal with a mixed OTC prescription drug, Crawford said, and that has led to the decision to start a new round of public comment. Crawford conceded that science supports allowing older women to have over-thecounter access to the contraceptive, but said the FDA has not yet figured out how to do that without risking that younger teenagers--whom he said the FDA now defines as women 17 years old and younger--will get the pills. Crawford's announcement of further delay in the 28-month-long controversy over Plan B enraged two senators who had agreed to allow Crawford's nomination as commissioner to go unchallenged after the FDA promised to settle the issue by September 1. "I stunned and outraged and furious, " said Senator Patty Murray D-WA ; , who with Senator Hillary Clinton D-NY ; had questioned Crawford about the reasons for the original Plan B decision. "This is not only a broken promise to us, but another frightening example of politics trumping science at the FDA." Plan B, which consists of a concentrated dose of the medicines in most daily birth control pills, is opposed by many conservative groups opposed to abortion, who are said to have flooded the White House with protests against a decision to allow over-the-counter access to the drug, which they charge is a form of abortion. The FDA approved Plan B as a prescription contraceptive in July 1999, but in May 2004 then-acting commissioner Crawford overruled an advisory committee and rejected the manufacturer's application to sell the drug over the counter. The issue of whether Plan B will be available without prescription is considered important, since the pills can prevent pregnancy only if taken 72 hours or less after unprotected sex--a time constraint that advocate say might make it hard for a woman to contact her doctor and get a prescription. Several states, including Murray's home state of Washington, now allow over-the-counter sales of Plan B without age restrictions. Senators Murray and Clinton said in a statement that the chairman of the Senate Health, Education and Labor Committee had promised that if there was any further delay in the approval process, he would hold hearings on the Plan B controversy. "We are calling on him to honor this promise and promptly schedule a hearing to look into the FDA's approval process for this drug and to ensure that American patients are receiving access to safe and effective treatments in a timely manner, " they said. Continued on page 2.
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This work was supported by U. S. Public Health Service research grants AI 07250, CA 13422, CA 16288, and training grant GM 966 from the National Institute of General Medical Sciences.
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Reimbursed ; , the consultant's knowledge about the psychologist will be confidential. Two individuals could not serve as consultants for each other, unless the consultations are separated by at least two years unless justified by rural non-availability ; . This process would normally be provided pro bono to fellow psychologists, but in the case of a consultant who is much sought after, a fee could be necessary. It would be expected that most psychologists would attempt to consult with someone from whose feedback they believed they could benefit. The function of the consultant would require considerable skill and would be enhanced by a significant amount of experience in clinical supervision. Potential For Success It is my strong belief that this process of self-examination and peer-consultation would result in more benefit to consumers of services than the current continuing education process, but the proposed process would depend for its success on the psychologist's willingness to be observed, which would relate to his or her seriousness about professional growth. To provide some minimal recognition, if this process becomes a recognized professional development activity, consultants could affirm to an organization AACP, state psychological organization, or other ; that such consultation had taken place, and psychologists who had engaged in the process in three years out of four could be recognized with a letter or certificate by that organization. It might also become an alternate route to part or all of the relicensure continuing education requirement. There might be concern on the part of some consultants of being named in a later lawsuit regarding the care of the client whose material was reviewed, even though as noted above the focus would be mainly on the psychologist and not on the client. While this liability cannot be completely eliminated, it would be somewhat less than that liability that we already know exists for any direct supervisor of the clinical work of others. It might help to avoid this liability if the consultant's feedback was only about the psychologist and totally excluded comments about the clients or supervisees. The author received his doctorate from the University of Missouri and spent seven years as a psychologist in the Air Force, followed by the last thirty in public mental health in San Bernardino CA. He served as an APA accreditation site visitor and is currently an appeals panel member, as well as a member of the AACP board. He has special interests in training, clinical supervision, and selfesteem. He may be contacted at cebbe alum t.
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