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February 19, 2008

February 22, 2008 The Honorable Gayle Harrell Chair, House Health Quality Committee 214 House Office Building Tallahassee, FL 32399 Re: Concerns with HB 385

Dear Madame Chair:
We have met on several occasions with representatives of Planned Parenthood to
discuss concerns with HB 385/SB 780. We have also met with the House sponsor, and
staff of the Senate sponsor. At each of these meetings, representatives of Planned
Parenthood participated. At these meetings, we have discussed our concerns with the
bills, which are sufficiently serious that if we are unable to address them, we will oppose
the legislation. We list the concerns and amendments to address them below.

Problematic Structure and Definitions – Emergency Contraception
As you likely know, Catholic health ministries in Florida are directed to provide
compassionate care to victims of sexual assault and to treat them with medications that
would prevent ovulation, sperm capacitation or fertilization. The aim is to prevent
pregnancy in situations of sexual assault. However, taking action that would have an
abortifacient effect is not permitted, because of the direct attack on innocent human life.
Specifically, we are concerned about the term “emergency birth control” and definition
used in lines 72-74. We cannot accept a definition that includes “devices” as the current
bill does. Intrauterine devices (IUDs) are not the standard of care for treating victims of
sexual assault currently, and they clearly have the effect of preventing implantation after
fertilization. Any mechanism to “prevent pregnancy after sexual intercourse” is broader
than “mechanisms approved by the FDA to prevent pregnancy after sexual assault”.
The bill places a premium on using “factually and medically accurate information” (lines
79-83). The medical and scientific literature overwhelmingly uses the term “emergency
contraception” – not “emergency birth control” and the bill should be amended
accordingly. We recommend the following amendment:
"Emergency birth control contraception" means any drug or device approved by the United States Food and Drug Administration that delays ovulation or 1 Ethical and Religious Directives for Catholic Health Care Services, United States Conference of Catholic Bishops, #36 (USCCB: Washington), 2001. incapacitates sperm, thereby preventing pregnancy after sexual assault prevents pregnancy after sexual intercourse. (Strike all subsequent references to “emergency birth control” and insert “emergency contraception”.)
Problematic Structure and Definitions – Duties of Providers
Levonorgestrel is effective within 72 hours of sexual assault and United States Food and
Drug Administration (FDA) guidelines call for a pregnancy test before administering it.
With a pregnancy test, there is a psychological benefit to a woman knowing that she was
pregnant prior to the assault.
There also needs to be some limit on the providing of these drugs, i.e., no obligation to
provide them when provision is contraindicated. In its current form, the bill essentially
places the patient’s wishes above the professional judgment of the practitioner. This
combined with overly broad terms and definitions are very problematic. Amendments
are needed that direct provision of emergency contraception within 72 hours of the
assault, that include a pregnancy test in the specified protocol (as FDA guidelines direct)
and respect professional clinical judgment to the section beginning at line 89:
(a) A health care practitioner licensed under chapter 458, chapter 459, or
chapter 464, Florida Statutes, or a health care facility licensed under chapter
395, Florida Statutes, that provides care to a rape survivor shall:
1. Provide each female rape survivor with medically and factually accurate,
clear, and concise information concerning emergency birth control, including its
indications and contraindications and the risks associated with its use.
2. Inform each female rape survivor of her medical option to receive emergency
birth control contraception.
(b) If emergency birth control contraception is requested, the health care
practitioner shall immediately provide the female rape survivor with the complete
regimen of emergency contraception birth control if she is not already pregnant,
the 72-hour effectiveness period has not elapsed and it is not otherwise
medically contraindicated.

Penalties for Non-Compliance are Overly Severe
Lines 124 to 141 outline penalties for failing to comply with the previous section.
Provisions give the Agency for Health Care Administration (AHCA) very broad and
vague enforcement powers. Something more reasonable is needed. We suggest
striking the section:
(4) ENFORCEMENT AND PENALTIES.--In addition to any other remedies provided by law, the agency shall respond to complaints and shall periodically determine, using all available investigative tools, whether a health care facility is in compliance with this section. If the agency determines that a health care facility is not in compliance with this section, the agency shall: (a) Impose a fine of $5,000 per woman who is denied medically and factually accurate and objective information about emergency birth control or who is not offered or provided with emergency birth control. (b) Impose a fine of $5,000 for failure to comply with subsection (2). For every 30 days that a health care facility is not in compliance with subsection (2), an additional fine of $5,000 shall be imposed. (c) After two violations, suspend or revoke the health care facility's license or deny the health care facility's application for a license.

Our position in treating victims of sexual assault is clear: treat them in their entirety with
compassion, and help to avoid pregnancy without harming an innocent human being that
has been conceived. In the areas of family planning and abortion, there is precedent in
Florida law to establish conscience protection. In lines 142 to 147 of the bill remove
abortion-related conscience protection outlined in Ch. 390. Provisions to remove
protection must be deleted:
Section 3. Access to contraception.-- (1) For all purposes, "contraception" means any drug or device approved by the United States Food and Drug Administration to prevent pregnancy. (2) The provision of contraception shall not be subject to or governed by chapter 390, Florida Statutes. While Catholic health ministries comply with the current standard of care morally, there is some possibility that landscape may change (e.g., perhaps in the future, the medical standard of care will include inserting IUDs in children who might be susceptible to another assault new drugs might be categorized as “emergency contraception” that are clearly abortifacient or clearly act to impede implantation of the embryo, etc.). This uncertainty and unwavering concern for human life conceived by rape require that the bill contain meaningful conscience protection. A number of states that have adopted emergency contraception (EC) laws have broad health care right of conscience protections that are applicable in these situations. Florida does not currently. However, as already noted, there is precedent for conscience protection under Florida law relative to: 1) abortion, 2) family planning services, 3) end-of-life care, and 4) participation in executions. To address the situation, we recommend the following amendment: at line 142:
healthcare facility licensed by the state of Florida under chapter 395, Florida
Statutes and no health care practitioner licensed under chapter 458, chapter 459,
or chapter 464, Florida Statutes that provides care to a rape survivor shall be
required to provide medications or treatments when such action violates
conscience. Such conscience may include the expectation that a medication or
treatment may destroy a fertilized ovum or developing human being.

Significant Changes to Pharmacy Practice for All Pharmacies
The changes outlined in Section 4 provide significant changes to pharmacy policy in
Florida law. While in some way, the bill outlines policies relative to conscience that have
been adopted by a number of pharmacies, there are other pharmacies for which these
provisions would create new and substantial burdens.
This bill also places new obligations on every pharmacy to ensure a customer can obtain
any approved pharmaceutical contraceptive if it stocks any single contraceptive. This
may circumvent purchasing policies that are in place across the industry and places a
new obligation on pharmacists to “transfer” prescriptions. Prescriptions belong to the
customer – not the pharmacist. While pharmacists often assist in obtaining prescriptions
they do not stock, they are not subject to a mandate as outlined in the bill. It may also
eliminate age requirements relative to the over-the-counter availability of emergency

Concerns with Contraception & Relation to Abortion
Certainly, we and many others oppose elective contraceptive use because of harmful
effects on women and families. The suggestion that there is insufficient access to
contraceptives to prevent abortions is certainly dubious, especially considering that
according to the Guttmacher Institute, 54% of women who seek abortions were using
contraception the month they became pregnant.
It is our position that increased access to contraceptives is not the best way to decrease
abortions through public policy. Indeed, even many supporters of abortion have
suggested that by increasing access to contraception, a society will increase its numbers
of abortions. Policies that decrease abortions and the rate of abortion include
addressing the reasons women cite for having abortions and parental involvement laws.
Studies show that such policies work.
For these reasons, this section of the bill should be deleted.
Thank you very much for considering our concerns with HB 385.
Michael B. Sheedy Associate Director for Health cc: The Honorable Representative Audrey Gibson


Microsoft word - contraindic.lactancia-cymsa.doc

CONTRAINDICACIÓN DE LA LACTANCIA DROGAS Y LACTANCIA INTRODUCCIÓN El consumo de medicaciones durante el embarazo es una práctica común. En un estudio que incluyó a 14000 mujeres durante su embarazo y lactancia, se observó que el 79% tomaba por lo menos una droga, con un promedio de 3,3 medicamentos diferentes durante el curso del amamantamiento. En estos casos, debe analizarse el r

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