In response to the abortion lobby’s demand that Plan B, a morning-after pill, be available without a prescription, the Food and Drug Administration (FDA) turned to the public for input on whether it can or should be done. Concerned Women for America (CWA) retained expert attorneys who researched the legal, regulatory and medical aspects and provided extensive reasoning on why the FDA cannot and should not approve this drug as over-the-counter (OTC).
The American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), Family Research Council and Christian Medical Association joined with CWA to describe why the FDA does not have the authority to do what the abortion lobby is demanding. If it did, we explained, it would be detrimental to women and girls.
The FDA asked three questions:
Should the FDA define its interpretation on when a drug can be available both with a prescription and without? We answered yes. Some drugs have been approved for over-the-counter status when in lower dosages and for different purposes than its prescription-only cousins. But Plan B would be the same dosage and same purpose under the scheme put forth by its owner, Barr Labs.
Would the FDA be able to enforce an age-related restriction in which a drug would be available to anyone over a certain age, but only available by prescription to those under that age? We answered no. Even state law enforcement departments have a difficult time upholding age restrictions on alcohol and tobacco, using sting operations to catch and penalize offenders. The FDA does not have the resources, capability or motivation to ensure that the drug is not sold indiscriminately to minors.
May the same drug be sold in the same packaging as both prescription and over-the-counter? We answered no. By law, a drug’s label must clearly state if it is available by prescription or over-the-counter. This protects patients from mistakenly taking a drug that requires a doctor’s oversight.
Sens. Hillary Clinton (D-New York) and Patty Murray (D-Washington) answered the FDA with a letter that did not address whether the FDA has the authority to do what Barr Labs and its allies in the abortion industry insist. They did, however, highlight how well-placed operatives, who have taken control of the American Medical Association (which has steadily been losing members partly due to its politicization) and the American College of Obstetricians and Gynecologists (which recently argued that its own members should be forced by law and against their conscience to refer women to abortionists), and others within the FDA, have been successful in driving the debate by ignoring evidence that disproves their arguments.
CWA’s 37-page response pointed out that:
Courts have recognized the safety risks of oral contraceptives.
The federal statute that governs the FDA restricts all drugs that require professional supervision to prescription sale.
Some meaningful difference must exist between drugs that are sold by prescription and those available OTC.
FDA has no authority to create a third class of drugs “behind-the-counter.” The U.S. Justice Department and National Association of Attorneys General have opposed a third class of drugs.
Enforcement falls to states, local governments and pharmacies. FDA has no statutory authority, resources or mechanisms to ensure enforcement. Previous attempts (such as with cough medicine with codeine) have failed.
This would create a huge burden on pharmacists, who would need training in patient counseling and lose time for dispensing drugs. The costs would be borne by all patients.
Doctors presented compelling reasons for patients to be seen by a medical expert before receiving Plan B:
There are common medical risks associated with birth control pills, which is why no one is arguing that low-doses of Plan B become available without prescription.
Patients seeking morning-after pills need additional medical attention to: discover underlying medical conditions that would preclude a woman from taking the drug; check for ectopic pregnancy (which, if left undiscovered, could lead to serious harm or death); test for sexually transmitted diseases (STDs); administer a pap smear to test for cervical cancer (caused in nearly all cases by HPV, an STD, which can be conveyed through sexual contact with or without a condom); provide counseling on birth control; and to educate patients to follow the necessary instructions.
Sexually abused minors need adults to detect and rescue them from their abusers. Doctors would have an opportunity to ask questions if a girl seeks or someone sends her for Plan B. If the drug can be obtained easily, it removes what may be the best chance of freeing her and catching her abuser.
Don Thompson, M.D., provided heart-wrenching examples which we recounted for the FDA of why patients need medical intervention if they feel the need for the morning-after pill.
I was caring for a 20-year-old woman who was a junior in college, where I was performing periodic pap smears and microscopic examinations (colposcopy) of her cervix after her outpatient cryosurgery to treat the precancerous changes discovered on an earlier pap smear. As part of my evaluation, I always identify risk factors that help identify which patients are at high risk versus lower risk so treatment and counseling can be directed most appropriately.
This young lady was at high risk because she had had over three lifetime sexual partners (she had had four), and she had first had sex at age 15 (anytime before age 17 is high risk because of HPV sensitivity). When I asked her what she had been taught in high school about sex and its risks, she said that the risks were just glossed over and that the message was that if you are going to have sex, then you just needed to use birth control to avoid getting pregnant. No one had ever explained the other risks of sex, like cervical cancer and other sexually transmitted infections.
Another patient was a 17-year-old who had only started having sex in the previous year, and had only had one sexual partner. She was referred for evaluation of an abnormal pap smear that was discovered during her first exam when she was prescribed birth control pills for the first time. Her colposcopic exam was abnormal, and I did several biopsies of her cervix. When I tried to schedule her for a follow-up exam two weeks later, her main concern (and that of her mother) was that the appointment not conflict with her high school graduation celebration.
Her biopsies came back highly abnormal, with a result of carcinoma in situ, a condition that required urgent surgery to remove the cancer before it spread. Instead of celebrating the major step of graduating high school with her classmates, she was faced with a diagnosis of cancer and the anxiety of wondering if the cone biopsy of her cervix was able to get all the cancer, and if she was ever going to be able to get pregnant and carry a baby to term.
She and her mother were totally ignorant of the risks of sexually transmitted infections and cervical cancer, and had only come in to the clinic to get birth control pills so she would not get pregnant. If she had been able to get the morning-after pill without seeing a health care professional (and her mother clearly would have purchased it for her over-the-counter), she probably would have gone on to develop invasive cervical cancer in the next year because of the aggressive strain of human papilloma virus with which she was infected.
I had another 18-year-old patient who suffered from anorexia nervosa. She had an insatiable need for reassurance from others, and moved from one dependant relationship to another, using sex as the foundation for her relationships. I treated her and one boyfriend for Chlamydia and worked closely with our counseling center to provide supportive services for her issues with her distorted body image. Despite cautions about sexual activity and sexually transmitted diseases, she continued in self-destructive relationships.
Our clinic had a policy that the morning-after pill must be provided to anyone who requested it, and she was a regular client on Monday mornings. Despite counseling, she refused to think ahead and use other forms of birth control, but instead continued to engage in “spontaneous” sexual activity since she had easy access to the morning-after pill.
Thousands of people responded to the FDA’s request for input. Please pray that FDA officials will reject demands to make Plan B easily available.
Wendy Wright is CWA’s executive vice president.
For access to CWA’s full response to the FDA, click here.