FDA decision right
Agency was right to reject over-the-counter sales of a powerful
By Tony Staley
The Food and Drug Administration made the right call this month by refusing to allow Barr
Pharmaceuticals of Woodcliff Lake, N.J., to sell a "morning-after pill" over-the-counter.
In making its decision, the FDA rejected the advice of its Nonprescription Drugs Advisory Committee and the Advisory Committee for Reproductive Health Drugs, which in December voted 23-4 to recommend that the FDA allow the drug, known as Plan B, to be sold without a prescription.
How over-the-counter sales of this powerful drug could have ever been recommended should puzzle and disturb most people.
Basically, Plan B is a large dose of progestin-only birth control pills - normally available only by prescription - that are to be taken within 72 hours after unprotected intercourse.
The pills prevent conception - or, if conception has already taken place - abort the new life.
Even regular doses of progestin have several short-term health risks. Long-term risks from the high doses of progestin in Plan B are not known. And if the drugs were available without prescriptions it's a safe bet they would be used in ways not planned by the manufacturer, such as regular, rather than infrequent use, or by men giving it to women to ingest unknowingly.
In rejecting Barr's request, Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said in a letter to the company: "You have not provided adequate data to support a conclusion that Plan B can be used safely by young adolescent women for emergency contraception without the professional supervision of a practitioner licensed by law to administer the drug."
However, that leaves open the possibility the FDA could reverse itself if Barr can allay the agency's fears, as the company is intent on doing.
Sadly, too many people consider the termination of life through either chemical or surgical abortion as being more important than the mental, physical, spiritual or emotional well-being of the women. That is both a tragedy and an outrage.
Pro-lifers are often accused of caring more about pre-born babies than they do about pregnant women. But clearly, too often abortion-rights advocates are more concerned about abortion as a right - and a highly lucrative one at that - than they are in the women they claim to represent.
The FDA should not allow over-the-counter sales of Plan B or similar drugs. The risks are too great to make this powerful drug as readily available as aspirin or chewing gum.