ANNAPOLIS – When the abortion drug RU 486 becomes available in a month, it won’t be hard for most Maryland practitioners to obtain the controversial pill – if they want to prescribe it, government controls won’t stop them.
The state is leaving it up to the federal government to determine which doctors qualify to dispense the drug, however the federal government is leaving it up to the pharmaceutical company – which is leaving it up to the doctors.
The Food and Drug Administration approved mifepristone, widely known as RU 486, last week with restrictions as to which health care practitioners would be allowed to dispense the drug.
Mifepristone, which is trade named Mifeprex, is a non-surgical method for ending early pregnancy up to 49 days after the beginning of a woman’s last menstrual period. A patient takes two drugs, including mifepristone, over a two- week period. The combination is approximately 92 to 95 percent effective for ending a pregnancy.
Danco Laboratories, the sole U.S. company licensed to oversee production of the abortion drug, puts the FDA restrictions on a prescriber’s agreement and sends it to practitioners nationwide for a signature.
The only Maryland agency with any authority on this matter is the Maryland Board of Physician Quality Assurance, which typically reacts to complaints.
“This medication should be treated like any other drug approved by the FDA. If the board is aware that the physician is not complying with the FDA guidelines, it would serve as a basis for a board investigation,” said Dr. Donald C. Chambers, board vice chairman.
The FDA requires doctors who dispense RU 486 be able to: – accurately judge the duration of pregnancy; – diagnose ectopic (or tubal) pregnancies; – provide surgical intervention or make arrangements to provide such care through others in cases of incomplete abortion or severe bleeding;
– and assure access to facilities equipped to provide blood transfusions and resuscitation.
Although these restrictions mean women must have ready access to surgical abortions, many practitioners who do not perform surgical abortions have said that they would likely offer the drug if it were approved, according to a 1997 survey in the Journal of the American Medical Women’s Association.
“It will be up to the physician’s interest to use it appropriately, and the distributor’s interest to see that it’s done,” said a spokesman for the FDA who declined to be identified.
The reality is that to become a prescribing physician for RU 486, all it takes is a signature on file with Danco.
“We trust physicians to be responsible health care providers and responsible people,” said Heather O’Neill, a Danco official. She said she is not worried that enforcement of the FDA restrictions would be left up to the pharmaceutical company and its distributors.
Lists of doctors with a Danco account will not be made publicly available, said Danco official Pam Long.
O’Neill said the distributors, who will be responsible for collecting the signed prescriber’s agreements, also will be responsible for periodically checking to see that doctors who are authorized to receive the drug are still licensed to practice.
To get more information about mifepristone, you can contact Danco at 877- 432-7596 or visit its website at www.earlyoptionpill.com.