FDA panel approves addition of folic acid to OCs: combo product still in 'concept' stage.(News)

GAITHERSBURG, MD. -- The Food and Drug Administration's Advisory Committee for Reproductive Health Drugs voted unanimously that an oral contraceptive pill is a reasonable delivery vehicle for folic acid supplementation.

The 19-member panel debated a proposal submitted by Ortho-McNeil Pharmaceutical, a subsidiary of Johnson & Johnson, to develop a combination oral contraceptive/folic acid product. Active and inert tablets would contain 400 [micro]g of synthetic folic acid, the daily level of folic acid intake recommended by the U.S. Public Health Service and the Institute of Medicine to reduce the risk of neural tube defects (NTDs) in women of reproductive age.

Representatives from the company did not state any specific plans for marketing a combination OC/folic acid product and repeatedly emphasized to panelists that the drug was still in the "concept" stage.

According to data presented by the Centers for Disease Control and Prevention (CDC), an estimated 4,000 NTD-affected pregnancies occur yearly, and 50% of these are preventable. Approximately 1,000 NTD-affected pregnancies have been avoided since 1998, when the FDA mandated grain fortification with folic acid, the synthetic form of folate.

"We should be doing whatever is necessary to safely increase the amounts of folic acid that women of reproductive age need to get to eliminate all folic acid-preventable birth defects," said Dr. Joseph Mulinare of the National Institute of Child Health and Human Development, who presented data on behalf of the FDA.

Most panelists agreed that folic acid supplementation is safe, but a few expressed concerns that users of a combination OC/folic acid pill who also take a vitamin supplement and eat folic acid-fortified foods could consume more than 1,000 [micro]g of folic acid per day, the recommended upper limit of folic acid ...