FDA review should clarify Plan B use


POSTED: Monday, March 30, 2009

THE federal government's withdrawal of age restrictions on an emergency contraceptive will not substantially change the drug's availability in Hawaii.

State law already allows for wider distribution of the birth control pills, called Plan B, but a requirement that the nonprescription drug be held behind the pharmacy counter unreasonably interferes with access and privacy.

A federal judge this week ordered the Food and Drug Administration to remove within 30 days Bush-era rules on Plan B that limit the contraceptive to females 18 and older. The court also told the FDA to consider approving it for younger females, as is allowed in Hawaii, and as recommended by the American Medical Association, the World Health Organization and other public health groups.

The court harshly criticized FDA officials for capitulating to the Bush administration's political and ideological views in improperly setting the age limit. Officials ignored recommendations of an advisory panel, its scientists and its director of women's health, who eventually resigned in protest.

President Barack Obama's pledge to rely on science in making decisions and a new FDA leadership give hope that the agency will act independently and restore scientific principles to its judgments.

Hawaii has had a law authorizing Plan B since 2003 and has worked with pharmacists and physicians to dispense the emergency contraceptive without prescription to females 14 and older. However, the federal government's 18-and-older rule caused confusion, leading some pharmacists to turn away younger females. The FDA's changes should provide clarity.