Family Group Plans Legal Challenge To 'Plan B' Decision

By Nathan Burchfiel | July 7, 2008 | 8:06 PM EDT

( - The same day the Food and Drug Administration announced it has approved the Plan B "emergency contraception" for over-the-counter sale, family groups are gearing up to challenge the decision in court.

The conservative Family Research Council (FRC) announced in a release that it is "pursuing legal and legislative options against the FDA for its deliberate disregard for women's health and the law."

Tom McClusky, Vice President of Government Affairs at FRC, told Cybercast News Service that the group is already working with other family groups, doctors' groups and elected officials to formulate a legal challenge to the decision.

He accused the FDA of illegally sidestepping Congress by "deciding independently it can change its own rules." He said the dual status of the drug - meaning it is easily available for one age group but not another - is unprecedented and constitutes a change in statute, which must be proposed and approved by Congress.

Rep. Mark Souder (R-Ind.), chairman of the House Drug Policy Committee, issued a statement on the ruling, saying the FDA is "abandoning its own requirements for allowing dual-marketing of drugs and jeopardizing the health of women who take the regimen without a doctor's supervision."

Souder added that the FDA is "performing regulatory gymnastics in justifying the unprecedented dual-marketing plan for a drug as both OTC (over-the-counter) and by prescription where there is no meaningful difference between the OTC and prescription-only versions."

Calling the dual-marketing plan "legally-unfounded," Souder said it "directly conflicts with the FDA's prior, consistent statutory interpretation that requires a meaningful difference in the drug."

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