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Health News

Groups sue FDA over "morning-after" pill ruling

WASHINGTON (Reuters) - Two conservative organizations and other groups have asked a court to overturn U.S. regulators’ decision to allow nonprescription sales of Barr Pharmaceuticals Inc.’s “morning-after” contraceptive.

The Family Research Council and Concerned Women for America said they filed suit on Thursday against the U.S. Food and Drug Administration over its August 2006 ruling on Barr’s Plan B drug.

The lawsuit says the FDA violated laws and regulations when it allowed Plan B to be sold to adults without a prescription. The FDA ordered that the pills be kept behind pharmacy counters and only given to girls younger than 18 with a doctor’s order.

The groups said the FDA lacked the authority to approve such a plan, and to set different rules based on age.

They also said Barr’s data did not establish Plan B was safe or effective. The product is a set of two pills that can prevent pregnancy if taken within 72 hours of intercourse.

“The agency skirted laws and regulations put in place to ensure drugs are safe and effective, relenting under undue pressure from political operatives,” Concerned Women for America President Wendy Wright said in a statement.

The lawsuit seeks to reverse the FDA decision and require a prescription for all Plan B sales.

Two other groups, the American Association of Physicians and Surgeons and Safe Drugs for Women, also joined the suit.

Barr spokeswoman Carol Cox said the company believed the FDA decision was “scientifically sound and fully consistent with applicable law.”

“Barr will seek to intervene in the case and will defend the FDA’s actions vigorously,” she said.

FDA spokeswoman Susan Cruzan said the agency does not comment on lawsuits.

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