Plan B: FRC Lawsuit Against FDA

debate Plan B Friday the Family Research Council,

filed a federal lawsuit against the Food and Drug Administration (FDA) to overturn the FDA’s approval of the “Plan B” morning-after pill for over-the-counter (OTC) use by women 18 and older.

Charmaine is quoted in The Washington Times,

“It’s really simple — it just needs to be overturned,” said Charmaine Yoest, FRC’s vice president for communications. …”It’s very clearly caught up in political dynamics and I would go so far as to say there is electoral politics involved here…”

FRC’s press release continues,

The lawsuit alleges the following violations by the FDA:

The data submitted by Plan B’s owner did not establish that it is safe or effective.

The FDA lacks authority to approve the same drug for both over-the-counter (OTC) and prescription-only distribution.

The FDA lacks authority to approve distribution based on the buyer’s age.

The FDA lacks authority to approve “behind-the-counter”-a drug that is neither fully OTC nor prescription only.

The FDA approved Plan B for non-prescription use without conducting the necessary rulemaking required by the Administrative Procedure Act and the Federal Food, Drug and Cosmetic Act.

The sudden reversal by FDA and Commissioner von Eschenbach had the distinct appearance of resulting from improper political pressure exerted by Senators Clinton and Murray who made clear that they put “holds” on von Eschenbach’s confirmation until he acted on Plan B.

The FDA’s approval ensures that girls will have unsupervised access to Plan B even though FDA has found that Plan B is unsafe for girls without medical supervision, as denoted by the fact it is prescription-only for those under 18.

The FDA failed to require Plan B’s owner to comply with the Pediatric Research Equity Act which protects children and adolescents

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Even the liberal feminists agree. Sort of.

Watch Charmaine debate Plan B on NBC and Democracy Now.

Thank you (foot)notes:

See March Together at What’s the real story about Plan B?

See Charmaine’s Plan B quote in the Daily Princetonian.

See more on the liberal FDA Commissioner, who is a democraTIC contributor.