July 10, 2006

The activist group that filed a lawsuit claiming political pressure from the White House and others forced the FDA to delay approving OTC sale of a controversial contraceptive is now urging the president to order the agency to approve the drug.

The Center for Reproductive Rights (CRR) asked the White House in a July 6 letter to direct the FDA to approve Barr Pharmaceutical's Plan B (levonorgestrel) contraceptive. However, while the group now wants the White House to influence the FDA, CRR is also planning to depose Jay Lefkowitz, President Bush's former assistant for domestic policy, to determine if he influenced the agency's decision to delay OTC approval.

"We are taking all steps possible to increase the availability of Plan B for women," CRR spokeswoman Dionne Scott said in response to questions about this change in strategy. But other observers see it differently.

"What they're really saying is that FDA shouldn't make decisions based on political pressure unless [they] agree with it," Peter Pitts, director of the Center for Medicine in the Public Interest and a former FDA associate commissioner for external relations, said. "That's called hypocrisy."

The White House must get involved because the agency's delay in approving the company's contraceptive conflicts with the administration's position on contraception, CRR's letter said. Referencing a letter from John Agwunobi, HHS' assistant secretary of health, supporting "safe and effective" contraceptive products, the group argued that such interference is necessary.

Agwunobi's statement is "directly at odds" with the FDA's delay in making a decision on Plan B, CRR said.

"If the administration indeed supports safe and effective products and services to assist responsible adults in making decisions about preventing or delaying conception, then there is no reason for its failure to support the availability of emergency contraception," CRR added. The group's letter is available at www.crlp.org/pdf/CRRBUSHLetter.0706.Final.pdf (http://www.crlp.org/pdf/CRRBUSHLetter.0706.Final.pdf). (http://www.fdanews.com/did/5_133/)