Susan Wood, the former assistant commissioner for women’s health at the Food and Drug Administration, came to Syracuse Wednesday night in an event sponsored by Planned Parenthood, Central New York National Organization of Women and the Greater Syracuse NOW.

Wood resigned from the FDA in August 2005 in response to the FDA’s decision to delay over-the-counter status of Plan B emergency contraception, despite overwhelming recommendation by FDA scientific staff.

‘Like the impact the Roe v. Wade decision had on women’s reproductive health care, this decision will have significant impact on women’s lives, too,’ said Betty DeFazio, external affairs director for Planned Parenthood of the Rochester/Syracuse region.

DeFazio said increased access to Plan B is an important method in order to reduce the number of abortions in America.

Wood criticized the process the FDA used in determining whether Plan B would be allowed over-the-counter status. She said the FDA’s professional staff did not play a role in the decision, but rather the decision came from somewhere else.

Before Plan B’s proposal was rejected, the drug went through all the necessary steps in order to gain acceptance, Wood said. The advisory committee meeting was performed well, with both the FDA staff and the company sponsoring Plan B presenting their data adequately.

After the meeting concluded, 28-0 voted that the product was safe and 23-4 voted in favor of awarding Plan B over-the-counter status, Wood said.

Even with overwhelming support from the meeting and from the FDA’s professional staff, the FDA eventually rejected Plan B’s over-the-counter status, Wood said.

‘The FDA does not have to follow the advice of its advisory committees,’ Wood said. ‘That’s been done before. What doesn’t usually happen is that the professional staff agrees with the advisory committee, and then it is overruled.’

Wood said it is still unclear as to who rejected Plan B’s proposal.

Alice Honig, a former professor of child development at Syracuse University, said she cannot understand why no one has yet to investigate the FDA to figure out who turned down Plan B’s approval.

‘No one can find out who made these decisions?’ Honig said. ‘No one in the media knows how this scientifically approved product was squashed? There must be someone who was there when the decision was overruled.’

Honig proposed a request to journalists to uncover the reasons why Plan B’s over-the-counter status was overruled.

‘Journalists from any newspaper must investigate what happened at the FDA when the decision was made,’ Honig said. ‘Someone needs to take up that challenge.’

Wood requested her own proposal to the audience of more than 100 at the May Memorial Unitarian Universalist Society.

‘We have to be critics,’ Wood said. ‘We have to criticize the agency when it is necessary in order to get it back on track.’

Wood said the credibility of the FDA has already been damaged. It is the FDA’s job to figure out if the general public can read a product’s label and use the product correctly. Their decisions should be based on the science of a product and not on the controversy that arises, she said.

Wood closed the evening on a positive note.

‘We all have this vision, and it is a hopeful one, of making this world a better place,’ she said. ‘We still have to continue looking forward, and not backward.’

Published on January 17, 2006 at 12:00 pm