Mary Pendergast, former US Food and Drug Administration (FDA) Deputy Commissioner under President Clinton, and Peter Pitts, the former FDA Associate Commissioner under President George W. Bush, offered scathing critiques of Secretary of Health and Human Services Secretary Kathleen Sebelius during an interview on 1 January 2012.
Appearing on WUSA9's BioCenturyTV, Pendergast called the recent decision by Sebelius to overrule the FDA's decision in favor of less restrictive access to Plan B One Step a, "drive-by-shooting."
"Secretary Sebelius has opened the door to political reversals of FDA scientific and medical decision-making, and once you open the door there's no way to close it," said Pendergast. "I expect to see a lot of additional interventions in FDA decisions going forward."
Pendergast noted that while Plan B's manufacturer, Teva Pharmaceuticals, has been invited to submit more evidence, the implication was that Kathleen Sebelius herself would be making the determination. This is problematic, says Pendergast, because Sebelius is not a scientist.
"This is the first time the Secretary of Health and Human Services has ever over-ruled the FDA," said Pitts, adding that this opens the door to further interference by DHHS secretaries.
Pendergast took this to mean interference in decisions that have a moral component, such as controversial abortofacient drugs like Mifepristone (RU-486), while Pitts noted that it could also mean a back-door to comparative effectiveness decision-making.
Pitts said that it is likely that companies and individuals may start to directly lobby the Secretary regarding certain decisions. This could mean decisions made in favor-or against the favor- of a controversial company or product.
Both Pendergast and Pitts advocated for a more independent FDA, though they differed on what that agency might look like. Pendergast said that while it is beneficial to have a Cabinet-level secretary advocating on behalf of the agency and defending it from budget cuts, in light of recent decisions by the Secretary she is now in favor of making the agency fully independent. Pitts advocated for possibly endowing the Secretary with a fixed, 6-year term to shield the agency from day-to-day politics, and making the agency report directly to the President.
Pendergast expressed particular concern regarding the long-term impact of this decision, saying that she is worried the FDA may start to become as susceptible to political interference as the US Environmental Protection Agency is.
Even if Sebelius' decision is reversed, noted Pitts, it is impossible to reverse a precedent.(BiocenturyTV - "Politics Intrudes")