Pressure on FDA could stall advances – ex-official
16 Nov 2005 21:51:10 GMT
By Michael Conlon
CHICAGO, Nov 16 (Reuters) – A former U.S. Food and Drug Administration official who quit the agency because it failed to make a “morning after” contraceptive available without a prescription said on Wednesday she fears other health a aadvances could also be sidetracked.
Susan Wood, who headed the FDA’s Office of Women’s Health, said she was “very worried” political pressure on the agency from the same conservative groups who opposed wider availability of the contraceptive could also result in a delay for a new vaccine that protects against cervical cancer.
That vaccine counteracts sexually transmitted human papillomavirus or HPV, which causes most cases of cervical cancer.
“I am deeply concerned about that,” she said in response to a question from the audience following a lecture at the University of Illinois-Chicago.
She said some of the same forces who opposed over-the-counter sales for Barr Pharmaceuticals’
“That appalls me.” she said. “I also worry when and if we reach an HIV vaccine” that the same argument will be raised, she said.
Plan B is a set of prescription-only pills that can prevent pregnancy if taken within 72 hours of sexual intercourse. Barr’s request to sell Plan B without a prescription drew intense political lobbying from supporters and opponents.
After the FDA initially rejected the proposal in May 2004, the company filed a new application asking to sell Plan B over the counter for females age 16 and older while keeping the prescription requirement for younger girls. In August 2005, the FDA said it was indefinitely postponing a ruling on the matter.
Wood told her audience the Plan B denial was unprecedented because FDA staff and an advisory panel of outside experts both agreed on the need to make the drug available without a prescription.
Americans need to “demand better of our health agencies … of our government,” she said. The Plan B decision, Wood said, “is a clear example, unfortunately, of when something has gone terribly wrong.”
An investigative report done for the U.S. Congress and released earlier this week found that the FDA’s 2004 decision was “unusual,” in part because of the involvement of high-level managers.
Congressional Democrats who requested the investigation said it provided evidence that opposition from political conservatives had swayed the FDA review.
But the FDA said it questioned “the integrity of the investigative process that results in such partial conclusions … the report mischaracterizes facts and does not appear to take into consideration the input provided by the FDA.”
A Reuters news service article, “Pressure on FDA could stall advances,” by Michael Conlon, discusses the political pressures on FDA regarding women’s health issues. This sort of pressure isn’t happening with psychedelic and marijuana research, where science still carries the day.