Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Will Advocacy & Politics Sway FDA to Approve "Pink Pill" for Women?

Will Advocacy & Politics Sway FDA to Approve "Pink Pill" for Women? | Pharmaguy's Insights Into Drug Industry News |

For the most recent FDA review, no new efficacy data were presented. Instead, the sponsor of flibanserin provided additional safety data, including a study suggesting the absence of next-day driving impairments, a comparison of the product’s adverse effect profile with that of other marketed products, and an analysis confirming the potentiating effects of alcohol on adverse events. Although the driving study was reassuring, isolated comparisons of safety across products can be misleading because FDA product reviews are not fundamentally comparative in nature. Notably, the alcohol interaction study took place in a sample of 25 healthy volunteers, only 2 of whom were women.

Several additional features of the regulatory path involving flibanserin are noteworthy. First, following the FDA’s second rejection of flibanserin in 2013, an advocacy group called Even the Score was formed to advocate for what it called “gender equality” in access to treatments for sexual dysfunction. The group, initially created through the efforts of a consultant to flibanserin’s manufacturer who formerly directed the FDA’s Office of Women’s Health, promoted the claim that there are 26 approved medications for male sexual dysfunction but none for women. The claim has been rejected by the FDA, because there are no approved products for low sexual desire in men, and the 26 medications include multiple formulations of testosterone. Although flibanserin is not the first product to be supported by a consumer advocacy group in turn supported by pharmaceutical manufacturers, claims of gender bias regarding the FDA’s regulation have been particularly noteworthy, as have the extent of advocacy efforts ranging from social media campaigns to letters from members of Congress.

The second noteworthy feature in the FDA application for flibanserin was the use of a patient-reported outcome of sexual desire as the primary efficacy variable for approval. Sexual desire is known only to the person experiencing it, and patient-reported outcomes measure such concepts without interpretation from others. Patient-reported outcomes are increasingly prioritized in research and other drugs have been approved with these outcomes as primary end points (although none based on sexual desire). Among all new molecular entities and biologic license applications approved by the FDA from 2006-2010, Gnanasakthy et al identified 17% (20 of 116 products) that granted patient-reported outcome claims as the primary outcome on the approved label.

These features of flibanserin—the Even the Score advocacy campaign, the shifting efficacy end points and use of a patient-reported outcome measure, the tenuous risk-benefit balance among the studied population and potential for widespread off-label use, and an unmet medical need—are not totally unfamiliar territory for the FDA, but represent a challenge when they occur simultaneously. What makes the approval process for flibanserin even more unique is the politically charged atmosphere in which the FDA will decide how all these trade-offs should best be navigated.

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Will FDA Approval the "Pink Pill" Now That Peggy Hamburg Isn't Commissioner?

Will FDA Approval the "Pink Pill" Now That Peggy Hamburg Isn't Commissioner? | Pharmaguy's Insights Into Drug Industry News |

It's been in the works for years: a pill to help women with low sex drives. Women who've tested it love it. So, why hasn't it been approved? CBS 2's Erin Kennedy explores the controversy.

Amanda Parrish, a busy working mother of four, says sex was often the last thing on her mind.

“It got to where I’d be one of those women who would try to maybe be asleep before he got to bed,” Parrish said.

Her doctor diagnosed HSDD or hypoactive sexual desire disorder.

The prescription: enter a clinical trial of flibanserin, a little pink pill designed to boost a woman’s low libido.

Amanda got results.

“At the end of a long day even if I had worked and even if I had gotten the kids fed there was a desire there that previously had not been there,” she said.

“It actually balances out dopamine and serotonin so that women have more sexual thoughts, more fantasies,” said Northwestern Medicine’s Dr. Lauren Streicher, describing how it works in the brain.

So, if flibanserin worked for Amanda and 45 percent of women in the studies, why has it been rejected twice by the FDA?

Experts noted it didn’t work much better than a placebo and others say therapy, not a drug, should be the first choice for busy, stressed-out women.

Outspoken critics, like Dr. Adriane Fugh-Berman, director of Georgetown University’s research project PharmedOut, are also concerned about side effects.

“15 percent of the women in flibanserin trials dropped out because of side effects of sedation and nausea and fatigue,” Dr. Fugh-Berman.

“It’s my hope that the FDA approves it. I’ll be the first in line to get it,” said Amanda Parrish.

Earlier this year, Sprout Pharmaceuticals, which makes flibanserin, submitted new research on the pill’s impact on driving ability to the FDA. Those results showed no adverse effect.

The FDA holds another hearing concerning the pink pill’s approval next month.

Pharma Guy's insight:

A coalition of consumer advocacy groups and drug makers launched an online campaign – complete with a petition – to pressure the FDA to approve more drugs to treat female sexual dysfunction. Called Even The Score, the crusade claimed that there are more than two dozen drugs available to help men combat sexual problems, but none for women. Is FDA sexist? Read more:

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Just as I Predicted: Now that Peggy Hamburg is No Longer FDA Commish, an FDA Panel approved the "Pink Pill"

"Marketing won over science today," said one doctor.

1) A panel of advisers to the Food and Drug Administration just recommended the agency approve a new drug designed to boost womens' sex drives.

2) Flibanserin — a pill dubbed the 'female Viagra' — has already been rejected by the FDA twice since 2010 out of concerns that its harms outweigh its benefits.

3) The 18-6 vote is considered a "major victory" for the drug, since the FDA more often than not adopts the advice of the expert group and same panel voted unanimously against flibanserin in the past.

4) Critics have raised questions about the efficacy of flibanserin. They've also accused the pharmaceutical industry of inventing the medical condition — hypoactive sexual desire disorder — that the drug would supposedly treat.

Pharma Guy's insight:

LOL! I anticipated this result: 

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