Feds Approve Little Pink Pill, Skeptics Raise Big Red Flag

Contributed by Natalie Blazer

After two highly-publicized failures in 2010 and 2013, the first prescription drug to enhance women’s sexual drive – known as “Female Viagra” or “the little pink pill” – succeeded in winning regulatory approval last week. The Food and Drug Administration’s Aug. 18 decision was not entirely surprising, given that an advisory committee of outside experts had recommended in June the drug be approved – albeit with precautions required to ensure that the drug was not overused. The FDA is not required to follow the advice of its committee (which in this case voted favorably by 18 to 6), but usually does so.

Although the approval has been heavily touted as a victory for women, Flibanserin, manufactured by Sprout Pharmaceuticals and marketed as Addyi, is actually the first drug approved to treat a lowered or absent libido for either sex. Viagra and other drugs available for men are not approved to increase desire.

Specifically, the FDA approved Addyi to treat “acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.” Some surveys estimate that HSDD affects about 10 percent of women.

According to the agency’s press release, the drug is approved for women whose loss of sexual desire causes marked distress or interpersonal difficulty and is not the result of illness, relationship problems or side effects of other medicines. Similar to some anti-depressant and anxiety medications, Addyi is thought to work by changing the balance of certain brain neurotransmitters like dopamine and serotonin.

The little pink pill’s road to approval has been an interesting one. After Addyi’s second FDA denial in 2013, a coalition called Even the Score began actively lobbying for the drug’s approval (the agency’s rejection struck many women’s groups as unfair in light of the relatively speedy approval of Viagra in the 1990s, and even prompted gender bias accusations against the FDA.) For the last 18 months, Even the Score has rallied together a highly visible women’s sexual health campaign in support of “Female Viagra,” a movement some have analogized to the lobbying efforts by advocacy group Act Up that pushed the FDA on AIDS drugs in the 1980s.

Some women’s groups are claiming Addyi’s approval is the biggest breakthrough for female sexual health since the oral contraceptive. But critics of the campaign say that advocates have co-opted the women’s movement to pressure federal regulators into approving a drug that is at best minimally effective and at worst the cause of serious side effects.

Significantly, Addyi’s label has a boxed warning – the strongest kind – saying the drug should not be used by those who drink alcohol, since that combination can increase the risk of severely low blood pressure and fainting. According to the FDA’s website, the most common adverse reactions associated with the use of Addyi are dizziness, somnolence (sleepiness), nausea, fatigue, insomnia and dry mouth. Women are advised to stop using the drug if they see no result after eight weeks.

In apparent response to the advisory committee’s precaution that the drug not be overused, Sprout Pharmaceuticals has said it would not advertise on radio or television for 18 months after the drug’s approval. Cindy Whitehead, the chief executive of Sprout, declined to forecast sales of Addyi, and said that the company would focus its marketing on doctors, not consumers.

As our readers can probably predict, some doctors will likely prescribe the drug beyond approved uses in the label (i.e., “off-label” use), which they are allowed to do. For example, although the drug was approved for premenopausal women only, physicians may prescribe it for postmenopausal women as well. Some may even prescribe the drug off-label to men.

Critics of the drug have penned letters to the FDA, urging it to reject Addyi despite the advisory committee’s favorable vote. Concerns voiced in the letter include that it is unreasonable to expect that young women taking Addyi would refrain from drinking alcohol, as well as Sprout’s financial backing of the public relations campaign that presumably played a large part in persuading the committee.

The most common question mark surrounding the drug’s approval, however, is whether low sexual desire in women is actually a medical condition. Even if one rules out a host of common factors of flagging desire – relationship troubles, poor body image, cultural messages – the science of this affliction is not well-understood. Treating with a pharmaceutical drug what is arguably not a medical condition at all has many critics raising the big red flag on the little pink pill. (Amusingly, one letter to the FDA from sex researchers in the Netherlands and Belgium said the drug was based on the mistaken notion that lack of spontaneous sexual desire was in any way abnormal.)

At this time, it is unclear how much the drug will cost or whether insurance companies will cover it. What is immediately clear, however, is that should the pill ultimately make it to market (target date: October 17), it will undoubtedly be the subject of any number of products liability claims, which we will be sure to monitor. The uncertain nature of this “condition,” coupled with the colossal hype surrounding its approval, can almost guarantee that Female Viagra may have the roughest leg of its journey yet ahead.