FDA To Consult Patients In Ongoing Development of Female Sexual Disorder Drugs

Under the fifth authorization of the Prescription Drug User Fee Act (PDUFA) in 2012, the FDA expressed commitment to making patients a greater part of the agency’s regulatory process and has already conducted meetings with patients suffering from a range of diseases which, as yet, have no effective treatment. Under pressure from Women’s groups, the FDA announced that female sexual disorder (FSD) is set to become the eleventh patient-focused meeting conducted by the agency.

Criticism of the FDA followed their rejection of proposed flibanserin, an FSD drug from Sprout Pharma, evaluated for its safety and efficacy in treating Hypoactive Sexual Desire Disorder (HSDD) and touted as the “female Viagra.”

There are over sixteen drugs on the market that treat male sexual dysfunction, but as yet, there are no comparable options for women. Women’s groups suggest that this discrepancy reflects a pattern of FDA sluggishness with regards to women’s health issues.

While experts agree that the FDA could do more to address women’s health issues, some doctors argue that concern over flibanserin is justified.

In a letter addressed to the FDA urging the agency not to approve flibanserin, the Women’s Health Network wrote: “While the Network agrees with Sprout’s assertion that women deserve to have our problems with sex taken seriously, we do not believe that a minimally effective drug that must be taken daily, causes significant side effects and has not been evaluated for long-term safety offers women a serious solution.”

Other experts and activists argue that the FDA is being overly cautious and suggest that it should be up to the patient and her doctor to decide whether she can accommodate the potential risks involved.

Slate quoted Terry O’Neill, president of NOW who said: “When it comes to approving drugs for male sexual dysfunction, the FDA says yes with more limited research and serious side effects, but when it comes to women, their go-slow tactics are preventing us from having access to a treatment option where we make the decision in consultation with our healthcare provider.”

The FDA initiative Patient-Focused Drug Development aims to let patients play a stronger role in risk/benefit assessment of potential treatments. Options for women suffering from FSD and the surrounding concerns are on the table for discussion when the FDA meets with patients in October.