When Governments Disagree about Pharmaceuticals
By Pooja Nagarajan, Drug Regulatory Affairs Graduate Student, 2015
The clashes between several federal agencies involved in the regulation of food and drugs has time and again proven to be a matter of concern, raising questions about the need for a more unanimous system of regulation and jurisdiction. This has been exemplified by the conflicting decisions of the two most revered federal agencies in the world, the U.S FDA and the European EMA, in approving the product “Intrinsa.” Intrinsa, also popularly known as the “Female Viagra,” was a transdermal testosterone patch used for treatment of suppressed libido in surgically menopausal women.
The API (active pharmaceutical ingredient) in Intrinsa, testosterone, is a natural sex hormone produced in men and, to a lesser extent, in women. Reduced sexual desire is usually associated with low levels of testosterone. During menopause, total testosterone production decreases by 25%. However, following an oophorectomy, a surgical procedure which removes the ovaries, the testosterone levels in women are almost halved. Intrinsa releases testosterone through the skin into the bloodstream to restore the levels seen before removal of the womb and ovaries.
Intrinsa was rejected by the U.S FDA in 2004. The FDA condemned the company funded clinical trials as “inadequate” to assess issues of long term safety. Panel members also raised grave concerns about the risks of cardiovascular disease and breast cancer associated with a drug that appeared to offer women, on average, little more than one extra episode of sexual activity a month, compared with placebo. Though Intrinsa was ostensibly marketed for use in surgically menopausal women, it risked likely off-label use of the product by normal women who were oblivious of the adverse effects of the hormone. But in 2006, EMA approved the product, citing that the product’s benefits outweigh the risks and gave the green signal for its marketing.
These incongruous decisions pose questions about regulations worldwide and highlight the demand for a unified panel to regulate food and drug products worldwide. Doing so may finally set a standard that can be agreed upon across borders.
Read more at:
Moynihan, R. (2004). FDA panel rejects testosterone patch for women on safety grounds. British Medical Journal.