Pharmaceutical

Appeals judges side with Big Pharma in Androgel case

androgel pump 435x435 Appeals judges side with Big Pharma in Androgel caseA U.S. appeals court in Atlanta sided with Big Pharma in an April ruling, allowing “pay-for-delay” arrangements between brand-name and generic drug manufacturers. At the center of this ruling was the testosterone drug Androgel, a blockbuster drug made by Brussels-based Solvay (now Abbott Pharmaceuticals) that brought in $594 million in 2010 and promises explosive growth in the future as more and more men turn to it for its sexually restorative effects.

Solvay was originally granted a 17-year patent in 2003, which barred other drugmakers from developing a generic version of the topical gel until 2015. However, three drug companies challenged the patent and demonstrated to the U.S. Food and Drug Administration (FDA) that they could make versions of the popular testosterone gel without infringing on its patent.

In response, Solvay cut a deal with its competitors – a pay-for-delay agreement in which the competitor companies would agree not to make and market a generic version of Androgel for nine years in exchange for a cut of Solvay’s Androgel profits.

The U.S. Federal Trade Commission tried to block the agreement by suing the companies involved.

FTC Chairman Jon Leibowitz estimates pay-for-delay agreements, which have become all too common in the drug industry, cost U.S. consumers about $3.5 billion a year in artificially high drug prices. Sadly, every time the FTC has tried to challenge these agreements in court or persuade Congress to bar them in the first place, it has failed.

“We continue to believe this conduct violates the antitrust laws,” Leibowitz said in a statement, saying such deals were a “lose-lose” for consumers. He said the FTC “will consider all our options going forward.”

One of those options is to push for legislation in lieu of antitrust laws, a course of action that could happen, of course, with Congressional action. But with so many members of Congress beholden to corporate interests, legislation in favor of the average citizen may be a long time in the making.

Androgel is a topical testosterone replacement drug available in 1% and 1.62% formulas. Users of the gel are advised to cover the application area (usually the upper arm or shoulder) to shield others from coming into contact with the drug. Secondary exposure can have a number of detrimental effects on women and children.

Women exposed to Androgel either through contact with the user or his clothing, towels, or sheets, can develop symptoms associated with increased testosterone levels, including changes in hair distribution and acne.

Children exposed to Androgel and other topical testosterone drugs may experience premature sexual development, including inappropriate enlargement of the penis or clitoris, premature development of pubic hair, increased erections, aggressive behavior, and advanced bone age.

Sources:

Bloomberg
Drugpatentwatch.com