Testosterone Gel Manufacturer Sues FDA For Not Announcing Approval

The manufacturer of a generic testosterone gel has filed a lawsuit against the Food and Drug Administration (FDA), seeking to force the drug regulatory agency has to publish an announcement regarding their medication’s bioequivalence results.  

On March 21, the pharmaceutical company Perrigo filed a complaint (PDF) seeking declaratory and injunctive relief against the FDA, in the U.S. District Court for the District of Columbia.

According to claims raised in the testosterone gel lawsuit, the FDA has violated the Federal Food, Drug and Cosmetic Act by refusing to publish that the company’s generic medication is a bioequivalent to AndroGel, which is the leading testosterone replacement therapy on the market. Perrigo’s generic AndroGel equivalent was approved more than a year ago.

Perrigo claims that the FDA has a duty to update the agency’s Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book, in a timely manner. The book contains therapeutic equivalence (TE) ratings for generic drugs, which generic drug manufacturers use as the basis for claims that their drugs are the same as taking the brand name version.

According to Perrigo, the FDA approved it’s generic testosterone gel 1% in January 2013, finding it to be therapeutically equivalent to AndroGel. The company says it has repeatedly asked the FDA to publish its TE rating in the Orange Book, but the agency has not responded and has even published TE ratings for other products that were approved after Perrigo.

Under the FDC Act, the FDA is required to update the Orange Book every 30 days, including each drug that has been approved.

Dispute Over Generic Testosterone Gel

The Perrigo lawsuit comes as the FDA faces citizen’s petitions filed by other testosterone manufacturers, which claim that the agency has no right to designate testosterone gels as therapeutically equivalent.

In September 2011, a petition was filed by the makers of AndroGel, specifically aimed to prevent approval of Perrigo’s generic testosterone gel. The petition was filed by Abbott, which spun off AbbVie in January 2013, which is now an independent company manufacturing AndroGel.

Auxilium Pharmaceuticals, which makes Testim testosterone gel, filed another petition in March 2013, which specifically challenges another generic drug manufacturer, Upsher-Smith Laboratories, Inc.

According to the petitions, the FDA has to require generic testosterone drug manufacturers to show skin transfer studies, hand-washing studies, skin irritation and sensitization studies, and potentially showering studies to show the likelihood of the drug being spread to others before it can truly say they are bioequivalent to the brand name product.

In 2009, the FDA required new warnings for AndroGel, Testim and other testosterone gel products about the risks associated with secondary exposure to the medication. Women and children may see biological reactions from testosterone gel exposure, including changes in hair patterns, changes affecting the genitals, early signs of puberty in children, and potentially harmful effects on the unborn children of pregnant women who are exposed.

Publishing the TE ratings of Perrigo’s new testosterone gel could result in lawsuits from those companies as well.

Perrigo claims that the FDA’s inaction has hurt the company financially and violates the FDA Act and constitutes an unreasonable delay and breach of its duties. The company wants a mandatory injunction compelling the FDA to publish the TE rating as soon as possible and a judgment that the FDA’s actions were unlawful.

Testosterone Therapy Heart Problems

The action for declaratory and injunctive relief comes as the FDA is also reviewing recent concerns about serious and potentially life-threatening side effects of testosterone treatments, including a potential increased risk of heart attacks, strokes and death. Several consumer groups have suggested that stronger warnings need to be placed on all forms of testosterone replacement therapy, which are available as gels, patches, injections and pellets.

Even though concerns about the potential link between heart attacks and testosterone drugs have existed for years, a study published late last year in the Journal of the American Medical Association (JAMA) suggested that testosterone drugs may increase the risks of heart attacks, strokes and deathamong older men with certain pre-existing heart conditions.

The JAMA study was followed by a report published by the medical journal PLoSOne in January 2014, which found thatlow testosterone treatments may double the risk of heart attack for young men with heart disease as well as for men age 65 and older who had no prior heart problems. The researchers estimated that for every 1,000 men over the age of 65 who uses AndroGel or another TRT product, 11.52 may suffer a heart attack. That compares to only 5.27 men per 1,000 who do not use testosterone.

Testosterone replacement therapy has increased in popularity in recent years, as direct-to-consumer marketing has encouraged men to seek prescription treatment for low testosterone levels, or “low T”, if they are experiencing fatigue, decreased sexual virility or other symptoms that are often common with aging.

In recent years, the use of testosterone drugs has increased more than a factor of five, with more than $1.9 billion in sales in 2012. More than five million testosterone product prescriptions were filled last year in the U.S. alone.

A growing number of AndroGel lawsuits, Testim lawsuits and other testosterone treatment lawsuits are now being pursued by men throughout the United States who claim that the drug makers withheld information about the risk of heart attacks, strokes and blood clots associated with use of the medications.