Did the Food and Drug Administration treat Amgen (AMGN) differently than Johnson & Johnson (JNJ) when reviewing applications for their drugs?
A federal judge ruled late last week that the agency, in fact, may have acted inconsistently when it denied pediatric exclusivity for a blockbuster Amgen drug and ordered the FDA to explain its reasoning. The ruling could mean that Amgen may eventually win six months of pediatric exclusivity, which would allow the company to forestall generic competition to a best-selling drug.
The case is being closely watched because it marks a rare instance in which a drug maker filed a lawsuit against the FDA for denying an incentive the companies typically receive for studying their medicines for children. In its lawsuit, which was filed last May, Amgen argued it was denied an extra six months to exclusively sell Sensipar, which is given to people who are on dialysis due to chronic kidney disease, even after complying with agency requests to run various pediatric studies.
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