The big news today is that a federal judge ordered the Food and Drug Administration to rule on a human growth hormone product made by a Novartis AG unit, adding pressure for the agency to deal with the high-stakes question of generic copies of biotechnology drugs.
The decision by Ricardo M. Urbina, a judge in the U.S. District Court for the District of Columbia, came in response to a suit filed by Sandoz, a generics unit of Novartis, a Swiss pharmaceuticals maker. The suit, which named top officials of the FDA and its parent agency, the Department of Health and Human Services, alleged that the agency violated federal law by failing to either approve or reject Sandoz’s July 2003 application to market Omnitrope, a version of human growth hormone.
The judge’s opinion issued today — saying the agency is required to meet a statutory deadline in its decisions on whether to approve drugs — could strengthen the hands of drug companies. Judge Urbina wrote that the FDA had “identified no compelling reason for this court to excuse its delay.”
Silence, it seems, is not always golden.
Sandoz’s application “remains stuck in the ether,” the judge wrote, citing the “egregiousness of the delay.” The opinion says the FDA must meet statutory requirements, which include the option of giving the company a hearing before the Secretary of Health and Human Services about whether its drug is approvable.
The moral of the story is that delay based on silence doesn’t wash. Nor should it. Silence is the excuse of a weak argument. However, delay based on lack of expertise is a very good reason to defer a decision. Since Judge Urbina offered a hearing before the Secretary as a remedy, I predict that is precisely what will be offered.
Who wins? You make the call.
