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Judge Blocks FDA’s Attempt to Make Generic Version of Sedative Precedex Available

Reuters reports that a federal judge has issued a temporary restraining order against the FDA which prevents it from allowing the sale of generic versions of a sedative called Precedex. Precedex is manufactured by a drug company called Hospira Inc. However, the court’s decision has nothing to do with any sort of medication or pharmaceutical error. The order that the generic drugs not be produced had nothing to do with any kind of medical malpractice. Instead it has to do with drug company profits.

FDA Rules Generic Manufacture Okay, but Court Steps in

The FDA had previously ruled that drugmakers could sell generic Precedex so long as the labeling of the generic drugs left out information about uses that are covered by Hospira’s patent on the drug. The patent covers “intensive care unit sedation.” In response, Hospira filed a lawsuit the very next day requesting a restraining order preventing the FDA’s ruling from going into effect.

One generic drug maker, a company called Mylan Inc., has joined the lawsuit on the side of the FDA. Mylan had received approval from the FDA to make generic Precedex, so it is being directly affected by the restraining order. However, the judge in the case determined that any harm Mylan (or any other generic company) suffers because of the restraining order “would pale in comparison” to the harm Hospira would suffer without it. Hospira claims in its lawsuit that it will lose tens of million of dollars if the FDA decision is not permanent overturned.

Patent for One Use of Precedex Has Expired

In its report on the case, the Wall Street Journal explains what Precedex is actually used for. It is approved for use in two types of patients: (1) patients with breathing tubes in intensive-care, and (2) patients without breathing tubes before and during surgeries and other procedures. The patent covering the use of the drug in non-intensive-care settings has expired. The patent having to do with intensive-care use of the drug does not expire until 2019. The FDA only approved generic manufacture so long as the generic drugs were not labeled with information for intensive-care use. But Hospira sued anyway, and now any generic manufacture of the drugs are on hold, even though the first patent expired.

Hospira has a lot to gain by preventing generic manufacturers from entering the market to compete against their name-brand product. Precedex accounts for roughly 11% of Hospira’s $4 billion of annual sales, or approximately $440 million a year.
Judges Takes Back Part of His Order
The Court’s original order not only prevented future generic manufacturing, but it also ordered the FDA to recall any generic Precedex that had already been sold or distributed. This is not due to any claim that the generic versions are harmful, just Hospira’s claim that the generic drugs would hurt the company’s bottom line. But the next day the judge recalled that portion of his order due to a request from Mylan, the generic drug manufacturer. Mylan had already started selling the generic drug, and because there are no safety concerns about it, Mylan argued that the FDA had no authority to conduct the ordered recall, so the Court relented.

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