Newspaper article St Louis Post-Dispatch (MO)

Kv Tangles with FDA over Files Firm Worried about Publicity

Newspaper article St Louis Post-Dispatch (MO)

Kv Tangles with FDA over Files Firm Worried about Publicity

Article excerpt

After federal agents seized many of its drugs on April 21, KV Pharmaceutical Co. asked a federal court to keep secret details of the raid because KV feared publicity would hurt its sales, court records show.

And while KV was petitioning the court to keep government files sealed, the company was telling shareholders it couldn't talk about the seizure because it was obeying the court's order for secrecy.

Neither KV nor government attorneys commented on the legal maneuverings during the eight weeks that the files were sealed.

Federal court officials refused to discuss the matter. All petitions and appeals to the court were kept sealed during the debate over secrecy.

The legal wrangling took place at a time when trading in KV's stock had been halted by the American Stock Exchange and while U.S. officials were discussing the seizure.

But except for a terse press release, Brentwood-based KV kept silent from April 21 to May 4, when it sent a 2 1/2-page letter to shareholders.

Federal court records here show that KV petitioned for secrecy several times, saying publication of federal documents would damage its reputation and its revenue.

KV, which specializes in generic and controlled-release drugs, did not return calls for this story.

The first request for secrecy came from the Food and Drug Administration, which sued KV in federal court on April 20.

The FDA charged that KV had violated the agency's guidelines on manufacturing practices such as quality control, record-keeping and plant cleanliness.

The FDA later said KV had failed to fix many problems cited by agency inspectors. Some problems remained uncorrected for up to 12 months.

Because the FDA planned to seize KV's drugs on April 21, it wanted to make sure federal agents would be unimpeded confiscating the drugs at 11 sites in the St. Louis area.

After the drugs were seized, KV issued a brief press release, acknowledging that an unidentified amount of KV's products had been seized.

Five days later, the FDA asked the court to unseal the files, which identify the drugs and the sites where they had been seized. …

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