Kv Cited by FDA for False Data Firm Also May Lose Right to Sell Two Heart Drugs

Article excerpt

KV Pharmaceutical Co. of Brentwood is one of 19 companies on a special Food and Drug Administration warning list, government documents say.

The FDA, which regulates thousands of medical companies, only puts a firm on the warning list when it is

cited for extreme or repeated cases of providing "false and misleading" data.

"False and misleading information" for some product applications raised "significant questions with regard to the reliability" of KV's test data, says one document explaining why KV has been on the list since April 1993.

Until KV corrects the problems, the FDA has halted scientific review of some drugs submitted by KV for agency approval. The number of drugs is unknown.

KV, which makes timed-release drug technologies and generic drugs, has run afoul of the FDA before.

Twenty months ago, federal agents confiscated many of KV's prescription drugs following a raid on KV's headquarters, some plants and offices in the St. Louis area.

The FDA seized the drugs, charging that KV had failed to follow certain federal regulations covering "good manufacturing practices," including record-keeping and quality control.

Federal documents also say that the FDA is planning to revoke permission for KV to sell two types of prescription heart drugs.

The Post-Dispatch obtained the documents by making a request under the Freedom of Information Act. KV has never told shareholders that it is on the FDA list of companies making "false and misleading" statements.

Calls to KV's chief executive, vice chairman, corporate secretary, director of investor relations and assistant to the director of investor relations were not returned.

When a company seeks FDA approval of a product, it must submit test data showing that the drug is safe and effective. The company also must demonstrate that it can prove that its data is correct.

Companies that fail to meet this requirement can be placed on FDA's Applications Integrity Policy list, whose bureaucratic name doesn't adequately describe problems that FDA has investigated.

This list covers companies that have committed "fraud, untrue statements of material fact, bribery and/or illegal gratuities," the FDA says.

For a company to make the list, the FDA "must establish a pattern or practice of covered misconduct," Brad Williams, director of FDA's division of drug labeling compliance, said in a prepared statement.

"This has usually been falsification of original (product) applications, annual reports, supplements or bribery," he said.

If a company submits bad data, the FDA's response can be as strong as seizing products, ordering a recall or referring the matter to a federal grand jury.

KV landed on the FDA's list just before federal agents staged their raid on April 21, 1993.

"Your firm submitted false or misleading information in applications filed with this agency," says an April 14, 1993 letter to KV from Dr. …

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