The Food and Drug Administration plans to revoke permission for
KV Pharmaceutical Co. to sell three prescription drugs, charging
that KV submitted "false and misleading" information to the agency.
Some test data that KV sent to the FDA on these generic drugs
contradicted company records, the agency says.
Some reports sent to the FDA contained successful drug-test
results but omitted failing results, the FDA says.
"Because KV submitted untrue statements . . . the agency cannot
be assured of the products' stability," the FDA says in a notice to
be published Monday in the Federal Register, a daily compendium of
"Moreover, the agency can no longer be assured as to the
accuracy and validity of any of the data used to support approval
and continued approval of these (drug) applications," the FDA
Companies seeking FDA approval to sell drugs must submit tests
showing that the products are safe and effective. Makers of generic
drugs must show that their products are equivalent to brand-name
A key issue is stability: Will a drug retain its strength,
quality and purity during the period described on its label?
Brentwood-based KV has 30 days to file an appeal, and it has 60
days to submit data to support that appeal.
"KV has no comment on the proposed grounds for withdrawal since
it has not had the opportunity to evaluate fully FDA's proposal,"
the company said Friday in a prepared statement.
A revocation notice is extremely rare. The FDA issued only two
notices to the makers of drugs for human use in 1993, the last year
for which data was available.
The FDA says that nearly 15,000 companies make, repack, store,
label, test or distribute drugs for human use.
The KV drugs cited by the FDA are:
Erythromycin ethylsuccinate oral suspension (200 and 400
milligrams), a children's antibiotic.
Disopyramide phosphate extended release capsules (100
milligrams), a treatment for erratic heartbeats.
Nitroglycerin extended release capsules (2.5 milligrams), a
medication for angina pectoris, chest pains associated with heart
KV says it doesn't market those products now. "As a result,
there is no financial impact on KV's business due to (the FDA's)
proposal," it said.
KV sells two other versions of nitroglycerin and one other
version of disopyramide phosphate that aren't affected by the FDA's
But the drugs cited by the FDA were involved in dramatic
EES, the antibiotic, was the focal point of an 18-month federal
criminal investigation. Last month, KV pleaded guilty to four
misdemeanor counts of misbranding the drug.
KV will pay $600,000 in fines and costs under a plea bargain
that still must be approved by a federal judge.
In addition, KV's former director of quality assurance, John L.
Walter, pleaded guilty to one misdemeanor count that carries a
maximum of one year in jail and/or a fine of $100,000.
Disopyramide phosphate and nitroglycerin were among many drugs
seized by federal agents in April 1993 when they raided KV's
headquarters, plants and offices in the St. Louis area.
The drugs were confiscated because KV had failed to correct
manufacturing problems such as recordkeeping and quality control.
KV signed a consent decree with the FDA in June 1993 admitting
no wrongdoing while promising to improve its manufacturing
practices. Eventually, KV said, most of the seized products were
cleared for marketing by the FDA.
Charles Breen, director of the FDA's St. Louis branch, used a
driver's license analogy in describing the agency's latest action
against KV. …