Get rid of worm ridder, district judge rules

FDA Consumer, Sept-Oct, 1997 by Isadora Stehlin

Because Bingman Laboratories Inc., of Sarahsville, Ohio, had made and sold WRM-RID Dog Wormer since 1955, company president W.D. Semple believed the product had the government's tacit approval. FDA believed differently.

On March 31, Judge Joseph Kinneary, of the U.S. District Court for the Southern District of Ohio, granted FDA's motion for summary judgment and ordered the destruction of almost $26,000 worth of WRM-RID, previously seized by the government. The court agreed with FDA that the product was illegal because the company never submitted data to show safety or effectiveness of the product as required by federal law. The company had argued that its product was legal because it had been on the market before effectiveness data became a requirement for approval of new animal drugs.

Semple promoted WRM-RID for parasitic tapeworm, hookworm and roundworm infestations in dogs and cats. These infestations can cause vomiting, diarrhea, loss of appetite, weight loss. anemia, and death.

The two active ingredients in WRM-RID are piperazine phosphate and arecoline hydrobromide. Piperazine phosphate is approved for roundworm infestation in dogs and cats. Arecoline hydrobromide is not approved at all.

The combination of the two drugs in one product is not approved "nor is it recognized by the veterinary profession for any use," Susan Homire, D.V.M., an FDA veterinarian, told the court. She added that an extensive scientific literature search produced no published studies on the safety or effectiveness of WRM-RID or any product with the same combination of active ingredients for the uses recommended in the product labeling.

FDA has inspected Bingman Laboratories periodically since it began marketing WRM-RID in the 1950s but did not cite the company for any deficiencies until April 9, 1991, when FDA's Cincinnati district office informed Semple by letter that the agency considered WRM-RID an unapproved new animal drug. FDA based its decision on, among other things, the fact that there was no new animal drug application on file with respect to the product's use or intended use.

Semple responded in letters dated April 17 and Aug. 26, that WRM-RID was not subject to the requirement for a new animal drug application because it had been on the market before an Oct. 10, 1962, amendment to the 1938 Federal Food, Drug, and Cosmetic Act added a requirement for effectiveness for all drugs.

Although discussions with staff from FDA's Center for Veterinary Medicine did not convince Semple that WRM-RID was a new animal drug, he told agency investigators during inspections in August and November 1992 that he would stop making the drug until the issue was resolved.

Members of the center's division of compliance and surveillance met with Semple again in April 1993 to discuss the need for a new animal drug application for WRM-RID, but no progress was made in changing Semple's mind.

During an inspection in March 1994, Diane McDaniel, an investigator with FDA's Columbus resident post found that the company was still making WRM-RID. When McDaniel asked for production records, the plant manager said he would first have to talk to Semple, who conducted business from his home in Florida.

Semple called McDaniel the next day and told her that he kept all production records at his home and would send her current labeling and production records for the most recent batch of WRM-RID. McDaniel returned to the plant to collect a sample.

Within a week, McDaniel received a letter from Semple, but the labels and production records he said he would send were not included. Instead, Semple wrote, "For your information, there has been no change in the WRM-RID formula, manufacturing process, label claims and dosage directions since 1955."

In April 1994, Evelyn Forney, a compliance officer with FDA's Cincinnati district office recommended that the agency seek seizure of the product because Semple continued to deny that WRM-RID was covered under the 1962 amendment.

The Center for Veterinary Medicine agreed with Forney's recommendation, and in August, the U.S. Department of Justice, at FDA's request, filed a complaint for forfeiture and condemnation. On Sept. 12, U.S. marshals seized 154 kilograms (339 pounds) of WRM-RID, as well as labels and packaging for the product, at the Sarahsville plant.

Semple filed a claim for ownership Sept. 22, and on Oct. 13, he filed an answer to the government's complaint. He continued to assert that WRM-RID was on the market before the 1962 amendment and therefore exempt from FDA approval under a "grandfather clause."

For Semple's assertion to be true under the 1962 amendment he had to prove that the current WRM-RID was:

* chemically identical to the drug in existence on Oct. 9, 1962, the day before the 1962 amendment took effect

* commercially available on Oct. 9, 1962

* generally recognized as safe on that date

* not covered by a new drug application on that date

* labeled exactly the same as it was before the 1962 amendment took effect.

Semple insisted that "there has been no change in the WRM-RID formula, manufacturing process, label claims an dosage directions since 1955." But when asked to submit to FDA documentation to back up these claims, he never did.