Listen up, eardrop makers: FDA says get products approved or face prosecution

In two actions announced on Wednesday, the FDA made it clear it would not tolerate drug manufacturers and distributors selling unapproved prescription drugs in the U.S. that it says put consumers at risk. It announced a federal permanent injunction against a company that continued to sell suppositories after being repeatedly warned they needed to be evaluated and approved by the FDA. Separately, it warned makers of unapproved children's eardrops they may face prosecution if they don't stop selling them.

The injunction and consent decree were entered by a federal judge against Acino Products of Hamilton, NJ, and its president, Ravi Deshpande. The FDA said the company had been peddling unapproved hydrocortisone acetate suppositories under the brand names Rectacort-HC and GRx HiCort 25 to treat inflamed hemorrhoids, chronic ulcerative colitis and other medical conditions. It said that Deshpande was shipping products for Ascend Laboratories, which is a subsidiary of Indian drugmaker Alkem Laboratories, but never got them approved.

FDA investigators inspected the Acino Products facility in March 2014, August 2014, and again in January. Each time, the FDA said that Deshpande was warned that he could not continue to manufacture and distribute the unapproved drugs and that the company needed to destroy what it had on hand. The injunction is to guarantee that happens.

Last fall, the FDA oversaw the destruction of what it estimated were about $11 million worth of Ascend products that it had federal marshals seize from an Ohio warehouse in May 2014. The FDA also got a permanent injunction that banned Ascend, and anyone associated with the company, from manufacturing and distributing any drugs until it gets them approved by the FDA.

The actions against Acino and Ascend may serve as an example for manufacturers of unapproved children's eardrops. Without naming names, the agency announced on Wednesday that it had put manufacturers of what are often referred to as otic eardrops on notice that they can face prosecution if they continue to manufacture or distribute products that have not been run through the FDA process. It pointed out that there are FDA-approved drops for treating ear infections that are unaffected by the warning. But it said it has found any number of products that contain active ingredients, such as benzocaine and hydrocortisone, that have never been evaluated by the FDA for safety, effectiveness and quality.

Because the products have not been evaluated, the agency pointed out that consumers have no way of knowing if patients are getting a proper dose or if the products are contaminated. It said the labels fail to warn consumers they are not FDA-approved.

"Taking enforcement actions against these unapproved products will protect patients from unnecessary risks," Cynthia Schnedar, director of CDER's office of compliance, said in a release. "There are many FDA-approved prescription products to treat ear infections, so we expect little or no impact on patients from the removal of these unapproved and potentially unsafe products."

- read the FDA Acino consent decree announcement
- here's the FDA Medwatch notice on eardrops
- here's the FDA release on eardrops