The Food and Drug Administration will take punitive action against two generic drug companies implicated in a bribery scandal and plans to inspect the plants of another 20 leading manufacturers, the agency announced Wednesday.
The agency will seek to permanently remove from the market more than two dozen drugs made by Par Pharmaceuticals of Spring Valley, N.Y., and Vitarine Pharmaceuticals Inc., of Springfield, N.Y., the agency said. These drugs, which have been the focus of a federal investigation, already have been voluntarily recalled by the companies.
Par officials have admitted bribing chemists in the FDA's generics division to gain speedy approval for its drugs and Vitarine admitted that it defrauded the government by submitting false safety test data about its products.
Par produces three of the drugs the FDA is seeking to permanently remove. These include orphengesic, a muscle relaxant; orphengesic forte, a stronger version of the same drug, and hydrochlorothiazide and triamterene tablets, a combination blood pressure drug. Vitarine produces 25 drugs that the FDA is attempting to remove, including antibiotics and a generic version of the brand name blood pressure drug Dyazide.
The two companies were told the action was being taken because the original applications for approval "contained untrue statements of material fact," meaning that the firms had falsified information in seeking agency approval for the drugs.
Both firms can request a hearing on the FDA's action.
Roger W. Jordan, president of Vitarine, confirmed that his company had been notified by the FDA of the pending action and said that "scientists responsible for the misstatements in the . . . applications were discharged" and that "much of the information relied upon by the FDA for withdrawal was discovered during the course of an intensive investigation conducted by Vitarine management and was voluntarily provided by the company to the FDA."
Further, Jordan said, the company has submitted data to the FDA "adequate to correct any material misstatements" and hopes that the agency will review the data "in a timely fashion." He added: "There are no indications of any problem of safety or efficacy with respect to any of the listed products."
Par officials could not be reached for comment.
The decision to examine the plants of 20 generic companies expands federal inspections announced earlier. Initially, FDA launched inspections of 11 generic companies where they suspect manufacturing or other problems.
There have been no allegations of wrongdoing against the 20 additional companies to be checked. "These companies are not under suspicion," said an HHS source. "This is just an added layer of safety."
At the 11 companies under suspicion, the agency is reviewing drug applications, and conducting new laboratory tests of potentially questionable drugs.
The new action comes amid a widening federal investigation of the generic drug industry, which produces almost one-third of the prescription drugs made in the United States. Generic drugs are low-priced copies of brand-name prescription drugs whose patents have expired. The industry reported sales totaling $3.4 billion last year.
The generics industry has been under investigation by both the U.S. attorney in Baltimore and the House Energy and Commerce oversight subcommittee.
Three FDA chemists in the agency's generics division pleaded guilty to accepting illegal gifts from generic companies and they since have left the agency.
There are about 350 generic companies nationwide but the vast majority of generic drugs are produced by several dozen of those firms.
Vitarine admitted that it had defrauded the government by submitting false safety test data on a generic hypertension drug. The company said that it actually had performed the tests on capsules that contained the brand name drug, Dyazide, rather than its generic version. The drug was recalled by the company June 1.
Earlier this week, the FDA said that it also is investigating a major brand-name drug firm for manufacturing problems unrelated to those associated with the generics probe. The FDA refused to identify the company.
FDA sources said that the focus of the brand-name company inquiry is related to quality control and other difficulties and that the agency expects the firm "to shut down for a few weeks to clean up its problems." Further, there is no reason to believe the company's products are unsafe.