The commissioner of the federal Food and Drug Administration has declared war on the already embattled generic drug industry, which has been under fire for violating federal safety or manufacturing standards.
"We are not going to rest until we get to the bottom of this. We are angry and embarrassed, just as I think consumers are," said Dr. Frank E. Young in a Deseret News interview Monday night.Young, in Salt Lake City to address Utah Medical Device Conference at the Hilton Hotel Tuesday, said the FDA is intensifying its probe of those generic drug companies that have have been "absolutely despicable, scurrilous and irresponsible."
At least 10 companies making generic drugs - including some of the biggest - recently rocked public confidence through revelations that they had substituted the original patent drug for the generic drug in tests to win FDA approval.
Others, Young said, falsified information and "some even stooped to offering gratuities to FDA employees, and regrettably three accepted. They are dismissed, no longer there, and it is a great embarrassment to us."
Young is overseeing the investigation of the 30 most prescribed generic drugs. The drugs constitute 76 percent of new prescriptions for generics. The study will be completed in 11 weeks, but in the meantime the FDA is inspecting 11 firms on a for-cause basis and will investigate 20 more.
"We will refer any problems they find to the appropriate regulatory authority, and if there are any unsafe products, we will pull them off the market immediately," Young stressed. "We have not found evidence of anything unsafe."
Still, FDA officials admit that the generic-drug crisis has been a blow to sick people who believed assurances of the companies that generic medication was not only cheaper but just as good as the brand-name kind.
The problem is the latest to plague the gigantic federal agency, which also has been criticized for its snail's pace procedures in approving new drugs.
Young, a New York-born physician and former vice president for health affairs at the University of Rochester, said many steps have been taken to remedy this.
In coordination with Utah Sen. Orrin Hatch, ranking Republican on the Senate Labor & Human Resources Committee, the FDA has reduced by 20 percent the time required for a drug to be introduced, tested and put on the market, Young said. Total development time for drugs for the desperately ill - people with AIDS, Alzheimer's, major heart problems - has dropped from 7.8 years to 4.2 years.
The FDA is also working closely with Hatch, and it has succeeded in making new drugs quickly available to the desperately ill through "treatment investigational new drug status," or IND, which allows the use of a new drug on target groups.
Young said the most recently approved IND treatment drug - surfactant - "was great news to little people." The breakthrough drug, tagged by specialists as a significant advancement in perinatal care, is being used in Utah to save the lives and reduce the long-term complications of Mountain West newborns suffering from hyaline membrane disease.
Neonatologists at Primary Children's Medical Center, LDS Hospital and the University of Utah Health Sciences Center, where Young also spoke Tuesday, are among the 12 centers in the United States authorized to use surfactant to "rescue" newborns with severe lung problems.
Yet, said Young, the drug hasn't completed clinical trials. Nor has its manufacturer submitted an application to the FDA for evaluation.
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Medical industry
-Utah has more than 100 medical-device firms, which employ 4,000.
-Two firms - Ballard Medical and Utah Medical - are among the six medical-device firms listed with the 100 fastest-growing U.S. companies.
-Several internationally recognized medical devices, such as the artificial heart, originated in Utah.