Only 2 of 12 Generic Drug Makers Found Free of Problems in FDA Investigation

WASHINGTON —  The Food and Drug Administration told members of Congress on Monday that investigators gave a clean bill of health to only two of a dozen generic drug manufacturers specially targeted for investigation.

The preliminary results of the FDA’s investigation showed that 10 of the firms had problems that included violations of “good manufacturing practices,” sloppy record-keeping and apparent frequent deviations from production specifications, FDA investigators told members of the House Energy and Commerce subcommittee on oversight and investigations. The firms investigated include several already implicated for bribery and fraud.

The firms were targeted for special investigation because FDA officials suspected that they would find compliance violations. In addition, the agency recently announced that it intends to inspect another 20 generic plants where no problems are suspected. Also, the FDA is analyzing the nation’s 30 leading generic drugs to be certain that they are safe and effective.

Industry Being Investigated

The generic drug industry--which includes 350 firms--has been the target of a widening federal inquiry by the subcommittee and the U.S. attorney in Baltimore.

Thus far, there is no evidence that generic drugs on the market are dangerous. Nevertheless, subcommittee Chairman John D. Dingell (D-Mich.) declared: “We can no longer be sure that generic drugs are safe and effective because we can no longer be sure that . . . the basic contracts between FDA and the generic drug firms do not contain materially false information.” Dingell promised a relentless investigation by the subcommittee “until the necessary changes . . . are achieved.”

Paul F. Vogel, deputy director of the FDA’s generic drug compliance staff, told the subcommittee that the agency’s inquiry had found numerous instances of missing paper work and departures from standard manufacturing practices, which usually involve equipment or labeling.

Vogel said the most serious irregularities found by the FDA involved firms trying to submit another company’s drug for testing in place of its own and manufacturing drugs with formulas different from those that already had been approved by the agency.

Difference in Processing

One company, Vogel said, “changed the way it processed the active ingredient” in an epilepsy drug without agency approval, causing problems with the way the drug dissolved in the bloodstream. This “could result in sub-therapeutic blood levels,” Vogel said. Then, he added, “after making the change, (the company) did not assess the impact of the change.”

In another case, he said, a firm was forced to recall a powerful hypnotic tranquilizer after it was incorrectly labeled as an antihistamine. “A young boy had to be hospitalized,” Vogel said. “Fortunately, he recovered.”

Dingell said the results of these inspections “raise very serious questions about whether the industry can be trusted to supply accurate information to the FDA . . . and whether that information remains accurate for those generic drugs which have been approved for sale to American consumers.”

The two companies where FDA officials said they found no problems were Able Laboratories and Zenith Labs, both of which have “minimal production and sales.” Vogel said that Able produced only one generic drug and that Zenith “was just emerging from bankruptcy.”

Firms Found Lacking

The companies where the FDA found irregularities included Bolar Pharmaceuticals, which has already been accused of trying to substitute a brand-name drug for its own generic during pre-approval testing; Par Pharmaceutical Inc. and its subsidiary, Quad Pharmaceuticals, which have pleaded guilty to offering bribes to FDA chemists in an attempt to gain speedier approval for their drugs, and Vitarine Pharmaceuticals, which has admitted falsifying test data for one of its generic drugs.

The other firms were American Therapeutics Inc., Barre-National, Pharmaceutical Basics Inc., Superpharm Corp., Watson Laboratories and Pharmafair.