A special task force convened by the scandal-plagued generic drug industry made its final recommendations yesterday, suggesting that the Food and Drug Administration assume much tighter authority over the testing and manufacture of generic drugs.
The task force, chaired by Washington lawyer Lewis Engman, was set up in February following revelations of misconduct involving more than a dozen generic drug companies.
Most of the wrongdoing involved what is known as bioequivalence, the process by which generic companies prove that their products are chemically indistinguishable from the brand-name drugs they are copying. Some companies were found guilty of falsifying data to make it appear their products were as effective and safe as existing brand-name products when they were not.
In addition, a number of generic firms were found guilty of bribing FDA officials in order to expedite the approval of drugs.
As a result, the task force focused on giving the FDA greater scrutiny over how generic products were tested and establishing clearer, objective guidelines for the approval of drugs submitted to the agency.
Among the suggestions:
That the FDA should set out guidelines for proving bioequivalence for specific categories of drugs.
That once a drug is approved, the FDA should issue a statement describing how the review of the drug was conducted and its rationale for "decisions on key issues."
That companies disclose in their drug applications any financial arrangements between themselves and testing laboratories.
That Congress give the FDA additional authority to debar individuals who commit certain offenses from further participation in the drug industry, and seek larger criminal penalties and impose civil monetary penalties on wrongdoers. The task force recommended against the debarment of corporations, which had been sought by some lawmakers, saying that it could "harm the public interest by denying consumers products whose safety and effectiveness are unaffected by the specific illegal actions."
That the generic industry develop codes of conduct, encourage reporting of adverse reactions to generic drugs, and educate health professionals on the tests and methods used to demonstrate bioequivalence.