No Plans to Expand Review Capabilities
Yet more proof — as though any more where were needed — that the F.D.A. is a wholly owned subsidiary of big pharma.

At a time when the use of low-cost generic drugs is being embraced as one of the few ways to rein in skyrocketing health care costs, the Food and Drug Administration has a backlog of more than 800 applications to bring new generic products to the market — an all-time high.

As a result, experts say, fewer generic drugs will be available to consumers in the years ahead than the industry is ready and able to provide. The FDA, however, has told Congress that the office that reviews new generics needs no additional money, and the agency has no plans to hire more reviewers.
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Drug experts say more widespread use of generics could save billions. The Express Scripts study estimated that wider generic use could have saved $20 billion in 2004 alone. But because many generic drugs are antibiotics or other drugs that treat short-term conditions — rather than the chronic problems treated by brand-name cholesterol, blood-pressure and antidepressant drugs — only 37 percent of drugs dispensed, as opposed to prescriptions, are generic, according to IMS Health.

The FDA backlog is expected to balloon in the next few years. An unprecedented $60 billion to $70 billion a year in brand-name drugs — such as Zocor, Zoloft, Pravachol and Ambien — will come off patent in the United States over the next four years, creating opportunities for spirited generic competition and greatly reduced prices.

“It’s pretty simple — the more generics we have, and the more quickly we get them, the more savings for consumers,” said Steve Miller, author of the Express Scripts study.

Mark Merritt, president of the Pharmaceutical Care Management Association, which represents pharmacy benefit managers, said 90 percent of the time doctors and patients agree to switch to a newly approved generic by the next refill.

But without an increase in staffing at the Office of Generic Drugs, advocates of generics say, the public will get those savings more slowly, and sometimes not at all.

The view within the FDA appears to be quite different. In testimony before Congress last summer, then-FDA Commissioner Lester M. Crawford said the agency was approving on average one generic drug per day, calling that a sign that “the system seems to be working” and that “we are meeting our deadlines.” He said there was no need for additional staff in the generics office.

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