FDA Lagging on Generic Drug Approvals

According to a Washington Post report, the FDA has a record number of generic drug applications waiting for agency action. The backlog has reached more than 800 and, without expanding the review capabilities of the agency in the area of generic drugs, “experts say, fewer generic drugs will be available to consumers in the years ahead than the industry is ready and able to provide.”

Remarkably, the agency has told Congress that has no plans to expand the review process by hiring additional reviewers or requesting increased funding.

What is troublesome about this situation is that the pharmaceutical industry now funds more than 50% of the FDA’s fast-track approval process for branded drugs, and overall, there are some 2,500 employees assigned to review an average of about 150 New Drug Applications (NDA) a year. The new drug evaluation and monitoring budget was about $400 million last year.

Generics, however, have a small budget ($26 million in 2004), an enormous number of new applications each year (almost 800 in 2005 alone), and a staff of only about 200 to review them. Having the generic industry fund the approval process with “user fees” similar to the brand-name payments has been suggested.

Thus, as generics become more critical to the effort to keep healthcare costs down and when these drugs are often the only ones the poor, elderly, and uninsured can afford, they are being tied up in a bureaucratic quagmire.

Significantly, generic applications, which are less complicated and should take less time to review, are taking a longer average time to act on than the more complex NDAs.

At the same time, however, expensive, often unnecessary “me too” or combination brand name drugs are sailing through the approval process without any delay.

As reported in the Washington Post, Rep. Henry A. Waxman (D-Calif.), a sponsor of the law that made generic drugs more easily available and no supporter of the big pharmaceutical companies, stated: “This huge backlog of generic applications is just unacceptable. “This is the time for the FDA to be ramping up its generic reviews, not to be falling so badly behind.”

Moreover, the “branded industry has to be delighted by this backlog,” said Jake Hansen, vice president for government affairs for Barr Laboratories Inc., a maker of generic drugs. “If they can’t stop competition in the courts, stopping it as applications go through the regulatory process is just as effective. For consumers, to flatline or cut funding makes absolutely no sense.” (WP 2/4/06).

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