Gottlieb to Generics Industry: "Show me the money."

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  • 02/17/2006

On 2/4, blogging on a report that there was a backlog of generic drug applications at the FDA, I suggested that the agency seriously consider user-fees for this important area of responsibility. And it looks like that’s going to happen.

Scott Gottlieb, the FDA’s feisty and forward-looking deputy commissioner for medical and scientific affairs plans to tell the generic drug industry today that it is time for the government to charge its member companies fees so the agency can hire more staff and exprdite the processing of applications to market new generic medications.

In a speech he is scheduled to deliver to the Generic Pharmaceuticals Association in Florida, Gottlieb plans to say that user fees — like those paid by the makers of brand-name drugs, medical devices and animal drugs — are needed to keep up with generic reviews.

“From our perspective at FDA, we have seen user fee programs applied to our medical device and new drug programs with great success,” a copy of his speech says.

Gottlieb is scheduled to say in his speech that raising funds from generic-drug companies would allow the agency to review applications faster, to have more scientific data analyzing whether proposed new generics are equivalent to established brand-name drugs, and to address potential safety issues once the drugs are on the market.

Per Scott, “It’s not fair to compare our work in our generic drug office to our work in the new drug office, as some have done, without acknowledging that our new drugs program has benefited from funding tools that are not available to us when it comes to generic drugs.”

Use of generic drugs — which must be equivalent to the branded products that they duplicate — has been growing steadily, with more than 53 percent of prescriptions now filled with generics. That percentage could increase
quickly because an unprecedented number of major branded drugs will lose their patent protection in the next few years.

In addition to raising the user-fee issue, Gottlieb is set to outline a number of agency initiatives to speed generic reviews. One is a formal lifting of a ban on direct telephone conversations between FDA reviewers and generic drug makers. Another involves grouping bioequivalence review applications for the same or similar drugs.

You tell em Scott.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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