Drugmakers have much at stake in legislation to refund the FDA, but Endo Health Solutions ($ENDP) may be trying to get a little something special for itself.
While most of the attention has focused additional fees paid by drugmakers to expedite reviews, and new authority for the FDA to inspect and oversee foreign drug manufacturing, Endo has apparently had something much more specific in mind. The New York Times reports that lobbyists for Endo have gotten language inserted into the proposed House bill requiring the FDA to use some of the extra user fees to conduct tests specific to generic copies of Lidoderm, the company's most prized drug.
The patch for shingles relief contributed $825 million in sales to Endo last year, about 30% of its total, so generic competition looks particularly foreboding to the company. Endo has argued in a "citizen petition" to the FDA that its product is unique because it delivers drugs directly to the affected area, not through the bloodstream, making traditional tests by generic competitors on absorption rates insufficient. If competitors have to do additional tests to show how much drug and how their products deliver, it will cost them time and money and provide Endo with some relief of its own.
The Times says neither the company or the lobbying firm would comment, but that Congressional aides acknowledge compromise language was included in the bill. It specifies the FDA must use some of the fees from generic drugmakers to develop new measurements of the equivalence of "locally acting" generic and branded drugs. It requires the agency to "describe the amounts spent, data generated and activities undertaken," but doesn't say how regulators must decide upon those measurements, reports the Times.
While Senate bill writers also were lobbied on Endo's concern, that version of the bill, passed 96-1 last week, does not contain the same language. So if the House passes its bill this week as expected, the special provision could get lost in negotiations over reconciling the two versions, or not.
- read The New York Times story
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