Regulatory Focus™ > News Articles > Report: Lobbying Pushes Bioavailability Testing Provisions Into House User Fee Bill

Report: Lobbying Pushes Bioavailability Testing Provisions Into House User Fee Bill

Posted 30 May 2012 | By

A well-connected pharmaceutical company has succeeded in inserting a provision into the House's marked-up version of pending user fee legislation to require some fees go toward research to determine whether a generic is as safe and effective as the product to which it is compared, reports The New York Times.

The Times reports Endo Pharmaceuticals, soon to be renamed Endo health Solutions, hired a former Congressman and a former House staff member to lobby members of the House Energy and Commerce Committee on behalf of the proposal.

The company currently obtains roughly 30% of its income from an anesthetic patch known as Lidoderm, which is primarily used to control symptoms in Shingles patients. The company will soon lose patent protection on Lidoderm, however, and is seeking to carve out an exception to current bioavailability testing rules, explains The Times.

Endo argues current bioavailability testing, which looks at factors such as absorption, distribution, metabolism and excretion (ADME), is inadequate for testing Lidoderm because its product is not intended to enter the blood stream. Instead, Endo argues would-be generic competitors should be required to conduct in-human testing to show their products' equivalency to Lidoderm.

The company seems to have been successful thus far, with language similar to what it desired making it into the Energy and Commerce Committee's marked-up version of the Food and Drug Administration (FDA) Reform Act, reports The Times.

"The language ultimately included in the House bill […] requires the FDA to develop new ways of measuring the equivalence of 'locally acting' generic and brand-name medicines, with the help of the fees to be paid by the generic-drug makers," explains The Times. "The bill directs the agency to 'describe the amounts spent, data generated and activities undertaken.' But it does not say how the agency should rule on any particular drug."

Since the Senate's version of the user fee legislation, the FDA Safety and Innovation Act, does not contain a similar provision, the measure could be brought up during negotiations between the two chambers if the FDA Reform Act is passed in the House.

Read more:

The New York Times - Drug Maker Seeks Protection Within Bill Favoring Generics

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