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As the call for the reimportation of prescription drugs grows louder on Capitol Hill and in state capitals, the nation’s second-largest drugmaker and the industry’s trade association are embarking on campaigns to change the tenor of the debate.
As momentum builds toward pushing reimportation legislation through Congress this year, pharmaceutical industry representatives are actively trying to refocus the debate about drug pricing.
To ensure drugmakers submit appropriate data and avoid product development delays, the FDA should distinguish between valid and probable biomarkers and develop minimum data standards in its final pharmacogenomics (PGx) guidance, according to industry comments submitted to the agency.
The FDA needs to clarify the distinction between valid and probable biomarkers and develop minimum data standards in its final pharmacogenomics (PGx) guidance to ensure drug manufacturers submit the appropriate data and avoid delays in product development, according to industry comments received by the agency recently.
Time limits for drugmakers to begin dispute resolution (DR) proceedings with the FDA following facility inspections aren’t long enough and place manufacturers at a disadvantage that is likely to result in incomplete DR requests, PhRMA recently told the agency.
The time limitations defined in an FDA draft guidance on dispute resolution would place manufacturers at a disadvantage when using the system or result in dispute resolution requests that are incomplete, according to PhRMA.
Even as the FDA urges industry to move toward electronic track-and-trace technologies as part of the agency’s campaign against counterfeit drugs, drugmakers and other interested parties are still trying to figure out how to do that — and what it would cost.
PhRMA believes time limitations defined in an FDA draft guidance on dispute resolution (DR) would place manufacturers at a disadvantage when using the system or result in dispute resolution requests that are incomplete.
U.S. drug manufacturers won’t see any relief from tough market barriers in Australia, since U.S. trade representatives failed to convince that country to revise its price control system under a newly signed free trade agreement.
The press secretary for Republican Rep. Billy Tauzin reacted with scorn to a public advocacy group’s request that the Louisiana congressman be investigated for ethics violations in light of reports that he has been offered a job by a drug industry trade association.