US Policy Quick Bits: Tax Reform, Sen. Franken, And 3D-Printing
A concise look at key US policy developments and events that unfolded over the past week, including tax reform, an update on Sen. Franken, and important policy-development updates at US FDA.
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As Takeda discloses that it is considering making a bid to acquire Shire, other big pharma companies look likely to assess their own interest in the firm. Pfizer and AbbVie are among those that may lay their cards on the table.
BFFs With FDA? Repeat Visits From Investigators Can Lead To Poor Device Quality, Recalls, Study Suggests
When a US FDA investigator is overly familiar with a company and its people, it can lead to a weaker facility inspection that might not uncover quality system problems – which in turn could lead to troublesome devices and recalls. So says a study conducted by professors at the University of Wisconsin, Indiana University and the University of Minnesota, which found that a device-maker's recall hazard increases 21% when it's inspected a second time by the same investigator. Even more concerning: The recall hazard shoots up 57% after an investigator's third audit of a firm. Might rotating investigator assignments help? And how might the agency's new "program alignment" inspectional scheme affect how often an investigator visits a particular firm?
Under tax reform legislation recently passed by Congress, a 20% tax on products made in domestic territories will adversely affect the many device firms with Puerto Rican plants that currently enjoy a lower, 4% tax rate on profits. And a second tax provision usually relied upon by medtech companies, the R&D tax credit, also loses ground under the final Senate bill passed Dec. 2.