PhRMA, GPhA Back Plan to Exempt Fees from Sequestration

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PhRMA, GPhA Back Plan to Exempt Fees
PhRMA, GPhA Back Plan to Exempt Fees
Plans to make fees drugmakers pay the US FDA in future exempt from mandatory Government spending cuts have been welcomed by industry groups.

Under sequestration measures enacted in March the US Food and Drug Administration (FDA) is expected to lose $85m (€63m) of the user fees paid by branded and generic drugmakers for facility inspections and drug reviews.

This would be damaging for the FDA – particularly its efforts to expedite reviews – according to Reps. Anna G. Eshoo (D-Calif.), Leonard Lance (R-N.J.), Doris Matsui (D-Calif.) and Mike Rogers (R-Mich.)​ who proposed making future fees exempt in a Bill last week.

"It's extremely troubling that the FDA's industry-financed user fees are being sequestered. If the intent of sequestration is to limit public spending, withholding private monies is counterintuitive,” said Eshoo, who serves as a senior member on the Energy and Commerce Committee.

The Pharmaceutical Research and Manufacturers of America (PhRMA) welcomed the plan, explaining that under the current mandatory budget cuts “it ​remains deeply concerned about the impact of sequestration on the FDA ability to fulfill its critical public health mission.

Prescription drug user fees cannot, by law, be used for any purpose other than to support FDA’s human drug review program. Their sequestration does not decrease the nation’s deficit, but only serves to exacerbate the severe budgetary constraints of a historically underfunded agency. This is detrimental to patients, regulatory science and public health​.”

The industry group commended the authors of the new Bill adding that “We also appreciate the efforts of members of the House and Senate Appropriations Committees to find a bipartisan resolution which would restore the FDA’s access to prescription drug user fees which have already been sequestered.

The Generic Pharmaceutical Manufacturer’s Association (GPhA) took a similar view. The organisation thanked the Bill authors for “recognizing that privately-funded user fees should be exempt from sequestration, and instead used to eliminate avoidable financial strain on the FDA.​ “

The organisation added that efforts to reduce the backlog of generic drug applications put in place by the GDUFA legislation of 2012 would be undermined if fees are sequestered.

Related topics: Regulatory & Safety, Regulations

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