Senate Releases CBO Report Scoring Costs of PDUFA Legislation and more

May 19

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Advocacy at a Glance offers you the bullet point summary of current advocacy issues associated with the goals of the Alliance for a Stronger FDA.

Senate Releases CBO Report Scoring Costs of PDUFA Legislation. Just prior to taking their user fee reauthorization bill to the Senate floor, the Senate HELP Committee released the CBO report on the costs of the legislation. The report can be found by clicking here. The report concludes that:
- All the user fee money collected will be spent, but because outlays (actual expenditures) lags spending authority (and collection of the funds), the bill has a positive 5 year total and marginally contributes to reducing the deficit.
- There is about $100M per year in new non-user fee programming, rising to about $200M per year by the fifth year.
- There may be some impact on VA, Medicare, Medicaid, etc. drug spending but the plusses and the minuses just about even out (our comment: the analysis is based on so many assumptions that it probably doesn’t have much predictive value).

With the Senate appropriations committee having reported its FY 13 FDA funding and now with the release of the CBO estimates to correct the Senates user fee numbers, this week's Analysis and Commentary section includes a snapshot of the Senate position on FY 13 FDA funding, including user fees.

Drugs Approved Faster in US than Europe or Canada According to an Article in the May 16 Issue of the New England Journal of Medicine. The article concludes that: For novel therapeutic agents approved between 2001 and 2010, the FDA reviewed applications involving novel therapeutics more quickly, on average, than did the EMA or Health Canada, and the vast majority of these new therapeutic agents were first approved for use in the United States.

Pre-sequester Funding Situation for FDA in FY 13 Getting Clearer