Latest Draft Of Rep. Dingell’s Global Drug Safety Bill Would Exempt Small Firms From Inspection Fees
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA would have flexibility to set inspection schedules; committee may use bill to address FDA executive bonuses
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Small drug companies could get a financial break under inspection provisions of the House Energy and Commerce Committee's evolving bill to improve safety in global drug manufacturing and distribution. The latest draft from panel Chairman John Dingell, D-Mich., and colleagues would allow FDA to waive or reduce inspection fees for small firms. The draft language on drug safety is being circulated this week to panel members and stakeholders to obtain their input on a number of issues, including the definition of a small business. Sections of the draft FDA Globalization Act dealing with food and medical device safety are still being ironed out by committee staff. The legislative effort was sparked last year by several incidents of contaminated imports and later gained additional impetus from the importation of the contaminated active ingredient for heparin. The initial focus was on increasing inspections of imports and foreign facilities with funds provided by fees on imports. The new discussion draft would impose fees on both domestic and foreign drug establishments to fund their inspections. Center for Drug Research and Evaluation Director Janet Woodcock estimated during May 1 committee hearings that the agency needs several hundred million dollars to improve its inspection programs (1 (Also see "FDA Should Be Allowed To Schedule Foreign Inspections Based On Risk – CDER’s Woodcock" - Pink Sheet, 1 May, 2008.)). The previous discussion draft called for inspection of every facility every two years. The new draft gives FDA greater leeway to establish a schedule based on risk factors for a particular facility, as requested by Woodcock at the hearings. However, the draft would still provide a minimum requirement, now proposed at every four years, although the draft flags this as an item for continued discussion. The discussion draft includes a new section that would require drug manufacturers and processors to institute quality risk management plans. Such plans would have to include provisions for assessing the qualifications of suppliers, monitoring incoming materials and instituting specifications and test methods to verify drug ingredients' identity, quality, strength and purity. The committee also seeks input on electronic pedigree provisions, country of origin labeling and civil penalties. Dingell and panel colleagues have been critical of FDA bonuses to top-level officials and have included a placeholder in the draft bill to add language on this issue. - Cathy Dombrowski ([email protected]) |