FDALegislativeWatch

Enantiomers, Antibiotics May Benefit As Hatch Pushes Incentives In FDA Bill

Exclusivity and other incentives to encourage antibiotic development are among the details being negotiated by Senate Health, Education, Labor and Pensions Committee members as part of the FDA Revitalization Act.

MDUFMA Reauthorization Proposal In A Nutshell

Under the Medical Device User Fee & Modernization Act, FDA collects user fees from manufacturers seeking approval to market devices. In return for the user fees, which supplement Congressional appropriations, FDA is expected to meet certain performance goals to improve the timeliness of its premarket reviews. MDUFMA sunsets Sept. 30, requiring reauthorization of the program. FDA's proposal for reauthorization includes the following provisions, in summary:

Collectively, the device industry would pay 31% more in user fees in fiscal 2008 than in fiscal 2007 to meet increased FDA costs. The fees would increase 8.5% annually over the next five years.

Individual application fees would decline significantly beginning in FY 2008 as the overall financial burden is spread more broadly through the introduction of two new annual fees - one for establishment registration ($1,700) and one for filing periodic reports ($6,500). The new fees are geared to account for 50% of all device user fees, and would create a more consistent revenue stream for the agency.

Small businesses would get a bigger break as application fees are further reduced from current levels for firms with annual sales of $100 million or less.

FDA's interim review "cycle" goals would be eliminated, enabling the agency to refocus on an interactive review process, while some of its final approval decision goals are made more rigorous.

Proposal includes provisions for diagnostic imaging and IVD guidances, as well as for streamlining and expanding the "accredited person" third party inspection program.

Current MDUFMA "triggers" tied to device-specific appropriations and agency spending would be extended intact.

This article is reprinted from "The Gray Sheet" – April 23, 2007

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© FDC Reports 2007 - All Rights Reserved

Follow-On Pathway Necessary For Industry To Be Invested, Woodcock Says

"The Pink Sheet" sat down with FDA Chief Medical Officer Janet Woodcock to discuss the agency's forthcoming guidances related to follow-on proteins. Woodcock testified that the agency is in the process of developing guidance for approval of follow-on biologics under the 505(b)(2) pathway at the House Oversight and Government Reform Committee hearing on generic biologics March 26 (¹"The Pink Sheet" April 2, 2007, p. 13). Woodcock has been a long-time champion of the scientific issues that underscore the follow-on debate, including the need for the terminology of "follow-on proteins" to be clear that the products are biotech proteins.

Generic Biologics May See Life After PDUFA; Senate Mark-Up Possible In May

Leadership of the Senate Health Committee remains committed to creating a pathway for follow-on biologics, despite the fact that language was not included in an omnibus FDA bill passed out of committee April 18.

DTC Ads May Need To Stretch Beyond 60 Seconds Under Pending Rx Safety Bill

A 60-second direct-to-consumer ad could become unrealistic if legislation mandating inclusion of new warning language is passed, presenters at the recent DTC National Conference said.

Rx Safety Bill Produces Restless REMS; Core Of "KEnzi" Is Narrowed But Intact

The Rx safety oversight system outlined in the legislation passed out of the Senate Health Committee April 18 has a greater focus on active surveillance systems than the bill originally introduced by Sens. Edward Kennedy, D-Mass., and Michael Enzi, R-Wyo.

PDUFA Draft Bill Adds $70 Mil. For Rx Safety To User Fee Totals; Mark-Up Looms

A draft of the bill to reauthorize FDA's user fee program would add $70 million to the total fee negotiated by the agency and industry in order to pay for additional Rx safety oversight.

DTC Advisory Review Fee To Vary Based On Number Of Expected Submissions

Under the Prescription Drug User Fee Act agreement between FDA and industry, the level of user fees for advisory review of direct-to-consumer television ads will depend on the number of ads sponsors expect to submit for review during a given year.