FDALegislativeWatch

Follow-On Biologics Bill Clears Senate Cmte. With Stronger Language On Exclusivity Cap

The Senate Health Education, Labor and Pensions Committee cleared legislation June 27 that creates a pathway for follow-on biologics and provides a single, 12-year exclusivity period for innovator products.

Risk Disclosure In Drug Ads Will Be FDA's Focus After House Defeats DTC Ban

The revised language on direct-to-consumer advertising in the FDA safety bills pending in Congress no longer allows the agency to ban ads, but creates a number of new disclosure requirements for the spots.

FDA User Fee Reauthorization Bill Cleared For House Floor Action

A medical device user fee reauthorization bill was approved June 21 by the House Energy and Commerce Committee and cleared for floor debate. The legislation largely mirrors proposals previously negotiated by industry and FDA, with some additional amendments addressing postmarket safety concerns (see chart: "¹Selected User Fee Bill Amendments From House Energy and Commerce Committee:").

Follow-On Biologics Deal Gives Brands 12 Years Of Exclusivity

A 12-year exclusivity period would be granted to innovator companies by follow-on biologics legislation that will be marked up by the Senate Health, Education, Labor and Pensions Committee June 27.

Patent Reform Markup (Brief)

A markup of sweeping legislation to update the U.S. patent system for the first time in 50 years remains on the Senate Judiciary Committee's agenda for June 21 after being held over last week to allow further deliberation. A letter from several Republican committee members to Committee Chair Patrick Leahy, D-Vt., and Ranking Member Arlen Specter, R-Penn., says additional discussion among members, staff, the Patent and Trademark Office, the Department of Justice, and stakeholders is needed. The bill has moved rapidly through both houses of Congress, with contentious provisions including mandatory apportionment of damages, post-grant opposition, the granting of broad rule-making authority to PTO, and possible amendment of the Inequitable Conduct Doctrine (¹"The Pink Sheet," June 11, 2007, p. 8)....

This article is reprinted from "The Pink Sheet" – June 18, 2007

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© FDC Reports 2007 - All Rights Reserved

Senate Hears Patent Reform Concerns (Brief)

Senate Judiciary Committee postpones scheduled markup of the Patent Reform Act, S. 1145, until June 21 in response to a letter from five Republican committee members citing input from several industries including the medical device sector. The June 11 letter to committee chairman and bill sponsor Patrick Leahey, D-Vt., asks for more hearings so that the bill's provisions on apportionment of damages, post-grant opposition, and rulemaking authority for the U.S. patent office can "be more carefully examined to ensure that they do not undermine innovation, increase frivolous litigation, or undermine property rights" (¹"The Gray Sheet" June 4, 2007, p. 3). Companion bill H.R. 1908 awaits markup in the House Judiciary Committee after passing out of subcommittee last month....

This article is reprinted from "The Gray Sheet" – June 18, 2007

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© FDC Reports 2007 - All Rights Reserved

DTC Ads Should Include Clearer Risk Information, PhRMA Review Panel Urges

Direct-to-consumer drug advertising should strive to present health risk information with few distracting background visuals or activities, an outside review panel convened by the Pharmaceutical Research and Manufacturers of America is recommending.

FDA Not Saying What House Democrats Want To Hear

Henry Waxman and House Democrats held an Oversight and Government Reform Committee meeting on GlaxoSmithKline's Avandia to highlight the need to stronger postmarketing oversight FDA.

Committee Chairman Waxman, D-Calif., is hoping to advance his proposed House Prescription Drug User Fee act reauthorization bill that contains more stringent FDA's drug safety authority provisions than its counterpart which recently passed the Senate (1"The Pink Sheet" May 14, 2007, p. 16).

However, Democrats were unable to prompt FDA Comissioner Andrew von Eschenbach to acknowledge that increased regulatory authority would help the agency direct and enforce postmarketing commitments. The following is part of a discussion between John Tierney, D-Mass., and von Eschenbach during the June 6 hearing.

PTO Wants Inequitable Conduct Doctrine Revised in Patent Reform Bill

With identical patent reform legislation moving rapidly through both houses of Congress, the U.S. Patent and Trademark Office is asking that the inequitable conduct doctrine be revised to encourage applicants to provide more and better information to examiners about their inventions.

BIO's Lucky Number 7? Follow-On Biologics Debate Offers Exclusivity Midpoint

A "split the difference" approach to determining how much exclusivity innovators would receive under a pathway establishing follow-on biologics would give brand products seven years of data exclusivity.