Washington Editor

WASHINGTON - Just before breaking for the 4th of July recess, a Senate committee voted unanimously in favor of a stem cell research-related bill, albeit a rather non-controversial one.

The Health, Education, Labor and Pensions committee last week approved legislation labeled the "Stem Cell Therapeutic and Research Act of 2005," which would allow qualified cord blood stem cell banks to assist in establishing and maintaining a National Cord Blood Stem Cell Bank Network. A measure to develop a national infrastructure for collecting stem cells derived from cord blood, it would establish a system for donor consent, make cord blood units available to transplant centers for stem cell transplantations and make those not appropriate for clinical use available for peer-reviewed research.

The legislation, introduced by Sen. Orrin Hatch (R-Utah), authorizes up to $34 million of support in the next fiscal year, with another $53 million in each of the following fiscal years up to 2010. "This bill is a critical step in demonstrating the commitment of the federal government behind this new, widely supported field of stem cell research," he said in a prepared statement. Hatch, who also supports authorizing additional federal funding for embryonic stem cell research, called the measure a "compromise bill" to lawmakers opposed to embryonic stem cell research.

Original cosponsors include Sens. Chris Dodd (D-Conn.), Richard Burr (R-N.C.), Jack Reed (D-R.I.) and John Ensign (R-Nev.).

The funding not only covers the establishment of the National Cord Blood Stem Cell Bank Network but also reauthorizes the bone marrow registry program. Sen. Mike Enzi (R-Wyo.), the committee's chairman, said the legislation had strong support and pledged to work for a quick passage by the full Senate. Hatch's office noted that it was developed in consultation with the House of Representatives and is expected to pass Congress and reach President Bush's desk later this summer.

The bill is S. 1317.

More Divisive Bill Still On Table

A bipartisan group of senators last week held a news conference in support of a bill designed to expand the federal funding for embryonic stem cell research, "The Stem Cell Research Enhancement Act."

That measure is a companion to legislation that passed the House last month by a vote of 238-194. Among those in attendance were Hatch and Sens. Gordon Smith (R-Ore.), Tom Harkin (D-Iowa), Dianne Feinstein (D-Calif.) and Edward Kennedy (D-Mass.). In collaboration with various patient groups, they said they would promote the legislation across the country during this week's recess.

Harkin is a sponsor of the bill, which would allow federal funding for stem cell research using lines derived under strict ethical requirements from excess in vitro fertilization embryos, regardless of the date they were derived. Smith serves as the chairman of the Senate's Special Committee on Aging.

Its House counterpart is co-sponsored by Reps. Mike Castle (R-Del.) and Diana DeGette (D-Colo.). Both bills have solid bipartisan footing, and observers expect the Senate version to pass before a final draft moves to the White House. If so, President Bush is expected to issue his first veto, and opponents to the bills say there is not enough support in Congress to overcome a veto.

Bill Proposed For Medical Tort Reform

New legislation has been introduced to promote tort reform in the medical space.

Sens. Max Baucus (D-Mont.) and Enzi are co-sponsoring a bill called the Fair and Reliable Medical Justice Act as an alternative to current medical tort litigation. The proposed measure also represents a different approach to other bills that seek to cap medical malpractice compensation.

Instead, the Baucus-Enzi legislation would establish pilot programs on a state-by-state basis to help them test systems to resolve health care-related disputes through three different means: early disclosure and compensation, which encourages health care providers to disclose medical errors and offer just compensation for patients' injuries; administrative determination of compensation, through which an administrative board of patient advocates, providers and attorneys would establish classes of avoidable injuries and determine compensation rates for each; and special health care courts that would be presided over by judges with health care expertise. Under the latter model, states also would have to provide an appeals process for reviewing decisions of the health court.

The bill, which would provide $500,000 in seed money to help each state develop an application for the program, does not preclude access to traditional tort litigation system as part of the dispute resolution process.

FluMist Subject Of FDA Reprimand

The FDA recently censured MedImmune Inc. for a consumer-directed flyer on FluMist (Influenza Virus Vaccine Live, Intranasal).

In a letter to the Gaithersburg, Md.-based company, the agency's Office of Compliance and Biologics Quality, part of its Center for Biologics Evaluation and Research, called the product's vaccine assessment tool flyer "misleading" for leaving out risk-associated material. Specifically, the agency further chastised MedImmune for "failing to include sufficient information on risks and adequate directions for use," adding that the company "encouraged the potentially unsafe use of FluMist."

It took issue with statements on the flyer that noted "risks associated with all vaccines, including FluMist," and that said "like any vaccine, FluMist does not protect 100 percent of individuals vaccinated." In calling such statements minimal, the FDA said MedImmune should revise the flyer to include broader risk information related to contraindications, warnings, precautions and adverse reactions.

The FDA noted that the promotional material's verbiage violated a section of the Federal Food, Drug, and Cosmetic Act, and its dissemination is in violation of another section of the law.

In addition, the agency also called the company on an apparent labeling mistake, noting that the flyer incorrectly stated the indication for healthy adults between 19 and 49 when FluMist actually is indicated for healthy adults between 18 and 49, among others. MedImmune was told to immediately cease distributing the promotional material and submit a written response within 10 business days, as well as plans to supply corrected flyers to those that already received the promotional material in question.

In a conclusion, the FDA warned that a failure to comply could result in regulatory action, including seizure or injunction, without further notice.

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