Washington Editor

WASHINGTON - Ever since President Bush appeared on television in August 2001 to inform America of his decision to fund research on certain stem cell lines, scientists, right-to-lifers and nearly everyone else with an opinion has voiced it.

Bush agreed to allow the federal government (via the National Institutes of Health in Bethesda, Md.) to fund the controversial research on about 60 (now 78) stem cell lines that met certain criteria at the time of the announcement. After America settled down from the Sept. 11 terrorist attacks, members of Congress began peeling back the layers of the Bush decision and found lots to pick at.

Some scientists, who bent the ears of Congress, believed many of the lines were not viable and difficult to access.

At a recent Senate Appropriations Committee meeting, Elias Zerhouni, director of the NIH, submitted testimony saying that in fiscal year 2002, the NIH spent about $11 million for human embryonic stem cell research to increase availability of stem cell lines for scientists. More than 60 investigators at 48 sites have received awards, including 14 investigator-initiated grants and 44 administrative supplements (used to set up labs, etc.).

Pediatric Lobby Looking For Success In The Senate

While Congress is out of session with a Memorial Day break, behind the scenes work continues, particularly for lobbyists.

One bill that hasn't generated a lot of ink would require biotechnology and pharmaceutical companies to conduct pediatric trials on products that could be used off-label in children. For the Chicago-based American Academy of Pediatrics (AAP), success of that legislation would be a major coup.

Even though the pending legislation would require companies to conduct additional trials, the Biotechnology Industry Organization and the Pharmaceutical Research and Manufacturers of America (PhRMA) haven't had a lot to say.

Jeff Trewhitt, spokesman for PhRMA, several weeks ago told BioWorld Today the legislation, known as "The Pediatric Equity Act," is acceptable because it contains an expiration date of 2007.

But it's that element of the legislation that bothers the AAP.

Marjorie Tharp, spokeswoman in Washington for AAP, told BioWorld Today AAP is displeased with the expiration, or "sunset amendment," as well as a few other technical issues having to do with enforcement.

Specifically, AAP believes the FDA should have the authority to say a drug is not properly branded or labeled if a company fails to conduct the pediatric studies. Also, the AAP wants companies that agreed to conduct pediatric trials under the Pediatric Rule of 1998 to be required to fulfill that obligation. (The Pediatric Rule of 1998 was struck down in federal court.)

As a remedy to that loss, Sen. Mike DeWine (R-Ohio) introduced The Pediatric Equity Act, which was unanimously approved by the Senate Health, Education, Labor and Pensions Committee. The Pediatric Equity Act would allow companies to seek waivers on specific products and would provide companies with an appeals process. It also would give the FDA authority to pull a product if a company refused to conduct trials. And, it applies to all new drugs and biologics that are intended to be used similarly in pediatrics and adults. (See BioWorld Today, March 24, 2003.)

Tharp said AAP is working to get enforcement changes incorporated into the legislation before it gets to the Senate floor.

"Once it gets to the floor, it is going to be very difficult to get changes, and certainly difficult in the House, with the knowledge that the House is going to follow the Senate's lead," she said.

Senators Criticize Europe For Biotechnology Ban

The Senate last week passed a resolution supporting President Bush's decision to pursue a case within the World Trade Organization against the European Union over its five-year moratorium on approving agriculture biotechnology products. (See BioWorld Today, May 19, 2003.)

Introduced by Sens. Kit Bond and Jim Talent, both Republicans from Missouri, the resolution criticizes the EU for closing its doors to bioengineered foods, a move that has costs American farmers close to $300 million a year in corn exports.

The moratorium is viewed as illegal by many in the U.S., including Bond. Other countries signing on to the WTO case against the Europeans are Argentina, Canada and Egypt. Countries expressing support are Australia, Chile, Colombia, El Salvador, Honduras, Mexico, New Zealand, Peru and Uruguay.

"Regrettably, Europe's fastest-growing exports are hysteria and under-appreciated plant scientists," said Bond, in a prepared statement asking the Europeans to "join us in our efforts to help feed the world, not scare the world."

As part of the WTO dispute, the U.S. and like-minded countries will meet with EU officials over the next two months in an attempt to resolve the issues. If, at the end of the 60 days, no resolution has been achieved, the U.S. and cooperating countries may request a panel to hear the arguments. Settlement procedures usually take about 18 months.