Washington Editor

WASHINGTON - Allegations of an improper relationship waylaid a vote on Lester Crawford's nomination as the FDA's permanent commissioner.

The 66-year-old already has served as its acting head for the past year, and President Bush recently officially nominated him to take over the position. But charges against him, made anonymously by an FDA employee, relate to a personal relationship Crawford allegedly had with an unnamed female official at the agency. That information was leaked to The Washington Post by undisclosed Senate staffers, who said the allegations also include questions about promotions received by the woman in question.

The rumors prompted a congressional committee to postpone a hearing on the appointment, which had been scheduled for last week, and request an internal agency investigation into the matter.

The Senate Committee on Health, Education, Labor and Pensions had planned to take a vote on Crawford four weeks after the initial hearing, at which he answered a variety of questions on issues related to COX-2 drug safety and similar matters involving antidepressants, drug reimportation and the status of an application to make the Plan B morning-after contraceptive available over the counter. (See BioWorld Today, March 19, 2005.)

He also thanked his wife, who was in attendance, for her long support of his career.

But before last week's planned meeting, word circulated that the nomination would be blocked by Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) because of their questions surrounding Plan B. They have urged the FDA to speed its decision on making it an over-the-counter product, but the agency has yet to render a verdict.

The new inquiry will delay any further deliberations on Crawford's nomination. Crawford, who has enjoyed a long FDA career as its deputy commissioner and as its administrator of the food safety and inspection service, received Bush's nomination two months ago. The agency has been without a permanent commissioner since Mark McClellan left more than a year ago to serve as administrator of the Centers for Medicare & Medicaid Services. (See BioWorld Today, Feb. 23, 2004, and Feb. 16, 2005.)

White House statements continue to back Crawford. Should the appointment eventually move forward through the committee, it would remain subject to confirmation by the full Senate body. A rescheduled date for the delayed committee meeting has yet to be announced.

New Stem Cell Legislation Introduced

Pushing for federal incentives for state stem cell programs, Rep. Nancy Johnson (R-Conn.) introduced the Stem Cell Research Investment Act of 2005 that would allow individual states to issue $30 billion in zero-interest bonds to fund their own stem cell research initiatives. The federal government would provide a tax credit to the bondholder in lieu of interest payments, relieving states of their financial burdens.

"States are spearheading cutting-edge research that holds great promise for breakthroughs on some of the most debilitating diseases," Johnson said, adding that it's important to "not let the financial burden fall completely on the shoulders of local taxpayers and state governments."

Under the bill, the federal government would make $10 billion available in bond authority to the states in each of the next three years. States would be able choose to issue bonds specifically to fund stem cell research programs. The bond authority would be allocated on a first-come, first-serve basis with no more than 50 percent going to any one state, and all are eligible, regardless of whether or not they already have stem cell research programs.

There would be strict limitations on the types of embryonic stem cells that would qualify for research. For example, the embryo would need to be created for fertility treatment purposes only, no longer of clinical use and otherwise would be destroyed. Also, those for whom embryos are created would have to agree to donate the embryo, and neither they nor fertility clinics or labs that help create them can receive payments for donating the embryo for scientific study.

The bill is patterned on a model set forth in California, the $3 billion bond issue authorized under Proposition 78, and is backed by a bipartisan team of congressional supporters including Reps. Mike Castle (R-Del.), Barbara Lee (D-Calif.), Jim Ramstad (R-Minn.), Loretta Sanchez (D-Calif.), Christopher Shays (R-Conn.), Rob Simmons (R-Conn.) and Leonard Boswell (D-Iowa).

Patent Suit Set For Supreme Court

The Supreme Court is scheduled Wednesday to hear oral arguments related to a patent case between Integra LifeScience Holdings Corp. and Merck KGgA, a lawsuit that involves a research exemption to patent infringement.

Specifically, the defendants at Merck, of Darmstadt, Germany, were involved in research related to a genetic sequence called the RGD peptide. Integra, of Plainsboro, N.J., holds patents related to the RGD peptide and offered to license its intellectual property upon learning of Merck's activities. Merck declined, asserting that its research was exempt to patent law because of a provision in the Patent Act, Section 271(e)(1).

Integra's suit followed.

At issue for drug developers is whether they will be able to continue early stage research without legal patent rights, or whether they will have to obtain licenses for intellectual property earlier in the research stage. The latter scenario could produce lengthier and costlier drug development.

FDA Authority Hit By Judge

The agency's ban on the nutraceutical ephedra was struck down by a federal judge following a lawsuit brought forth by some makers of the weight-loss product. It was pulled off the market a year ago after being linked to more than a hundred deaths.

But two companies that marketed a low-dose version of the product - Park City, Utah-based Nutraceutical Corp. and its Solaray subsidiary - challenged the ban in federal court. However, the decision doesn't necessarily mean that the product will return to the market.

The judge ruled that the FDA must determine doses at which ephedra is unsafe, rather than making a sweeping ban of all doses of the substance. It is thought that the ruling will not reverse the ban of high-dose ephedra.

Bush Makes HHS Nomination

President Bush nominated Alex Azar to serve as deputy secretary of the Department of Health and Human Services (HHS). His nomination remains subject to Senate confirmation. Azar served for four years as the general counsel at HHS.