Washington Editor

WASHINGTON - A federal judge has delayed issuing a ruling in a case brought against the District of Columbia in opposition to its proposed drug price control measure.

"He does not want to rule until the 30 legislative days have run," explained Charles Lucas, a vice president at the Biotechnology Industry Organization and its general counsel, "because he does not want to interfere with the congressional process."

Congress has ultimate oversight authority on laws passed here per a home rule bill that makes D.C. legislation subject to congressional review by Senate and House committees for 30 legislative days. That period is expected to expire on Dec. 9 or 10, Lucas told BioWorld Today, and there is little chance that the federal lawmakers will do anything about the Prescription Drugs Excessive Pricing Act before then.

But Judge Richard Leon of the U.S. District Court of the District of Columbia said "he did not want to act, in his mind, prematurely by ruling before Congress has had the full legislative opportunity to decide whether it wants to do something," Lucas added. "It's just a matter of deference to Congress."

At the two-hour hearing held last week, BIO was seeking a preliminary injunction against D.C.'s price control measure, along with the Pharmaceutical Research and Manufacturers of America (PhRMA).

The law was written to allow suits against drug companies by the D.C. government or an individual if the wholesale price of a patented prescription drug in D.C. is 30 percent higher than the price in four countries with price control measures in place: Australia, Canada, Germany or the UK.

BIO has charged that the D.C. act is unconstitutional, contending that it is pre-empted by federal law that relates to the dormant commerce clause, the foreign commerce clause and the supremacy clause. (See BioWorld Today, Oct. 31, 2005.)

"The judge has consolidated both the preliminary injunction motion and the hearing on the merits," Lucas said. "He went through all three of the major constitutional issues that we have raised."

Until the case comes back up, BIO and PhRMA will work on addressing a new wrinkle raised by D.C., a standing issue, which relates to whether the trade associations' members have established immediate injury if the statute takes effect. They have a week to submit their responses.

"We would anticipate his ruling would address all three of our issues," Lucas said, "and will be based, in essence, on the record that exists before the court at this time."

But should the judge, who said he has 280 pending cases before him, fail to act after the 30 legislative days expire, the law will take effect until he rules. But Lucas concluded with the hope "that he will rule very promptly" after the congressional review period concludes.

Travel Rules Could Curb Disease Spread

Seeking to update measures aimed at thwarting the spread of communicable diseases, federal health officials are proposing more transparency from the traveling public.

Specifically, the plan calls for more passenger information from U.S.-bound international flights and cruises to track possible exposures, an effort that partly stems from the spread of severe acute respiratory syndrome two years ago. Notably, fears over avian influenza represent a more immediate backdrop to the proposal, released last week by the Centers for Disease Control and Prevention.

Bird flu, of course, remains on the minds of many these days, especially in light of the recent reports of its possible spread into the western Canadian province of British Columbia. A duck there tested positive for a type of bird flu last week, although Canadian health officials classified the strain as benign and therefore different than the H5N1 virus that is feared for its lethal nature.

Bird Flu Legislation Still Stalled

New hurdles have popped up in the fight for federal bird flu funding over liability protection.

Proponents of legislative language to shield vaccine makers from lawsuits have long argued that such a measure would spur further development in the space, which has been lacking for years. But opponents have charged that such liability protection amounts to a special favor to the drug industry.

The argument essentially pits Republicans against Democrats, with the former largely in favor of lawsuit limitations and the latter leaning in the other direction.

Previously reported problems surfaced over the cost of President Bush's $7.1 billion pandemic preparedness plan. (See BioWorld Today, Nov. 2, 2005, and Nov. 14, 2005.)