Washington Editor

WASHINGTON - With congressional attention here largely focused on the current Supreme Court vacancy and another probable opening on the bench these days, Rep. Curt Weldon (R-Pa.) urged biodefense-focused companies to "stay involved politically" in order to keep homeland security at the forefront of the legislative agenda this year.

Addressing a gathering July 11 that included representatives from the biotech community, government agencies and the military, the congressman spoke about passing the second BioShield Act. He said his congressional colleagues understand the importance of such a measure, but added that it could get shelved behind other issues such as Supreme Court nominations.

To avoid that, Weldon advised attendees of the Capitol Hill BioDefense Showcase to better operate within the political process. He said that every one of the 535 senators and representatives in Washington had at least one staff person dedicated to homeland security issues. "Each of you can make contact with your representatives' offices," Weldon added.

"Because of the urgency of the issue," he also said, "we absolutely need your involvement."

Other lawmakers on Capitol Hill sought private sector involvement all week long on the topic, as a number of committee hearings were held on biodefense matters.

At a gathering of the House Subcommittee on Emergency Preparedness, Science and Technology, industry representatives said they need more information about possible terror threats from government agencies such as the Department of Homeland Security and the Department of Health and Human Services to balance difficulties in bioterrorism countermeasure development - namely its risks, high costs and low returns on investment. Biotech and drug companies have expressed concern about liability issues.

Another concern discussed during the hearing related to the government's Material Threat Assessment (MTA) process that examines biological, chemical, radiological and nuclear agents of greatest concern to guide BioShield requirements and acquisitions. BioShield funds can only be used for countermeasures identified by MTA, and over the past year, just four MTAs have been released - anthrax, smallpox, botulinum toxin and radiological/nuclear devices.

That led some at the hearing, both industry and government representatives, to wonder whether the agencies were communicating well. But many acknowledge that there remain kinks to be worked out.

"All these things are being figured out as we go," Lance Gordon, president and CEO of San Diego-based VaxGen Inc., said at the Capitol Hill BioDefense Showcase. Question marks about product development and manufacturing are still on the table, as are legal issues, he said.

Other hearings focused on similar issues were held last week by the Senate Health, Education, Labor and Pensions Committee and the House Government Reform Committee.

Pain Drug Pulled Soon After Approval

Purdue Pharma LP voluntary suspended sales of Palladone (hydromorphone HCl extended-release) Capsules, a move sparked by FDA concern that patients could be at significant risk of overdose if they fail to follow the warnings contained in the narcotic painkiller's Medication Guide and Prescribing Information against alcohol consumption while on the drug.

The agency's Center for Drug Evaluation and Research noted that pharmacokinetic data showed that the co-ingestion of Palladone and alcohol resulted in dangerous increases in the peak plasma concentrations of hydromorphone. Those elevated levels might be lethal, even in opioid-tolerant patients.

The product received FDA approval in September and was launched in February. Purdue, of Stamford, Conn., said it is not aware that the alcohol-Palladone combination has caused injury to any of the nearly 11,500 patients for whom the medicine has been prescribed.

The company also said it has implemented a plan to reformulate Palladone to reduce its alcohol interaction risk.

ED Drugs Possibly Linked To Blindness

The FDA has warned users of the popular PDE5 class of oral erectile dysfunction drugs of a possible link to blindness.

Updated labeling for Cialis, Levitra and Viagra reflects a small number of post-marketing reports of sudden vision loss, attributed to a condition called non-arteritic ischemic optic neuropathy, in which blood flow is blocked to the optic nerve. If patients on the drugs experience sudden or decreased vision loss in one or both eyes, the FDA has advised them to stop taking the medicine and call a doctor. Also, those already taking or considering taking the products should inform health care professionals if they have ever had severe loss of vision, which might reflect a prior episode of the condition and puts them at an increased risk of developing it again.

Still, the FDA acknowledged that it is not yet possible to determine whether Cialis, Levitra and Viagra were the cause of vision loss or whether it's related to other factors such as high blood pressure or diabetes, or to a combination of those problems.

FDA Committee Gathers On Asthma Concerns

The agency's Pulmonary-Allergy Drugs Advisory Committee met for two days last week to discuss the implications of recently available data related to the safety of long-acting beta-agonist bronchodilators. Also, committee members discussed the continued need for the essential use designations of prescription drugs for asthma and chronic obstructive pulmonary disease.

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