Washington Editor

WASHINGTON - The Senate should soon vote on a bill designed to create a new government agency to fund mid-stage product development for biological weapons and infectious diseases, said Rep. Mike Rogers (R-Mich.), a sponsor of the House version who was speaking at a pandemic flu meeting last week.

The measure, which would establish the Biomedical Advanced Research and Development Authority (BARDA) as a single source of federal authority to fund the so-called valley of death, already has cleared in the lower chamber.

Called the "Biodefense and Pandemic Vaccine and Drug Development Act of 2006," H.R. 5533 provides for $160 million in each of the next two government fiscal years. Rogers' co-sponsor on the bipartisan bill is Rep. Anna Eshoo (D-Calif.). (See BioWorld Today, Oct. 2, 2006.)

BARDA, which would be part of the Department of Health and Human Services, is designed to better attract industry participation despite continued question marks around market uncertainty absent clear federal government articulation on product needs. Its money is expected to bridge the gap for companies that have succeeded in funding early research projects through the National Institutes of Health, for instance, but can't internally finance more advanced development to the point of procurement under Project BioShield.

The Senate is taking up the matter in the context of reauthorizing a broader bioterrorism- and pandemic-related law, the "Public Health Security and Bioterrorism Preparedness and Response Act of 2002," incorporating BARDA in the process. That bill, S. 3678, is intended to aid public health systems at state and local levels to deal with such issues by extending grants to those types of agencies through 2011. It is co-sponsored by Sens. Richard Burr (R-N.C.) and Edward Kennedy (D-Mass.).

Should the reauthorization pass, the BARDA measure would be subject to conference negotiations for the House and Senate to reconcile their two versions. Provisions related to antitrust protections are among differences that would require resolution, as the Senate bill includes language to allow drug companies to quickly collaborate in the event of an emergency without fear of government charges of complicity.

Some in the industry have expressed disappointment with BARDA's initial annual funding amount of $160 million approved by the House over the next two years; originally a little more than $1 billion was proposed, a bigger budget still part of the Senate version. But Rogers conceded that more money was unlikely to be approved this year, telling BioWorld Today that its opening budget would nevertheless provide "a kickstart" to BARDA. More money can be found later.

"We have to get it started first," he said. "This is the egg," adding that efforts to boost BARDA's budget would come up next year.

It's hoped that Congress would wrap up the matter during the current congressional lame-duck session. "Our goal is to get this done by the end of the year," Rogers said, and future Senate Majority Leader Harry Reid (D-Nev.) has indicated that bioterrorism is among the top items to be addressed before the Christmas recess.

Failure to do so, some observers fear, could portend further industry distaste for collaborating with the government on bioterrorism and pandemic work. It also could open the door for repealing liability protections worked into last year's defense spending bill.

Grassley Puts New Hold On FDA Nominee

Acting FDA Commissioner Andrew von Eschenbach is facing yet another roadblock in his confirmation process, contrary to growing calls for stable leadership at the agency.

Sen. Charles Grassley (R-Iowa) has placed a hold on von Eschenbach's vote, making him the third current hurdle to confirmation. As chairman of the Senate Finance Committee, Grassley is formally blocking the process because of von Eschenbach's "failure to comply" with subpoenas related to the antibacterial drug Ketek (telithromycin, from Sanofi-Aventis Group), he wrote to Senate Majority Leader Bill Frist (R-Tenn.). In addition, he said the FDA and HHS are on average 101 days late in responding to "numerous" other committee requests.

"The authority and integrity of Senate and committee processes are being challenged," Grassley wrote, "and due concern should be shown to this nomination."

Sens. Jim DeMint (R-S.C.) and David Vitter (R-La.) have had holds in place for two months, the former because of safety concerns around the abortion pill RU-486 and the latter over legalizing drug reimportation.

Previously, Sens. Hillary Clinton (D-N.Y.) and Patty Murray (D-Wash.) had a hold on von Eschenbach's nomination, but they lifted their opposition after the FDA approved over-the-counter sales of the Plan B contraceptive product to women 18 and older.

Drug Safety Discussed At HELP Hearing

At a meeting of the Senate Health, Education, Labor and Pensions (HELP) Committee last week, Ranking Member Edward Kennedy (D-Mass.) said the FDA "urgently needs treatment."

His comment was echoed by several witnesses who praised the timing of a bill to reform the agency that he and committee Chairman Mike Enzi (R-Wyo.) introduced earlier this year, S. 3807. Both Kennedy and Enzi, who will swap committee leadership roles in the next Congress, indicated a willingness to continue to work together on the matter. And both used the hearing to essentially vet their bipartisan proposal relative to the recent Institute of Medicine report on drug safety.

"If there were ever a time to address these issues," said Sheila Burke, who co-chaired the panel that produced the IOM report, "it is now."

While some witnesses differed on the degree of change needed at the FDA - for instance, whether the agency should be allowed to restrict direct-to-consumer drug advertising, and if so, for how long after approval - all agreed that the FDA needs more money to improve its safety oversight capabilities. Several expressed their preference that appropriated funds be increased rather than tapping the industry for more user fees, with one suggestion that the user-fee system be abandoned altogether. In addition, most seemed to agree with the IOM assessment that the public would be better served if the FDA managed a drug throughout its lifecycle through an increased post-approval role.