Washington Editor

WASHINGTON - Senate debate on amendments to the "Food and Drug Administration Revitalization Act" is dragging into this week after lawmakers failed to finish their business on the wide-ranging legislation last week.

At its core, the comprehensive bill would renew the Prescription Drug User Fee Act (PDUFA) and authorize new safety powers at the FDA, among other things. Failing to ratify it would hamstring the agency's approval process, and because of its must-pass nature, it's attracting a number of attachments.

Much of last week's holdup centered on an effort to add prescription drug importation language to the bill, also labeled S. 1082, which President Bush has vowed to veto should such a provision get attached. A vote on that amendment, offered by Sens. Byron Dorgan (D-N.D.) and Olympia Snowe (R-Maine), could come as early as this afternoon.

Their language would permit Americans to buy cheaper drugs from countries deemed to be acceptable by certain safety standards, such as Canada or many European nations.

The "American people ought to be able to make the global economy work for them" as long as the drugs are FDA approved and handled in a secure chain of custody, Dorgan said on the Senate floor. Noting that U.S. consumers pay the highest drug prices in the world, he cited a new report from the Congressional Budget Office that points to $50 billion in projected savings over the next 10 years if Americans are allowed to buy from abroad.

However, opponents decried such cost-savings claims and warned that importation would open the door for more drug safety problems.

Sen. Richard Burr (R-N.C.) called it "somewhat ironic" to amend legislation that's heavily focused on safety with language that could make it easier for counterfeit drugs to enter U.S. supplies. Up to 10 percent of global supplies are fake, according to the World Health Organization. "These products may not even have an active ingredient," Burr said.

Echoing such sentiments was Jim Greenwood, president and CEO of the Biotechnology Industry Organization (BIO), who also told BioWorld Today that "importing price controls from countries with socialized health care" is not a good policy to effect lower costs because it would undermine industry innovation by harming investments.

Recalling his own days in Congress, he said the issue first arose when senior citizens clamored for more affordable access, a problem that the Medicare Part D drug benefit has made great strides in solving. For uninsured Americans, "a better policy is to figure out how to get them coverage," Greenwood said, "as opposed to some artificial mechanism."

To thwart Dorgan's amendment, Sen. Thad Cochran (R-Miss.) offered a second-degree amendment to require the Department of Health and Human Services to certify that imported drugs pose no additional safety risks and result in significant savings. That language would essentially obviate importation, Cochran said, because administration officials have indicated that they can't make such certifications.

Critics have called his language a poison pill.

Dorgan's amendment should have enough support for passage after an effort to block it failed Thursday. Lawmakers voted 63-28 in favor of invoking cloture, ending opponents' tactics to stall a vote on attaching it to S. 1082. At least three-fifths of the Senate must agree to end such debate.

One amendment was added to the bill last week, language from Sen. Richard Durbin (D-Ill.) to ensure the safety of human and pet food. Another amendment was rejected, a proposal from Sen. Wayne Allard (R-Colo.) to strike provisions related to market exclusivity.

Among those still to be considered are amendments on requiring counterfeit-resistant technologies for prescription drugs, establishing a priority review process to encourage the development of tropical disease treatments, restricting citizens petition abuse, regulating internet pharmacies, protecting against school requirements to take certain drugs for admission and permitting pet turtle sales with appropriate salmonella risk preventions.

No amendment on follow-on biologics has come up, but Sen. Edward Kennedy (D-Mass.), chairman of the Health, Education, Labor and Pensions Committee from which FDA-related bills such as S. 1082 arise, has said that follow-on language would be entered in a conference to merge the broad bill with legislation to come from the House of Representatives.

Senate floor action on S. 1082 began last Monday.

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