Amendment To Permit Drug Reimportation Could Go Up for Vote

The Senate on Thursday plans to hold a cloture vote to decide whether to limit debate on an amendment to a bill (S 1082) to reauthorize the Prescription Drug User Fee Act that would allow prescription drug reimportation from other nations, CongressDaily reports (Edney, CongressDaily, 5/2).

The legislation, which the Senate Health, Education, Labor and Pensions Committee approved in April, would reauthorize PDUFA, which will expire on Sept. 30, through 2012. The bill, sponsored by committee Chair Edward Kennedy (D-Mass.), in large part follows a proposal that FDA submitted to Congress earlier this year under which pharmaceutical companies would pay the agency about $393 million in user fees in fiscal year 2008, compared with $305 million in FY 2007.

The legislation increased the amount in the proposal by $50 million.

According to the Congressional Budget Office, the bill, which also includes a number of prescription drug safety provisions, would cost $547 million over five years.

Sens. Byron Dorgan (D-N.D.) and Olympia Snowe (R-Maine) have proposed an amendment that would attach to the legislation a reimportation bill (S 242) they introduced in January.

The bill would allow consumers, pharmacies and wholesalers to purchase FDA-approved prescription drugs that are manufactured at FDA-inspected facilities in 19 industrialized nations. Under the legislation, which would establish a regulatory framework for reimportation, FDA would regulate shipments of prescription drugs reimported into the U.S. for commercial or personal use.

The bill also would require FDA to inspect Canadian prescription drug exporters 12 times annually. The Bush administration has said President Bush would veto the reauthorization legislation in the event that the bill includes the amendment (California Healthline, 5/2).

In response, Thad Cochran (R-Miss.) has proposed an amendment to the amendment proposed by Dorgan and Snowe that would require the HHS secretary to ensure reimportation would "pose no additional risk to the public health" and would "result in a significant reduction in the cost of covered products."

According to CQ Today, approval of the amendment proposed by Cochran would "nullify" the amendment proposed by Dorgan and Snowe because Bush administration officials have "repeatedly said they cannot guarantee the safety of any foreign drug" (Armstrong, CQ Today, 5/2).

Sen. Judd Gregg (R-N.H.) said that, under the amendment proposed by Dorgan and Snowe, "a lot of people are going to get hurt and some are going to die."

However, Dorgan said that the amendment includes provisions to ensure the safety of prescription drugs reimported from other nations. He added, "All the protestation on the Senate floor on this issue is protestation on behalf of the pharmaceutical industry" (Dilanian, USA Today, 5/3).

The Senate on Wednesday also debated a number of other amendments to the reauthorization bill.

The Senate voted 94-0 to approve an amendment proposed by Senate Majority Whip Richard Durbin (D-Ill.) that would seek to improve FDA oversight of food safety. The amendment would allow FDA to fine food companies that do not properly report contamination and would require companies to maintain records on food safety and make them accessible to the agency (CQ Today, 5/2). In addition, the amendment would implement more restrictions on food production and labels (Baltimore Sun, 5/3).

The Senate also voted 53-41 to reject an amendment proposed by Sen. Wayne Allard (R-Colo.) that would have eliminated from the reauthorization bill a provision to limit the period of market exclusivity for pharmaceutical companies that test their medications in children (CQ Today, 5/2).

Two editorials and an opinion piece on Thursday addressed issues related to the reauthorization bill. Summaries appear below.

• New York Times: The reauthorization bill "would usher in much-needed reforms" at FDA but "also risks making the agency even more dependent on funds from the industry it regulates," according to a Times editorial. "This is a dangerous dependency for an agency that regulates such a critical part of the nation's health care system," the editorial states. The editorial concludes, "Perhaps the best course would be to reauthorize the fees for two years, not the five written into the current Senate bill," to allow FDA, the Bush administration and Congress time to determine "a way to wean the FDA from its risky dependency" (New York Times, 5/3).
• Washington Post: The amendment proposed by Dorgan and Snowe is "unneeded" and could threaten the passage of the reauthorization bill, according to a Post editorial. Supporters maintain that reimportation will "solve the problem of drug pricing" because "U.S. drug firms sell prescription medications to countries such as Canada at low prices," but the "situation ... would quickly change if Canadian distributors started to recycle large quantities of drugs back to the United States," the editorial states, adding, "Further, President Bush has threatened to veto the bill if it contains such language." The editorial concludes, "For the sake of common sense, and to enhance the chances of urgently needed legislation, the Senate should reject the importation amendment before passing the bill" (Washington Post, 5/3).
• Peter Pitts/Robert Goldberg, Washington Times: "Allowing such amendments" as the measure proposed by Dorgan and Snowe "to a bill designed to revitalize the FDA and restore its credibility is the closest Congress can get to voting on a sick joke," Pitts, president of the Center for Medicine in the Public Interest and a former FDA associate commissioner, and Goldberg, vice president for research at CMPI, write in a Times opinion piece. The authors conclude, "Congress has ample power to restore the luster that FDA has lost in recent years" and "should not squander that power on political folly. It should pass the FDA Revitalization Act and build a bright future for the agency" (Pitts/Goldberg, Washington Times, 5/3).