House May Be Stopping Point For Rx Importation Bills, Hill Staffer Says

The House could be the last line of defense for blocking prescription drug importation legislation, rather than the Senate, a House subcommittee staffer said Nov. 17 at the Pharmaceutical Regulatory & Compliance Congress in Washington, D.C.

Dan Elling, health policy aide to House Ways & Means Health Subcommittee Chairman Nancy Johnson (R-Conn.), said that GOP leaders in the lower chamber are more able to deter consideration of reimportation bills than their counterparts in the Senate.

"Given the House rules and the way they're structured, it's a lot easier for us to keep importation legislation off the House floor," he said.

If House leaders are able to stop importation legislation in the upcoming session, that would mark a reversal of the roles played by the two chambers in the 108 Congress. During those two years, opposition to drug imports in the Senate - particularly among the chamber's top Republicans - ensured the issue did not move forward on the Hill.

GOP leaders in the House have continuously opposed the practice as well, but a number of Republicans broke ranks to vote for a bill allowing imports from a handful of developed countries in July 2003. The measure from Rep. Gil Gutknecht (R-Minn.) passed 243-186 (¹ (Also see "Rx Reimportation Passes House; CBO Score May Keep It Out Of Medicare Rx" - Pink Sheet, 28 Jul, 2003.), p. 13).

Elling characterized the decision by House Majority Leader Dennis Hastert (R-Ill.) to hold a vote on Gutknecht's bill as an anomalous consequence of the tight vote on the Medicare Modernization Act.

Hastert agreed to allow the importation measure onto the floor in exchange for a few additional votes on the initial House version of the Medicare bill.

Elling cautioned that GOP leaders could make a similar tradeoff on reimportation if they need extra votes on priority legislation in the next session.

Elling cautioned also that the Senate might be more amenable to importation in the upcoming session because several of the new Republicans voiced support for drug importation on the campaign trail (² (Also see "GOP Victory Won’t End Rx Import Debate: New Senators Want Open Borders" - Pink Sheet, 8 Nov, 2004.), p. 5).

"Given the political climate, something will be done eventually, and I encourage all of your companies to try to come back with something that you see that's acceptable to your industry," Elling said.

GlaxoSmithKline VP-Federal Government Relations Sally Walsh likewise noted that the ranks of Senate Republicans who support importation will be larger in 2005.

She dubbed one incoming member, Sen. Tom Coburn (R-Okla.), "the father of importation" during his time in the House.

Walsh also said that drug companies will be "hard pressed" to find a new Democratic ally in the Senate to replace retiring Sen. John Breaux (D-La.), though she cited Sen. Ben Nelson (D-Neb.) as one possibility.

The outcome of the presidential race, on the other hand, "is very good" for industry because of the candidates' positions on drug imports, Walsh asserted.

The Bush Administration "has been a good ally for us in opposition to 'unsafe' drug importation," she explained. In contrast, Democratic candidates John Kerry and John Edwards endorsed the practice "every time they had the opportunity to bring [it] up."

Walsh added that one of the "biggest concerns" for GSK will be the conclusions of the HHS task force on reimportation. The task force's analysis is due in December under the Medicare Modernization Act (³ (Also see "Importation Debate Highlights Need For Lower Rx Prices, McClellan Says" - Pink Sheet, 6 Sep, 2004.), p. 33).

Schering-Plough VP-Federal Government Affairs Robert Lively expressed a more pointed concern that the executive branch could implement importation administratively following publication of that report.

"I would not rule out some sort of December surprise," Lively said, noting that HHS could finally certify that drug importation is safe and cost-effective.

"I don't know if the White House is on that page yet, but it's something we should all keep our ears on," Lively remarked.

Bush declared during the second presidential debate that administrative action on importation could come in December (⁴ (Also see "Rx Imports: President Bush Says Decision Could Come In December" - Pink Sheet, 18 Oct, 2004.), p. 17).

Lively said the drug industry has to find some way "to get this issue off the table," if only so that future nominees for top jobs at HHS, FDA and the Centers for Medicare & Medicaid Services can get through the Senate confirmation process "without this being the number one issue that they have to answer to."

A Democratic Hill staffer meanwhile raised a new concern about drug importation: that the bills proposed thus far may contravene discrimination prohibitions from the World Trade Organization.

House Energy & Commerce Committee Minority Staffer John Ford told the conference that lawmakers may not be able to establish an importation regime that excludes drugs from most countries without violating WTO rules.

Energy & Commerce Ranking Member John Dingell (D-Mich.) is a longstanding opponent of drug importation, and Ford renewed his boss' criticisms of the practice.

Even if policymakers could design a paradigm in which reimportation is safe, Ford argued, public expectations that the incoming drugs will be "cheap and plentiful" will not be satisfied.

Elling, on the other hand, noted that Rep. Johnson voted for the Gutknecht bill, but he stressed that "she does have concerns about the safety issues."

The Republican aide added that drug importation is an issue in which the political attractiveness outweighs the problems with the policy when it comes time to vote. "It's a difference between politics and policy," he said.

To combat the positive public perception of reimportation, Elling recommended that opponents of the practice focus on trade issues.

"If it's tackled more as a trade issue than a safety issue, I think you may be able to get more leverage," he said.

A study on global drug pricing practices is forthcoming from HHS, the Commerce Department and trade negotiators (⁵ (Also see "Global Price Controls Elimination May Not Affect U.S. Rx Costs – Economist" - Pink Sheet, 9 Aug, 2004.), p. 19).