Despite solid House approval, the idea of letting Americans buy prescription drugs from foreign suppliers at a fraction of the U.S. cost still faces a formidable hurdle in the Senate. Key senators in both parties argue that the safety risks may be too great.
Supporters of the House bill acknowledged the uncertain future of their legislation. But they said the strong 243-186 vote early Friday morning, in the face of opposition from the White House and GOP leaders and an intense lobbying effort by the pharmaceutical industry, was evidence of growing grass-roots demand for cheaper medicine.
"We've won the first battle; the second battle begins when the House and Senate hold a conference committee." said U.S. Rep. Jo Ann Emerson of Cape Girardeau on Friday during a teleconference. "We've got all of August to spend time meeting one-on-one with colleagues in Congress with regard to issues on research and development and safety concerns."
The House bill, sponsored by Reps. Emerson, Gil Gutknecht, R-Minn., and Rahm Emanuel, D-Ill., orders the Health and Human Services Department to set up a system to allow importation of FDA-approved drugs from FDA-approved facilities in Canada, the European Union and seven other nations.
The measure also would require imported medicine to be shipped in anti-tampering and anti-counterfeiting packaging.
Opening access to imported drugs, which can be half or even a tenth the cost of an identical product sold in America, could cost the pharmaceutical industry billions that it says it needs to research new treatments.
"I don't know if we are going to win this fight," said Rep. Dan Burton, R-Ind., a conservative who joined with some of the House's most liberal Democrats in promoting the measure. But "last night we sent a very strong message" to the pharmaceutical industry that it is going to have to re-evaluate the prices they charge American consumers.
It goes well beyond language in a $400 billion measure to provide a prescription drug benefit to Medicare recipients now being crafted by House and Senate negotiators. Both the House and Senate Medicare bills would allow imports only from Canada and require the Health and Human Services Department to certify that the imports are safe.
Congress has twice before passed legislation dealing with drug importation, but both required HHS certification and HHS secretaries in both the Clinton and Bush administrations have refused to do so.
On Thursday 53 senators signed a letter opposing, on safety grounds, efforts to make it easier to import drugs. "We do not believe it would be prudent to remove these vital safeguards, especially when Congress is in the process of enacting a Medicare prescription drug benefit that includes improved access to more affordable generic drugs," said the letter signed by Sens. Orrin Hatch, R-Utah, and Don Nickles, R-Okla., two leading negotiators on the Medicare bill, and Sen. Edward Kennedy of Massachusetts, top Democrat on the health committee.
The Pharmaceutical Research and Manufacturers of America (PhRMA), which represents the industry, had unleashed an all-out effort to defeat the House bill. The PhRMA was "encouraged" by the senators' opposition to what it said was a bill that would "jeopardize the safety of our nation's medicine supply and import foreign governments' price controls."
The Bush administration said the bill was "dangerous legislation" and Food and Drug Administration commissioner Mark McClellan said the measure "creates a wide channel for large volumes of unapproved drugs and other products to enter the United States that are potentially injurious to public health and pose a threat to the security of our nation's drug supply."
But Gutknecht said the 243 votes for his bill, despite a "heavy-handed" industry lobbying campaign, was a wakeup call for the Bush administration. President Bush, added Burton, normally a staunch ally of the White House, should "use the bully pulpit to deal with the prescription drug industry."
Emerson said they had prevailed despite "an army of 600-plus lobbyists and millions of dollars of misinformation," and said senators too could be won over once they learned that the House bill had strong safety provisions to prevent tampering and counterfeiting.
One of the 53 signators to the Senate letter, Emerson's Missouri colleague, Republican Sen. Jim Talent, said the Emerson bill was "reasonable and important" and he would support a Medicare bill with reimportation provisions that had adequate safety standards.
The House vote, said Rep. Sherrod Brown, D-Ohio, was a "declaration of independence from the stranglehold that big PhRMA has had on this institution for all too many years."
The bill is H.R. 2427.
Staff writer Christine Pagano contributed to this report.