Washington Editor

WASHINGTON - The House of Representatives voted 255-170 Friday in favor of mandating government negotiations on Part D drug prices, but the wrangling and negotiations over the measure are only beginning.

The Medicare Prescription Drug Price Negotiation Act of 2007, H.R. 4, would require the secretary of the Department of Health and Human Services to negotiate lower Part D drug prices on behalf of Medicare beneficiaries. The bill, which would repeal the Medicare non-interference clause and prevent the government from establishing a national formulary, is sponsored by Rep. John Dingell (D-Mich.), the chairman of the House Energy and Commerce Committee.

The vote largely followed party lines, with no Democrats casting votes against the measure. Only 24 Republicans were in favor of it.

Medicare beneficiaries, who number 43 million seniors, consume more than 40 percent of prescription drugs in the U.S., but at a higher cost than that paid by other federal agencies. Upon introducing this bill, Dingell said that Part D drug prices are more than 80 percent higher than prices negotiated elsewhere in the government, such as the Veterans Administration and Medicaid, and more than 60 percent higher than prices in Canada.

"This common-sense legislation will deliver lower premiums to seniors, lower prices at the pharmacy and savings for all taxpayers," Dingell said on the House floor. In addition, he called the measure "an overdue step to improve the Part D drug benefit for the millions who depend on it."

Critics, on the other hand, assailed the bill as a step toward price controls, a group that includes HHS Secretary Mike Leavitt, who has cautioned against any form of government-run health care system. They also said the government wouldn't realize much in the way of savings through direct negotiations, a sentiment echoed in a report issued last week by the Congressional Budget Office.

The upper chamber appears to be taking a different approach to Part D negotiations. At a hearing on the topic Thursday, Senate Finance Committee Chairman Max Baucus (D-Mont.) indicated that he seems to favor a more flexible approach. While he said the noninterference clause should be repealed, he said HHS should be able to choose when to negotiate.

In addition, Baucus said the National Institutes of Health should begin conducting studies of certain drug classes to compare cost effectiveness and efficacy between products. Witnesses at the hearing testified that negotiations would be most beneficial in relation to single-source drugs, those that have no competition. In addition, they warned against copying the VA's prescription drug plan, which features far fewer drugs than those currently available under Part D.

President Bush last week said he would veto the House bill.

House Again Clears ESC Bill

The House cleared legislation to relax federal funding restrictions on embryonic stem cell research, passing the bill 253-174 on Thursday, and not surprisingly, the president said he would veto the measure.

The Stem Cell Research Enhancement Act of 2007, H.R. 3, is sponsored by Reps. Diana DeGette (D-Colo.) and Mike Castle (R-Del.). Identical to last year's bill that passed 238-194 in the House, H.R. 810, it would expand the number of stem cell lines derived from embryos slated to be discarded from in vitro fertilization clinics available for federal funding. (See BioWorld Today, Jan. 10, 2007.)

"It is clear that a majority of the House, just like a majority of Americans, back potentially life-saving stem cell research," Castle said in a statement. DeGette added, "It is time for President Bush to allow this groundbreaking research to move forward."

The Senate is expected to take up its version of the bill, S. 5, in the coming weeks. It's expected that Bush's planned veto could be overridden in the Senate, where 67 votes are needed, but achieving the 290 votes needed for a House override appears less probable.

Earlier last week, DeGette suggested that the bill could advance as an attachment to must-pass legislation, circumventing the veto. Whatever happens, the bill's backers believe Bush's policy would end when his term in office expires.

DeGette and Castle say he has rebuffed all their requests to meet with him on the issue.

Legislators Propose Canadian Drug Imports

In an effort to put downward pressure on the price of prescription drugs, a bipartisan bloc of lawmakers last week introduced legislation to permit drug importation from Canada and elsewhere. The bill, called The Pharmaceutical Market Access and Drug Safety Act, would allow individuals to order medications directly from outside the U.S. when using an FDA-registered and approved Canadian pharmacy. It would also allow U.S.-licensed pharmacists and wholesalers to import FDA-approved medications from a number of other industrialized nations to pass along the savings to patients.

"American consumers are charged the highest prices in the world for prescription drugs," said Sen. Byron Dorgan (D-N.D.) during a news conference on Wednesday, "and it's fundamentally unfair."

All of this would place additional responsibilities on the FDA. In the case of Canadian pharmacies, the agency would have to examine, register and inspect those facilities, and relative to pharmacist and wholesaler imports, the agency would have to ensure medical histories, verify prescriptions and track shipments.

The bill was introduced by Dorgan, Sen. Olympia Snowe (R-Maine) and Reps. Jo Ann Emerson (R-Mo.) and Rahm Emanuel (D-Ill.).

MDS responds

MDS Pharma Services, a contract research organization whose pharmacokinetic services done between 2000 and 2004 are being questioned by the FDA, said it would support its clients with independent audit activities to ensure the accuracy of those data.

Last week, the agency said it would be mailing more than 1,100 letters to drug companies to identify MDS Pharma-conducted pharmacokinetic studies during the period in question, and for those that are found, drugmakers would have to validate their findings through audits, new analyses or repeating their tests. MDS Pharma, of King of Prussia, Pa., said the FDA approach represents an efficient path to fix this issue for its clients. (See BioWorld Today, Jan. 11, 2007.)