Up and down for drug imports :: Namibia Internet Gateway cc ::

Articles: Up and down for drug imports

Posted by admin on Friday, July 16, 2004 - 02:13 AM

A renewed push is on to allow reimportation or importation of prescription drugs to the United States, and prospects are wobbly, despite some bipartisan support, with a lot of ups and downs on Capitol Hill.
The House passed the fiscal year 2005 appropriations bill for the Department of Agriculture, Rural Development, Food and Drug Administration and so-called related agencies. Other than funding the FDA, its language allows importation of drugs from other countries, but the provision could very well be dropped in the Senate, where there is less support. The White House Office of Management and Budget weighed in against the idea in a statement. "While this provision theoretically limits the importation of prescription drugs to drugs approved by the Food and Drug Administration, it would be virtually impossible for the FDA to verify that drugs being imported are indeed FDA approved and not counterfeit," the OMB statement said. Democratic and Republican lawmakers this week joined the seniors group AARP on the Hill to try to push forward S. 2328, a bill sponsored by Sens. Byron Dorgan, D-N.D., and Olympia Snowe, R-Maine, to legalize importation and have the FDA regulate it. A recent AARP poll found eight out of 10 people ages 50 and older support legal importation of drugs and 79 percent of respondents said the cost of prescription drugs would be an important factor in their presidential vote. Sen. Orrin Hatch, R-Utah, chairman of the Senate Judiciary Committee, opened that committee's consideration of importation Wednesday on a discouraging note for supporters. "It seems that the safety of imported drugs remains in doubt in the minds of the experts at FDA," Hatch said. Hatch also said S. 2328 raises patent and antitrust law questions. "The bill appears to alter current law with respect to domestic patent rights once overseas sales occur," he said. Committee member Dorgan defended the bill. "In fact, the amount of potentially unsafe drugs coming into the country has exploded because people who can't afford high U.S. prices have been buying their medications over the Internet under a system that is virtually unregulated by the Food and Drug Administration," he said. The Senate Committee on Health, Education, Labor and Pensions -- also known as the HELP Committee -- is scheduled to mark up S.2328 next week. A panel discussion Thursday, sponsored by the Institute for Policy Innovation in Washington, heard from health experts about numerous examples of illegal importation -- from countries besides Canada, such as India, China and Nigeria, along with stories from patients who have been harmed by counterfeit drugs. Rick Roberts of the University of San Francisco told his personal account in a video. He said he had been unknowingly injecting counterfeit medicine to treat his AIDS and if he had suffered complications or death, no one would have assumed the cause was anything but his own sickness. Maureen Casey of Giuliani Partners LLC, which has investigated importation, said it is an issue of patient safety and not pharmaceutical access. "We have to do something about the price of medications in the United States, but ... the solution right now, it does not appear, is importation," she said. Panelists generally agreed importation would not be any safer or easier to regulate if legalized. The FDA's Tom McGinnis said there is a common misconception prescription drugs are cheaper in Canada, but when it comes to generic brands, U.S. prices are actually 7 percent to 8 percent cheaper. BACK IN THE HOUSE... The House Wednesday passed the U.S.-Australia Free Trade Agreement, which contains language that would prohibit reimportation of drugs covered by Australia's pharmacy benefit program and would set up a process through which the United States could issue objections to any Australian government decision to add new drugs to the list. The OMB said the FTA does not block the U.S. government from passing reimportation legislation but merely upholds existing U.S. law that "gives any patent holder the right to control sales (including by contract) of its product in the United States. This right, a core principle of U.S. patent law for more than 100 years, applies to all U.S. patents, not just pharmaceuticals." Rep. Rahm Emanuel, D-Ill., called the trade deal tainted by the drug language. "Unfortunately, what we have in this agreement is a back-door attempt to continue to force Americans to pay the highest drug prices anywhere in the world and undercut the bipartisan support for lowering drug prices for American seniors and taxpayers," he said in a statement. -0- FDA FUNDING BILL LEAVES HOUSE WITH PENALTY CLAUSE The Food and Drug Administration's general counsel was the target of a penalty amendment, sponsored by Rep. Maurice Hinchey, D-N.Y., which passed in the House as part of the fiscal 2005 Department of Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill. The amendment would take $500,000 from the chief counsel's budget and give it to FDA's Center for Drug Evaluation and Research. Hinchey sponsored the amendmend because he is upset with actions by FDA Chief Counsel Daniel Troy. He's accused Troy of taking FDA "in a radical new direction" by engaging the agency in private, state civil lawsuits on the side of pharmaceutical and medical device companies sued by consumers. Troy, appointed by President Bush in 2001, is the first chief counsel to be a political appointee -- not a civil servant. "These are cases in which the court has not asked for FDA involvement, involving drug companies and medical device manufacturers who are being sued by people harmed by their products," Hinchey said in written remarks prepared for a news conference Wednesday. Hinchey said more than 600 FDA working hours have been used in four such cases. In one case Troy sided with Pfizer, Hinchey said, which Troy had represented in a case while a partner at Wiley, Rein and Fielding, a Washington law firm. Dr. Lester M. Crawford, acting FDA commissioner, issued a statement in support of Troy. "FDA has accurately reported the scope and nature of Dan's private sector work. Any allegation that he has not conducted himself in compliance with applicable legal and ethical rules is simply false," Crawford said. -0- INSURANCE REBATE PROGRAM OFFERED IN L.A. COUNTY L.A. Care Health Plan and the non-profit Blue Shield of California Thursday began a $5 million joint venture called HealthyRebates. The program, billed as a reward and incentive, will provide rebates of $20 per member or up to $100 per household per month to individuals or families who have purchased health insurance on the private market. To qualify people must have an income at or below 200 percent of poverty -- roughly $37,000 per year or $3,142 per month for a family of four -- and not have access to an employee sponsored group health plan. The companies estimate at least 18,000 Los Angeles County residents are eligible for the program, out of almost 100,000 who buy insurance on the private market. Howard Kahn, chief executive office of L.A. Care Health Plan, told UPI's HealthBiz focus group testing of the concept showed "the $20 per person, per month did make a difference" in people's ability to continue to afford health insurance. Data supplied to HealthBiz by the groups showed the average cost of individual coverage purchased privately in Los Angeles County ranged from $90-$158 per month, while family coverage ranged from $280-$480 per month. Blue Shield CEO Bruce Bodaken said, "In California, 85 percent of the working uninsured are not offered or are not eligible for employer-sponsored insurance." He said this "modest" financial assistance would help them afford to continue purchasing coverage on their own. -0- PELOSI TRIES TO JUMPSTART DRUG NEGOTIATION BILL Minority Leader Nancy Pelosi, D-Calif., this week took action to try to force the House to take up legislation to allow the Department of Health and Human Services to negotiate with pharmaceutical companies for lower prices on Medicare drugs. Pelosi is seeking signatures of House members on a discharge petition that would require the Republican leadership to bring the bill to the floor for consideration. -0- MEDICARE'S NEW OBESITY POLICY The Centers for Medicare and Medicaid Services Thursday put out a new policy on obesity coverage in the senior health insurance program. Nothing will happen right away but Medicare will now review scientific data to determine if obesity treatments improve outcomes for seniors and the disabled -- with an eye toward potentially covering those interventions. The policy removes old language in the Medicare coverage manual that says obesity is not an illness -- and therefore treatment is not medically necessary -- the linchpin for coverage under Medicare. The policy also allows the public to ask for a determination on specific treatments.

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