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WASHINGTON, Aug 19, 2004 (United Press International via COMTEX) -- President Bush and Democratic presidential candidate Sen. John Kerry both are talking about drug reimportation this week on the campaign trail but Kerry also has added a twist to his health platform -- prescription drug advertising.
Kerry's campaign contends one reason for "sky high (drug) prices is drug advertising" and that the Food and Drug Administration has been lax in responding to false and misleading drug ads -- at the same time direct-to-consumer advertising is on the rise.
"Spending on advertising and marketing by pharmaceutical companies more than doubled from 1996 to 2001 - rising far faster than spending on research and development, the campaign noted on its Web site. "Many of these advertisements do not disclose all of the information consumers could use, yet drive up costs of prescription drugs."
This is a stale issue that has been on the back burner since hearings in 2003.
Pulling from government studies over the past several years and information released in January from Rep. Henry Waxman, D-Calif., the ranking minority member of the House Committee on Government Reform, the Kerry campaign notes that FDA enforcement actions in 2003 on false drug ads were 75 percent lower than the average number during the final years of the Clinton administration.
This issue is more complex -- and difficult to explain to voters -- than the Kerry campaign portrays. A Kerry staffer told Health Biz the hope is that a crackdown on misleading ads would lead to fewer ads and lower costs.
A July 2003 hearing by the Senate Special Committee on Aging, however, heard the following testimony.
"There is no evidence to suggest that DTC advertising affects the price of medicine," said Marjorie Powell, senior assistant general counsel to the Pharmaceutical Researchers and Manufactuers of America. "To the contrary, studies that have examined this have found that there is no direct relationship between the amount of money spent on DTC advertising and price increases for a prescription drug."
"While consumers take notice of and sometimes act upon prescription drug advertisements, the rapid growth of DTCA has not been associated with a commensurate explosion in the rate at which consumers report that they demand and receive advertised products," testified Meredith Rosenthal, assistant professor of health economics and policy at the Harvard School of Public Health.
There also are surveys -- a couple done by FDA -- that show DTC advertising is viewed as beneficial to patients and physicians.
Many health experts have been concerned for years about the large percentage of drug costs eaten up by overall marketing and advertising but FDA has said it cannot do prior reviews on every ad and it is not known how much might be saved by weeding out the bad ads when, in reality, FDA generally uses its enforcement to request ads be changed not eliminated.
"FDA generally cannot require that prescription drug advertisements be reviewed and approved prior to their use," FDA's Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research told a Senate committee in 2003.
"Prior FDA review of advertisements occurs only in very narrow circumstances, primarily for products receiving accelerated approvals. In other words, FDA's review of promotional materials is intended to occur post hoc - once the materials have appeared in public," she testified at the same Senate hearing.
FDA's staff of some 40 reviewers in 2002 got about 36,700 pieces of promotional material for review -- of that 486 were DTC broadcast ads and about 6,000 were print DTC ads. The FDA review process per ad can take a couple of weeks and, according to Woodcock's testimony, from January 1997 to her 2003 testimony FDA issued a total of 64 notices of violations, warning letters and other letters to companies concerning problem broadcast ads. In that time period it issued 56 such letters regarding print advertising.
REIMPORTATION -- IT NEVER REALLY GOES AWAY
As much as the Bush administration wanted the reimportation issue to go away -- and it's done a pretty good job so far keeping the reins on legislation moving through Congress -- it comes up time and again and most recently in the presidential campaign.
Reimportation is a key health topic for the Democratic ticket of Kerry-Edwards, with Sen. John Edwards, the vice presidential nominee, preaching to the choir in Minnesota that seniors there pay 208 percent more for prescription drugs in the U.S. than they would in Canada. As if in Minnesota -- a reimportation battleground pitting the state against FDA -- they needed encouragement to run across the border and buy cheaper Canadian drugs.
President Bush had the tougher sell in Hudson, Wis., which is spitting distance from Minneapolis, Wednesday when he was asked about it. Expressing his concerns about the safety of reimporting or importing drugs, Bush told the crowd: "But I'm looking at this. There is a lot of pressure in Congress for importation. So I think it makes sense for us to make sure that we can do so in a safe way. If it's safe, then it makes sense."
Even while shoring up safety concerns -- Bush's comments are as close to an endorsement as the administration has come since Health and Human Services Secretary Tommy Thompson told reporters he'd advise Bush not to veto any reimportation legislation that came to his desk.
Bush then went on to defend U.S. drugmakers' ability to charge higher rates to recoup research and development expenses. The United States is about the only country without drug price controls and Bush said the higher prices pharmaceutical companies can charge allow them to continue to "be on the leading edge of change."
"I mean, they've come up with some amazing cures for diseases through research and development. And it's an incentive for them to be able to recoup that investment," he said.
After which he talked patent limits and lower-cost generics for a minute and then exited by saying: "Listen, I've got the hook, I got the sign to go. We could be here for hours, but the problem is, there's about 15,000 people waiting somewhere else..." Yep, and they'll probably be asking about reimportation.
VOTERS WRAPPED IN ECONOMY, TERRORISM
Healthcare at one point in 2002 was the second most important issue to voters but a new Washington Post/ABC News poll shows that it has fallen now to No. 4 -- behind the economy, terrorism and the war in Iraq.
Only 12 percent of the 1,010 voters surveyed in July said healthcare was the top issue.
MEDICARE DRUG LAW GETS FORMULARY LIST
United States Pharmacopeia or USP, which has the contract with the Centers for Medicare and Medicaid Services to create a drug formulary for the new Medicare prescription drug benefit that begins in 2006, Thursday released a draft version that shows a different than expected format for such a list.
The drug list contains 146 categories -- such as Sedatives/Hypnotics, Nasal and Throat Agents, Ophthalmics, Dental and Oral and Cardiovascular. Within those categories are classes of drugs -- such as ACE Inhibitors, Angiotensin II Receptors, and beyond that are listed the subdivisions, such as different types of penicillin.
In its draft report, UPS said its Expert Committee "chose an approach that begins with diagnosis and then links diagnosis to treatment, including treatment with a prescription drug. This simple paradigm reflects the day-to-day
interaction between practitioners and patients and provided the Expert Committee with one method to viewing the universe of potential prescription drug needs."
While the list is based on the regular ICD-9 diagnostic categories used in most drug formularies the appearance is different than what many in the industry are accustomed to seeing.
Mark Merritt, president of the Pharmaceutical Care Management Association, which represents the pharmacy benefit managers that likely will oversee a large portion of the Medicare drug benefit, issued a statement that said the UPS approach "would move far beyond how formularies are structured currently in the commercial marketplace and could have the unintended consequence of increasing costs and jeopardizing a workable Medicare prescription drug benefit for seniors."
There also has been lobbying by drug companies to have more than 300 categories included in the formulary, which experts fear could lead to higher utilization and costs for the Medicare program.
Copyright 2004 by United Press International.