11 July 2004

Seniors' Prescriptions Drug Costs: Rx for hope and frustration

WASHINGTON-- Geraldine and James Keon of Westland joined a busload of seniors in Windsor this week looking for bargains on prescription drugs.

Last year, their cross-border trips saved the Keons about $1,200 on seven prescriptions that they take for ailments including heart disease, high blood pressure and acid gas reflux.

Americans bought about $1 billion in pharmaceuticals from Canada last year, saving up to 70 percent over the cost of drugs in the United States, according to the Canadian International Pharmacy Association. Canadian drugs are cheaper because of government incentives for physicians to prescribe less expensive pharmaceuticals.

Like millions of other American seniors on fixed incomes or without prescription insurance, the Keons -- she's 79 and he's 80 -- have been looking to Washington for relief and the chance to buy their drugs closer to home. But an effort to lift federal restrictions on reimporting drugs, especially from Canada, has stalled.

Drug manufacturers are trying to stave off drug reimportation legislation, spending millions on lobbying and expanding free or low-cost drug programs for the working poor and uninsured. Drug giant Pfizer announced such a program Wednesday.

That pressure has slowed legislative efforts led by -- among others -- Michigan Sen. Debbie Stabenow, who chairs the Senate Democratic Health Task Force, to allow cheaper drugs from Canada and other nations to be sold in the United States.

The bill had bipartisan support, including from Republicans Trent Lott of Mississippi, John McCain of Arizona, Olympia Snowe of Maine and Arlen Spector of Pennsylvania. A bill introduced by Republican senators is competing with the Stabenow-backed bill.

A hearing on that bill was to be scheduled in July but likely will be postponed because Congress recesses July 22 and won't reconvene until after Labor Day and the conventions of the Democratic and Republican parties.

The Bush administration is lukewarm on changing the law, but Tommy Thompson, secretary for the U.S. Department of Health and Human Services, said this spring the administration was open to Canadian reimportation with strict regulation.

Mom vs. research money

The case of Sen. Lott, a conservative Republican who initially was an opponent of reimportation, illustrates the competing pressures politicians feel on the issue. On the one hand, the nation's multibillion-dollar drug industry says that profits it makes are needed to fund research on new life-saving medicines.

On the other hand, there's Mom.

Lott said in a committee hearing this year that he changed his position because he no longer could justify to his mother why her medicine was so expensive.

Ron Pollack, executive director of Families USA, a Washington-based consumer health care organization that backs the bipartisan bill, said: "If this bill can get on the floor, it's got a very good chance of passing -- but notice I said, 'If it comes to the floor."'

Drug companies sharply raised many drug prices before the Medicare bill that was passed last November took effect and gave seniors the government's new discount cards.

Many seniors said the cards gave them little relief. That's why they keep going to Canada.

The U.S. Food and Drug Administration says it's unlawful to return to the United States with prescriptions filled in Canada but acknowledges it does not target individuals. In fact, many seniors say they are open with border officials when asked what they are bringing back from Canada.

But there's a new obstacle: Some U.S. drug companies are withholding drugs from Canadian pharmacies that fill U.S. prescriptions, depleting supplies in some areas. Manufacturers including Eli Lilly and Co. and GlaxoSmith Kline are restricting supplies, said David McKay, executive director of the Canadian International Pharmacy Association, which represents 45 pharmacies and supports drug reimportation.

Supplies of Lipitor, a cholesterol-lowering medicine used by 11 million Americans this year, have been restricted.Pfizer requires companies to sign a legal declaration to sell only to Canadians.

"We can't supply what we can't get," McKay said.

Drug companies are protecting the huge investment they make developing new drugs and getting them approved for market, said Jeff Trewhitt, spokesman for the Pharmaceutical Research and Manufacturers of America. The organization has spent millions of dollars lobbying against drug reimportation, citing safety concerns. PhRMA represents 90 companies that sell 90 percent of prescriptions in the United States.

"Importation would be a matter of bringing into this country somebody else's failed price controls," Trewhitt said. "American consumers are subsidizing the research and development spending of their pharmaceutical industry while consumers and patients in other countries are free-riding."

For struggling seniors and others without insurance, Trewhitt recommends comparison shopping and using the Medicare discount cards. Another alternative is PhRMA's patient assistance programs, which gave $18 million in free prescriptions to 6.2 million patients last year, he said. See www.helpingpatients.org.

Concerns about safety

One of the major concerns that the pharmaceutical industry and some members of Congress raise over reimportation is the safety of drugs brought into the United States from other countries.

U.S. Rep. John Dingell, the longest-serving member of the U.S. House and a longtime advocate for senior citizens, voted against a reimportation bill in the House last year.

Dingell said the Senate bill Stabenow wants would expand the FDA's authority without enough resources to regulate an influx of drugs and would require the FDA to implement the bill too quickly -- within 90 days of passage. Dingell would rather negotiate lower prices for seniors, as the Department of Veterans Affairs does.

"There's no guarantee that it's going to be safe or that the drugs are not going to be counterfeit," Dingell said.

Stabenow said the bill does provide necessary safeguards, including FDA inspection of foreign facilities that manufacture medications. She was among the first in Congress to advocate for the seniors who go to Canada.

"It's not about putting folks on a bus to go to Canada," she said. "It's about the local pharmacy being able to do business with pharmacies in Canada."

Pharmaceutical companies say they would continue withholding drugs from Canadian pharmacies that do business with U.S. consumers if reimportation is permitted. The bill Stabenow supports, however, would make that illegal.

Owen Christie, an Army veteran, and his wife, Virginia, were in Windsor Thursday buying prescription drugs for Owen's son, a self-employed maintenance worker without prescription coverage.

Christie of Brownstown Township keeps his own costs down thanks to the Department of Veterans Affairs plan for veterans. But his son Eric, 42, needs cholesterol-lowering medicine.

Christie's trips save his son about $500 for a three-month supply. He pays $218 in Windsor for generic Apo-Pravastatin.

He agrees with Dingell about the benefits of the VA program but said that isn't helping his son.

"If they had the whole country on that type of program, it would save us all money and time," Christie said.

Efforts outside of Congress have helped some people.

Macomb County was the first to offer drug discount programs for seniors in southeastern Michigan, and Wayne County followed. Oakland County recently hooked up with an Ohio company to provide low-cost prescriptions drugs to the working poor.

Under that program, Prescription Relief of Columbus, Ohio, works with more than 100 pharmaceutical companies' charitable units to supply prescriptions to eligible individuals for $7 a month. In return, the drug companies get a tax write-off and an avenue to get rid of drugs that are nearing their expiration dates.

Last year, Michigan and Vermont formed the first joint venture to buy prescription drugs in bulk for Medicaid recipients and other low-income residents. So far, the state has saved about $40 million and has spent $560 million on drugs for poor people.

The efforts help, but Geraldine Keon remains disappointed, especially with the outcome of the Medicare bill last year.

She and James Keon have been without prescription drug coverage since he retired in 1987 after 40 years at a small tool-and-die company. They started what they thought were stopgap trips to Canada two years ago as they waited for Congress to help.

The result was a Medicare bill that she said offers little coverage until they pay thousands, prohibits the government from bargaining for lower drug costs and bans reimportation.

"After all this, we're still in limbo," Keon said.

Connie Hierta, 73, got her Medicare prescription drug card last week. The former customer service manager at a manufacturing firm in Detroit has had no coverage since 1995, when she reduced her hours to part-time. She retired in January.

Last year, she spent $3,672 in Canada, a third of what she said she would spend in the United States for her seven prescriptions.

"I had hopes until they came through with that last bill," said Hierta, referring to the Medicare bill. "Now, we're stuck."

SIDEBAR
LAW NOT ENFORCED

Americans who bring prescription drugs they have purchased in Canada or other countries into the United States are breaking the law, but U.S. Food and Drug Administration officials say they are not interested in prosecuting or confiscating pharmaceuticals from individuals who purchase and bring medicine for themselves back from foreign countries. In fact, busloads of senior citizens who travel to Canada from metro Detroit often are open with Canadian and U.S. customs officials about the intent of their trips and what they are bringing back.

The larger issue now for Americans who buy Canadian drugs is that pharmaceutical companies are cracking down on stores that sell to non-Canadians by limiting drug supplies or -- in the case of Pfizer -- making pharmacies sign statements to fill only Canadian prescriptions.

PROPOSED BILLS

Two U.S. Senate bills would allow drug importation into the United States from Canada and other countries. How they compare:

Pharmaceutical Market Access and Drug Safety Act (Democrat-sponsored)

1. The FDA has 90 days to create rules permitting drug importation. U.S. pharmacies and drug wholesalers can import medicines from Canada in the first year and 19 other countries thereafter. Individuals could be shipped prescriptions from mail order or Web sites from FDA-approved Canadian pharmacies.

2. It's unlawful for drugmakers to limit supply or alter drugs to fail FDA standards.

3. A 1-percent user fee is imposed to fund FDA inspections.

4. Exporters to individuals must post a bond that they forfeit if they send unsafe drugs.

Safe Importing of Medical Products and RX Therapies Act (GOP-sponsored)

1. The FDA has one year to make safety recommendations before permitting imports from Canada and up to three years for 15 European Union countries. The FDA could ban drugs from some nations.

2. There is no provision making it unlawful to reduce supply or alter drugs to fail FDA standards.

3. A new, uncapped user fee program is established, paid for by all foreign and domestic businesses engaged in importation to pay for FDA inspections.

4. Licensing requirements and penalties are established for all online pharmacies that illegally conduct or solicit U.S. business.

BY RUBY L. BAILEY
DETROIT FREE PRESS WASHINGTON STAFF

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