Washington Editor

WASHINGTON - Given their current resources and authority, FDA officials do not believe they can guarantee the safety and efficacy of prescription drugs reimported from other countries.

Even if the government opened and inspected every box of drugs that entered the U.S., the FDA said it could not assure consumers that products made outside its jurisdiction are authentic. Just as important, said John Taylor, the FDA's associate commissioner for regulatory affairs, is that the FDA has an extremely difficult time protecting consumers who buy drugs off the Internet because it is difficult to track down the origin of some of the companies.

While it is illegal to reimport or import prescription drugs, traditionally the FDA has not enforced the policy.

Taylor and William Hubbard, the FDA's associate commissioner for policy and planning, testified Wednesday before the Senate Judiciary Committee on the implications of drug importation. FDA officials were careful not to take a side on the issue, even after one senator accused the two of supporting policies that cost senior citizens millions of dollars.

Hubbard presented the committee with 25 pages of written testimony that included an outline of recent incidents of counterfeit and unapproved drugs entering the U.S.

For example, last summer the FDA and U.S. Customs and Border Protection Agency conducted spot examinations on mail shipments in Miami, New York, San Francisco and Carson, Calif. Of the 1,153 shipments examined, the overwhelming majority (1,019 packages, or 88 percent) contained unapproved drugs. The drugs arrived from many countries: 16 percent from Canada, 14 percent from India, 14 percent from Thailand; and 8 percent from the Philippines, Hubbard told the committee.

In another example, the FDA in February learned about an Internet site selling contraceptive patches that contained no active ingredient. The website's domain name, www.rxpharmacy.ws, is registered to American Style Products of New Delhi, India.

But for every horror story, there's a story with a happy ending.

Indeed, Rep. Bernard Sanders (I-Vt.) told committee members that he knows of breast cancer patients who purchased tamoxifen in Montreal for one-tenth the price they would pay in the U.S.

Sanders, who doesn't hide his disdain for the pharmaceutical industry, said that the industry's safety concerns around reimportation are bogus. He said the industry "lies" and has more than 800 well-paid lobbyists from both parties who are prepared to descend on Congress at any given hour to protect the profits of the drug giants.

"But the evidence is overwhelming," he said. "We can lower drug costs by 25 [percent] to 50 percent by allowing reimportation."

Challenging Sanders' remarks, Rep. Don Nickles (R-Okla.) cited a report from the Congressional Budget Office (CBO) that said reimporting prescription drugs from abroad would provide a savings of about 1 percent to American consumers. (The CBO is a non-partisan office.)

"Are we willing to jeopardize safety and health to save 1 percent?" Nickles asked.

Others believe reimportation legislation is not necessary because drug prices for seniors will fall as sections of the new Medicare law are implemented.

The Medicare law contains a provision that allows reimportation from Canada, provided Tommy Thompson, secretary of Health and Human Services, certifies that the practice is safe. As part of the law, Thompson's office was mandated to set up a task force to study the issue.

Sen. Orrin Hatch (R-Utah), chairman of the judiciary committee, said it might be beneficial for Congress to receive the task force report before considering any legislation in the area.

"I recognize that the report is not due until after the election and the strategy of some is to attempt to use Election Day politics as leverage for legislation, and that sound policy will not win out," Hatch said.

There are several bills floating around the Senate pertaining to the issue.

In April, Sen. Byron Dorgan (D-N.D.) introduced bipartisan legislation (S.2328) that would allow American consumers, pharmacies and drug wholesalers to import FDA-approved prescription drugs. The bill also would punish drug companies seeking to protect and control their products by limiting sales to Canadian wholesalers and pharmacies. (See BioWorld Today, April 23, 2004.)

Similar legislation passed in a 243-186 vote in the House last year.

Meanwhile, Judd Gregg (R-N.H.), chairman of the Senate Committee on Health, Education, Labor and Pensions, introduced separate legislation (referred to as the Safe Importing of Medical Products and Rx Therapies Act) that would allow U.S. citizens to import from Canada now, and from the European Union in three years. That legislation would provide the FDA with money to regulate the program. (See BioWorld Today, June 14, 2004.)

And Sens. Russ Feingold (D-Wis.), Patrick Leahy (D-Vt.) and Mark Dayton (D-Minn.) introduced legislation (S.477, referred to as Preserving Prescription Drug Discounts Act) that would deny tax breaks to drug companies that limit supplies of prescription drugs to Canadian pharmacies that provide Americans with prescription drugs.

The House Appropriations Committee in June approved a measure that would prevent the FDA from enforcing a ban on reimporting prescription drugs from other countries.

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