House drops FDA safeguards from drug reimportation bill

Strong opposition has not fazed lawmakers hunting for ways to lower the price of drugs and Medicare reform.

By Joel B. Finkelstein, amednews staff. Aug. 18, 2003.

Washington -- House passage of new drug reimportation legislation sets the stage for a clash with the Senate over safety concerns.

Both bodies earlier this summer included reimportation language in their visions of Medicare reform. Those provisions require the Food and Drug Administration to certify the safety of reimportation, something the agency has refused to do in the past.

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But the new House bill would allow reimportation without requiring the FDA to certify the process. That language now supplants the earlier reimportation provision and has become the position of House lawmakers negotiating with the Senate on a final Medicare package.

The House move came despite intense lobbying efforts from the pharmaceutical industry and opposition from some medical groups, including the American Medical Association.

"We don't want to sacrifice safety for affordability," said Donald J. Palmisano, MD, AMA president.

The Bush administration also has come out strongly against reimportation. FDA officials have done everything short of lobbying Congress members to discourage the passage of any reimportation legislation.

Seniors will spend $1.8 trillion on prescription drugs in the next 10 years.

The House and Senate bills differ on points other than the need for FDA approval. The Senate measure would allow reimportation only from Canada. The House bill covers only FDA-approved drugs produced at FDA-approved factories. The drugs can come from the European Union, Australia, Canada, Iceland, Israel, Japan, Liechtenstein, New Zealand, Norway, Switzerland and South Africa.

As a further safety precaution, the legislation requires reimported prescriptions drugs to carry counterfeit-resistant labels, based on the technology used by the U.S. Treasury Dept. to protect against counterfeit dollars. Drugs without these labels could be reimported pending FDA inspection.

One selling point for reimportation is that it is the only measure lawmakers have offered to control rising drug costs and limit the price tag of a Medicare drug benefit.

"We simply cannot afford to pass a prescription drug benefit without considering cost," said Rep. Gil Gutknecht (R, Minn.), the bill's author, during a hearing. The Congressional Budget Office estimates that seniors will spend $1.8 trillion on prescription drugs in the next 10 years.

"Does anyone believe we will solve a $1.8 trillion problem with a $400 billion solution?" he said, referring to the estimated cost of a drug benefit for seniors.

Furthermore, a new study from the consumer group Families USA showed that the cost of the 50 drugs most commonly used by seniors rose 3.4 times faster than inflation in 2002.

With costs rising that rapidly, "any port in the storm is useful," said Families USA President William Vaughn.

The rising cost of drugs means many seniors with chronic conditions cannot afford their medications. As many as 30% skip pills or don't fill prescriptions because of cost, according to the Kaiser Family Foundation.

Safety concerns pervade the debate

Opponents of importation argue that cost concerns cannot outweigh safety concerns.

Although no statistics on the counterfeiting of prescription drugs are available, it seems to be a growing problem internationally. The FDA and U.S. Customs and Border Protection have noted a significant increase in counterfeit drugs -- both those manufactured in the United States and those imported from other countries -- although numbers are small.

30% of seniors skip pills or don't fill prescriptions because of high costs.

Internationally the problem is huge, however, and the medical community worries that making reimportation legal will open the flood gates to counterfeiters.

That concern, while real, is overblown, said the House bill's proponents. "There's risk everywhere we turn," Vaughn said. People become sick from imported foods, but no one argues that the United States should stop bringing in produce from other countries, he noted.

Gutknecht points out that "unaffordable prescription drugs do nothing to improve the health of American consumers."

While the AMA's Dr. Palmisano said he agrees that drugs need to be more affordable, giving up the protections Americans are accustomed to is not the way to go. Instead, he suggested, Congress should help to create a market environment in which people can afford health insurance and let the plans negotiate better drug prices.

"The risk is unacceptable without the safeguards of FDA oversight," he said. "This is not a junk TV; this is something that could kill you."

ADDITIONAL INFORMATION:

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Thomas, the federal legislative information service, for bill summary, status and full text of the Pharmaceutical Market Access Act of 2003 (HR 2427) (thomas.loc.gov)