DrugBuyers.Com: House Ok's Plan to Import Rx Drugs

Here is a reprint about what happened with these initiatives. Take care. Billylll

December 27, 2000 In a Turnaround, White House Kills Drug-Import Plan
By ROBERT PEAR
Senator Byron L. Dorgan was an author of the drug-import plan.
The Associated Press
WASHINGTON, Dec. 26 ?

The Clinton administration today killed a program created by Congress to allow imports of low-cost prescription drugs. The administration said the import plan would not be safe and would not save money for consumers.

Donna E. Shalala, the secretary of health and human services, said the program, adopted by Congress with much fanfare, was severely flawed. "These flaws," Dr. Shalala said, "undermine the potential for cost savings associated with prescription drug reimportation and could pose unnecessary public health risks."

Even though President Clinton had previously questioned the feasibility of the program, expressing doubts even as he signed it into law, the timing of Dr. Shalala's finding was a surprise. The Clinton administration could easily have left the issue to President-elect George W. Bush, but instead invoked a provision of the law to abort the program.

At a presidential debate on Oct. 17, Mr. Bush said the drug-import program "makes sense" as a way to help people buy medicines at affordable prices. But advisers to Mr. Bush said today that he would also consider other ways to moderate spending on prescription drugs, which has grown rapidly in recent years.

The drug-import program was included in the annual spending bill for the Agriculture Department and the Food and Drug Administration. President Clinton supported a version of the drug-import program approved by the Senate on July 19 by a vote of 74 to 21. "I urge you to send me the Senate legislation," Mr. Clinton said in a letter to Congressional leaders in late September.

The bill was revised in negotiations between the House and the Senate. When Mr. Clinton signed it on Oct. 28, he said the program was "little more than a false promise," because of what he described as "loopholes." But Mr. Clinton gave no hint that his concerns were so deep that he would terminate the program before trying to carry it out.

In her letter today, Dr. Shalala said the drug-import law had at least three "flaws and loopholes":
? Federal laws requires government-approved labeling on any prescription drug sold in this country, and drug makers could block imports of medications by denying importers access to those labels.
? Authority for the import program would have expired after five years. Wholesalers would have been reluctant to buy the equipment needed to test and distribute imported drugs because they could not be sure of "long-term financial returns."
? Drug makers could have thwarted the intent of Congress by requiring drug distributors to sell imported drugs at high prices.

Under the law, drug makers could not completely block the sale or distribution of imported drugs in the United States. But, through contracts with drug distributors, they could have tried to limit the supply or set the price of such drugs.

House Republican leaders, taking political heat over the high cost of prescription drugs, embraced the import scheme six weeks before Election Day. But in subsequent negotiations, they opposed efforts by some Democrats to limit the prices that could be charged for imported drugs.

As a result, there was no guarantee that American consumers would receive the discounts available to consumers in other countries. The purpose of the measure was to help Americans gain access to prescription drugs at the lower prices charged in foreign countries that regulate drug prices.

The law allowed pharmacists and wholesalers to import prescription drugs that meet federal safety standards. After working out details of the legislation in October, Congress at the last minute added a proviso saying that it would take effect only if the secretary of health and human services demonstrated to Congress that it would "pose no additional risk to the public's health and safety" and would "result in a significant reduction in the cost of covered products to the American consumer."

In a letter today to Mr. Clinton, Dr. Shalala said she could not make either showing. Gail R. Wilensky, a health policy adviser to Mr. Bush, said, "That effectively kills the provision." The new administration and the new Congress, Ms. Wilensky said, will have to decide whether to try to perfect the program or to "pursue other strategies to slow the growth in spending on pharmaceuticals."

Such alternatives, she said, include changes in Medicare and in drug patent laws. Senator Byron L. Dorgan, Democrat of North Dakota and an author of the legislation creating the drug- import program, said he was "deeply disappointed, puzzled and surprised" by Dr. Shalala's action. "I would have thought the administration would want to make this provision of the law work for the benefit of American consumers," said Mr. Dorgan, who has taken constituents to Canada to buy low-price prescription drugs. Mr. Dorgan said he would urge Mr. Bush to reverse Dr. Shalala's decision, but had little confidence that he would succeed. "The new administration will be more hospitable to the pharmaceutical industry than this one is," Mr. Dorgan said.

Drug companies lobbied against the drug-import legislation, saying it would expose American consumers to unsafe, impure and counterfeit drugs. Jackie Cottrell, a spokeswoman for the Pharmaceutical Research and Manufacturers of America, said, "Secretary Shalala's findings today confirm all of our concerns." Ms. Cottrell said the trade association had not discussed the drug-import program with the administration since Mr. Clinton signed the bill.

Aides to Senator James M. Jeffords, Republican of Vermont, said he would try to persuade the new administration to reverse the decision. Joseph Karpinski, a spokesman for Mr. Jeffords, said: "Today's decision puts Democrats in a difficult political position. It's now the Democrats who are blocking access to affordable prescription drugs. If the new administration reverses the Shalala position, Republicans will be the heroes." Representative Bernard Sanders, independent of Vermont, led efforts to allow more drug imports, saying they could reduce drug costs in the United States by 30 percent to 50 percent. But, Mr. Sanders said today that "given the loopholes that the Republican Congressional leadership placed in the bill at the request of the pharmaceutical industry, there are serious questions whether the law, as currently written, would have had an impact."

Individuals can still buy drugs from abroad. Scores of consumers cross the border and buy medications in Canada or Mexico. Also, growing numbers of consumers buy drugs from foreign countries over the Internet. Federal officials have expressed concerns about both types of purchases, but they say that they generally do not challenge consumers importing small quantities of prescription drugs for personal use.

Drug companies say they now have virtually complete control over the custody of prescription drugs, from the factory floor to the retail pharmacy. But after drugs leave the United States, they say, they cannot be sure of the conditions under which the drugs are stored and handled. In her letter, Dr. Shalala took a jab at Mr. Bush and Republicans in Congress.

Allowing drug imports, she said, can never be a substitute for providing drug benefits to the elderly as an integral part of Medicare, nor is the solution a prescription drug program run by the states to help people with low incomes.

Mr. Bush has proposed such a program, to provide "an immediate helping hand" to the elderly.
HOUSE VOTES TO PROTECTPERSONAL PRESCRIPTION MAIL ORDER
From Foreign Countries

What follows is part of an article published in 'The Washington Post',Tuesday, July 11, 2000.

"House Blocks Drug Import Curbs"

Amid growing public resentment of high prescription drug prices, the House voted overwhelmingly yesterday to prevent the government from discouraging the purchasing of drugs in Canada or other countries where the medicines are cheaper....The FDA sometimes sends warning letters to those caught doing it.

The [Food and Drug Admin] gives its employees discretion to permit import of drugs that violate its restrictions so long as they are intended for personal use.

The House approved 363 to 12, an amendment to an FDA appropriations bill that would prevent the agency from enforcing the importation ban.... A second amendment, approved 370 to 12, would bar the agency from sending warning letters."

When this is actually signed into law it may affect the way you do business as it effectively removes most import restrictions as long as the drugs are "intended for personal use."