In This Article
Subscribe to Health UpdatesSenate Restricts Entry of Cheap Foreign Medications
by
findingDulcinea Staff
Drugs made outside the United States must meet stringent safety standards––a stricture that, say critics, hobbles legislation that would have improved access to cheaper, foreign pharmaceuticals.
30-Second Summary
Brand-name prescription drugs cost as much as 70 percent more in the United States than in other countries.
May 7––The Senate altered legislation that would have increased access to those cheaper foreign medications. The amendment, which passed in a 49–40 vote, requires that imported prescription drugs meet the same safety standards as U.S.-made pharmaceuticals.
Supporters of the safety amendment argue that the original bill, the Dorgan–Snowe legislation (s. 2328), would have exposed U.S. patients to dangerous drugs. Under the amended law, imports will have to be tested, and also be shown to be cheaper than domestically produced alternatives.
Opponents of the amendment, such as bill-sponsor Sen Byron Dorgan (D–ND), assert that the legislation is being changed to benefit the big pharmaceutical corporations. These critics say that by creating impossibly stringent approval regulations, senators have effectively blocked the importation of foreign drugs.
The FDA approves of the amendment. But its judgment has come into question after it approved the anti-arthritis drug Vioxx, a medication withdrawn from sale in 2004 when it was shown to increase the risk of heart attack and stroke.
May 7––The Senate altered legislation that would have increased access to those cheaper foreign medications. The amendment, which passed in a 49–40 vote, requires that imported prescription drugs meet the same safety standards as U.S.-made pharmaceuticals.
Supporters of the safety amendment argue that the original bill, the Dorgan–Snowe legislation (s. 2328), would have exposed U.S. patients to dangerous drugs. Under the amended law, imports will have to be tested, and also be shown to be cheaper than domestically produced alternatives.
Opponents of the amendment, such as bill-sponsor Sen Byron Dorgan (D–ND), assert that the legislation is being changed to benefit the big pharmaceutical corporations. These critics say that by creating impossibly stringent approval regulations, senators have effectively blocked the importation of foreign drugs.
The FDA approves of the amendment. But its judgment has come into question after it approved the anti-arthritis drug Vioxx, a medication withdrawn from sale in 2004 when it was shown to increase the risk of heart attack and stroke.
Headline
Sen. Edward Kennedy (D–Mass.) sponsored the safety amendment, a move he claimed he took against his will with the sole intention of protection the central provisions of the legislation from a threatened presidential veto. Kennedy said that the White House "is listening more to the big drug companies than to the American people."
Source: Bloomberg News
Reference Material
This page shows how the Kennedy-sponsored amendment changed the original Dorgan–Snowe legislation.
Source: The full text of the amended bill
Sen. Byron L. Dorgan (D–ND) provides a Q&A on drug legislation as well as a summary of the bill's provisions prior to amendment.
Source: Sen. Byron Dorgan
Critics of the Safety Amendment
Sen. Byron Dorgan
Senator Byron L. Dorgan (D-N.D.), sponsor of the original legislation, asked the Senate if it’s fair that “the American people [are] paying the highest prices in the world for prescription drugs? The answer is, no; it is not fair.”
Senator Byron L. Dorgan (D-N.D.), sponsor of the original legislation, asked the Senate if it’s fair that “the American people [are] paying the highest prices in the world for prescription drugs? The answer is, no; it is not fair.”
Source: Sen. Dorgan's Biography
“Today's vote is a setback, to be sure, but it is not the end of our effort to make prescription drugs more affordable," Sen. Dorgan stated in a press release issued in response to the amendment's passage.
Source: Sen. Dorgan's Reaction
Sen. Olympia Snowe
Republican Senator from Maine Olympia Snowe co-sponsored the original legislation. Commenting on the amendment’s impact, Snowe told the Senate that the additional regulations made importation “an impossible thing. If Congress wants to import drugs, they should take that provision out.”
Republican Senator from Maine Olympia Snowe co-sponsored the original legislation. Commenting on the amendment’s impact, Snowe told the Senate that the additional regulations made importation “an impossible thing. If Congress wants to import drugs, they should take that provision out.”
Source: Sen. Snowe's Biography
Sen. Bernie Sanders
Senator Bernie Sanders (I-Vt.) also supported the Dorgan–Snowe legislation, saying on the Senate floor that “this amendment will mean that Americans from one end of our country to the other, people with chronic illnesses, senior citizens . . . that finally these Americans . . . will no longer continue to be ripped off by the pharmaceutical industry.”
Senator Bernie Sanders (I-Vt.) also supported the Dorgan–Snowe legislation, saying on the Senate floor that “this amendment will mean that Americans from one end of our country to the other, people with chronic illnesses, senior citizens . . . that finally these Americans . . . will no longer continue to be ripped off by the pharmaceutical industry.”
Source: Sen. Sanders's Biography
Supporters of the Safety Amendment
Sen. Thad Cochran
Republican Senator from Mississippi Thad Cochran introduced the second-degree safety amendment, saying on the Senate floor that Sen. Dorgan’s original act would “put in jeopardy the process we now have to ensure the safety of prescription medications and protect the health of the American people.”
Republican Senator from Mississippi Thad Cochran introduced the second-degree safety amendment, saying on the Senate floor that Sen. Dorgan’s original act would “put in jeopardy the process we now have to ensure the safety of prescription medications and protect the health of the American people.”
Source: Sen. Cochran's Biography
After the Senate approved his amendment, Sen. Chochran said in a press release that “it is a matter of common sense to make certain that any change we make to the law does not result in less protection in terms of the safety of the drugs supplied to the American people.”
Source: Sen. Cochran's Press Release
Sen. Mike Enzi
Sen. Mike Enzi (R-Wyo.) was a staunch supporter of Sen. Cochran’s amendment, saying in a press release that Dorgan’s act would “put patient lives at risk. I urge my colleagues to oppose it.”
Sen. Mike Enzi (R-Wyo.) was a staunch supporter of Sen. Cochran’s amendment, saying in a press release that Dorgan’s act would “put patient lives at risk. I urge my colleagues to oppose it.”
Source: Sen. Enzi's Biography
The Pharmaceutical Research and Manufacturers of America (PhRMA), representing the country’s largest pharmaceutical and biotechnology companies, criticized Sen. Dorgan’s Prescription Drug Importation Act. The PhRMA stated that “the importation of medicines from foreign countries, in our view, is equivalent to importing into America the soaring epidemic of dangerous counterfeits around the world.”
Source: The Pharmaceutical Research and Manufacturers of America
The White House
The May 1 statement declared that the administration would “strongly oppose any provision that might be added … regarding the importation of prescription drugs that does not address the serious safety concerns identified in the December 2004 Department of Health and Human Services Task Force.”
Source: Statement of Administration Policy
The White House made it clear on May 1 that it would veto the bill if it allowed for the unregulated importation of medications.
Source: The Hill
The Food and Drug Administration
The U.S. Food and Drug Administration (FDA) says its main concern is safety. The FDA’s site offers specific information on importing prescription drugs including warnings for consumers and regulatory actions and policy.
Source: FDA––Consumer Information
A member of the FDA's Office of Regulatory Affairs explains, "If you buy drugs that come from outside the U.S., the FDA doesn't know what you're getting, which means safety can't be assured.” The author further states, “With an unapproved drug, you can't be sure that it has been shipped, handled, and stored under conditions that meet U.S. requirements.”
Source: FDA––Article on Drug Importation
Health and Human Services Task Force
The December 2004 Department of Health and Human Services task force report on prescription drug importation concluded that safety measures necessitated by the introduction of imported drugs would mean that the “overall national saving from legalized commercial importation will likely be a small percentage of total drug spending.”
Source: Drugstore News
“Many comments stated that pharmacies in Canada are regulated and meet the same standards as pharmacies in the U.S. Other comments noted that many Internet pharmacies accept orders for drugs without a prescription and are hard to locate to determine whether they adhere to pharmacy practice standards or from where they obtain their drug products.” This is from the 144-page HHS task force report on prescription drug importation, published in December 2004.
Source: The HHS Report
The deputy commissioner for policy at the FDA, Randall Lutter, spoke to a Senate subcommittee regarding the importation of drugs in March 2007. He reiterated the findings of the 2004 HHS task force report. An appendix to Lutter’s testimony, linked to here, covers selected drug importation cases investigated by the FDA.
Source: Randall W. Lutter
Background
The Medicare Reform Bill of late 2003 opened the door to inexpensive drug imports. This news report considers the passage of that legislation.
Source: CNN
“Activities of the unregulated market expose patients to serious health risks through the delivery of often poorly documented, unsafe, ineffective or low quality medicines,” said the president of the United Nations International Narcotics Control Board (INCB). That statement was made in the INCB’s annual report for 2006.
Source: The UN International Narcotics Control Board '06 Report
Related Links
In July 2004, pharmaceutical giant Pfizer announced that it would offer discounts and free medications to the uninsured. Analysts conjectured that Pfizer acted to counter the online foreign pharmacies that have flooded the market with inexpensive drugs.
Source: CNN
Vioxx
The FDA came under fire in 2004 when a non-steroidal anti-inflammatory (NSAID) it had approved was withdrawn from the market. Vioxx was primarily used to treat arthritis. However, it was found to increase the risk of heart attack and stroke.
The FDA came under fire in 2004 when a non-steroidal anti-inflammatory (NSAID) it had approved was withdrawn from the market. Vioxx was primarily used to treat arthritis. However, it was found to increase the risk of heart attack and stroke.
Health correspondent Susan Dentzer discusses the Senate hearings regarding the FDA’s disastrous approval of Vioxx. Apparently, the FDA allowed Vioxx to be marketed despite studies linking the anti-arthritis drug to an increased risk of heart attack and stroke.
Source: PBS––Vioxx Senate Hearings
Dr. David Graham, an official at the FDA's Office of Drug Safety, testified during the Senate hearing. He said, “The FDA as currently configured is incapable of protecting America against another Vioxx.” He characterized the FDA’s actions as “profound regulatory failure.”
Source: Dr. David Graham: Senate Testimony
The decision on the amendment was taken via a "voice vote," which is defined as a vote “in which the Presiding Officer states the question, then asks those in favor and against to say ‘Yea’ or ‘Nay,’ respectively, and announces the result according to his or her judgment. The names or numbers of Senators voting on each side are not recorded.”
Source: U.S. Glossary of Terms
The FDA has warned U.S. drug makers “to be especially vigilant” in watching for diethylene glycol, a syrup used as a industrial solvent. According to the New York Times, counterfeiters have been replacing more expensive substances with diethylene glycol in drugs, food, toothpaste, and other products. It is estimated that thousands have died from taking medicine containing the syrup.
Source: FDA Warning: Contaminated Syrup
The Mayo Clinic offers information concerning the use of prescribed drugs while taking other medications, proper storage of medicine, and possible side effects.
Source: The Mayo Clinic
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