Numerous groups, from the agency responsible for regulating the drug market to medical associations and the pharmaceutical industry, oppose liberalization of drug importation laws. Still, the legislation is introduced every year and proponents of a more open market say allowing more drugs to be imported into the United States would reduce the burden of high medical costs on seniors, the uninsured and other citizens. They also point out that Americans pay more than most other countries for prescription drugs. Opponents also say other efforts to hold down prescription drug costs have not been successful.
The Partnership for Safe Medicines, the Academy of Managed Care Pharmacy (AMCP) and more than two dozen other groups have gone on record opposing proposed Congressional legislation that would allow pharmaceuticals to be imported into the United States.
Legislators in both the House and Senate proposed amending the Senate’s Food and Drug Administration Safety and Innovation Act. In 2012, legislators in both the House and Senate and from both parties unsuccessfully moved to amend the bill (S 3187) reauthorizing the FDA's prescription drug and medical device user-fee programs. The Prescription Drug User Fee Act (PDUFA) must be must be re-authorized every six years.
Sen. John McCain (R-Arizona) introduced the amendment allowing drugs to be imported through Canadian online pharmacies with the support of Senators Charles Grassley (R-Iowa) and Olympia Snowe (R-Maine). McCain bitterly blamed industry lobbyists for pressuring Senate members to reject the amendment which failed 43-54.
Before the vote took place, McCain said, "In a normal world this would probably require a voice vote, but what we're about to see is the incredible influence of the special interests, particularly pharma, here in Washington, that keeps people who cannot — that have to make a choice between eating and medicine."
Grassley, who has long favored allowing drug importation from Canada, said he considered drug importation a free-trade issue that spurs competition and that allowing Americans to access less expensive drugs from outside the United States would force drug companies to re-think pricing.
Snowe said that Americans pay 50 percent more for prescription drugs than Canadians and that allowing drug imports from Canada would be a cost saving for the government for individuals and for companies that provide health insurance for employees.
Opponents of drug importation say potential problems with importing drugs outweigh the benefits.
“Many drugs that have been imported into this country from foreign countries have been shown to be counterfeit, substandard, adulterated, of dubious origin and potentially dangerous,” according to AMCP CEO Edith Rosato.
The Pharmaceutical Manufacturers Association's (PhRMA) position on drug importation is that it is unsafe. PhRMA points to online pharmacies as the leading purveyor of counterfeit drugs targeted to people with everything from depression to cancer and high blood pressure.
Each time the legislation is introduced, the industry lobbies fiercely to kill it. The FDA has been concerned about the legislation for years. In 2003, John Taylor, III, the FDA's associate commissioner for regulatory affairs, testified before a Senate committee hearing on drug importation . He called legislation allowing importation inconsistent with efforts to keep the drug supply safe, and said allowing imported drugs would “overwhelm” the regulatory system.
“FDA continues to have serious public health concerns regarding legislation that would allow the importation of drugs from outside the current safety system established by Congress under the Federal Food Drug and Cosmetic Act,” said Taylor. “When it comes to buying drugs internationally, outside our existing regulatory protections, FDA has consistently concluded that the Agency is unable to endorse a “buyer beware” approach.”
The FDA also cited inadequate resources for inspecting and approving drugs sourced from foreign countries.
Then as now, the FDA maintained that faster approval of more cost-effective generic drugs and improving the efficiency of the drug development process are preferred methods for lowering the costs of prescription drugs.