With prescription drug prices soaring and President Donald Trump vowing to take action, an old idea is gaining fresh traction: allowing Americans to buy medicines from foreign pharmacies at far lower prices. A new bill in Congress to allow the practice would modify previous safety standards and remove a barrier that proved insurmountable in past attempts to enable progress.

Congress came close to allowing importation through the Medicare Modernization Act in 2003 but added one firm precondition that has proved a nonstarter. The secretary of Health & Human Services had to guarantee that imported medications posed no additional risk to public safety and would save money.

“That is a fairly absolute standard and a high bar to cross,” said Elizabeth Jungman, director of public health at the Pew Charitable Trusts. Such an exacting standard – guaranteeing that no imported prescriptions posed a threat – has kept any secretary of HHS from condoning it.

In an open letter to Congress, four former commissioners of the Food and Drug Administration argue consumer drug importation remains too risky to permit. “It could lead to a host of unintended consequences and undesirable effects, including serious harm stemming from the use of adulterated, substandard, or counterfeit drugs,” they said in the letter distributed to media organizations. It was signed by Robert Califf, Margaret Hamburg, Mark McClellan, and Andrew von Eschenbach, who each headed the FDA at various times during 2002 through 2016.

The recent proposal, from senators Bernie Sanders (I-Vt.) and Cory Booker (D-N.J.) and Bob Casey (D-Pa.) drops that requirement. Instead, it sets up a regulatory system in which Canadian pharmacies that purchase supplies from manufacturers inspected by the FDA would be licensed to sell to customers across the border. The bill allows not only individuals but also drug wholesalers and pharmacies to buy from Canada.

After 2 years, HHS could allow importation from other countries that meet standards comparable to those of the United States.

Another bill in Congress, proposed in January by senators John McCain (R-Ariz.) and Amy Klobuchar (D-Minn.), focuses solely on allowing individuals to purchase drugs from such pharmacies.

President Trump has promised that “pricing for the American people will come way down.” Last week, he had a high-profile meeting at the White House with congressmen Elijah Cummings (D-Md.) and Peter Welch (D-Vt.) and the president of Johns Hopkins Hospital, Baltimore, Redonda Miller, MD, to discuss allowing Medicare to negotiate prices on outpatient medicines. Cong. Cummings told reporters later that President Trump said he supports Medicare price negotiation as well as the Sanders bill.

PhRMA, the drug industry’s trade group, has denounced Sanders’ proposal as it has others that enabled imports in the past.

“The bill lacks sufficient safety controls [and] would exacerbate threats to public health from counterfeit, adulterated, or diverted medicines, and increase the burden on law enforcement to prevent unregulated medicines and other dangerous products from harming consumers,” said PhRMA spokeswoman Nicole Longo.

Surveys indicate that up to 8% of Americans have bought medicines outside the United States, even though the practice is technically illegal and imported pills are subject to confiscation.

Around 45 million Americans – 18% of the adult population – said last year that they did not fill a prescription because of cost, according to an analysis of data from the Commonwealth Fund by Gabe Levitt, president of pharmacychecker.com, whose company helps Americans buy medications online by vetting overseas pharmacies and comparing prices for different drugs. Data compiled by the company compare Canadian prescription prices with those offered in New York and show drugs that frequently are three or more times as expensive in the United States as across the border.

For example, a simple Proventil asthma inhaler costs $73.19 in the United States vs. $21.66 in Canada. Crestor, the cholesterol-lowering drug, is $6.82 per pill in U.S. pharmacies but $2.58 in Canada. Abilify, a psychiatric medicine, is $29.88 vs. $7.58, according to pharmacychecker.com.

Many previous bills that permitted importation or that allowed Medicare to negotiate prices for its beneficiaries have failed in the face of $1.9 billion in congressional lobbying by the pharmaceutical industry since 2003, according to Open Secrets. But Americans may be reaching a tipping point of intolerance. In polling just before the election by the Kaiser Family Foundation, 77% of Americans called drug prices “unreasonable” and well over half favored a variety of proposals to address them.

To address safety concerns, the Sanders bill institutes several new strategies. Canadian pharmacies that want to be registered to sell to Americans would have to pay a fee to pay for additional FDA monitoring. A Government Accountability Office study would be required within 18 months of the final rule to address outcomes related to importation processes, drug safety, consumer savings, and regulatory expenses.

Allowing people to legally import medications would not completely solve the problem of high prescription drugs prices, advocates say, but would be a step in the right direction. Said Mr. Levitt, “the best way for Americans to afford their meds is to enact policies here to bring the prices down here.”

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Trump’s promise to rein in drug prices could open floodgate to importation laws