By ED SILVERMAN @Pharmalot
FEBRUARY 28, 2017
A group of lawmakers is introducing yet another bill that would allow Americans to import prescription medicines from Canada. And in a bid to quell long-standing criticism of the notion, the latest effort includes several provisions designed to address concerns that medicines bought from online pharmacies in other countries may not be safe.
Known as the Affordable and Safe Prescription Drug Importation Act, the bill would instruct the US Secretary of Health and Human Services to issue regulations allowing wholesalers, licensed US pharmacies, and individuals to import prescription drugs from licensed Canadian sellers. And the drugs would have to be made at facilities inspected by the US Food and Drug Administration.
After two years, however, the HHS secretary would have authority to permit importation from countries in the Organization for Economic Cooperation and Development that “meet specified statutory or regulatory standards that are comparable to US standards,” according to the bill. Nearly three dozen countries are members of the OECD.
“In 2014, the US spent about 40 percent more on prescriptions per person than Canada, twice as much as the average major industrialized country,” according to talking points that were distributed with the bill. “… In order to get the medicine they need, millions of people are buying their prescription drugs from other countries.”
The legislation — which is being spearheaded by Senator Bernie Sanders (I-Vt.) and Representative Elijah Cummings (D-Md.), who have conducted various probes into drug pricing — comes amid escalating national angst over the cost of prescription medicines. Poll after poll finds Americans want the federal government to take action, although there has been little movement on the national level.
As many as 77 percent of Americans reported last fall that drug costs are unreasonable, up from 72 percent a year earlier, according to a poll by the Kaiser Family Foundation. At the time, 71 percent favored allowing Americans to buy prescription drugs imported from Canada, among other measures they would like the federal government to pursue to lower their bills.
Although President Trump recently complained about “astronomical” prices,” he has not released any plan. But his remarks have placed drug makers on the defensive. A few pledged to limit annual price hikes to single-digit increases, while others have released data to argue their price increases have been reduced by rebates to middlemen that act on behalf of insurers.
Meanwhile, a bill introduced in the House is gaining support because it would presumably address some price gouging by providing incentives to drug makers to develop generics when there is a lack of competition or a shortage exists. A somewhat similar piece of legislation was recently introduced in the Senate, but it would also temporarily permit prescriptions drugs to be imported in order to mitigate shortages.
Importation is hardly a new idea. In fact, this is only the latest attempt by various lawmakers to find a way for Americans to import medicines from Canada. But given that President Trump has previously voiced support for the idea — and also accused drug makers of “getting away with murder” — they apparently see an opening to renew the call.
Whether the effort can succeed, however, is unclear. Under a 2003 law, the FDA can issue waivers for individuals to import medicines for personal use. But importation is not otherwise permitted until the HHS secretary certifies that importation would not pose a health risk and could lower consumer costs. And ensuring safety of imported drugs has been cited by both drug makers and regulators as a concern. Nearly all Republicans have also dismissed the idea and this latest bill is being pushed by a mix of Democrats and Independents.
“I’ve seen this bill in various iterations many different times and they never really address two major concerns — safety and pricing,” said Peter Pitts, a former FDA associate commissioner who heads the Center for Medicine in the Public Interest, a think tank that is funded, in part, by the pharmaceutical industry.
“We exist in a closed regulatory system and when you bring in drugs from outside FDA control, I don’t care how you phrase it, it’s still caveat emptor. The products can’t be guaranteed, because there are holes [in the legislation], such as not being able to guarantee that product labeling is correct,” he told us.
And no drug from Canada is going to cost less than a co-pay, which is $20 or $30 for many people, so it’s highly unlikely that it will do anything for the majority of Americans with health insurance. So it offers a largely useless alternative. I think this is a good political talking point, but won’t deliver what it promises. Importation is a vampire issue — you can drive a stake through its heart, but it won’t die.”
To assuage safety concerns, the bill states that legally imported drugs must be purchased from an FDA-certified foreign seller and have the same active ingredient, route of administration, and strength as drugs approved in the US. And certain types of drugs, such as certain biologics, could be imported only by wholesalers or pharmacies.
In order to be a so-called certified foreign seller, the bill states that the operation must be a wholesale distributor or licensed foreign pharmacy that is current with applicable registration fees and sells only qualifying prescription drugs. There is a list of criteria to be met, which you can read here.
Americans can buy medicines only from pharmacies licensed in Canada, and only for personal use in quantities that do not exceed a 90-day supply. They must also have a valid prescription issued by a health care practitioner licensed to practice in the US. Any pharmacy selling a counterfeit drug is subject to a $250,000 penalty and 10 years imprisonment. And the HHS is required to ask the US Government Accountability Office to run a report after 18 months to assess the impact.
But the Pew Charitable Trusts raised concerns and argued that it may be difficult to enforce the requirement that medicines must be purchased from an FDA-certified foreign seller and there is no mechanism to make it possible for medicines to have the same electronic security and tracking system, which is used in the US to weed out counterfeits.
“This poses a safety risk with respect to imported product, but also undermines the entire system,” wrote Allan Coukell, who is senior director of the Pew health programs, in a letter to Sanders. And while he acknowledged that competition from imports could prompt drug makers to lower prices in the US, he also speculated that foreign governments might eventually limit imports to the US if domestic supplies become strained.
One backer of importation called it a “step in the right direction.” Gabriel Levitt, who is the president of PharmacyChecker.com, which vets online pharmacies, wrote us that “if passed, the new bill … simply instructs the FDA to finally help Americans do what they already do, purchase lower cost medication from safe, international online pharmacies.”
We should note that one of the lawmakers who is co-sponsoring the bill is Sen. Cory Booker (D-NJ), who last month was one of 13 Democratic Senators who voted against an amendment to a budget procedure that would have allowed imports from Canada. His vote angered progressive Democrats. New Jersey is home to a few large drug makers and numerous smaller ones. The amendment was introduced by Sanders and Sen. Amy Klobuchar (D-Minn).